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1. A novel kidney disease index reflecting both the albumin-to-creatinine ratio and estimated glomerular filtration rate, predicted cardiovascular and kidney outcomes in type 2 diabetes

Author

Hertzel C. Gerstein, Chinthanie Ramasundarahettige, Alvero Avezum, Jan Basile, Ignacio Conget, William C. Cushman, Gilles R. Dagenais, Edward Franek, Mark Lakshmanan, Fernando Lanas, Lawrence A. Leiter, Nana Pogosova, Jeffrey Probstfield, Peter J. Raubenheimer, Matthew Riddle, Jonathan Shaw, Wayne H.-H. Sheu, Theodora Temelkova-Kurktschiev, Ibrahim Turfanda, and Denis Xavier

Subjects
Risk Factor, Kidney, Albuminuria, Cardiovascular Outcomes, Kidney Outcomes, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Background The estimated glomerular filtration rate (eGFR) and the albumin-to-creatinine ratio (ACR) are risk factors for diabetes-related outcomes. A composite that captures information from both may provide a simpler way of assessing risk. Methods 9115 of 9901 Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) participants with both an ACR and eGFR at baseline were included in this post hoc epidemiologic analysis. The hazard of higher baseline levels of 1/eGFR and natural log transformed ACR (calculated as ln [ACR × 100] to eliminate negative values) and their interaction for incident major adverse cardiovascular events (MACE), kidney outcomes, and deaths was estimated. The hazard of the geometric mean of these two baseline measures (the kidney disease index or KDI) was also assessed. Results A non-linear relationship was observed between 1/eGFR and all three outcomes, and between ln [ACR × 100] and the kidney outcome. There was also a negative interaction between these two risk factors with respect to MACE and death. Conversely, a linear relationship was noted between the KDI and all three outcomes. People in the highest KDI fifth experienced the highest incidence of MACE, death, and the kidney outcome (4.43, 4.56, and 5.55/100 person-years respectively). C statistics for the KDI were similar to those for eGFR and albuminuria. Conclusions The KDI combines the baseline eGFR and ACR into a novel composite risk factor that has a simple linear relationship with incident serious outcomes in people with diabetes and additional CV risk factors. Trial Registration clinicaltrials.gov NCT01394952.

Published
2022
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2. Association of Lipids, Lipoproteins, and Apolipoproteins with Stroke Subtypes in an International Case Control Study (INTERSTROKE)

Author

Martin J. O’Donnell, Matthew McQueen, Allan Sniderman, Guillaume Pare, Xingyu Wang, Graeme J. Hankey, Sumathy Rangarajan, Siu Lim Chin, Purnima Rao-Melacini, John Ferguson, Denis Xavier, Liu Lisheng, Hongye Zhang, Prem Pais, Patricio Lopez-Jaramillo, Albertino Damasceno, Peter Langhorne, Annika Rosengren, Antonio L. Dans, Ahmed Elsayed, Alvaro Avezum, Charles Mondo, Conor Judge, Hans-Christoph Diener, Danuta Ryglewicz, Anna Czlonkowska, Nana Pogosova, Christian Weimar, Romana Iqbal, Rafael Diaz, Khalid Yusoff, Afzalhussein Yusufali, Aytekin Oguz, Ernesto Penaherrera, Fernando Lanas, Okechukwu S. Ogah, Adesola Ogunniyi, Helle K. Iversen, German Malaga, Zvonko Rumboldt, Shahram Oveisgharan, Fawaz Al Hussain, Yongchai Nilanont, and Salim Yusuf

Subjects
stroke, risk factor, dyslipidemia, lipoproteins, apolipoproteins, case-control, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background and Purpose The association of dyslipidemia with stroke has been inconsistent, which may be due to differing associations within etiological stroke subtypes. We sought to determine the association of lipoproteins and apolipoproteins within stroke subtypes. Methods Standardized incident case-control STROKE study in 32 countries. Cases were patients with acute hospitalized first stroke, and matched by age, sex and site to controls. Concentrations of total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein A1 (apoA1), and apoB were measured. Non-HDL-C was calculated. We estimated multivariable odds ratio (OR) and population attributable risk percentage (PAR%). Outcome measures were all stroke, ischemic stroke (and subtypes), and intracerebral hemorrhage (ICH). Results Our analysis included 11,898 matched case-control pairs; 77.3% with ischemic stroke and 22.7% with ICH. Increasing apoB (OR, 1.10; 95% confidence interval [CI], 1.06 to 1.14 per standard deviation [SD]) and LDL-C (OR, 1.06; 95% CI, 1.02 to 1.10 per SD) were associated with an increase in risk of ischemic stroke, but a reduced risk of ICH. Increased apoB was significantly associated with large vessel stroke (PAR 13.4%; 95% CI, 5.6 to 28.4) and stroke of undetermined cause. Higher HDL-C (OR, 0.75; 95% CI, 0.72 to 0.78 per SD) and apoA1 (OR, 0.63; 95% CI, 0.61 to 0.66 per SD) were associated with ischemic stroke (and subtypes). While increasing HDL-C was associated with an increased risk of ICH (OR, 1.20; 95% CI, 1.14 to 1.27 per SD), apoA1 was associated with a reduced risk (OR, 0.80; 95% CI, 0.75 to 0.85 per SD). ApoB/A1 (OR, 1.38; 95% CI, 1.32 to 1.44 per SD) had a stronger magnitude of association than the ratio of LDL-C/HDL-C (OR, 1.26; 95% CI, 1.21 to 1.31 per SD) with ischemic stroke (P

Published
2022
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3. Factors Associated with Anxiety and Depressive Symptoms in 2775 Patients with Arterial Hypertension and Coronary Heart Disease: Results from the COMETA Multicenter Study

Author

Nana Pogosova, Sergey Boytsov, Dirk De Bacquer, Olga Sokolova, Aza Ausheva, Alexander Kursakov, and Hugo Saner

Subjects
anxiety symptoms, depressive symptoms, arterial hypertension, coronary heart disease, lifestyle risk factors, stress, psychosocial risk factors, Diseases of the circulatory (Cardiovascular) system, RC666-701, Public aspects of medicine, RA1-1270
Abstract

Aim: To identify associations of anxiety symptoms (AS) and depressive symptoms (DS) with other psychosocial and lifestyle risk factors in primary care patients with arterial hypertension (AH) and/or coronary heart disease (CHD). Methods: COMETA (Clinical-epidemiOlogical prograM of studying psychosocial risk factors in cardiological practice in patiEnts with arterial hyperTension and ischemic heArt disease) is a multicenter cross-sectional study performed in 30 big cities of Russia with two to five out-patient clinics per city randomly selected and two to five general practitioners (GPs) per an out-patient clinic. Each GP included 8–10 consecutive patients with AH and/or CHD. AS and DS were assessed by the Hospital Anxiety and Depression Scale. Results: 325 GPs enrolled 2775 patients (mean age 66.7 years, 72% women) with AH (60.8%), CHD (2.6%), and AH plus CHD (36.6%). Moderate/severe (≥11 HADS) AS were found in 25.5% and DS in 16.3% patients. The strongest associations of AS and DS were revealed for high stress level (OR 5.79; 95% CI [4.18–8.03]), moderate stress level (OR 2.34; 95% CI [1.73–3.16]), low social support (OR 1.87; 95% CI [1.31–2.68]) and female gender (OR 1.78; 95% CI [1.41–2.25]). Low physical activity, unhealthy eating, unemployment and low income were also positively associated with both AS and DS (p < 0.003 for all). Conclusion: In out-patients with AH and CHD, AS and DS were strongly associated with higher levels of stress, low social support, unemployment, low family income and unhealthy lifestyle such as low physical activity, low fruit and vegetables intake and excessive salt consumption. Our findings indicate that patients with AH and CHD, who have anxiety and depressive symptoms need extra attention and monitoring in regard to stress and lifestyle risk factor control.

Published
2021
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4. Telemedicine Intervention to Improve Long-Term Risk Factor Control and Body Composition in Persons with High Cardiovascular Risk: Results from a Randomized Trial

Author

Nana Pogosova, Yulia Yufereva, Olga Sokolova, Anara Yusubova, Alexander Suvorov, and Hugo Saner

Subjects
risk factors, high cardiovascular risk, physical inactivity, unhealthy nutrition, smoking, obesity, anxiety, depression, preventive counseling, telemedicine technology, Diseases of the circulatory (Cardiovascular) system, RC666-701, Public aspects of medicine, RA1-1270
Abstract

Telehealth strategies may offer an advantage over standard institutional based interventions for improvement of cardiovascular risk in high-risk patients long-term Background: Telehealth strategies are increasingly used to support people at high cardiovascular risk long-term, but is it unclear if these interventions are effective at improving cardiovascular risk. Objective: To evaluate the effects of a telemedicine technology-based program on risk factor control and body composition in patients at high cardiovascular risk. Methods: This is a population based randomized controlled trial. 100 patients at high and very high cardiovascular risk were randomly assigned to a telemedicine technology-based program consisting of: Comprehensive counseling on risk factors delivered by a physician; biweekly remote support via phone delivered by a trained nurse during the first three months after enrollment; and a control group receiving routine care with individual single-session counseling on patients’ current risk factors without further support. The follow-up period was 1 year. Results: Mean age of participants was 59.9 ± 4.5 years, 80% were women. Weight (–0.582; p < 0.001), waist circumference (–0.429; p = 0.01), body mass index (–0.216; p < 0.001) diastolic blood pressure (–0.881; p = 0.04), total cholesterol (–0.149; p = 0.01) and LDL cholesterol (–0.123; p = 0.003) were lower in the intervention group compared to the control group after 12-month. Body fat mass was also lower (–0.352; p = 0.01) and lean mass was higher (0.92; p = 0.03) in the intervention group. Anxiety scores (–2.5; p < 0.002) and depression scores (–2.6; p < 0.001) were also lower in the intervention group. Conclusions: Among older people at high cardiovascular risk, the addition of telehealth strategies using remote support by phone calls over a period of 3 month resulted in small but significant improvements of cardiovascular risk factors, body composition, anxiety, and depression which are maintained long-term. Such telehealth strategies may offer an advantage over standard institution-based interventions.

Published
2021
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5. Alcohol Intake as a Risk Factor for Acute Stroke

Author

Andrew, Smyth, Martin, O'Donnell, Sumathy, Rangarajan, Graeme J, Hankey, Shahram, Oveisgharan, Michelle, Canavan, Clodagh, McDermott, Denis, Xavier, Hongye, Zhang, Albertino, Damasceno, Alvaro, Avezum, Nana, Pogosova, Aytekin, Oguz, Danuta, Ryglewicz, Helle Klingenberg, Iversen, Fernando, Lanas, Annika, Rosengren, Salim, Yusuf, and Peter, Langhorne

Subjects
Neurology (clinical)
Abstract

Background and ObjectivesThere is uncertainty about the association between alcohol consumption and stroke, particularly for low-moderate intake. We explored these associations in a large international study.MethodsINTERSTROKE, a case-control study, is the largest international study of risk factors for acute stroke. Alcohol consumption was self-reported and categorized by drinks/week as low (1–7), moderate (7–14 for females and 7–21 for males), or high (>14 for females and >21 for males). Heavy episodic drinking (HED) was defined as >5 drinks on ≥1 day per month. Multivariable conditional logistic regression was used to determine associations.ResultsWe included 12,913 cases and 12,935 controls; 25.0% (n = 6,449) were current drinkers, 16.7% (n = 4,318) former drinkers, and 58.3% (n = 15,076) never drinkers. Current drinkers were younger, male, smokers, active, and with higher-paid occupations. Current drinking was associated with all stroke (OR 1.14; 95% CI 1.04–1.26) and intracerebral hemorrhage (ICH) (OR 1.50, 95% CI 1.21–1.84) but not ischemic stroke (OR 1.06; 95% CI 0.95–1.19). HED pattern was associated with all stroke (OR 1.39; 95% CI 1.21–1.59), ischemic stroke (OR 1.29; 95% CI 1.10–1.51), and ICH (OR 1.76; 95% CI 1.31–2.36). High level of alcohol intake was consistently associated with all stroke, ischemic stroke, and ICH. Moderate intake was associated with all stroke and ICH but not ischemic stroke. Low alcohol intake was not associated with stroke overall, but there were regional differences; low intake was associated with reduced odds of stroke in Western Europe/North America (OR 0.66; 95% CI 0.45–0.96) and increased odds in India (OR 2.18; 95% CI 1.42–3.36) (p-interaction 0.037). Wine consumption was associated with reduced odds of all stroke and ischemic stroke but not ICH. The magnitudes of association were greatest in those without hypertension and current smokers.DiscussionHigh and moderate intake were associated with increased odds of stroke, whereas low intake was not associated with stroke. However, there were important regional variations, which may relate to differences in population characteristics of alcohol consumers, types or patterns of consumption.

Published
2022

6. Dulaglutide and cardiovascular and heart failure outcomes in patients with and without heart failure: a post‐hoc analysis from the REWIND randomized trial

Author

Kelley R.H. Branch, Gilles R. Dagenais, Alvaro Avezum, Jan Basile, Ignacio Conget, William C. Cushman, Petr Jansky, Mark Lakshmanan, Fernando Lanas, Lawrence A. Leiter, Prem Pais, Nana Pogosova, Peter J. Raubenheimer, Lars Ryden, Jonathan E. Shaw, Wayne H.H. Sheu, Theodora Temelkova‐Kurktschiev, M. Angelyn Bethel, Hertzel C. Gerstein, Ramasundarahettige Chinthanie, and Jeffrey L. Probstfield

Subjects
Cardiology and Cardiovascular Medicine
Published
2022

7. The importance of cardiorehabilitation in the era of modern treatment of cardio­vascular diseases

Author

Goar-Nana Pogosova

Subjects
Cardiac Rehabilitation, Cardiovascular Diseases, Cardiology, Humans, Vascular Diseases, Cardiology and Cardiovascular Medicine, Exercise Therapy
Abstract

Cardiac rehabilitation (CR) has a class IA indication in international and national guidelines as an intervention with proven efficacy for decreasing cardiovascular and all-cause mortality in various categories of cardiological patients. However, CR is one of the least used current technologies for the treatment of patients with cardiovascular diseases worldwide. This article presents the state of the CR problem during the epoch of high-tech treatments of cardiovascular diseases; the prevalence of using CR in various countries; traditional and new methodological approaches, including telemedicine; and clinical and prognostic effects of CR in various categories of patients with cardiovascular diseases.

Published
2022

8. Association of Psychosocial Stress With Risk of Acute Stroke

Author

Catriona, Reddin, Robert, Murphy, Graeme J, Hankey, Conor, Judge, Denis, Xavier, Annika, Rosengren, John, Ferguson, Alberto, Alvarez-Iglesias, Shahram, Oveisgharan, Helle K, Iversen, Fernando, Lanas, Fawaz, Al-Hussein, Anna, Czlonkowska, Aytekin, Oguz, Clodagh, McDermott, Nana, Pogosova, German, Málaga, Peter, Langhorne, Xingyu, Wang, Mohammad, Wasay, Salim, Yusuf, Martin, O'Donnell, and Alfzalhussein, Yusufali

Subjects
Risk, Psychosocial Stress, Acute Stroke, General Medicine
Abstract

ImportancePsychosocial stress is considered a modifiable risk factor for stroke. Given the prevalence of chronic and acute exposure to stress, it represents a potentially attractive target for population-health interventions.ObjectivesTo determine the association of psychosocial stress with the risk of acute stroke and explore factors that might modify the association of stress with risk of acute stroke in a large international population.Design, Setting, and ParticipantsINTERSTROKE is an international retrospective case-control study of risk factors for first acute stroke in 32 countries in Asia, North and South America, Europe, Australia, the Middle East, and Africa. A total of 13 462 patients with stroke and 13 488 matched controls were recruited between January 11, 2007, and August 8, 2015. The present analyses were performed from June 1 to 30, 2021, and included 13 350 cases and 13 462 controls with available data on psychosocial stress.ExposuresPsychosocial stress and occurrence of stressful life events within the preceding year were measured using a standardized questionnaire of self-reported stress at home and work.Main Outcomes and MeasuresThe association of stress with acute stroke and its subtypes was examined using multivariable conditional logistic regression and factors that might modify the association, particularly self-reported locus of control.ResultsAmong 26 812 participants included in the analysis, the mean (SD) age of cases was 62.2 (13.6) years; that of controls, 61.3 (13.3) years; 7960 cases (59.6%) and 8017 controls (59.6%) were men. Several periods of stress and permanent stress were reported for 2745 cases (20.5%) and 1933 controls (14.4%), with marked regional variation in prevalence, with the lowest in China (201 of 3981 [5.0%] among controls and 364 of 3980 [9.1%] among cases) and highest in South East Asia (233 of 855 [26.1%] among controls and 241 of 782 [30.8%] among cases). Increased stress at home (odds ratio [OR], 1.95 [95% CI, 1.77-2.15]) and at work (OR, 2.70 [95% CI, 2.25-3.23]) and recent stressful life events (OR, 1.31 [95% CI, 1.19-1.43]) were associated with an increased risk of acute stroke on multivariable analyses (vs no self-reported stress). Higher locus of control at home was associated with a reduced odds of all stroke (OR, 0.73 [95% CI, 0.68-0.79]), and higher locus of control both at work and at home were associated with a lower odds of acute stroke and significantly diminished the association with stress at work (OR, 2.20 [95% CI, 1.88-2.58]; P = .008 for interaction) and home (OR, 1.69 [95% CI, 1.44-1.98]; P < .001 for interaction) for acute stroke.Conclusions and RelevancePsychosocial stress is a common risk factor for acute stroke. The findings of this case-control study suggest that higher locus of control is associated with lower risk of stroke and may be an important effect modifier of the risk associated with psychosocial stress.

Published
2022

9. Potential for optimizing management of obesity in the secondary prevention of coronary heart disease

Author

David R. Wood, D. Lovic, Kornelia Kotseva, Guy De Backer, Erkin M. Mirrakhimov, Jan Bruthans, Hasan Hasan-Ali, Piotr Jankowski, Zlatko Fras, Nana Pogosova, Catriona Jennings, Dirk De Bacquer, Lars Rydén, Delphine De Smedt, Maria Dolzhenko, Nina Gotcheva, and Seppo Lehto

Subjects
Pediatrics, medicine.medical_specialty, medicine.medical_treatment, Coronary Disease, 030204 cardiovascular system & hematology, Overweight, Management of obesity, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Weight loss, Weight Loss, Secondary Prevention, medicine, Humans, Obesity, 030212 general & internal medicine, Risk factor, business.industry, Health Policy, medicine.disease, Quality of Life, Smoking cessation, Female, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Weight gain
Abstract

Aims Prevention guidelines have identified the management of obese patients as an important priority to reduce the burden of incident and recurrent cardiovascular disease. Still, studies have demonstrated that over 80% of patients with coronary heart disease (CHD) fail to achieve their weight target. Here, we describe advice received and actions reported by overweight CHD patients since being discharged from hospital and how weight changes relate to their risk profile. Methods and results Based on data from 10 507 CHD patients participating in the EUROASPIRE IV and V studies, we analysed weight changes from hospital admission to the time of a study visit ≥6 and Conclusions The management of obesity remains a challenge in the secondary prevention of CHD despite a beneficial effect of weight loss on risk factor prevalences and quality of life. Cardiac rehabilitation programmes should include weight loss interventions as a specific component and the incremental value of telehealth intervention as well as recently described pharmacological interventions need full consideration.

Published
2021

10. Poor adherence to lifestyle recommendations in patients with coronary heart disease: results from the EUROASPIRE surveys

Author

Guy De Backer, David R. Wood, Euroaspire, Kornelia Kotseva, Delphine De Smedt, Lars Rydén, Felicity Astin, Catriona Jennings, Nana Pogosova, and Dirk De Bacquer

Subjects
medicine.medical_specialty, Epidemiology, medicine.medical_treatment, Coronary Disease, 030204 cardiovascular system & hematology, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Risk Factors, Weight loss, Surveys and Questionnaires, medicine, Humans, In patient, 030212 general & internal medicine, Risk factor, Life Style, Rehabilitation, business.industry, medicine.disease, Obesity, Coronary heart disease, Family medicine, medicine.symptom, Cardiology and Cardiovascular Medicine, business
Abstract

Aims Despite the high use of cardioprotective medications, the risk factor control in patients with coronary heart disease (CHD) is still inadequate. Guidelines identify healthy lifestyles as equally important in secondary prevention as pharmacotherapy. Here, we describe reasons for poor lifestyle adherence from the patient’s perspective. Methods and results In the EUROASPIRE IV and V surveys, 16 259 CHD patients were examined and interviewed during a study visit ≥6 months after hospital discharge. Data gathering was fully standardized. The Brief Illness Perception questionnaire was completed by a subsample of 2379 patients. Half of those who were smoking prior to hospital admission, were still smoking; 37% of current smokers had not attempted to quit and 51% was not considering to do so. The prevalence of obesity was 38%. Half of obese patients tried to lose weight in the past month and 61% considered weight loss in the following month. In relation to physical activity, 40% was on target with half of patients trying to do more everyday activities. Less than half had the intention to engage in planned exercise. Only 29% of all patients was at goal for all three lifestyle factors. The number of adverse lifestyles was strongly related to the way patients perceive their illness as threatening. Lifestyle modifications were more successful in those having participated in a cardiac rehabilitation and prevention programme. Patients indicated lack of self-confidence as the main barrier to change their unhealthy behaviour. Conclusion Modern secondary prevention programmes should target behavioural change in all patients with adverse lifestyles.

Published
2021

11. Rivaroxaban 2.5 mg Twice Daily Plus Aspirin Reduces Venous Thromboembolism in Patients With Chronic Atherosclerosis

Author

Nana Pogosova, Jacqueline Bosch, Deepak L. Bhatt, Keith A.A. Fox, Stuart J. Connolly, Marco Alings, Peter Verhamme, Eva Muehlhofer, Olga Shestakovska, Salim Yusuf, and John W. Eikelboom

Subjects
Peripheral Arterial Disease, Aspirin, Rivaroxaban, Physiology (medical), Humans, Drug Therapy, Combination, Venous Thromboembolism, Cardiology and Cardiovascular Medicine, Atherosclerosis, Platelet Aggregation Inhibitors, Factor Xa Inhibitors
Published
2022

12. HIV-RELATED ATHEROSCLEROSIS: STATE-OF-THE-ART-REVIEW

Author

Ashot Avagimyan, Nana Pogosova, Lev Kakturskiy, Mohammad Sheibani, Olga Urazova, Artem Trofimenko, Grizelda Navasardyan, Zinaida Jndoyan, Kristina Abgaryan, Federica Fogacci, Mattia Galli, Luciano Agati, Zhanna Kobalava, Davood Shafie, Mario Marzilli, Liana Gogiashvili, and Nizal Sarrafzadegan

Subjects
General Medicine, Cardiology and Cardiovascular Medicine
Published
2023

13. Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial

Author

John W. Eikelboom, Tomasz J. Guzik, Chinthanie Ramasundarahettige, Eva Muehlhofer, Patricio Lopez-Jaramillo, Salim Yusuf, Leanne Dyal, Scott D. Berkowitz, Keith A.A. Fox, Deepak L. Bhatt, Nana Pogosova, and Masira

Subjects
medicine.medical_specialty, Aspirin, Rivaroxaban, Vascular disease, business.industry, 030204 cardiovascular system & hematology, Overweight, medicine.disease, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antithrombotic, medicine, 030212 general & internal medicine, Myocardial infarction, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Stroke, medicine.drug
Abstract

Digital, Background Direct oral anticoagulants are administered in fixed doses irrespective of body weight, but guidelines recommend against their use in patients with extremes of body weight. Objectives This study determined the effects of dual-pathway inhibition antithrombotic regimen (rivaroxaban 2.5 mg twice daily plus aspirin 100 mg/day) compared with aspirin Halone across a range of patient body mass indexes (BMIs) and body weights. Methods This was a secondary analysis of the COMPASS (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) trial, which included patients with chronic coronary artery disease or peripheral artery disease. Efficacy and safety outcomes were studied in relation to BMI: (normal 18.5 ≤BMI 90 kg; as well as ≤120 kg vs. >120 kg). Results Among 27,395 randomized patients, 6,459 (24%) had normal BMI, 12,047 (44%) were overweight, and 8,701 (32%) were obese. The combination of rivaroxaban and aspirin compared with aspirin produced a consistent reduction in the primary outcome of cardiovascular death, stroke, or myocardial infarction, irrespective of BMI or body weight. For 18.5 ≤BMI 90 kg: 4.2% vs. 5.7%; HR: 0.74 (95% CrI: 0.61 to 0.90). Effects on bleeding, mortality, and net clinical benefit were consistent irrespective of BMI or bodyweight. Conclusions The effects of dual-pathway antithrombotic therapy are consistent irrespective of BMI or body weight, suggesting no need for dose adjustments in the ranges of weights and BMI of patients enrolled in the COMPASS trial. Further studies need to address this problem in relation to greater extremes of body weight. (Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease [COMPASS]; NCT01776424), Ciencias Médicas y de la Salud

Published
2021

14. Factors associated with health-related quality of life in heart failure in 23 000 patients from 40 countries: results of the G-CHF research programme

Author

Isabelle, Johansson, Kumar, Balasubramanian, Shrikant, Bangdiwala, Lisa, Mielniczuk, Camilla, Hage, Sanjib Kumar, Sharma, Kelley, Branch, Jun, Zhu, Kristian, Kragholm, Karen, Sliwa, Francois, Alla, Gerald, Yonga, Ambuj, Roy, Andres, Orlandini, Alex, Grinvalds, Tara, McCready, Nana, Pogosova, Stefan, Störk, John J V, McMurray, David, Conen, Salim, Yusuf, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Bayer

Subjects
Quality of life, Heart Failure, Male, Health Status, Global, Heart failure, Comorbidity, Middle Aged, Health status, Cross-Sectional Studies, Surveys and Questionnaires, Quality of Life, Correlates, Humans, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, Cardiology and Cardiovascular Medicine
Abstract

Aims: To examine clinical and social correlates of health-related quality of life (HRQL) in patients with heart failure (HF) from high- (HIC), upper middle- (UMIC), lower middle- (LMIC) and low-income (LIC) countries. Methods and results: Between 2017 and 2020, 23 292 patients with HF (32% inpatients, 61% men) from 40 countries were enrolled in the Global Congestive Heart Failure study. HRQL was recorded at baseline using the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12. In a cross-sectional analysis, we compared age- and sex-adjusted mean KCCQ-12 summary scores (SS: 0–100, higher = better) between patients from different country income levels. We used multivariable linear regression examining correlations (estimated coefficients) of KCCQ-12-SS with sociodemographic, comorbidity, treatment and symptom covariates. The adjusted model (37 covariates) was informed by univariable findings, clinical importance and backward selection. Mean age was 63 years and 40% of patients were in New York Heart Association (NYHA) class III–IV. Average HRQL was 55 SD 27. It was 62.5 (95% confidence interval [CI] 62.0–63.1) in HIC, 56.8 (56.1–57.4) in UMIC, 48.6 (48.0–49.3) in LMIC, and 38.5 (37.3–39.7) in LICs (p < 0.0001). Strong correlates (estimated coefficient [95% CI]) of KCCQ-12-SS were NYHA class III versus class I/II (−12.1 [−12.8 to −11.4] and class IV versus class I/II (−16.5 [−17.7 to −15.3]), effort dyspnoea (−9.5 [−10.2 to −8.8]) and living in LIC versus HIC (−5.8 [−7.1 to −4.4]). Symptoms explained most of the KCCQ-12-SS variability (partial R 2 = 0.32 of total adjusted R 2 = 0.51), followed by sociodemographic factors (R 2 = 0.12). Results were consistent in populations across income levels. Conclusion: The most important correlates of HRQL in HF patients relate to HF symptom severity, irrespective of country income level.

Published
2022

15. Similar cardiovascular outcomes in patients with diabetes and established or high risk for coronary vascular disease treated with dulaglutide with and without baseline metformin

Author

Wayne Huey-Herng Sheu, Hertzel C. Gerstein, Alvaro Avezum, Peter J Raubenheimer, Giulia Ferrannini, William C. Cushman, Jonathan E. Shaw, Nana Pogosova, Jeffrey L. Probstfield, Matyas Keltai, Mark Lakshmanan, Helen M. Colhoun, Linda Mellbin, Leanne Dyal, Petr Jansky, Rafael Diaz, Lawrence A. Leiter, Lars Rydén, Fernando Lanas, Jan Basile, Matthew C. Riddle, Valdis Pīrāgs, Gilles R. Dagenais, Patricio Lopez-Jaramillo, Prem Pais, and Masira

Subjects
medicine.medical_specialty, Proportional hazards model, business.industry, Hazard ratio, Type 2 diabetes, 030204 cardiovascular system & hematology, Cardiovascular disease, medicine.disease, Placebo, Metformin, 03 medical and health sciences, 0302 clinical medicine, Diabetes mellitus, Internal medicine, GLP-1-based therapy, medicine, Dulaglutide, 030212 general & internal medicine, Prediabetes, Mortality, Morbidity, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract

Digital, Objective Recent European Guidelines for Diabetes, Prediabetes and Cardiovascular Diseases introduced a shift in managing patients with type 2 diabetes at high risk for or established cardiovascular (CV) disease by recommending GLP-1 receptor agonists and SGLT-2 inhibitors as initial glucose-lowering therapy. This is questioned since outcome trials of these drug classes had metformin as background therapy. In this post hoc analysis, the effect of dulaglutide on CV events was investigated according to the baseline metformin therapy by means of a subgroup analysis of the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial. Research design and methods Patients in REWIND (n = 9901; women: 46.3%; mean age: 66.2 years) had type 2 diabetes and either a previous CV event (31%) or high CV risk (69%). They were randomized (1:1) to sc. dulaglutide (1.5 mg/weekly) or placebo in addition to standard of care. The primary outcome was the first of a composite of nonfatal myocardial infarction, nonfatal stroke, and death from cardiovascular or unknown causes. Key secondary outcomes included a microvascular composite endpoint, all-cause death, and heart failure. The effect of dulaglutide in patients with and without baseline metformin was evaluated by a Cox regression hazard model with baseline metformin, dulaglutide assignment, and their interaction as independent variables. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by a Cox regression model with adjustments for factors differing at baseline between people with vs. without metformin, identified using the backward selection. Results Compared to patients with metformin at baseline (n = 8037; 81%), those without metformin (n = 1864; 19%) were older and slightly less obese and had higher proportions of women, prior CV events, heart failure, and renal disease. The primary outcome occurred in 976 (12%) participants with baseline metformin and in 281 (15%) without. There was no significant difference in the effect of dulaglutide on the primary outcome in patients with vs. without metformin at baseline [HR 0.92 (CI 0.81–1.05) vs. 0.78 (CI 0.61–0.99); interaction P = 0.18]. Findings for key secondary outcomes were similar in patients with and without baseline metformin. Conclusion This analysis suggests that the cardioprotective effect of dulaglutide is unaffected by the baseline use of metformin therapy., Ciencias Médicas y de la Salud

Published
2020

16. Alcohol consumption patterns across Europe and adherence to the European guidelines in coronary patients: Findings from the ESC-EORP EUROASPIRE V survey

Author

Ilse C. Schrieks, Kairat Davletov, Erkin M. Mirrakhimov, Maryna Dolzhenko, Diederick E. Grobbee, Sabine van Oort, Kornelia Kotseva, Adriana J. van Ballegooijen, Joline W. J. Beulens, Inge A. T. van de Luitgaarden, Nana Pogosova, Dirk De Bacquer, Epidemiology and Data Science, ACS - Diabetes & metabolism, ACS - Heart failure & arrhythmias, and APH - Health Behaviors & Chronic Diseases

Subjects
Male, COUNTRIES, 0301 basic medicine, medicine.medical_specialty, Alcohol Drinking, Heart disease, Epidemiology, Coronary Disease, HEART-DISEASE, Guidelines, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Surveys and Questionnaires, Environmental health, Medicine and Health Sciences, Humans, Medicine, Alcohol consumption, In patient, EUROASPIRE, CESSATION ADVICE, ATTITUDES, Myocardial infarction, Risk factor, Cardiovascular risk factors, Aged, RISK, Consumption (economics), business.industry, MORTALITY, Middle Aged, medicine.disease, Excessive alcohol consumption, Europe, 030104 developmental biology, MYOCARDIAL-INFARCTION, Adherence, Female, LIFE-STYLE, DRUG THERAPIES, SMOKING, Cardiology and Cardiovascular Medicine, business
Abstract

Background and aims Alcohol consumption is an important risk factor for cardiovascular morbidity and mortality worldwide. The highest levels of alcohol consumption are observed in Europe, where alcohol as contributing cause of coronary heart disease (CHD) is also most significant. We aimed to describe alcohol consumption patterns across European regions and adherence to the current guidelines in patients with a recent CHD event. Methods The ESC-EORP survey (EUROASPIRE V) has been conducted in 2016–2017 at 131 centers in 27 European countries in 7350 patients with a recent CHD. Median alcohol consumption, as well as the proportion of abstainers and excessive drinkers (i.e. >70 g/week for women and >140 for men, as recommended by the European guidelines on cardiovascular prevention), was calculated for each region. To assess adherence to guidelines, proportions of participants who were advised to reduce excessive alcohol consumption and participants who were incorrectly not advised were calculated per region. Results Mean age was 64 years (SD: 9.5), 75% were male. Abstention rates were 53% in males and 77% in females, whereas excessive drinking was reported by 9% and 5% of them, respectively. Overall, 57% of the participants were advised to reduce alcohol consumption. In the total population, 3% were incorrectly not advised, however, this percentage differed per region (range: 1%–9%). In regions where alcohol consumption was highest, participants were less often advised to reduce their consumption. Conclusion In this EUROASPIRE V survey, the majority of CHD patients adhere to the current drinking guidelines, but substantial heterogeneity exists between European regions.

Published
2020

17. Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline

Author

Dragos Vinereanu, Georg Ertl, Stefan Störk, Deepak L. Bhatt, Nana Pogosova, John Varigos, Aldo P. Maggioni, Yan Liang, Andrew Tonkin, Stuart J. Connolly, Lars Rydén, Amparo Casanova, Jacqueline Bosch, Alvaro Avezum, Kelley R. Branch, Leanne Dyal, Rafael Diaz, Kevin W Reeh, Robert G. Hart, Keith A.A. Fox, Katalin Keltai, Patricio Lopez-Jaramillo, Mukul Sharma, Martin O'Donnell, Matyas Keltai, Eva Lonn, Lisheng Liu, Jun Zhu, Jeffrey L. Probstfield, Gilles R. Dagenais, Leopoldo S. Piegas, Scott D. Berkowitz, Salim Yusuf, Eric E. Smith, John W. Eikelboom, and Jae-Hyung Kim

Subjects
Brain Infarction, Male, medicine.medical_specialty, Infarction, White matter, Physical medicine and rehabilitation, Rivaroxaban, medicine, Humans, Cognitive Dysfunction, Cognitive decline, Stroke, Aged, Advanced and Specialized Nursing, Aspirin, business.industry, Brain, Cognition, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Treatment Outcome, medicine.anatomical_structure, Covert, Drug Therapy, Combination, Female, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, Platelet Aggregation Inhibitors, Factor Xa Inhibitors, medicine.drug
Abstract

Background and Purpose: Covert brain infarcts are associated with cognitive decline. It is not known whether therapies that prevent symptomatic stroke prevent covert infarcts. COMPASS compared rivaroxaban with and without aspirin with aspirin for the prevention of stroke, myocardial infarction, and vascular death in participants with stable vascular disease and was terminated early because of benefits of rivaroxaban 2.5 mg twice daily plus aspirin over aspirin. We obtained serial magnetic resonance imagings and cognitive tests in a consenting subgroup of COMPASS patients to examine treatment effects on infarcts, cerebral microbleeds, and white matter hyperintensities. Methods: Baseline and follow-up magnetic resonance imagings were completed in 1445 participants with a mean (SD) interval of 2.0 (0.7) years. Whole-brain T1, T2 fluid-attenuated inversion recovery, T2* sequences were centrally interpreted by blinded, trained readers. Participants had serial measurements of cognition and function. The primary end point was the proportion of participants with incident covert infarcts. Secondary end points were the composite of clinical stroke and covert brain infarcts, cerebral microbleeds, and white matter hyperintensities. Results: At baseline, 493 (34.1%) participants had infarcts. Incident covert infarcts occurred in 55 (3.8%) participants. In the overall trial rivaroxaban plus aspirin reduced ischemic stroke by 49% (0.7% versus 1.4%; hazard ratio [95% CI], 0.51 [0.38–0.68]). In the magnetic resonance imaging substudy the effects of rivaroxaban+aspirin versus aspirin were: covert infarcts: 2.7% versus 3.5% (odds ratio [95% CI], 0.77 [0.37–1.60]); Covert infarcts or ischemic stroke: 2.9% versus 5.3% (odds ratio [95% CI], 0.53 [0.27–1.03]). Incident microbleeds occurred in 6.6% of participants and 65.7% of participants had an increase in white matter hyperintensities volume with no effect of treatment for either end point. There was no effect on cognitive tests. Conclusions: Covert infarcts were not significantly reduced by treatment with rivaroxaban and aspirin but estimates for the combination of ischemic stroke and covert infarcts were consistent with the effect on ischemic stroke in the overall trial. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01776424.

Published
2020

18. The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial

Author

Matthew C. Riddle, Theodora Temelkova-Kurktschiev, Markolf Hanefeld, Wayne H-H Sheu, Ernesto Germán Cardona Muñoz, Hertzel C. Gerstein, Alvaro Avezum, William C. Cushman, Robert G. Hart, Rafael Diaz, Jan Basile, Nicolae Hancu, Helen M. Colhoun, Fady T. Botros, Fernando Lanas, Lars Rydén, Stephanie Hall, Patricio Lopez-Jaramillo, Lawrence A. Leiter, Petr Jansky, Jonathan E. Shaw, Matyas Keltai, Ignacio Conget, Mark Lakshmanan, Charles Atisso, Jeffrey L. Probstfield, Nana Pogosova, Peter J Raubenheimer, and Leanne Dyal

Subjects
Male, medicine.medical_specialty, Recombinant Fusion Proteins, Endocrinology, Diabetes and Metabolism, Glucagon-Like Peptides, 030209 endocrinology & metabolism, Type 2 diabetes, Placebo, Incretins, Glucagon-Like Peptide-1 Receptor, law.invention, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Double-Blind Method, Randomized controlled trial, Modified Rankin Scale, law, Internal medicine, Internal Medicine, Clinical endpoint, Humans, Hypoglycemic Agents, Medicine, Prospective Studies, 030212 general & internal medicine, Stroke, Glycated Hemoglobin, business.industry, Hazard ratio, Middle Aged, medicine.disease, Immunoglobulin Fc Fragments, Treatment Outcome, Diabetes Mellitus, Type 2, Female, Dulaglutide, business, Diabetic Angiopathies, medicine.drug
Abstract

Summary Background Cardiovascular outcome trials have suggested that glucagon-like peptide 1 (GLP-1) receptor agonists might reduce strokes. We analysed the effect of dulaglutide on stroke within the researching cardiovascular events with a weekly incretin in diabetes (REWIND) trial. Methods REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries. Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA1c was 9·5% or less (with no lower limit) on stable doses of up to two oral glucose-lowering drugs with or without basal insulin therapy were eligible if their body-mass index was at least 23 kg/m2. Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide). Randomisation was done by a computer-generated random code with an interactive web response system with stratification by site. Participants, investigators, the trial leadership, and all other personnel were masked to treatment allocation until the trial was completed and the database was locked. During the treatment period, participants in both groups were instructed to inject study drug on the same day at around the same time, each week. Strokes were categorised as fatal or non-fatal, and as either ischaemic, haemorrhagic, or undetermined. Stroke severity was assessed using the modified Rankin scale. Participants were seen at 2 weeks, 3 months, 6 months, and then every 3 months for drug dispensing and every 6 months for detailed assessments, until 1200 confirmed primary outcomes accrued. The primary endpoint was the first occurrence of any component of the composite outcome, which comprised non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular or unknown causes. All analyses were done according to an intention-to-treat strategy that included all randomly assigned participants, irrespective of adherence. The trial is registered with ClinicalTrials.gov , number NCT01394952 . Findings Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952). During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated. 158 (3·2%) of 4949 participants assigned to dulaglutide and 205 (4·1%) of 4952 participants assigned to placebo had a stroke during follow-up (hazard ratio [HR] 0·76, 95% CI 0·62–0·94; p=0·010). Dulaglutide reduced ischaemic stroke (0·75, 0·59–0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55–1·99; p=0·89). Dulaglutide also reduced the composite of non-fatal stroke or all-cause death (0·88, 0·79–0·98; p=0·017) and disabling stroke (0·74, 0·56–0·99; p=0·042). The degree of disability after stroke did not differ by treatment group. Interpretation Long-term dulaglutide use might reduce clinically relevant ischaemic stroke in people with type 2 diabetes but does not affect stroke severity. Funding Eli Lilly and Company.

Published
2020

20. Prediction of subclinical coronary atherosclerosis in patients with high and very high cardiovascular risk

Author

A A Arutyunov, V A Vygodin, Y M Yufereva, N P Kachanova, Nana Pogosova, OY Sokolova, and Koltunov Ie

Subjects
medicine.medical_specialty, Epidemiology, business.industry, Internal medicine, medicine, Cardiology, In patient, Cardiology and Cardiovascular Medicine, business, Coronary atherosclerosis, Subclinical infection
Abstract

Funding Acknowledgements Type of funding sources: None. Background Coronary atherosclerosis has a long subclinical period. It’s early detection may offer a possibility of timely initiation of preventive interventions Purpose To develop a diagnostic rule for detection of patients (pts) with high probability of subclinical atherosclerosis among those with high or very high cardiovascular (CV) risk. Methods This cross-sectional study enrolled 52 pts (32 men [62%]), aged 40 to 65 years [mean age 54.6 ± 8.0]) with high or very high CV risk (5-9 and ≥10% by The Systematic Coronary Risk Estimation Scale [SCORE], respectively). All participants underwent cardiac computed tomography (CT) angiography and calcium scoring. Traditional risk factors (RFs) (family history of premature CVD, smoking, overweight/obesity and abdominal obesity, hypertension, type 2 diabetes mellitus, lipids parameters (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides) and lipids-related markers (apolipoprotein A1, apolipoprotein B, ApoB/ApoA1 ratio), biomarkers of inflammation (high-sensitivity C-reactive protein [hs CRP], fibrinogen), indicator carbohydrate metabolism (glucose), ankle-brachial index, stress-test, carotid plaques according to ultrasound were evaluated in all pts. Psychological RFs were evaluated using Hospital Anxiety and Depression Scale and DS-14 for type D personality. Results All pts were divided into 2 groups according to the CT angiography results: pts in the main group (n = 21) had any non-obstructive lesions or calcium score >0, pts in the control group (n = 31) had intact coronary arteries. The groups did not differ in age or gender. 26 multiple linear logistic models for any subclinical atherosclerosis were developed based on obtained diagnostic features. Taking into account R-square = 0.344 (p = 0.0008), the best fitting model was follows: subclinical coronary atherosclerosis= -1.576 + 0.234 x SCORE ≥5% + 0.541 x hs CRP >2 g/l + 0.015 x heart rate (bpm) + 0.311 family history of premature CVD. The developed algorithm had sensitivity of 63% and specificity of 80%. Conclusions The created diagnostic model diagnostic model suggests the presence of subclinical coronary atherosclerosis in patients with high / very high CV risk with a high degree of probability. This easy-to-use method can be used in routine clinical practice to improve risk stratification and management choices in high-risk pts.

Published
2021

21. The effects of preventive counseling followed by remote support via phone on physical activity in patients with high cardiovascular risk

Author

A I Yusubova, Nana Pogosova, Y M Yufereva, A. Karpova, OY Sokolova, and A K Ausheva

Subjects
medicine.medical_specialty, Epidemiology, Phone, business.industry, Physical activity, Physical therapy, medicine, In patient, Cardiology and Cardiovascular Medicine, business
Abstract

Funding Acknowledgements Type of funding sources: None. Background Education may increase physical activity (PA) in patients (pts) with high cardiovascular (CV) risk. Objectives To assess the effects of preventive counseling with focus on diet modification with remote support by phone on PA levels in high CV risk pts. Methods This is a randomized controlled study of pts aged 40 to 65 years with high/very high CV risk (Systematic Coronary Risk Evaluation scale [SCORE], ≥5%) and any 2 metabolic syndrome criteria. Pts were randomized into 2 groups in 1:1 ratio. Intervention group received comprehensive preventive counseling with focus on healthy diet followed by 3 months of biweekly remote counseling by phone (a total of 6 sessions). Control group received usual care including basic preventive counseling. PA was assessed by International Questionnaire on Physical Activity (IPAQ) at baseline, at 6 and 12 months. Results A total of 100 pts (women, 80%, aged 59.85 ± 4.47 years) were randomized. Demographics and clinical features were balanced across groups. Despite the study intervention not focusing on PA, total PA, moderate PA and walking significantly increased in the intervention group vs control at 6 and 12 months. Conclusion The study intervention provided a significant increase of PA in high CV risk pts. Intervention group, mean ± standard deviation Control group, mean ± standard deviation P for change from baseline Total physical activities, МЕТ-min/week Baseline 1317.94 ± 1455.4 2029.42 ± 2811.84 After 6 months 2217.58 ± 1813.95*** 1793.26 ± 1863.54

Published
2021

22. The impact of different preventive counseling programs on medication adherence in patients with paroxysmal atrial fibrillation after catheter ablation

Author

Y M Yufereva, OY Sokolova, KV Davtyan, Nana Pogosova, AI Ovchinnikova, and A K Ausheva

Subjects
medicine.medical_specialty, Epidemiology, Paroxysmal atrial fibrillation, business.industry, Internal medicine, medicine.medical_treatment, medicine, Medication adherence, In patient, Catheter ablation, Cardiology and Cardiovascular Medicine, business
Abstract

Funding Acknowledgements Type of funding sources: None. Background Poor medication adherence is a major contributor to suboptimal health outcomes and increased costs in cardiovascular (CV) diseases including atrial fibrillation (AF). Purpose To assess the impact of different preventive counseling programs on medication adherence in AF patients (pts) after catheter ablation (CA). Methods A prospective randomized controlled study with 3 parallel groups of pts with paroxysmal AF after CA (radiofrequency or cryoablation). Pts were randomized (1:1:1) into 3 groups. Before discharge, pts from all groups received 1 preventive counseling session with focus on their individual risk factors profile. After discharge both intervention groups received 6 sessions of biweekly remote preventive counseling by phone (Group 1) or via email(Group 2) for 3 months after enrollment. Group 3 received usual care. Medication adherence was assessed using the 4-item Morisky-Green scale at baseline and at 12 months. Results A total of 135 pts aged 35 to 80 years were enrolled (mean age, 57.3 ± 9.1 years, men, 51.8%). The groups were well balanced according to demographic and clinical features. Baseline levels of non-adherenсe and partial adherence were high in all groups (53.4%, 71.1% and 73.3% respectively). At 1 year of follow-up pts from both intervention groups demonstrated a significant improvement of medication adherence vs control (table). Conclusions Preventive counseling programs with remote support via phone or e-mail improve medication adherence in AF pts after CA. Мedication adherence 1 group (support via phone) 2 group (support via e-mail) Control group P for Group 1 vs. control at 12 months P for Group 2 vs. control at 12 months Baseline After 12 months Baseline After 12 months Baseline After 12 months Adherence,% 46.7 60 28.9 60 26.7 31.1

Published
2021

23. Preventive counseling with subsequent remote support does not further improve the quality of life after catheter ablation of atrial fibrillation

Author

A A Arutyunov, Y M Yufereva, KV Davtyan, AI Ovchinnikova, Nana Pogosova, and OY Sokolova

Subjects
medicine.medical_specialty, Epidemiology, business.industry, Internal medicine, medicine.medical_treatment, medicine, Cardiology, Atrial fibrillation, Catheter ablation, Cardiology and Cardiovascular Medicine, medicine.disease, business
Abstract

Funding Acknowledgements Type of funding sources: None. Background Atrial fibrillation (AF) is associated with substantially reduced quality of life (QoL). Both catheter ablation (CA) and education have a potential to improve QoL in AF patients (pts). Purpose To assess the impact of preventive counseling with long-term support on QoL in pts after CA performed for paroxysmal AF. Methods A prospective randomized controlled study with 2 parallel groups of pts with paroxysmal AF after CA (radiofrequency or cryoablation). Pts were randomized (1:1) into 2 groups. Before discharge, both groups received 1 preventive counseling session with focus on their individual risk factors profile. After discharge pts from intervention group received biweekly preventive counseling via email for 3 months (6 sessions). Control group received usual care. QoL was assessed at baseline and at 12 months using SF-36 questionnaire. Results A total of 90 pts aged 35 to 80 years were enrolled (mean age, 57.4 ± 9.9 years, men, 52.2%). Both groups had a poor QoL at baseline, and both groups experienced improvement in the physical health component at 1 year, but the degree of this improvement in the intervention group was similar to the control (table). Conclusions Preventive counseling with remote support via email does not further improve QoL in AF pts after CA. Intervention group Control group P Integral component of physical health Baseline (points) mean ± SD 44.1 ± 7.9 40.2 ± 8.7 0.028 Mе (25%; 75%) 44.5 (38.7; 50.1) 38.6 (34.4; 47.1) At 12 months (points) mean ± SD 49.4 ± 6.0* 45.7 ± 7.7* 0.010 Ме (25%; 75%) 51.0 (45.2; 53.9) 46.3 (42.4; 50.6) Δ% after 12 months, Ме (25%; 75%) 11.8 (1.4; 32.7) 18.7 (-0.3; 30.4) n/s Integral component of mental health Baseline (points) mean ± SD 46.1 ± 9.0 45.0 ± 8.4 n/s Mе (25%; 75%) 47.8 (39.1; 53.9) 48.0 (37.2; 52.0) At 12 months (points) mean ± SD 48.2 ± 8.1 46.8 ± 8.7 n/s Ме (25%; 75%) 50.1 (46.1; 53.6) 48.0 (41.0; 54.3) Δ% after 12 months, Ме (25%; 75%) 3.6 (-10.8; 32.6) 8.9 (-15.6; 30.8) n/s * p

Published
2021

24. The effects of preventive counseling with remote support via e-mail on illness perception in patients with paroxysmal atrial fibrillation after catheter ablation

Author

AI Ovchinnikova, Y M Yufereva, KV Davtyan, OY Sokolova, Nana Pogosova, and A K Ausheva

Subjects
Illness perceptions, medicine.medical_specialty, Epidemiology, Paroxysmal atrial fibrillation, business.industry, Internal medicine, medicine.medical_treatment, medicine, Cardiology, Catheter ablation, In patient, Cardiology and Cardiovascular Medicine, business
Abstract

Funding Acknowledgements Type of funding sources: None. Background Illness perception (IP) affects health behaviors and coping strategies in chronic diseases, but our knowledge about IP in atrial fibrillation (AF) patients (pts) after catheter ablation (CA) is limited. Purpose To assess the impact of preventive counseling on IP in pts after AF catheter ablation. Methods A prospective randomized controlled study with 2 parallel groups of pts with paroxysmal AF after CA (radiofrequency or cryoablation). Pts were randomized (1:1) into 2 groups. Before discharge, both groups received 1 preventive counseling session with focus on their individual risk factors profile. After discharge pts from intervention group received 6 sessions of biweekly remote preventive counseling via e-mail over the first 3 months. Control group received usual care. IP was assessed using The Brief Illness Perception Questionnaire (BIPQ) at baseline and at 3, 6 and 12 months. Results A total of 90 pts aged 35 to 80 years were enrolled (mean age, 57.4 ± 9.9 years, men, 52.2%). The groups were well balanced according to demographic and clinical features. At 6 and 12 months of follow-up there was a significant improvement of the overall IP score in the intervention group vs control (table). Conclusions Preventive counseling with remote support via e-mail improves IP in AF pts after CA which may contribute to better long term outcomes. The overall score of IP Intervention group Control group P for change vs baseline Baseline (points) mean ± SD 42.2 ± 10.2 44.4 ± 9.5 n/s Mе (25%; 75%) 44 (35; 48.5) 45 (37; 51.5) At 3 months (points) mean ± SD 36.8 ± 8.1* 39.7 ± 7.9* 0.055 Mе (25%; 75%) 37 (33; 41) 41 (33.5; 47) Δ% after 3 months, Ме (25%; 75%) -14.3 (-23.2; 5.2) -13.0 (-16.8; -4.6) n/s At 6 months (points) mean ± SD 32.4 ± 7.3* 37.7 ± 8.7* 0.008 Mе (25%; 75%) 33 (27; 38) 37 (31; 44.5) Δ% after 6 months, Ме (25%; 75%) -24.2 (-33.7; -5.9) -18.4 (-24.0; -5.9) 0.040 At 12 months (points) mean ± SD 29.4 ± 7.6* 36.9 ± 8.2*

Published
2021

25. Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial

Author

Edward Franek, Denis Xavier, Nana Pogosova, William C. Cushman, Jonathan E. Shaw, Matyas Keltai, Purnima Rao-Melacini, Jeffrey L. Probstfield, Helen M. Colhoun, Fernando Lanas, Lawrence A. Leiter, Harpreet S. Bajaj, Lars Rydén, Mark Lakshmanan, Ignacio Conget, Markolf Hanefeld, Hertzel C. Gerstein, Peter J Raubenheimer, Gilles R. Dagenais, Patricio Lopez-Jaramillo, Wayne H-H Sheu, Jan Basile, Valdis Pirags, and Masira

Subjects
Blood Glucose, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Recombinant Fusion Proteins, Glucagon-Like Peptides, 030209 endocrinology & metabolism, Type 2 diabetes, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Randomized controlled trial, Double-Blind Method, Erectile Dysfunction, law, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Humans, Hypoglycemic Agents, 030212 general & internal medicine, Risk factor, Aged, business.industry, Incidence (epidemiology), Middle Aged, medicine.disease, Prognosis, Immunoglobulin Fc Fragments, Erectile dysfunction, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Dulaglutide, Female, business, Biomarkers, medicine.drug, Follow-Up Studies
Abstract

Digital, Background Diabetes is a major risk factor for erectile dysfunction, however, the effect of GLP-1 receptor agonists on erectile dysfunction is unknown. We aimed to assess the incidence, prevalence, and progression of erectile dysfunction in men treated with dulaglutide compared with placebo, and to determine whether dulaglutide's effect on erectile dysfunction was consistent with its effect on other diabetes-related outcomes. Methods The Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial was a double-blind, placebo-controlled randomised trial of the effect of dulaglutide on cardiovascular outcomes. REWIND was done at 371 sites in 24 countries. Men and women aged older than 50 years with type 2 diabetes, who had either a previous cardiovascular event or cardiovascular risk factors, were randomly assigned (1:1) to receive either dulaglutide or placebo. Participating men were offered the opportunity to complete the standardised International Index of Erectile Function (IIEF) questionnaire at baseline, 2 years, 5 years, and study end. We did an exploratory analysis, in which we included participants who completed a baseline and at least 1 follow-up IIEF questionnaire. The primary outcome for these analyses was the first occurrence of moderate or severe erectile dysfunction following randomisation, assessed by the erectile function subscores on IIEF. This analysis was part of the REWIND trial, which is registered with ClinicalTrials.gov, NCT01394952. Findings Between Aug 18, 2011, and Aug 14, 2013, 3725 (70·1%) of 5312 male participants with a mean age of 65·5 years (SD 6·4 years) were analysed, of whom 1487 (39·9%) had a history of cardiovascular disease, and 2104 (56·5%) had moderate or severe erectile dysfunction at baseline. The incidence of erectile dysfunction following randomisation was 21·3 per 100 person-years in the dulaglutide group and 22·0 per 100 person-years in the placebo group (HR 0·92, 95% CI 0·85–0·99, p=0·021). Men in the dulaglutide group also had a lesser fall in erectile function subscore compared with the placebo group, with a least square mean difference of 0·61 (95% CI 0·18–1·05, p=0·006). Interpretation Long-term use of dulaglutide might reduce the incidence of moderate or severe erectile dysfunction in men with type 2 diabetes., Ciencias Médicas y de la Salud

Published
2021

26. Factors Associated with Anxiety and Depressive Symptoms in 2775 Patients with Arterial Hypertension and Coronary Heart Disease: Results from the COMETA Multicenter Study

Author

Hugo Saner, OY Sokolova, Aza Ausheva, Nana Pogosova, Alexander Kursakov, Sergey Boytsov, and Dirk De Bacquer

Subjects
Male, Epidemiology, Coronary Disease, Disease, Anxiety, Hospital Anxiety and Depression Scale, psychosocial risk factors, ALCOHOL-USE, stress, depressive symptoms, Risk Factors, PERCEIVED SOCIAL SUPPORT, Anxiety symptoms, Medicine and Health Sciences, 610 Medicine & health, RISK-FACTOR CONTROL, Original Research, Depression, EUROPEAN-SOCIETY, CARDIOVASCULAR-DISEASE, Medicine, Psychology, Cardiovascular Medicine, Epidemiology, Preventive Medicine, Hypertension, Female, Public aspects of medicine, RA1-1270, medicine.symptom, Cardiology and Cardiovascular Medicine, Psychosocial, 360 Social problems & social services, arterial hypertension, medicine.medical_specialty, DISORDERS, Family income, Social support, Internal medicine, medicine, Diseases of the circulatory (Cardiovascular) system, Humans, MEDICATION ADHERENCE, coronary heart disease, Risk factor, METAANALYSIS, Aged, Community and Home Care, business.industry, Coronary heart disease, lifestyle risk factors, LIFE, Cross-Sectional Studies, MYOCARDIAL-INFARCTION, RC666-701, business
Abstract

Aim To identify associations of anxiety symptoms (AS) and depressive symptoms (DS) with other psychosocial and lifestyle risk factors in primary care patients with arterial hypertension (AH) and/or coronary heart disease (CHD). Methods COMETA (Clinical-epidemiOlogical prograM of studying psychosocial risk factors in cardiological practice in patiEnts with arterial hyperTension and ischemic heArt disease) is a multicenter cross-sectional study performed in 30 big cities of Russia with two to five out-patient clinics per city randomly selected and two to five general practitioners (GPs) per an out-patient clinic. Each GP included 8-10 consecutive patients with AH and/or CHD. AS and DS were assessed by the Hospital Anxiety and Depression Scale. Results 325 GPs enrolled 2775 patients (mean age 66.7 years, 72% women) with AH (60.8%), CHD (2.6%), and AH plus CHD (36.6%). Moderate/severe (���11 HADS) AS were found in 25.5% and DS in 16.3% patients. The strongest associations of AS and DS were revealed for high stress level (OR 5.79; 95% CI [4.18-8.03]), moderate stress level (OR 2.34; 95% CI [1.73-3.16]), low social support (OR 1.87; 95% CI [1.31-2.68]) and female gender (OR 1.78; 95% CI [1.41-2.25]). Low physical activity, unhealthy eating, unemployment and low income were also positively associated with both AS and DS (p < 0.003 for all). Conclusion In out-patients with AH and CHD, AS and DS were strongly associated with higher levels of stress, low social support, unemployment, low family income and unhealthy lifestyle such as low physical activity, low fruit and vegetables intake and excessive salt consumption. Our findings indicate that patients with AH and CHD, who have anxiety and depressive symptoms need extra attention and monitoring in regard to stress and lifestyle risk factor control.

Published
2021

27. Primary prevention efforts are poorly developed in people at high cardiovascular risk : A report from the European Society of Cardiology EURObservational Research Programme EUROASPIRE V survey in 16 European countries

Author

Jan Bruthans, Guy De Backer, Dusko Vulic, Arno W. Hoes, Kairat Davletov, Pedro Marques-Vidal, Erkin M. Mirrakhimov, Rafael G. Oganov, David R. Wood, J. Badariene, Željko Reiner, S. Mancas, Renata Cifkova, Diederick E. Grobbee, Hosam Hasan-Ali, Piotr Jankowski, Dan Gaita, Davor Miličić, Catriona Jennings, Lars Rydén, Maryna Dolzhenko, Aldo P. Maggioni, Mirza Dilic, Christos Lionis, Nana Pogosova, Nina Gotcheva, Dirk De Bacquer, Carlos Aguiar, Ana Abreu, and Kornelia Kotseva

Subjects
Male, medicine.medical_specialty, Epidemiology, Cardiovascular risk factors, Primary health care, Cardiology, Primary care, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Primary prevention, medicine, Humans, 030212 general & internal medicine, Aged, business.industry, Life style, Middle Aged, Europe, Primary Prevention, Guideline implementation, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Heart Disease Risk Factors, Female, Cardiology and Cardiovascular Medicine, business
Abstract

Background European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) V in primary care was carried out by the European Society of Cardiology EURObservational Research Programme in 2016–2018. The main objective was to determine whether the 2016 Joint European Societies’ guidelines on cardiovascular disease prevention in people at high cardiovascular risk have been implemented in clinical practice. Methods The method used was a cross-stional survey in 78 centres from 16 European countries. Patients without a history of atherosclerotic cardiovascular disease either started on blood pressure and/or lipid and/or glucose lowering treatments were identified and interviewed ≥ 6 months after the start of medication. Results A total of 3562 medical records were reviewed and 2759 patients (57.6% women; mean age 59.0 ± 11.6 years) interviewed (interview rate 70.0%). The risk factor control was poor with 18.1% of patients being smokers, 43.5% obese (body mass index ≥30 kg/m2) and 63.8% centrally obese (waist circumference ≥88 cm for women, ≥102 cm for men). Of patients on blood pressure lowering medication 47.0% reached the target of Conclusion The primary care arm of the EUROASPIRE V survey revealed that large proportions of people at high cardiovascular disease risk have unhealthy lifestyles and inadequate control of blood pressure, lipids and diabetes. Thus, the potential to reduce the risk of future cardiovascular disease throughout Europe by improved preventive cardiology programmes is substantial.

Published
2021

28. Variations in knowledge, awareness and treatment of hypertension and stroke risk by country income level

Author

Hongye Zhang, Charles Mondo, Okechukwu S Ogah, Conor Judge, Helle K. Iversen, Danuta Ryglewicz, Germán Málaga, Albertino Damasceno, R Iqbal, John Ferguson, Denis Xavier, Fawaz Al-Hussain, Anna Członkowska, Fernando Lanas, Nana Pogosova, Siu Lim Chin, Adensola Ogunniyi, Afzalhussein Yusufali, Martin O' Donnell, Antonio L. Dans, Graeme J. Hankey, Patricio Lopez-Jaramillo, Purnima Rao-Melacini, Hans-Christoph Diener, Christian Weimar, Sumathy Rangarajan, Magazi Daliwonga, Ernesto Peñaherrera, Liu Lisheng, Peter Langhorne, Zvonko Rumboldt, Alvaro Avezum, Andrew Smyth, Rafael Diaz, Xingyu Wang, Yongchai Nilanont, Shahram Oveisgharan, Prem Pais, Annika Rosengren, Salim Yusuf, Ahmed Elsayed, Khalid Yusoff, Aytekin Oguz, and Masira

Subjects
knowledge, blood pressure measurement, Medizin, clinical outcome, 030204 cardiovascular system & hematology, 0302 clinical medicine, middle aged, Epidemiology, awareness, purl.org/pe-repo/ocde/ford#3.02.04 [https], 030212 general & internal medicine, country economic status, antihypertensive therapy, Stroke, population attributable risk, risk, Knowledge awareness, adult, blood pressure, risk assessment, stroke, aged, female, priority journal, risk factor, antihypertensive agent, brain hemorrhage, Income level, epidemiology, cerebrovascular accident, Cardiology and Cardiovascular Medicine, cardiovascular risk, medicine.medical_specialty, hypertension, prevalence, self report, gross national income, Article, 03 medical and health sciences, male, Internal medicine, medicine, controlled study, human, Risk factor, business.industry, disease association, case control study, medicine.disease, major clinical study, brain ischemia, Blood pressure, Gross national income, Attributable risk, business, low income country
Abstract

Digital, Objective Hypertension is the most important modifiable risk factor for stroke globally. We hypothesised that country-income level variations in knowledge, detection and treatment of hypertension may contribute to variations in the association of blood pressure with stroke. Methods We undertook a standardised case-control study in 32 countries (INTERSTROKE). Cases were patients with acute first stroke (n=13 462) who were matched by age, sex and site to controls (n=13 483). We evaluated the associations of knowledge, awareness and treatment of hypertension with risk of stroke and its subtypes and whether this varied by gross national income (GNI) of country. We estimated OR and population attributable risk (PAR) associated with treated and untreated hypertension. Results Hypertension was associated with a graded increase in OR by reducing GNI, ranging from OR 1.92 (99% CI 1.48 to 2.49) to OR 3.27 (2.72 to 3.93) for highest to lowest country-level GNI (pheterogeneity, Ciencias Médicas y de la Salud

Published
2020

29. Anthracycline Associated Disturbances of Cardiovascular Homeostasis

Author

Ashot Avagimyan, Lev Kakturskiy, Nizal Sarrafzadegan, Nana Pogosova, and Kiyan Heshmat-Ghahdarijani

Subjects
medicine.medical_specialty, Modern medicine, Anthracycline, medicine.medical_treatment, Cardiovascular homeostasis, Context (language use), 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, medicine, Homeostasis, Humans, Anthracyclines, 030212 general & internal medicine, Intensive care medicine, Chemotherapy, Cardiotoxicity, Antibiotics, Antineoplastic, business.industry, Cancer, General Medicine, medicine.disease, Cardiovascular Alteration, Quality of Life, Cardiology and Cardiovascular Medicine, business
Abstract

Despite the dynamic progress of modern medicine, oncological and cardiovascular diseases (CVD) remain a severe economic burden worldwide. Therefore, the study of chemotherapeutic cardiotoxicity appears to be comprehensively demanded. Nowadays, pharmacological therapy in oncology has undoubtedly unprecedented development, but at the same time, the rates of cardiovascular complications of chemotherapy still remain unchanged. The well-established and highly effective, but at the same time, cardiotoxic anthracyclines have not lost their relevance. Furthermore, they remain indispensable components of an immense amount of chemotherapy regimens, such as AC, FAC, etc. Moreover, the anthracycline-containing chemotherapy regimens have become a standard of care in several cancer types. In the context of the above mentioned, the study of the pathophysiological mechanisms, biochemical aspects, and dynamics of the morphological remodeling of doxorubicin-induced cardiovascular homeostasis disturbances will enable finding new targets of pharmacological therapy, which either in the short or long perspectives, will have a beneficial effect, improving both the quality of life and prognosis of oncological patients. This article covers a versatile overview of the molecular mechanisms of doxorubicin-induced cardiotoxicity. The pathogenesis of cardiotoxicity assessment could help to explore specific molecular mechanisms that initiate cardiovascular alteration that may favorably affect the future development of targeted drugs that could prevent cardiovascular events in cancer patients.

Published
2022

30. Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis

Author

Ernesto German Cordona Munoz, Wayne Huey-Herng Sheu, Matyas Keltai, Hertzel C. Gerstein, Ignacio Conget, Helen M. Colhoun, Gilles R. Dagenais, Peter J Raubenheimer, William C. Cushman, Jonathan E. Shaw, Matthew C Riddle, Jan Basile, Leanne Dyal, Nana Pogosova, Patricio Lopez-Jaramillo, Lawrence A. Leiter, Lars Rydén, Jeffrey L. Probstfield, Stephanie Hall, Fernando Lanas, Theodora Temelkova-Kurktschiev, Prem Pais, Charles Atisso, Mark Lakshmanan, and Valdis Pirags

Subjects
Male, medicine.medical_specialty, Time Factors, Recombinant Fusion Proteins, Endocrinology, Diabetes and Metabolism, Glucagon-Like Peptides, Type 2 diabetes, Placebo, Incretins, Risk Assessment, Glucagon-Like Peptide-1 Receptor, law.invention, Double-Blind Method, Randomized controlled trial, law, Internal medicine, medicine, Humans, Hypoglycemic Agents, Uncategorized, Original Investigation, Aged, Unstable angina, business.industry, Incidence (epidemiology), Hazard ratio, Middle Aged, Cardiovascular disease, medicine.disease, Glucagon like peptide-1 receptor agonists, Immunoglobulin Fc Fragments, Treatment Outcome, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Heart Disease Risk Factors, Female, Dulaglutide, Cardiology and Cardiovascular Medicine, business, Mace, medicine.drug
Abstract

Background The Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) double blind randomized trial demonstrated that weekly subcutaneous dulaglutide 1.5 mg, a glucagon like peptide-1 receptor agonist, versus matched placebo reduced the first outcome of major adverse cardiovascular event (MACE), cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (594 versus 663 events) in 9901 persons with type 2 diabetes and either chronic cardiovascular disease or risk factors, and followed during 5.4 years. These findings were based on a time-to-first-event analysis and preclude relevant information on the burden of total major events occurring during the trial. This analysis reports on the total cardiovascular or fatal events in the REWIND participants Methods We compared the total incidence of MACE or non-cardiovascular deaths, and the total incidence of expanded MACE (MACE, unstable angina, heart failure or revascularization) or non-cardiovascular deaths between participants randomized to dulaglutide and those randomized to placebo. Incidences were expressed as number per 1000 person-years. Hazard ratios (HR) were calculated using the conditional time gap and proportional means models. Results Participants had a mean age of 66.2 years, 46.3% were women and 31% had previous cardiovascular disease. During the trial there were 1972 MACE or non-cardiovascular deaths and 3673 expanded MACE or non-cardiovascular deaths. The incidence of total MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 35.8 and 40.3 per 1000 person-years, respectively [absolute reduction = 4.5 per 1000 person-years; conditional time gap HR 0.90 (95% CI, 0.82–0.98) p = 0.020, and proportional means HR 0.89 (95% CI, 0.80–0.98) p = 0.022]. The incidence of total expanded MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 67.1 and 74.7 per 1000 person-years, respectively [absolute reduction = 7.6 per 1000 person-years; conditional time gap HR 0.93 (95% CI, 0.87–0.99) p = 0.023, and proportional means HR 0.90 (95% CI, 0.82–0.99) p = 0.028]. Conclusions These findings suggest that weekly subcutaneous dulaglutide reduced total cardiovascular or fatal event burden in people with type 2 diabetes at moderate cardiovascular risk. Clinical Trial Registration:https://www.clinicaltrials.gouv. Unique Identifier NCT01394952).

Published
2020

31. Alcohol consumption patterns across Europe and adherence to the European guidelines in coronary patients: findings from the ESC-EORP EUROASPIRE V survey

Author

A. J. van Ballegooijen, Kornelia Kotseva, Joline W. J. Beulens, Euroaspire Investigators, Nana Pogosova, D. E. Grobbee, Maryna Dolzhenko, Dirk De Bacquer, Erkin M. Mirrakhimov, Kairat Davletov, S. van Oort, I Van De Luitgaarden, and Ilse C. Schrieks

Subjects
medicine.medical_specialty, business.industry, Guideline adherence, Western europe, Emergency medicine, Epidemiology, medicine, Cardiology and Cardiovascular Medicine, business, Alcohol consumption, Coronary heart disease
Abstract

Introduction Alcohol consumption is an important risk factor for cardiovascular morbidity and mortality worldwide. The highest levels of alcohol consumption are observed in Europe, where alcohol as contributing cause of coronary heart disease (CHD) is also most significant. Purpose To describe patterns of alcohol consumption across different European regions and adherence to the current drinking guidelines in coronary patients with a recent CHD. Methods The EUROASPIRE V survey has been conducted in 2016–2017 at 131 centers in 27 European countries in 9,018 patients with a recent CHD. Median alcohol consumption, as well as the proportions abstainers and excessive drinkers (i.e. >70 grams of alcohol per week for women and >140 grams per week for men, as recommended by the European guidelines on cardiovascular prevention), were calculated for each European region (Eastern, Southern, Northern and Western Europe). To assess adherence to guidelines, proportions of participants who were advised to reduce excessive alcohol consumption, as well as the participants who were incorrectly not advised were calculated per European region. Results Mean age was 64 years (sd=9.5), 75% was male. Abstention rates were 51% in males and 74% in females, whereas excessive drinking was reported by 10% of the males (highest in Western Europe (18%) and lowest in Eastern Europe (5%)) and 6% of the females (also highest in Western Europe (12%) and lowest in Eastern Europe (1.4%)). Overall, 57% of the participants were advised to reduce alcohol consumption. In the total population, 3% was incorrectly not advised (Figure 1), but this percentage differed by region with 9% in Western Europe as compared to 1% in Eastern Europe. In regions where alcohol consumption was highest, participants were less often advised to reduce their consumption. Conclusion In this EUROASPIRE V survey the majority of patients with a recent CHD adhere to the current drinking guidelines and only a fraction of the population was incorrectly not advised to reduce consumption. However, substantial heterogeneity exists between European regions. Figure 1. Distribution of advice given per region Funding Acknowledgement Type of funding source: None

Published
2020

32. The effects of different preventive counseling programs on anxiety and depression symptoms in patients with paroxysmal atrial fibrillation after catheter ablation

Author

Y M Yufereva, O Y Sokolova, KV Davtyan, AI Ovchinnikova, and Nana Pogosova

Subjects
medicine.medical_specialty, business.industry, Paroxysmal atrial fibrillation, medicine.medical_treatment, Catheter ablation, Internal medicine, Cardiology, Medicine, Anxiety, In patient, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Depression (differential diagnoses)
Abstract

Background Depression and anxiety are common in patients (pts) with atrial fibrillation (AF). These psychosocial risk factors add to the symptoms burden and further deteriorate the quality of life. Purpose To assess the effects of different preventive counseling programs on anxiety and depression symptoms in pts after catheter ablation (CA) performed for paroxysmal AF. Methods This is a prospective randomized controlled study with 3 parallel groups of pts with paroxysmal AF after CA (radiofrequency or cryoablation). Pts were randomized into 3 groups in 1:1:1 ratio. During hospitalization for CA pts from all groups received single-session preventive counseling with focus on their individual cardiovascular risk factors profile. After discharge pts from Group 1 received remote preventive counseling by phone and pts from Group 2 – by email every two weeks for the first 3 months after enrollment (a total of 6 sessions). Group 3 received usual care. All pts underwent anxiety and depression assessment using Hospital Anxiety and Depression Scale (HADS) at baseline and at 12 months. Results A total of 135 pts aged 35 to 80 years were enrolled (mean age 57.3±9.1 years, 51.8% men). The groups were well balanced according to demographic and clinical features. At 1 year of follow-up there was a significant decrease in anxiety and depression scores as measured by HADS in both intervention groups vs. control (Table). Conclusions Preventive counseling followed by 3 months of remote support via phone and email reduced anxiety and depression level in AF pts after CA. Funding Acknowledgement Type of funding source: None

Published
2020

33. Predictors of emergency medical services utilization after different preventive counseling programs in paroxysmal atrial fibrillation patients after catheter ablation

Author

O Y Sokolova, Y M Yufereva, AI Ovchinnikova, KV Davtyan, and Nana Pogosova

Subjects
medicine.medical_specialty, Paroxysmal atrial fibrillation, business.industry, medicine.medical_treatment, Emergency medicine, Emergency medical services, Medicine, Catheter ablation, Cardiology and Cardiovascular Medicine, business
Abstract

Background Catheter ablation (CA) is known to reduce atrial fibrillation (AF) burden, but even after CA patients (pts) may remain symptomatic and seek for emergency care. Purpose To identify predictors of emergency medical services (EMS) utilization after different preventive counseling programs in paroxysmal AF pts after CA. Methods This is a secondary analysis of a randomized controlled trial in AF pts after CA (radiofrequency or cryoballoon) assessing the effects of a long-term preventive counseling program encompassing remote support. Pts were randomized into 3 groups in 1:1:1 ratio. During hospitalization for CA pts from all groups received single-session preventive counseling with focus on their individual cardiovascular risk factors profile. After discharge, pts from Group 1 received remote preventive counseling by phone and pts from Group 2 by email every two weeks for the first 3 months after enrollment (a total of 6 sessions). Group 3 received usual care. At baseline and at 12 months of follow-up, pts underwent assessments of their demographic parameters (age, sex, education level, marital status, and socioeconomic status) and psychological status (stress level using a 10-point visual analogue scale [VAS] and anxiety and depression by the Hospital Anxiety and Depression Scale [HADS]; transthoracic echocardiography, ECG and 24-hour ECG monitoring. A multivariate regression analysis of seeking for EMS was performed with patients' baseline parameters as independent variables. Results A total of 135 pts aged 35 to 80 years were enrolled (mean age 57.3±9.1 years, 51.8% men). Over 1 year of follow-up, 53 study participants called the ambulance (which made up for 90 calls) with no significant differences between the study groups. Age (odds ratio [OR] 1.8, 95% confidence interval [CI] 1.1–2.9; P=0.010), stress level ≥7 points (OR 3.2, 95% CI 1.4–7.5; P=0.007), left ventricular (LV) ejection fraction ≤62% (OR 2.6, 95% CI 1.1–6.1; P=0.024); and left atrial (LA) diameter ≥42 mm (OR 3.6, 95% CI 1.5–8.5; P=0.003) were independent predictors of an EMS call. Conclusions Age, perceived stress level, reduced LV function and LA size were independent predictors of EMS utilization after CA regardless of preventive counseling interventions. Funding Acknowledgement Type of funding source: None

Published
2020

34. The effects of different preventive counseling programs on stress level in patients with paroxysmal atrial fibrillation after catheter ablation

Author

Nana Pogosova, Y M Yufereva, O Y Sokolova, KV Davtyan, and AI Ovchinnikova

Subjects
medicine.medical_specialty, business.industry, Paroxysmal atrial fibrillation, medicine.medical_treatment, Internal medicine, Cardiology, Medicine, Catheter ablation, In patient, Cardiology and Cardiovascular Medicine, business, Stress level
Abstract

Background Stressful life events may trigger paroxysmal atrial fibrillation (AF) and chronic stress is known to negatively affect long-term outcomes in cardiovascular diseases. Purpose To assess the impact of different preventive counseling programs on stress level in patients (pts) after catheter ablation (CA) performed for paroxysmal AF. Methods This is a prospective randomized controlled study with 3 parallel groups of pts with paroxysmal AF after CA (radiofrequency or cryoablation). Pts were randomized into 3 groups in 1:1:1 ratio. During hospitalization for CA pts from all groups received single-session preventive counseling with focus on their individual cardiovascular risk factors profile. After discharge pts from Group 1 received remote preventive counseling by phone and pts from Group 2 by email every two weeks for the first 3 months after enrollment (a total of 6 sessions). Group 3 received usual care. All pts underwent stress assessment using a 10-point visual analogue scale (VAS) at baseline and at 12 months after CA. Results A total of 135 pts aged 35 to 80 years were enrolled (mean age 57.3±9.1 years, 51.8% men). The groups were well balanced according to demographic and clinical features. At 1 year of follow-up there was a significant reduction of average stress level in both intervention groups vs. control (Table). Conclusions Preventive counseling followed by 3 months of remote support via phone and email reduced the stress level in AF pts after CA. Funding Acknowledgement Type of funding source: None

Published
2020

35. Prediction of recurrent event in patients with coronary heart disease: the EUROASPIRE Risk Model

Author

Lars Rydén, Nina Gotcheva, Tomas Jernberg, Nana Pogosova, Kornelia Kotseva, Guy De Backer, Dirk De Bacquer, Johan De Sutter, Peter Ueda, Euroaspire, David R. Wood, D. Lovic, Erkin M. Mirrakhimov, Željko Reiner, Zlatko Fras, Seppo Lehto, Delphine De Smedt, Clinical sciences, Cardiology, and Vriendenkring VUB

Subjects
medicine.medical_specialty, Epidemiology, medicine.medical_treatment, Coronary Disease, Disease, Recurrent events, Percutaneous Coronary Intervention, Risk Factors, Internal medicine, Internal Medicine, Clinical endpoint, medicine, Humans, Myocardial infarction, Prospective Studies, Coronary Artery Bypass, patient management, Stroke, risk, Aged, business.industry, Public Health, Environmental and Occupational Health, Percutaneous coronary intervention, medicine.disease, Coronary heart disease, Heart failure, Conventional PCI, Cardiology, Cardiology and Cardiovascular Medicine, business
Abstract

AimsMost patients with established atherosclerotic cardiovascular disease (CVD) are at very high risk for developing recurrent events. Since this risk varies a lot between patients there is a need to identify those in whom an even more intensive secondary prevention strategy should be envisaged. Using data from the EUROASPIRE IV and V cohorts of coronary heart disease (CHD) patients from 27 European countries, we aimed at developing and internally and externally validating a risk model predicting recurrent CVD events in patients aged < 75 years.Methods and resultsProspective data were available for 12 484 patients after a median follow-up time of 1.7 years. The primary endpoint, a composite of fatal CVD or new hospitalizations for non-fatal myocardial infarction (MI), stroke, heart failure, coronary artery bypass graft, or percutaneous coronary intervention (PCI), occurred in 1424 patients. The model was developed based on data from 8000 randomly selected patients in whom the association between potential risk factors and the incidence of the primary endpoint was investigated. This model was then validated in the remaining 4484 patients. The final multivariate model revealed a higher risk for the primary endpoint with increasing age, a previous hospitalization for stroke, heart failure or PCI, a previous diagnosis of peripheral artery disease, self-reported diabetes and its glycaemic control, higher non-high-density lipoprotein cholesterol, reduced renal function, symptoms of depression and anxiety and living in a higher risk country. The model demonstrated excellent internal validity and proved very adequate in the validation cohort. Regarding external validity, the model demonstrated good discriminative ability in 20 148 MI patients participating in the SWEDEHEART register. Finally, we developed a risk calculator to estimate risks at 1 and 2 years for patients with stable CHD.ConclusionIn patients with CHD, fatal and non-fatal rates of recurrent CVD events are high. However, there are still opportunities to optimize their management in order to prevent further disease or death. The EUROASPIRE Risk Calculator may be of help to reach this goal.

Published
2020

36. Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial

Author

Angelyn Bethel, Matthew C. Riddle, Rafael Diaz, Patricio Lopez-Jaramillo, Jonathan E. Shaw, Fernando Lanas, Purnima Rao-Melacini, Tali Cukierman-Yaffe, Jeffrey L. Probstfield, Luis-Emilio Garcia-Perez, Wayne H-H Sheu, Valdis Pirags, Jan Basile, Edward Franek, Denis Xavier, Nana Pogosova, Helen M. Colhoun, Hertzel C. Gerstein, Stephanie Hall, Charles Atisso, Theodora Temelkova-Kurktschiev, Mark Lakshmanan, Peter J Raubenheimer, William C. Cushman, Lawrence A. Leiter, Matyas Keltai, Lars Rydén, and Everest

Subjects
Adult, Male, medicine.medical_specialty, Recombinant Fusion Proteins, Glucagon-Like Peptides, 030209 endocrinology & metabolism, Type 2 diabetes, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Internal medicine, medicine, Humans, Hypoglycemic Agents, Cognitive Dysfunction, Risk factor, Aged, business.industry, Hazard ratio, Montreal Cognitive Assessment, Middle Aged, medicine.disease, Immunoglobulin Fc Fragments, Treatment Outcome, Diabetes Mellitus, Type 2, Digit symbol substitution test, Female, Dulaglutide, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Digital, Background Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial. Methods REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m2. Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952. Findings Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1–5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85–1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79–0·95; p=0·0018). Interpretation Long-term treatment with dulaglutide might reduce cognitive impairment in people with type 2 diabetes. Further studies of this drug focused on brain health and cognitive function are clearly indicated., Ciencias Médicas y de la Salud

Published
2020

38. Potential and limitations of health policy to improve coronary heart disease prevention and to reduce the burden of disease: A Russian experience

Author

Sergey Suvorov, Nana Pogosova, Rafael G. Oganov, OY Sokolova, and Hugo Saner

Subjects
Time Factors, Epidemiology, Population, Psychological intervention, Coronary Disease, 030204 cardiovascular system & hematology, Risk Assessment, Russia, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Cause of Death, Environmental health, Humans, Medicine, Healthy Lifestyle, 030212 general & internal medicine, Healthcare Disparities, Disease management (health), Policy Making, education, Socioeconomic status, Health policy, education.field_of_study, business.industry, Health Policy, Health Status Disparities, Protective Factors, Prognosis, Coronary heart disease, Primary Prevention, Life expectancy, Cardiology and Cardiovascular Medicine, business, Risk Reduction Behavior, Psychosocial
Abstract

Background Mortality from cardiovascular diseases is particularly high in Russia compared with the European average. The National Priority Project ‘Health’, launched in 2005, aimed to promote prevention of non-communicable diseases, particularly cardiovascular diseases, in primary care and to increase availability of state-of-art cardiovascular disease management. Methods This is a multiregional population based study with analysis of indicators for cardiovascular health and coronary heart disease in Moscow, St Petersburg, the Moscow region and across Russia, including a total population of 143.7 million inhabitants between 2005 and 2013. Data were collected using conventional methodology and originate from open statistical sources. Results The overall age-standardized coronary heart disease mortality decreased in 2005–2013 by 24.7% from 383.6 to 289.0 per 100000 population, but with substantial interregional differences: it declined from 306.1 to 196.9 per 100,000 in Moscow (–35.7%), from 362.1 to 258.9 per 100,000 in St Petersburg (–28.5%) and from 433.8 to 374.3 per 100,000 in the Moscow region (–13.7%). Income in Moscow exceeded the national average 2–3-fold, and Moscow had the highest availability of modern treatments and interventions. Although vegetables, fruits and fish consumption increased overall in Russia, this trend was most prominent in Moscow. Indicators for psychosocial well-being also were best in Moscow. Life expectancy in Moscow is almost six years higher than the Russian average. Conclusion Health policy interventions turned out to be successful but with substantial interregional differences. Lower coronary heart disease mortality and higher life expectancy in Moscow may be due to a more favourable socioeconomic and psychological environment, more healthy eating and greater availability of medical care.

Published
2018

39. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial

Author

Sonia S Anand, Jackie Bosch, John W Eikelboom, Stuart J Connolly, Rafael Diaz, Peter Widimsky, Victor Aboyans, Marco Alings, Ajay K Kakkar, Katalin Keltai, Aldo P Maggioni, Basil S Lewis, Stefan Störk, Jun Zhu, Patricio Lopez-Jaramillo, Martin O'Donnell, Patrick J Commerford, Dragos Vinereanu, Nana Pogosova, Lars Ryden, Keith A A Fox, Deepak L Bhatt, Frank Misselwitz, John D Varigos, Thomas Vanassche, Alvaro A Avezum, Edmond Chen, Kelley Branch, Darryl P Leong, Shrikant I Bangdiwala, Robert G Hart, Salim Yusuf, JORGELINA SALA, LUIS CARTASEGNA, MARISA VICO, MIGUEL ANGEL HOMINAL, EDUARDO HASBANI, ALBERTO CACCAVO, CESAR ZAIDMAN, DANIEL VOGEL, ADRIAN HRABAR, PABLO OMAR SCHYGIEL, CARLOS CUNEO, HUGO LUQUEZ, IGNACIO J. MACKINNON, RODOLFO ANDRES AHUAD GUERRERO, JUAN PABLO COSTABEL, INES PALMIRA BARTOLACCI, OSCAR MONTANA, MARIA BARBIERI, OSCAR GOMEZ VILAMAJO, RUBEN OMAR GARCIA DURAN, LILIA BEATRIZ SCHIAVI, MARCELO GARRIDO, ADRIAN INGARAMO, ANSELMO PAULINO BORDONAVA, MARIA JOSE PELAGAGGE, LEONARDO NOVARETTO, JUAN PABLO ALBISU DI GENNERO, LUZ MARIA IBANEZ SAGGIA, MOIRA ALVAREZ, NESTOR ALEJANDRO VITA, STELLA MARIS MACIN, RICARDO DARIO DRAN, MARCELO CARDONA, LUIS GUZMAN, RODOLFO JUAN SARJANOVICH, JESUS CUADRADO, SEBASTIAN NANI, MARCOS RAUL LITVAK BRUNO, CAROLINA CHACON, LAURA ELENA MAFFEI, DIEGO GRINFELD, NATALIA VENSENTINI, CLAUDIO RODOLFO MAJUL, HECTOR LUCAS LUCIARDI, PATRICIA DEL CARMEN GONZALEZ COLASO, FREDY ANTONI FERRE PACORA, PAUL VAN DEN HEUVEL, PETER VERHAMME, BAVO ECTOR, PHILIPPE DEBONNAIRE, PHILIPPE VAN DE BORNE, JEAN LEROY, HERMAN SCHROE, PASCAL VRANCKX, IVAN ELEGEERT, ETIENNE HOFFER, KARL DUJARDIN, CLARISSE INDIO DO BRASIL, DALTON PRECOMA, JOSE ANTONIO ABRANTES, EULER MANENTI, GILMAR REIS, JOSE SARAIVA, LILIA MAIA, MAURO HERNANDES, PAULO ROSSI, FABIO ROSSI DOS SANTOS, SERGIO LUIZ ZIMMERMANN, RAFAEL RECH, EDUARDO ABIB JR, PAULO LEAES, ROBERTO BOTELHO, OSCAR DUTRA, WEIMAR SOUZA, MARIA BRAILE, NILO IZUKAWA, JOSE CARLOS NICOLAU, LUIZ FERNANDO TANAJURA, CARLOS VICENTE SERRANO JUNIOR, CESAR MINELLI, LUIZ ANTONIO NASI, LIVIA OLIVEIRA, MARCELO JOSE DE CARVALHO CANTARELLI, RICHARD TYTUS, SHEKHAR PANDEY, EVA LONN, JAMES CHA, SAUL VIZEL, MOHAN BABAPULLE, ANDRE LAMY, KEVIN SAUNDERS, JOSEPH BERLINGIERI, BOB KIAII, RAKESH BHARGAVA, PRAVINSAGAR MEHTA, LAURIE HILL, DAVID FELL, ANDY LAM, FAISAL AL-QOOFI, CRAIG BROWN, ROBERT PETRELLA, JOSEPH A RICCI, ANTHONY GLANZ, NICOLAS NOISEUX, KEVIN BAINEY, FATIMA MERALI, MICHAEL HEFFERNAN, ANTHONY DELLA SIEGA, GILLES R DAGENAIS, FRANCOIS DAGENAIS, STEEVE BRULOTTE, MICHEL NGUYEN, MICHAEL HARTLEIB, RANDOLPH GUZMAN, RONALD BOURGEOIS, DENNIS RUPKA, YAARIV KHAYKIN, GILBERT GOSSELIN, THAO HUYNH, CLAUDE PILON, JEAN CAMPEAU, FRANCIS PICHETTE, ARIEL DIAZ, JAMES JOHNSTON, PRAVIN SHUKLE, GREGORY HIRSCH, PAUL RHEAULT, WLODZIMIERZ CZARNECKI, ANNIE ROY, SHAH NAWAZ, STEPHEN FREMES, DINKAR SHUKLA, GABRIEL JANO, JORGE LEONARDO COBOS, RAMON CORBALAN, MARCELO MEDINA, LEONARDO NAHUELPAN, CARLOS RAFFO, LUIS PEREZ, SERGIO POTTHOFF, BENJAMIN STOCKINS, PABLO SEPULVEDA, CHRISTIAN PINCETTI, MARGARITA VEJAR, HONGYAN TIAN, XUESI WU, YUANNAN KE, KAIYING JIA, PENGFEI YIN, ZHAOHUI WANG, LITIAN YU, SHULIN WU, ZONGQUI WU, SHAO WEN LIU, XIAO JUAN BAI, YANG ZHENG, PING YANG, YUN MEI YANG, JIWEI ZHANG, JUNBO GE, XIAO PING CHEN, JUNXIA LI, TAO HONG HU, RUIYAN ZHANG, ZHE ZHENG, XIN CHEN, LIANG TAO, JIANPING LI, WEIJIAN HUANG, GUOSHENG FU, CHUNJIAN LI, YUGANG DONG, CHUNSHENG WANG, XINMIN ZHOU, YE KONG, ARISTIDES SOTOMAYOR, JOSE LUIS ACCINI MENDOZA, HENRY CASTILLO, MIGUEL URINA, GUSTAVO AROCA, MARITZA PEREZ, DORA INES MOLINA DE SALAZAR, GREGORIO SANCHEZ VALLEJO, MANZUR J FERNANDO, HENRY GARCIA, LUIS HERNANDO GARCIA, EDGAR ARCOS, JUAN GOMEZ, FRANCISCO CUERVO MILLAN, FREDY ALBERTO TRUJILLO DADA, BORIS VESGA, GUSTAVO ADOLFO MORENO SILGADO, EVA ZIDKOVA, JEAN-CLAUDE LUBANDA, MARKETA KALETOVA, RADIM KRYZA, GABRIEL MARCINEK, MAREK RICHTER, JINDRICH SPINAR, JIRI MATUSKA, MARTIN TESAK, ZUZANA MOTOVSKA, MARIAN BRANNY, JIRI MALY, MARTIN MALY, MARTIN WIENDL, LENKA FOLTYNOVA CAISOVA, JOSEF SLABY, PETR VOJTISEK, JAN PIRK, LENKA SPINAROVA, MIROSLAVA BENESOVA, JULIA CANADYOVA, MIROSLAV HOMZA, JINDRICH FLORIAN, ROSTISLAV POLASEK, ZDENEK COUFAL, VLADIMIRA SKALNIKOVA, RADIM BRAT, MIROSLAV BRTKO, PETR JANSKY, JAROSLAV LINDNER, PAVEL MARCIAN, ZBYNEK STRAKA, MARTIN TRETINA, YAN CARLOS DUARTE, FREDDY POW CHON LONG, MAYRA SANCHEZ, JOSE LOPEZ, CARMITA PERUGACHI, RICARDO MARMOL, FREDDY TRUJILLO, PABLO TERAN, JAAKKO TUOMILEHTO, HENRI TUOMILEHTO, MARJA-LEENA TUOMINEN, ILKKA KANTOLA, GABRIEL STEG, VICTOR ABOYANS, FLORENCE LECLERCQ, EMILE FERRARI, FRANCK BOCCARA, EMMANUEL MESSAS, PATRICK MISMETTI, MARIE ANTOINETTE SEVESTRE, GUILLAUME CAYLA, PASCAL MOTREFF, STEFAN STOERK, HANS-DIRK DUENGEN, CHRISTOPH STELLBRINK, OSMAN GUEROCAK, CHRISTOPH KADEL, RUEDIGER BRAUN-DULLAEUS, MICHAEL JESERICH, CHRISTIAN OPITZ, HANS-FRIEDRICH VOEHRINGER, KARL-FRIEDRICH APPEL, BERNHARD WINKELMANN, THOMAS DORSEL, SIGRID NIKOL, HARALD DARIUS, JURGEN RANFT, SEBASTIAN SCHELLONG, WOLFGANG JUNGMAIR, PIROZE DAVIERWALA, MARC VORPAHL, LASZLO BAJNOK, ZOLTAN LASZLO, EBRAHIM NOORI, GABOR VERESS, ANDRAS VERTES, ANDRAS ZSARY, ERNO KIS, LASZLO KORANYI, JUDIT BAKAI, ZOLTAN BODA, FERENC POOR, ZOLTAN JARAI, VENDEL KEMENY, JOHN BARTON, BRENDAN MCADAM, ANDREW MURPHY, PETER CREAN, NIALL MAHON, RONAN CURTIN, BRIAIN MACNEILL, SEAN DINNEEN, MAJDI HALABI, REUVEN ZIMLICHMAN, DAVID ZELTSER, YOAV TURGEMAN, ELIEZER KLAINMAN, BASIL LEWIS, AMOS KATZ, SHAUL ATAR, EUGENIA NIKOLSKY, STEFANO BOSI, MONICA NALDI, POMPILIO FAGGIANO, DEBORA ROBBA, LUCIO MOS, GIANFRANCO SINAGRA, FRANCO COSMI, LUIGI OLTRONA VISCONTI, DE MATTEIS CARMINE, GIUSEPPE DI PASQUALE, MATTEO DI BIASE, SARA MANDORLA, MARINO BERNARDINANGELI, GIOVANNI CARLO PICCINNI, MICHELE MASSIMO GULIZIA, MARCELLO GALVANI, FLAVIO VENTURI, GIORGIO MOROCUTTI, MARIA GRAZIA BALDIN, CARLO OLIVIERI, GIAN PIERO PERNA, VINCENZO CIRRINCIONE, TAKAYASU KANNO, HIROYUKI DAIDA, YUKIO OZAKI, NAOMASA MIYAMOTO, SHINICHI HIGASHIUE, HIROSHI DOMAE, SHINOBU HOSOKAWA, HIROO KOBAYASHI, TAKEHIKO KURAMOCHI, KENSHI FUJII, KAZUAKI MIZUTOMI, KEIJIRO SAKU, KAZUO KIMURA, YOSHIHARU HIGUCHI, MITSUNORI ABE, HARUHITO OKUDA, TOSHIYUKI NODA, TERUAKI MITA, ATSUSHI HIRAYAMA, HARUHIKO ONAKA, MORIAKI INOKO, MITSUGU HIROKAMI, MUNENORI OKUBO, YUTAKA AKATSUKA, MIZUHO IMAMAKI, HARUO KAMIYA, MAMORU MANITA, TOSHIHARU HIMI, HIDEKI UENO, YUJI HISAMATSU, JUNYA AKO, YASUHIRO NISHINO, HIDEO KAWAKAMI, YUTAKA YAMADA, YUKIHIRO KORETSUNE, TAKAHISA YAMADA, TETSURO YOSHIDA, HIDEKI SHIMOMURA, NORIYUKI KINOSHITA, AKIHIKO TAKAHASHI, KHALID YUSOFF, WAN AZMAN WAN AHMAD, MUHAMMAD RADZI ABU HASSAN, SAZZLI KASIM, AIZAI AZAN ABDUL RAHIM, DIMON MOHD ZAMRIN, MASAHARU MACHIDA, YORIHIKO HIGASHINO, NORIAKI UTSU, AKIHIKO NAKANO, SHIGERU NAKAMURA, TETSUO HASHIMOTO, KENJI ANDO, TOMOHIRO SAKAMOTO, F.J. PRINS, DIRK LOK, JOHANNES GERT-JAN MILHOUS, ERIC VIERGEVER, FRANK WILLEMS, HENK SWART, MARCO ALINGS, ROB BREEDVELD, KEES-JAN DE VRIES, ROGER VAN DER BORGH, FANNY OEI, STIENEKE ZOET-NUGTEREN, HANS KRAGTEN, JEAN PAUL HERRMAN, PAUL VAN BERGEN, MARCEL GOSSELINK, EDUARD HOEKSTRA, ERWIN ZEGERS, EELKO RONNER, FRANK DEN HARTOG, GERARD BARTELS, PETER NIEROP, COEN VAN DER ZWAAN, JACOB VAN ECK, EDWIN VAN GORSELEN, BJORN GROENEMEIJER, PIETER HOOGSLAG, MARC ROBERT DE GROOT, ALDRIN LOYOLA, DENNIS JOSE SULIT, NANNETTE REY, MARIA TERESA ABOLA, DANTE MORALES, ELLEN PALOMARES, MARC EVANS ABAT, GREGORIO ROGELIO, PHILIP CHUA, JOSE CARLO DEL PILAR, JOHN DENNIS ALCARAZ, GERALDINE EBO, LOUIE TIRADOR, JOSEFINA CRUZ, JOHN ANONUEVO, ARTHUR PITARGUE, MARIANNA JANION, TOMASZ GUZIK, GRZEGORZ GAJOS, MACIEJ ZABOWKA, ANDRZEJ RYNKIEWICZ, MARLENA BRONCEL, ANDRZEJ SZUBA, DANUTA CZARNECKA, PAWEL MAGA, IRINA STRAZHESKO, YURY VASYUK, ZHANNA SIZOVA, YURY POZDNYAKOV, OLGA BARBARASH, MIKHAIL VOEVODA, TATIANA POPONINA, ALEXEY REPIN, IRINA OSIPOVA, ANNA EFREMUSHKINA, NINA NOVIKOVA, OLEG AVERKOV, DMITRY ZATEYSHCHIKOV, ARKADIY VERTKIN, AZA AUSHEVA, PATRICK COMMERFORD, SAADIYA SEEDAT, LOUIS VAN ZYL, JAN ENGELBRECHT, ELLEN MAKONLI MAKOTOKO, CATHARINA ELIZABETH PRETORIUS, ZAID MOHAMED, ADRIAN HORAK, THOMAS MABIN, ERIC KLUG, JANG-HO BAE, CHEOLHO KIM, CHONG-JIN KIM, DONG-SOO KIM, YONG JIN KIM, SEUNGJAE JOO, JONG-WON HA, CHUL SOO PARK, JANG YOUNG KIM, YOUNG-KWON KIM, CHRISTINA JARNERT, THOMAS MOOE, MIKAEL DELLBORG, INGEMAR TORSTENSSON, PER ALBERTSSON, LARS JOHANSSON, FARIS AL-KHALILI, HENRIK ALMROTH, TOMMY ANDERSSON, EMIL PANTEV, BENGT-OLOV TENGMARK, BO LIU, GUNDARS RASMANIS, CARL-MAGNUS WAHLGREN, TIZIANO MOCCETTI, ALEXANDER PARKHOMENKO, VIRA TSELUYKO, VOLODYMYR VOLKOV, OLENA KOVAL, LYUDMYLA KONONENKO, OLEKSANDR PROKHOROV, VALERIY VDOVYCHENKO, ANDRIY BAZYLEVYCH, LEONID RUDENKO, VADYM VIZIR, OLEKSANDR KARPENKO, YAROSLAV MALYNOVSKY, VALENTYNA KOVAL, BORYS STOROZHUK, JAMES COTTON, ASOK VENKATARAMAN, ANDREW MORIARTY, DEREK CONNOLLY, PATRICK DAVEY, ROXY SENIOR, INDERPAUL BIRDI, JOHN CALVERT, PATRICK DONNELLY, JASPER TREVELYAN, JUSTIN CARTER, AARON PEACE, DAVID AUSTIN, NEVILLE KUKREJA, THOMAS HILTON, SUNNY SRIVASTAVA, RONALD WALSH, RONALD FIELDS, JOSEPH HAKAS, EDWARD PORTNAY, HARINDER GOGIA, ABRAHAM SALACATA, JOHN J. HUNTER, J MICHAEL BACHARACH, NICOLAS SHAMMAS, DAMODHAR SURESH, RICKY SCHNEIDER, PAUL GURBEL, SUBHASH BANERJEE, PAUL GRENA, NOEL BEDWELL, STEPHEN SLOAN, STEVEN LUPOVITCH, ANAND SONI, KATHLEEN GIBSON, RENEE SANGRIGOLI, RAJENDRA MEHTA, PETER I-HSUAN TSAI, EVE GILLESPIE, STEPHEN DEMPSEY, GLENN HAMROFF, ROBERT BLACK, ELLIS LADER, JOHN B. KOSTIS, VERA BITTNER, WILLIAM MCGUINN, KELLEY BRANCH, VINAY MALHOTRA, STEPHEN MICHAELSON, MICHAEL VACANTE, MATTHEW MCCORMICK, RALUCA ARIMIE, ALAN CAMP, GEORGE DAGHER, N. MATHEW KOSHY, STEPHEN THEW, FREDERICK COSTELLO, MARK HEIMAN, ROBERT CHILTON, MICHAEL MORAN, FREDRIC ADLER, ANTHONY COMEROTA, ANDREW SEIWERT, WILLIAM FRENCH, HARVEY SEROTA, ROBERT HARRISON, FAISAL BAKAEEN, SHUAB OMER, LOKESH CHANDRA, ALAN WHELAN, ANDREW BOYLE, PHILIP ROBERTS-THOMSON, JAMES ROGERS, PATRICK CARROLL, DAVID COLQUHOUN, JAMES SHAW, PETER BLOMBERY, JOHN AMERENA, CHRIS HII, ALISTAIR ROYSE, BHUWAN SINGH, JOSEPH SELVANAYAGAM, SHIRLEY JANSEN, WINGCHI LO, CHRISTOPHER HAMMETT, ROHAN POULTER, SESHASAYEE NARASIMHAN, HENRIK WIGGERS, HENRIK NIELSEN, GUNNAR GISLASON, LARS KOBER, KIM HOULIND, VIBEKE BOENELYKKE SOERENSEN, ULRIK DIXEN, JENS REFSGAARD, ELISABETH ZEUTHEN, PETER SOEGAARD, MARIAN HRANAI, LUDOVIT GASPAR, DANIEL PELLA, KATARINA HATALOVA, ERIKA DROZDAKOVA, IOAN COMAN, DOINA DIMULESCU, DRAGOS VINEREANU, MIRCEA CINTEZA, CRINA SINESCU, CATALINA ARSENESCU, IMRE BENEDEK, ELENA BOBESCU, DAN DOBREANU, DAN GAITA, ADRIAN IANCU, ADRIANA ILIESIU, DANIEL LIGHEZAN, LUCIAN PETRESCU, OCTAVIAN PIRVU, IULIA TEODORESCU, DAN TESLOIANU, MARIUS MARCIAN VINTILA, OVIDIU CHIONCEL, Divisions of Cardiology and Thromboembolism McMaster University Hamiton, Population Health Research Institute, McMaster University [Hamilton, Ontario], Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges], CHU Limoges, Neuroépidémiologie Tropicale (NET), CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Research Center [Associazione Nazionale Medici Cardiologi Ospedalieri] (ANMCO Research Center), Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO), Department of Statistics, University of Haifa [Haifa], Cardiology, University and Emergency Hospital, University of Edinburgh, VA Boston Healthcare System, Hamilton General Hospital, Universidad Autonoma de Madrid (UAM), Cardiology Department, Dipartimento di Bioscienze, University of Parma, University of Barcelona, Hospital Clinic Barcelona, Laval University and Hospital Heart and Lung Institute, UVSQ - UFR des sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), University Hospital Brno, Masaryk University, Department of Public Health, Hémostase, bio-ingénierie et remodelage cardiovasculaires (LBPC), Université Paris Diderot - Paris 7 (UPD7)-Université Paris 13 (UP13)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Galilée, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Pasteur [Nice] (CHU), Service de Cardiologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Saint-Antoine [APHP], Paris-Centre de Recherche Cardiovasculaire (PARCC - UMR-S U970), Université Paris Descartes - Paris 5 (UPD5)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Centre Hospitalier Régional Universitaire de Nîmes (CHRU Nîmes), CHU Gabriel Montpied (CHU), CHU Clermont-Ferrand, Department of Medicine (DEBRECEN - Dpt Medicine), University of Debrecen, University of Trieste, Lab Dev Cell Biol,Bunkyo Ku, The University of Tokyo, The Netherlands Organisation for Applied Scientific Research (TNO), Regional Specialist Hospital in Wroclaw, Research and Development Centre, Kamienskiego, Division of Angiology, Wroclaw Medical University, Sahlgrenska University Hospital/Östra, Cardiocentro Ticino [Lugano], University of Zürich [Zürich] (UZH), Danylo Halytskyi Lviv National Medical University, Department of Cardiology, Sandwell General Hospital, Physiopathologie et thérapie des déficits sensoriels et moteurs, Université Montpellier 2 - Sciences et Techniques (UM2)-IFR76-Institut National de la Santé et de la Recherche Médicale (INSERM), Rigshospitalet [Copenhagen], Université de Médecine Carol Davila, Cardiology Department [Târgu Mureș], University of Medicine and Pharmacy of Târgu Mureș, Institute for Cardiovascular Diseases C.C. Iliescu, Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM)-CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM), Associazione Nazionale Medici Cardiologi Ospedalieri [Firenze] (ANMCO), University of Parma = Università degli studi di Parma [Parme, Italie], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), CHU Gabriel Montpied [Clermont-Ferrand], The University of Tokyo (UTokyo), Universität Zürich [Zürich] = University of Zurich (UZH), and Copenhagen University Hospital

Subjects
Carotid Artery Diseases, Male, Myocardial Infarction, MESH: Lower Extremity, 030204 cardiovascular system & hematology, THERAPY, Stroke/epidemiology, MESH: Dose-Response Relationship, Drug, 0302 clinical medicine, Rivaroxaban, prevention, Hemorrhage/chemically induced, MESH: Peripheral Arterial Disease, MESH: Double-Blind Method, guidelines, MESH: Incidence, 030212 general & internal medicine, Cardiovascular Diseases/mortality, risk, RISK, MESH: Aged, MESH: Middle Aged, Incidence, General Medicine, Middle Aged, 3. Good health, Stroke, MESH: Myocardial Infarction, Lower Extremity, Cardiovascular Diseases, MESH: Platelet Aggregation Inhibitors, Factor Xa Inhibitors/administration & dosage, Drug Therapy, Combination, Female, MESH: Factor Xa Inhibitors, OUTPATIENTS, MESH: Rivaroxaban, management, MESH: Hemorrhage, metaanalysis, Lower Extremity/blood supply, Rivaroxaban/administration & dosage, Hemorrhage, MESH: Drug Administration Schedule, Amputation, Surgical, Drug Administration Schedule, MESH: Stroke, Peripheral Arterial Disease, 03 medical and health sciences, Double-Blind Method, atherothrombosis, Myocardial Infarction/epidemiology, MANAGEMENT, Humans, MESH: Amputation, MESH: Aspirin, Aspirin/administration & dosage, Platelet Aggregation Inhibitors/administration & dosage, METAANALYSIS, Aged, MESH: Humans, Aspirin, Dose-Response Relationship, Drug, MESH: Carotid Artery Diseases, MORTALITY, MESH: Cardiovascular Diseases, cardiovascular event rates, PREVENTION, CARDIOVASCULAR EVENT RATES, MESH: Male, outpatients, atrial-fibrillation, MESH: Drug Therapy, Combination, MESH: Morbidity, Carotid Artery Diseases/complications, lower-extremity amputation, Peripheral Arterial Disease/complications, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Morbidity, MESH: Female, Platelet Aggregation Inhibitors, Amputation/statistics & numerical data, Factor Xa Inhibitors
Abstract

BACKGROUND: Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications.METHODS: This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043).INTERPRETATION: Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding.FUNDING: Bayer AG.

Published
2018

41. Rationale, Design and Baseline Characteristics of Participants in the C ardiovascular O utco m es for P eople Using A nticoagulation S trategie s (COMPASS) Trial

Author

Jae Hyung Kim, Matyas Keltai, Ajay K. Kakkar, Masatsugu Hori, Fernando Lanas, Nana Pogosova, Gilles R. Dagenais, Salim Yusuf, Camilo Felix, Patrick J. Commerford, Christian Torp-Pedersen, Antonio L. Dans, Dragos Vinereanu, Katalin Keltai, Georg Ertl, Jong-Won Ha, Aldo P. Maggioni, Peter Verhamme, Khalid Yusoff, Frank Misselwitz, Nancy Cook Bruns, Eva Lonn, Vivian Lanius, Philippe Gabriel Steg, Jackie Bosch, Rafael Diaz, Deepak L. Bhatt, John Varigos, Lisheng Liu, Keith A.A. Fox, Jun Zhu, Petr Widimsky, Kaj Metsärinne, Patricio Lopez-Jaramillo, Stuart J. Connolly, Victor Aboyans, Edmond Chen, Lars Rydén, Paul Moayyedi, John W. Eikelboom, Marco Alings, Tomasz J. Guzik, Leopoldo S. Piegas, Stefan Störk, Alvaro Avezum, Alexander Parkhomenko, Kelley R. Branch, Andre Lamy, Fei Yuan, Yan Liang, Jeffrey L. Probstfield, Andrew Tonkin, Sonia S. Anand, Darryl P. Leong, Basil S. Lewis, Robert G. Hart, Mukul Sharma, and Martin O'Donnell

Subjects
long-term use, medicine.medical_specialty, medicine.drug_class, venous thromboembolism, Proton-pump inhibitor, 030204 cardiovascular system & hematology, Placebo, antiplatelet therapy, law.invention, peripheral arterial-disease, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Journal Article, medicine, Humans, acute coronary syndromes, Thrombolytic Therapy, 030212 general & internal medicine, Myocardial infarction, prior myocardial-infarction, Stroke, Randomized Controlled Trials as Topic, Pantoprazole, Aspirin, Rivaroxaban, business.industry, Anticoagulants, ta3121, atherothrombotic events, medicine.disease, 3. Good health, Surgery, atrial-fibrillation, Cardiovascular Diseases, randomized controlled-trial, Practice Guidelines as Topic, Cardiology and Cardiovascular Medicine, business, secondary prevention, medicine.drug
Abstract

BACKGROUND: Long-term aspirin prevents vascular events but is only modestly effective. Rivaroxaban alone or in combination with aspirin might be more effective than aspirin alone for vascular prevention in patients with stable coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban as well as aspirin increase upper gastrointestinal (GI) bleeding and this might be prevented by proton pump inhibitor therapy. METHODS: Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) is a double-blind superiority trial comparing rivaroxaban 2.5 mg twice daily combined with aspirin 100 mg once daily or rivaroxaban 5 mg twice daily vs aspirin 100 mg once daily for prevention of myocardial infarction, stroke, or cardiovascular death in patients with stable CAD or PAD. Patients not taking a proton pump inhibitor were also randomized, using a partial factorial design, to pantoprazole 40 mg once daily or placebo. The trial was designed to have at least 90% power to detect a 20% reduction in each of the rivaroxaban treatment arms compared with aspirin and to detect a 50% reduction in upper GI complications with pantoprazole compared with placebo. RESULTS: Between February 2013 and May 2016, we recruited 27,395 participants from 602 centres in 33 countries; 17,598 participants were included in the pantoprazole vs placebo comparison. At baseline, the mean age was 68.2 years, 22.0% were female, 90.6% had CAD, and 27.3% had PAD. CONCLUSIONS: COMPASS will provide information on the efficacy and safety of rivaroxaban, alone or in combination with aspirin, in the long-term management of patients with stable CAD or PAD, and on the efficacy and safety of pantoprazole in preventing upper GI complications in patients receiving antithrombotic therapy. ispartof: Canadian Journal of Cardiology vol:33 issue:8 pages:1027-1035 ispartof: location:England status: published

Published
2017

42. Design and baseline characteristics of participants in the <scp>R</scp> esearching cardiovascular <scp>E</scp> vents with a <scp>W</scp> eekly <scp>IN</scp> cretin in <scp>D</scp> iabetes ( <scp>REWIND</scp> ) trial on the cardiovascular effects of dulaglutide

Author

Helen M. Colhoun, Theodora Temelkova-Kurktschiev, Fernando Lanas, Wayne Huey-Herng Sheu, Shaun Holt, Charles Atisso, Matthew C. Riddle, Hertzel C. Gerstein, Nicolae Hancu, Jeffrey L. Probstfield, Valdis Pirags, Petr Jansky, Lawrence A. Leiter, Peter J Raubenheimer, Gilles R. Dagenais, Namsik Chung, Matyas Keltai, Jan Basile, Rafael Diaz, William C. Cushman, Patricio Lopez-Jaramillo, Edward Franek, Lars Rydén, Jonathan E. Shaw, Nana Pogosova, Denis Xavier, Alvaro Avezum, Ignacio Conget, Markolf Hanefeld, Ernesto Germán Cardona-Muñoz, Mark Lakshmanan, and Prem Pais

Subjects
medicine.medical_specialty, business.industry, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, 030204 cardiovascular system & hematology, medicine.disease, Clinical trial, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Blood pressure, Diabetes mellitus, Internal medicine, Heart failure, Internal Medicine, medicine, Physical therapy, Dulaglutide, Myocardial infarction, business, Stroke, medicine.drug
Abstract

The aim was to determine the effects of dulaglutide, a synthetic once-weekly, injectable human glucagon-like peptide 1 analogue that lowers blood glucose, body weight, appetite and blood pressure, on cardiovascular outcomes. People with type 2 diabetes, aged ≥50 years, with glycated haemoglobin (HbA1c) ≤9.5%, and either a previous cardiovascular event, evidence of cardiovascular disease or ≥2 cardiovascular risk factors were randomly allocated to a weekly subcutaneous injection of either dulaglutide (1.5 mg) or placebo and followed within the ongoing Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial every 3 to 6 months. The primary cardiovascular outcome is the first occurrence of the composite of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke. Secondary outcomes include each component of the primary composite cardiovascular outcome, a composite clinical microvascular outcome comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality. Follow-up will continue until the accrual of 1200 confirmed primary outcomes. Recruitment of 9901 participants (mean age 66 years, 46% women) occurred in 370 sites located in 24 countries over a period of 2 years. The mean duration of diabetes was 10 years, mean baseline HbA1c was 7.3%, and 31% had prior cardiovascular disease. The REWIND trial's international scope, high proportion of women, high proportion of people without prior cardiovascular disease and inclusion of participants whose mean baseline HbA1c was 7.3% suggests that its cardiovascular and safety findings will be directly relevant to the typical middle-aged patient seen in general practice throughout the world.

Published
2017

43. P2512Effects of two different preventive counselling programs with remote support on added sugar and refined carbohydrates intake pattern in coronary patients with abdominal obesity

Author

Y M Yufereva, A O Salbieva, A K Ausheva, A I Yusubova, A. Karpova, Nana Pogosova, and O Y Sokolova

Subjects
medicine.medical_specialty, Refined carbohydrates, business.industry, Internal medicine, medicine, Added sugar, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Abdominal obesity
Abstract

Background Restricting added sugar and refined carbohydrates is essential for a healthy diet, especially for overweight or obese patients (pts). Pts education has a potential to improve dietary patterns in coronary artery disease (CHD). Purpose To assess the impact of 2 preventive counselling programs with subsequent remote support resulted after hospitalization on salt intake in pts with CHD and obesity. Methods A prospective randomized parallel-group study in hospitalized nonsurgical pts with confirmed stable CHD and concomitant abdominal obesity. Most hospitalizations were due to elective percutaneous coronary intervention. Pts were randomized (1:1:1) into 3 groups. Before discharge, Groups 1 and 2 received comprehensive counselling with focus on diet followed by remote counselling by phone (Group 1) or via text messages (Group 2). Remote counselling was delivered weekly (Months 1–3) and then monthly (Months 4–6). Group 3 received standard advice only. Self-reported sugar/refined carbohydrates intake was assessed by consumption of added sugar, sugar-sweetened beverages and pastry. Results A total of 120 pts (mean age±SD, 57.75±6.25 years, men, 83.4%) were enrolled. The table presents self-reported dietary habits at baseline and at 12 months. At 1 year, significant improvements of relevant dietary habits vs control were seen in both intervention groups. Group 1 Group 2 Group 3 (control) Group 1 vs 3, Group 2 vs 3, (n=40) (n=40) (n=40) P for change from baseline P for change from baseline Amount of sugar added per cup tea or coffee, teaspoons, mean ± SD Baseline 2.65±0.77 2.45±0.81 2.48±0.72 At 12 months 2.08±0.83** 1.95±0.64** 2.47±0.69 Conclusion Pre-discharge preventive counselling with subsequent remote support in coronary patients with abdominal obesity resulted in significant improvement of dietary habits in terms of added sugar, sugar-sweetened beverages and pastry intake.

Published
2019

44. P2511Effects of two different preventive counselling programs with remote support on salt and sodium-reach foods intake patterns in coronary patients with abdominal obesity

Author

A O Salbieva, A K Ausheva, Nana Pogosova, O Y Sokolova, Y M Yufereva, A I Yusubova, and A. Karpova

Subjects
medicine.medical_specialty, chemistry, business.industry, Sodium, Internal medicine, medicine, chemistry.chemical_element, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Abdominal obesity
Abstract

Background Salt restriction is essential for a healthy diet, especially for patients (pts) with cardiovascular diseases. Pts education has a potential to promote healthier dietary patterns. Purpose To assess the impact of 2 preventive counselling programs with subsequent remote support resulted after hospitalization on salt intake in pts with coronary artery disease (CHD). Methods A prospective randomized parallel-group study in hospitalized nonsurgical pts with confirmed stable CHD and concomitant abdominal obesity. Most hospitalizations were due to elective percutaneous coronary intervention. Pts were randomized (1:1:1) into 3 groups. Before discharge, Groups 1 and 2 received comprehensive counselling with focus on diet followed by remote counselling by phone (Group 1) or via text messages (Group 2). Remote counselling was delivered weekly (Months 1–3) and then monthly (Months 4–6). Group 3 received standard advice only. Self-reported salt intake was assessed by consumption of sodium-reach foods such as sausages, pickles and by adding salt to cooked foods. Results A total of 120 pts (mean age±SD, 57,75±6,25 years, men, 83.4%) were enrolled. The Table presents self-reported dietary habits at baseline and at 12 months. At 1 year, significant improvements of relevant dietary habits vs control were seen in both intervention groups. Group 1 Group 2 Group 3 (Control) Group 1 vs 3, Group 2 vs 3, (n=40) (n=40) (n=40) P for change from baseline P for change from baseline Pts adding salt to cooked foods at least sometimes Baseline 87.5% 90.0% 85.0% At 12 months 25.0%** 10.0%** 89.5% Conclusion Pre-discharge preventive counselling with subsequent remote support in coronary patients with abdominal obesity resulted in significant improvement of dietary habits in terms of salt and high-sodium foods intake.

Published
2019

45. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial

Author

Hertzel C Gerstein, Helen M Colhoun, Gilles R Dagenais, Rafael Diaz, Mark Lakshmanan, Prem Pais, Jeffrey Probstfield, Fady T Botros, Matthew C Riddle, Lars Rydén, Denis Xavier, Charles Messan Atisso, Leanne Dyal, Stephanie Hall, Purnima Rao-Melacini, Gloria Wong, Alvaro Avezum, Jan Basile, Namsik Chung, Ignacio Conget, William C Cushman, Edward Franek, Nicolae Hancu, Markolf Hanefeld, Shaun Holt, Petr Jansky, Matyas Keltai, Fernando Lanas, Lawrence A Leiter, Patricio Lopez-Jaramillo, Ernesto German Cardona Munoz, Valdis Pirags, Nana Pogosova, Peter J Raubenheimer, Jonathan E Shaw, Wayne H-H Sheu, Theodora Temelkova-Kurktschiev, Mercedes Abella, Andrea Alebuena, Sandra Almagro, Eduardo Amoroso, Paula Anadon, Elizabeth Andreu, Guillermo Aristimuño, Maria Arzadun, Maria Barbieri, Raul Barcudi, Ines Bartolacci, Gabriel Bolobanich, Anselmo Bordonava, Miguel Bustamante Labarta, Betina Bustos, Alberto Caccavo, Alejandra Camino, Maria Cantero, Maria Carignano, Luis Cartasegna, Marcela Cipullo, Víctor Commendatore, Victoria Conosciuto, Osvaldo Costamagna, Claudia Crespo, Jose Cuello, Carlos Cuneo, Sandra Cusimano, Sofia Dean, Claudio Dituro, Andrea Dominguez, Miguel Farah, Alberto Fernandez, Florencia Fernandez, Adriana Ferrari, Patricia Flammia, Jose Fuentealba, Karina Beatriz Gallardo, Celso Garcia, Ruben Garcia Duran, Marcelo Garrido, Rodolfo Gavicola, Claudio Gerbaudo, Graciela Gilli, Ana Paula Giotto, Pedro Godoy Bolzán, Oscar Gomez Vilamajo, Fernando Guerlloy, Cristian Guridi, Narcisa Gutierrez Garrido, Eduardo Hasbani, Sonia Hermida, Miguel Hominal, Adrian Hrabar, Adrián Ingaramo, Alejandra Izzicupo, Mario Krynski, Mariana Lagrutta, Paulina Lanchiotti, Maria Langhe, Veronica Leonard, Javier Llanos, Ricardo Lopez Santi, Jorge Lowenstein, Cecilia Luquez, Ignacio Mackinnon, Melina Mana, Sara Manzur, Javier Marino, Carolina Martella, Roger Martinez, Re Matias, Javier Matkovich, Monica Meritano, Oscar Montaña, María Mulazzi, Juan Ochoa, Gustavo Paterlini, María Pelagagge, Maria Elena Peralta Lopez, Aldo Prado, Lorena Pruyas, Martín Racca, Carola Ricotti, Carolina Rodriguez, Mariano Romero Vidomlansky, Ricardo Ronderos, Ana Laura Sadowski, Jorgelina Sala, Alejandro Sánchez, Andrea Santoro, Lilia Schiavi, Mariano Sein, Virginia Sernia, Leonardo Serra, Maximiliano Sicer, Tomas Smith, Leonardo Soso, Georgina Sposetti, Andrea Steinacher, Jorge Stival, Jorge Tedesco, Hugo Tonin, Mauro Tortolo, Maria Ulla, Julio Vallejos, Marisa Vico, Luciana Virgillito, Virginia Visco, Daniel Vogel, Florencia Waisman, César Zaidman, Noemi Zucchiatti, Imran Badshah, Neale Cohen, Peter Colman, David Colquhoun, Timothy Davis, Spiros Fourlanos, Greg Fulcher, Jane Hamlyn, Cilla Haywood, Samantha Hocking, Maeve Huchinson, William Jeffries, Mervyn Kyl, Clement Lo, PeakMann Mah, Ashley Makepeace, Dolly Marope, Natalie Nanayakkar, Alison Nankervis, Neil Palmer, Barbara Palolus, Satish Pillai, Sarah Price, Joseph Proietto, Anne Reutens, Natassia Rodrigo, Abdul Sheikh, Greg Smith, Michelle So, Georgia Soldatos, Bronwyn Stuckey, Priya Sumithran, Helena Teede, Parind Vora, Lyn Williams, Eduardo Abib, Christiani Adão Poço, Érica Ferreira Alves, Janaina Andreatta Bernardi Barea, Livia Avezum Oliveira, Denise Ludovico da Costa de Castro, Ivan Correa da Cruz, Midiã Costa, Ivan Cruz, Sidney Cunha, Marco Antonio Vieira Da Silva, Renata de Carvalho Camara Bona, Bruna de Paula, Freddy Eliaschewitz, Guilherme Fazolli, Carlos Alberto Ferreira Filho, Jose Fortes, Cesar França, Denise Reis Franco, Paulo Roberto Genestreti, Flavio Giorgeto, Rodrigo Marques Gonçalves, Michele Elka Grossman, Ana Claudia Henrique Marcelino, Mauro Hernandes, Ana Horta, Cristiano Jaeger, Midia Kaneblai, Cecilia Kauffman Rutenberg, Jose Francisco Kerr Saraiva, Maria Angelica Lemos, Lilia Maia, Euler Roberto Manenti, Mariana Marques, Cynthia Melissa Valerio, Rodrigo Moreira, Flávia Mothé, Osana Maria Mouco, Philip Moura, José Carlos Moura Jorge, Carlos Nakashima, Marcelo Nakazone, Thiago Napoli, Cristiane Nunes, Joao Eduardo Nunes Salles, Karla Oliveira, Marcela Oliveira, Gracielly de Souza Pantano, Fabio Petri, Leonardo Piazza, Andreia Carla Pires, Patricia Pizzato, Sergio Prata, Dalton Precoma, Rafael Rech, Gilmar Reis, Heleno Reis, Elisabete Resende, Jose Ribas Fortes, Sylka Rodovalho, Fabio Rossi dos Santos, Joao Eduardo Salles, Célia Regina Sampaio, Thiago Santos, Vanessa Santos dos Santos, Tulio Silva e Quadros, Daniel Silveira, Katia Nunes Siqueira, M Teireira, Marcelo Uehara, C Valerio, Henrique Vianna, Maria Helena Vidotti, Guilherme de Lima Visconti, Maria Teresa Zanella, Viktoriya Andreeva, Radoslav Borisov, Nikolay Botushanov, Georgi Dimitrov, Kameliya Dimova, Tsvetan Dragoychev, Valentina Grigorova, Valentina Gushterova, Ivaylo Ivanov, Tatyana Kocelova, Dimo Kurktschiev, Milena Miletieva, Neli Nenkova-Gugusheva, Ralitsa Pancheva, Maria Pavlova, Dimitar Raev, Vesela Spasova, Anastas Stoikov, Dimitar Troev, Todor Yanev, Mariana Yoncheva-Mihaylova, Alexander Abitbol, Buki Ajala, Abdullh Alguwaihes, Jean-Luc Ardilouze, Nahla Aris-Jilwan, Amel Arnaout, Ronnie Aronson, Nadeem Aslam, Sandra Babin, Jean-Patrice Bailargeon, Allan Bailey, Harpreet Bajaj, Christian Beauchesne, Sorin Beca, Andre Belanger, Alan Bell, Diego Bellabarba, Lori Berard, Brian Berenbaum, Vincent Bergeron, Joseph Berlingieri, Frédéric Bernier, Phoebe Bishara, David Blank, Ian Blumer, Suzanne Brault, Donald Breton, André Carpentier, James Cha, Prakash Chandra, Jean-Louis Chiasson, James R Conway, Ghyslaine Couture, Nathalie Couture, Gilles Dagenais, Dyotirmoy Datta, Giuseppe D'Ignazio, Richard Dumas, Didier Fay, Andre Frechette, Louise Frenette, Daisy Fung, Nathalie Gagnon, Meri Galter, Jean Garon, Jean Sebastien Gauthier, Christian Geadah, Jeremy Gilbert, Ronald Girard, Ronald Goldenberg, Loren David Grossman, Nikhil Gupta, Jean-Pierre Halle, Marie-France Hivert, Ghislaine Houde, Robyn Houlden, Irene Hramiak, Ted Jablonski, Akshay Jain Jain, Hasnain Khandwala, Munish Khosla, C Lachance, Emilie Laflamme, Marie-France Langlois, Luc Larivee, Joanne Liutkus, Heather Lochnan, Saleem Malik, Charlotte McDonald, Pravinsagar Mehta, John Mihailidis, Alain Milot, Priya Narula, Patrice Nault, Arun Nayar, William Nisker, Gilles Ouellet, Jean Palardy, Minta Patel, Terri Paul, Sue Pedersen, Patrice Perron, Marie-Hélène Pesant, Paul Poirier, Marie-Claude Poulin, Zubin Punthakee, Waheed Rehman, Stuart Ross, P Sagar, Nouhad Saliba, Sam Sandler, Alicia Schiffrin, Robert Schlosser, Anila Seth-Sharma, Mark Sherman, David Sionit, Tharsan Sivakumar, Juan Soto, Eric St-Amour, Oren Steen, Jack Sussman, Adam Telner, Sheldon Tobe, David-Yaw Twum-Barima, Audrey Van Zanten, Nicole VanRossum, Jonathan Vecchiarelli, Rick Ward, John Wessengel, Stanley Weisnagel, Igor Wilderman, Vincent Woo, Natalia Yakubovich, Jean-Francois Yale, Zeina Yared, Monica Acevedo, Maria Loreto Aguirre, Andres Aizman, Maria Soledad Barroso, Leonardo Cobos, Alfredo Danin Vargas, Barbara Descalzi, Gonzalo Godoy, Elio Grumberg, Rodolfo Lahsen, Gladys Larenas, Eugenia Ortiz, Javier Paredes, Sergio Potthoff, Eva Retamal, Luis Rojas, Manuel Salgado, Claudio Santibanez, Carmen Solis, Benjamin Stokins, Jose Accini, Javier Acebedo, Lina Maria Agudelo Baena, Soraya Alarcon, Juliana Angel, Edgar Arcos, M Aroca Martinez, Leonor Atuesta, Jose Balaguera, Doris Ballestas, Sandra Isabel Barrera, Rosmy Barrios Reyes, Adolfo Bayona, Andres Bermudez, Diego Zarate Bernal, Marco Blanquicett, Victor Bravo, Wendy Bueno, Alvaro Burbano Delgado, Alberto Cadena, Andres Cadena, Sandra Caicedo, Carlos Celemin, Ricardo Consuegra, Cristhian Contreras Pimienta, Kelly Johenis Corredor, Carlos Cure, Lizeth Dayana De La Hoz Rueda, Erika Delgado, Sarahy Diaz, Marta Diego, Anabell Donado, William Encinales Sanabria, Juliana Escobar, Gillian Escorcia, Leonardo Forero, Laura Fuentes, Maria Garcia, Henry Garcia Lozada, Luis Garcia Ortiz, Angela Giraldo, Laura Gomez Gonzalez, Javier Granada, Corina Gutierrez, Natalia Henao, Edwin Hernandez, Olga Maria Herrera Uejbe, Juan Diego Higuera Cobos, Jaime Ibarra Gómez, Edwin Hernandez Jaimes, Monica Jaramillo, Nicolas Jaramillo, Carlos Jaramillo Gomez, Monica Jaramillo Sanchez, Ivonne Jarava Durán, Catalina Lopez Ceballos, Claudia Madrid, Elias María Amastha, Jennifer Mercado, Dora Ines Molina, Jessica Molina Soto, Carlos Montoya, Alexander Morales, Carolina Muñoz, Luis Alejandro Orozco, Oscar Osorio, Jorge Mario Palmera Sanchez, Adwar Peña, Jose Perez, Juan Perez Agudelo, Germán Pérez Amador, Carlos Pertuz, Irina Posada, Carlos Puerta, Adalberto Quintero, Diana Quiroz, Carmen Rendon, Alberto Reyes, Alvaro Reyes, Diana Ripoll, Carlos Rivera, Maria Rocha, Jose F Rodriguez, Kervis Asid Rodriguez Villanueva, Javier Emilio Rodriguez Zabala, Sindy Rojas, Maria Romero, Ricardo Rosero, Angelica Rocio Rosillo Cardenas, Lina Rueda, Gregorio Sanchez, Tatiana Sanchez, Arístides Sotomayor Herazo, Monica Suarez, Mariana Torres, Freddy Trujillo, Miguel Urina, Lazaro Van Strahlen, Carlos Velandia, Carolina Velasquez Guzman, Elizabeth Velazquez, Tatiana Vidal Prada, Juan Pablo Yepez Alvaran, Diego Zarate, Jana Andelova, Radka Benesova, Barbara Buzova, Vladimir Cech, Ida Chodova, Miroslav Choura, Antonin Dufka, Andrea Gamova, Jakub Gorgol, Tomas Hala, Hana Havlova, Dagmar Hlavkova, Petra Horanska, Juliana Ilcisin-Valova, Petra Jenickova, Ondrej Jerabek, Ilona Kantorova, Katerina Kolomaznikova, Iva Kopeckova, Miroslava Kopeckova, Karel Linhart, Tomas Linhart, Jan Malecha, Emilia Malicherova, Dana Neubauerova, Martina Oznerova, Radan Partys, Eva Pederzoliova, Maria Petrusova, Vera Prymkova, Eva Racicka, Ida Reissova, Eva Roderova, Libor Stanek, Alena Striova, Dana Svarcova, Petr Svoboda, Emilia Szeghy Malicharova, Jan Urge, Ladislav Vesely, Bedich Wasserburger, Hilde Wasserburgerova, Emil Zahumensky, Vaclav Zamrazil, Hasan Alawi, Ernestos Anastasiadis, Elisabeth Axthelm, Tasso Bieler, Christina Buhrig, Elizaveta Degtyareva, Frank Dellanna, Karl-Michael Derwahl, Stephan Diessel, Barbara Dogiami, Kirsten Dorn-Weitzel, Monika Ernst, Grit Faulmann, Baerbel Fetscher, Thomas Forst, Gabriele Freyer-Lahres, Klaus Funke, Xenia Ganz, Christiane Gleixner, Christoph Hanefeld, Sven Heinrichs, Stephanie Helleberg, Elena Henkel, Gerd Ruediger Hetzel, Caren Hoffmann, Frohmut Jacob, Stephan Jacob, Franziska John, Antonius Jonczyk, Wolfram Kamke, Christiane Klein, Martina Kleinhardt, Werner Kleophas, Christine Kosch, Kristin Kreutzmann, Achim Kühn, Young Hee Lee-Barkey, Alexander Lier, Sarah Maatouk, Joachim Minnich, Michael Mitry, Ilona Muessig, Diana Nicula, Martina Niemann, Joerg Nothroff, Petra Ott, Andreas Pfuetzner, Andreas Pfützner, Frank Pistrosch, Wildgard Pohl, Zdenka Prochazkova, Marlena Retkowska, Heiko Rosin, Daniela Sachsenheimer, Holger Samer, Mazin Sanuri, Axel Schaefer, Frank Schaper, Erik-Delf Schulze, Marita Schulze, Martina Schumann, Thomas Segiet, Veronika Sowa, Hans-Detlev Stahl, Franziska Steinfeldt, Madlen Teige, Bjoern Trieb, Diethelm Tschoepe, Peter Uebel, Bernd Warken, Ingo Weigmann, Klaus Weyland, Klara Wilhelm, Timea Balo, Miklos Balsay, Ilona Bende, Katalin Bezzegh, Zita Birkus, Barbara Buday, Melinda Csomai, Laszlo Deak, Eniko Dezso, Peter Faludi, M Faluvegi, Ilona Fazekas, Agota Feher, Csaba Fejer, Ervin Finta, Agnes Fulcz, Zsolt Gaal, Mihaly Gurzo, Krisztina Hati, Gabriella Herczeg, Ildiko Jozsef, Marta Juhasz, Katalin Keltai, Laszlo Koranyi, Eniko Kulcsar, Krisztina Kun, Andrea Laczko, Botond Literáti-Nagy, Izabella Mezo, Margit Mileder, I Moricz, Károly Nagy, Bela Nagybaczoni, Csaba Nemeth, Agnes Oze, Jozsef Pauer, Eva Peterfai, Bela Polocsanyi, Ferenc Poor, István Reiber, Csaba Salamon, Julia Sebestyen, Ildiko Torok, Marianna Tuu, Andrea Varga, Viktor Vass, Chul Min Ahn, Chulwoo Ahn, Park ByungWon, Hyuk-Jae Chang, Kiyuk Chang, Eui-Young Choi, Han Seok Choi, Jin-Wook Chung, Bum- Kee Hong, Young Joon Hong, Min Su Hyon, Myung Ho Jeong, Shinae Kang, Byeong-Keuk Kim, Ji-Hyun Kim, Ju Han Kim, Kee-Sik Kim, Moo Hyun Kim, Pum-Joon Kim, Soon-Kil Kim, Yong-Seok Kim, Young Kwon Kim, Yoon Seok Koh, Hyuck Moon Kwon, Byoung Kwon Lee, Byung-Wan Lee, Jin Bae Lee, Myoung-Mook Lee, Young-Mee Lim, Pil Ki Min, Jong Sung Park, Jongsuk Park, Keun Ho Park, Sungha Park, Wook Bum Pyun, Se Joong Rim, Dong-Ryeol Ryu, Hong-Seog Seo, Ki Bae Seung, Dong-Ho Shin, Doo Sun Sim, Young Won Yoon, Ilze Andersone, Kristine Babicka, Inga Balcere, Roberts Barons, Inguna Capkovska, Kristine Geldnere, Inese Grigane, Baiba Jegere, Ilze Lagzdina, Lija Mora, Sigita Pastare, Rota Ritenberga, Janina Romanova, Inta Saknite, Natalja Sidlovska, Jelena Sokolova, Sandra Steina, Iveta Strizko, Dace Teterovska, Brigita Vizina, Lina Barsiene, Gintare Belozariene, Laura Daugintyte-Petrusiene, Nijole Drungiliene, Nijole Garsviene, Ala Grigiene, Vytautas Grizas, Virginija Jociene, Dalia Kalvaitiene, Jugeta Kaupiene, Jurate Kavaliauskiene, Dalia Kozloviene, Ilona Lapteva, Birute Maneikiene, Jolanta Marcinkeviciene, Vaidilija Markauskiene, Salomeja Meiluniene, Almantas Norkus, Rita Norviliene, Vladimiras Petrenko, Ruta Radzeviciene, Gintare Sakalyte, Gediminas Urbonas, Skaiste Urbutiene, Donatas Vasiliauskas, Dzilda Velickiene, Carlos Aguilar, Marco Alcocer, Juan Antonio Avalos-Ramirez, Ramiro Banda-Elizondo, Rubria Bricio-Ramirez, Karla Cardenas Mejia, Francisco Cavazos, Jesus Chapa, Erika Cienfuegos, Astrid De la Peña, Gilberto de la Peña Topete, Manuel Odin De los Rios Ibarra, Daniel Elias, Claudia Flores-Moreno, Pedro Garcia Hernandez, Luis Gerardo Gonzalez, Rosa Linda Guerra Moya, Arturo Guerra-Lopez, Raymundo Hernandez Baylon, Carolina Herrera Colorado, Marisol Herrera-Marmolejo, Neri Islas-Palacios, Esteban Lopez, Fernando Lopez, Agustin Lopez Alvarado, Rosa Isela Luna Ceballos, Enrique Morales Villegas, Gualberto Moreno-Virgen, Rosa Linda Parra Perez, Sara Pascoe Gonzalez, Irving Peralta-Cantu, Roopa Previn, Rosa Ramirez, Rubria Ramirez, Maria Guadalupe Ramos Zavala, Monica Rodriguez, Rocio Salgado-Sedano, Ana Claudia Sanchez-Aguilar, Edith Santa Rosa Franco, Leobardo Sauque-Reyna, Rodrigo Suarez Otero, Ivonne Torres, Enrique Velarde-Harnandez, Juan Villagordoa, Efrain Villeda-Espinoza, Jorge Vital-Lopez, Cristian Jair Zavala- Bello, John Baker, Elaine Barrington-Ward, Thomas Brownless, Richard Carroll, Simon Carson, Michelle Choe, Andrew Corin, Brian Corley, Richard Cutfield, Neelam Dalaman, Paul Dixon, Paul Drury, Keith Dyson, Chris Florkowski, Monica Ford, William Frengley, Colin Helm, Colin Katzen, Jane Kerr, Manish Khanolkar, David Kim, Renata Koops, Jeremy Krebs, Robert Leikis, Kwan Low, Alison Luckey, Richard Luke, Susan Macaulay, Rodney Marks, Catherine McNamara, Dean Millar-Coote, Steven Miller, Naomi Mottershead, James Reid, Narcisa Robertson, Ian Rosen, David Rowe, Ole Schmiedel, Russell Scott, Jeffrey Sebastian, Davitt Sheahan, Victoria Stiebel, Ian Ternouth, Chris Tofield, Dirk Venter, Michael Williams, Miles Williams, Fiona Wu, Simon Young, Malgorzata Arciszewska, Anna Bochenek, Piotr Borkowski, Przemyslaw Borowy, Tomasz Chrzanowski, Edward Czerwinski, Marek Dwojak, Agnieszka Grodzicka, Izabela Janiec, Joanna Jaruga, Ewa Krystyna Jazwinska-Tarnawska, Krystyna Jedynasty, Danuta Juzwiak-Czapiewska, Jadwiga Karczewicz-Janowska, Jan Konieczny, Marek Konieczny, Marek Korol, Maciej Kozina, Ewa Krzyzagorska, Ewa Kucharczyk-Petryka, Roman Laz, Anna Majchrzak, Zdzislawa Mrozowska, Michal Mularczyk, Elzbieta Nowacka, Jadwiga Peczynska, Robert Petryka, Radoslaw Pietrzak, Dorota Pisarczyk-Wiza, Aleksandra Rozanska, Zofia Ruzga, Emilia Rzeszotarska, Malgorzata Sacha, Marzenna Sekulska, Anna Sidorowicz-Bialynicka, Teresa Stasinska, Agnieszka Strzelecka-Sosik, Teresa Swierszcz, Katarzyna Miroslawa Szymkowiak, Olga Turowska, Krystyna Wisniewska, Maciej Wiza, Iwona Wozniak, Katarzyna Zelazowska, Bernadetta Ziolkowska-Gawron, Danuta Zytkiewicz-Jaruga, Adrian Albota, Carmina Alexandru, Rodica Avram, Cornelia Bala, Diana Barbonta, Roxana Barbu, Daniela Braicu, Nicoleta Calutiu, Doina Catrinoiu, Anca Cerghizan, Alina Ciorba, Anca Craciun, Rodica Doros, Livia Duma, Ancuta Dumitrache, Ioana Ferariu, Anca Ferician Moza, Alexandrina Ghergan, Gheorghe Ghise, Mariana Graur, Mihaela Gribovschi, Bogdan Mihai, Laura Mihalache, Madalina Mihalcea, Nicoleta Mindrescu, Magdalena Morosanu, Andrea Morosoanu, Maria Mota, Anca Moza, Valerica Nafornita, Narcisa Natea, Simona Nicodim, Cristina Nita, Adriana Onaca, Mircea Onaca, Cristina Pop, Lavinia Pop, Amorin Popa, Alexandrina Popescu, Luchiana Pruna, Gabriela Roman, Mihaela Rosu, Alexandra Sima, Doina Sipciu, Carmen Narcisa Sitterli-Natea, Iosif Szilagyi, Minodora Tapurica, Adrian Tase, Adriana-Carmen Tutescu, Luminita Vanghelie, Ioana Verde, Adrian Vlad, Mihaela Zarnescu, Roman Akhmetov, Irina Allenova, Irina Avdeeva, Oksana Baturina, Irina Biserova, Nikolay Bokovin, Irina Bondar, Natalia Burova, Galina Chufeneva, Elena Chumachek, Marina Demidova, Alexander Demin, Vera Drobysheva, Irina Egorova, Lev Esenyan, Ekaterina Gelig, Sergey Gilyarevsky, Maria Golshmid, Arseniy Goncharov, Anastasia Gorbunova, Ivan Gordeev, Vera Gorelysheva, Tatiana Goryunova, Irina Grebenshchikova, Roman Ilchenko, Maria Ivannikova, Saule Karabalieva, Juliya Karpeeva, Elena Khaykina, Zhanna Kobalava, Irina Kononenko, Oxana Korolik, Anna Korshunova, Victor Kostenko, Irina Krasnopevtseva, Ludmila Krylova, Polina Kulkova, Irina Kuzmina, Alla Ledyaeva, Sergey Levashov, Natalia Lokhovinina, Vadim Lvov, Narine Martirosyan, Sergey Nedogoda, Rostislav Nilk, Yulia Osmolovskaya, Alexey Panov, Olga Paramonova, Ekaterina Pavlova, Elena Pekareva, Nina Petunina, Svetlana Ponamareva, Galina Reshedko, Alla Salasyuk, Malvina Sepkhanyan, Alexandr Serebrov, Olesya Shabelnikova, Andrey Skvortsov, Olga Smirnova, Oxana Spiridonova, Svetlana Strogova, Evgeny Taratukhin, Sergey Tereschenko, Lubov Trukhina, Olga Tsarkova, Vera Tsoma, Farid Tumarov, Natalya Tyan, Tatiana Tyurina, Svetlana Villevalde, Elena Yankovaya, Ludmila Zarutskaya, Elena Zenkova, Aysha Badat, Frederik Bester, Suzanne Blignaut, Dirk Blom, Susan Booysen, Warren Boyd, Brigitte Brice, Susan Brown, Lesley Burgess, Reina Cawood, Kathleen Coetzee, Hillet Conradie, Tanja Cronje, Douwe de Jong, Graham Ellis, Shaunagh Emanuel, Ingrid Engelbrecht, Sharne Foulkes, Done Fourie, Gilbert Gibson, Thirumani Govender, Sumayah Hansa, Allana Colleen Hemus, Firzana Hendricks, Marshall Heradien, Chantelle Holmgren, Zaheer Hoosain, Emile Horak, Johannes Howard, Ignatius Immink, E. Janari, Daksha Jivan, Karl Klusmann, Weik Labuschagne, Yen-yu Lai, Gulam Latiff, J. Lombaard, Hanlie Lottering, Ronel Meeding, Shirley Middlemost, Haroon Mitha, Ismail Mitha, Sandile Mkhwanazi, Rajendran Moodley, Almeri Murray, Dany Musungaie, Yasmin Osman, Kirsten Peacey, Larisha Pillay-Ramaya, Catharina Pretorius, Hans Prozesky, Mahomed Sarvan, E Scholtz, Attila Sebesteny, Bianca Skinner, Michael Skriker, M Smit, Anna-Marie Stapelberg, Nicolaas Swanepoel, Dorothea Urbach, Dina van Aswegen, Francois van Zyl, Louis Van Zyl, Esme Venter, Shahid Wadvalla, Jeffrey Wing, Karen Wolmarans, Cristina Abreu, Pilar Aguilà, Eva Aguilera, Nuria Alonso, Carmen Alvarez, Priscila Cajas, Jose Carlos Castro, Roger Codinachs, Jose Contreras, Maria Jose Coves, Carmen Fajardo, Juan Carlos Ferrer, Neus Font, Mar Garcia, Maria Apolonia Gil, Fernando Gomez, Lluis Alberto Gomez, Jose Gonzalbez, Jose Luis Griera, Luís Masmiquel, Didac Mauricio, Silvia Narejos Perez, Juana Ana Nicolau, Olga Noheda Contreras, Josefina Olivan, Josefina Olivares, Emilio Ortega, Silvia Pellitero, Salvador Pertusa, Ferran Rius, Irene Rodriguez, Carlos Sánchez-Juan, Dolores Santos, Berta Soldevila, David Subias, Manel Terns, Carlos Trescoli, Judith Vilaplana, Alicia Villanueva, Jaan Albo, Kjell Antus, Mattias Axelsson, Lisa Bergström, Emil Binsell-Gerdin, Kurt Boman, Fabian Botond, Annika Dotevall, Anna Graipe, C Jarnet, Jessica Kaminska, Anders Kempe, Michael Korhonen, Carina Linderfalk, Bo Liu, Karl Ljungstroem, Karl Ljungström, Lennart Malmqvist, Linda Mellbin, Thomas Mooe, Peter Nicol, Anders Norrby, Ake Ohlsson, Annika Rosengren, Jan Saaf, Staffan Salmonsson, Olof Strandberg, Karl-Axel Svensson, Bengt-Olov Tengmark, Georgios Tsatsaris, Anders Ulvenstam, Peter Vasko, Chwen-Tzuei Chang, Hsin-Mei Chang, Jung-Fu Chen, To-Pang Chen, Ming-Min Chung, Chia-Po Fu, Te-Lin Hsia, Shih-Che Hua, Ming-Chun Kuo, Chia-ln Lee, I-Te Lee, Kae-Woei Liang, Shih Yi Lin, Chieh-Hsiang Lu, Wen-Ya Ma, Dee Pei, Feng-Chih Shen, Ching-Chieh Su, Shuo-Wei Su, Tsai-Sung Tai, Wan-Ni Tsai, Yi-Ting Tsai, Shih-Chen Tung, Jun-Sing Wang, Hui-I Yu, Ahmed Al-Qaissi, Vijayaraman Arutchelvam, Stephen Atkin, Simon Au, Myint Myint Aye, Stephen Bain, Cristina Bejnariu, Patrick Bell, Deepak Bhatnagar, Rudy Bilous, Neil Black, Ursula Brennan, Barbara Brett, Jana Bujanova, Elaine Chow, Andrew Collier, Amanda Combe, Christopher Courtney, Hamish Courtney, James Crothers, Patrick Eavis, Jackie Elliott, Salvatore Febbraro, Jim Finlayson, Rajiv Gandhi, Sharon Gillings, Jonathan Hamling, Roy Harper, Tim Harris, Kahal Hassan, Simon Heller, Alison Jane, Zeeshan Javed, Tim Johnson, Stephen Jones, Adele Kennedy, David Kerr, Brian Kilgallon, Judith Konya, John Lindsay, Lina Lomova-Williams, Helen Looker, David MacFarlane, Sandra Macrury, Iqbal Malik, Rory McCrimmon, Douglas McKeith, John McKnight, Biswa Mishra, Racha Mukhtar, Ciara Mulligan, Maurice O'Kane, Tolu Olateju, Ian Orpen, Tristan Richardson, Desmond Rooney, Shorsha Bae Ross, Thozhukat Sathyapalan, Naveen Siddaramaiah, Lee Euan Sit, Jeffrey Stephens, Frances Turtle, Ammar Wakil, Emma Walkinshaw, Asem Ali, Robert Anderson, Richard Arakaki, Omar Aref, Mehrdad Kevin Ariani, David Arkin, Salomon Banarer, George Barchini, Arti Bhan, Kelley Branch, Donald Brautigam, Stephen Brietzke, Maridez Brinas, Yudit Brito, Casey Carter, Kimberely Casagni, Sabina Casula, Simon Chakko, Seth Charatz, Dale Childress, Lisa Chow, Malgorzata Chustecka, Subha Clarke, Lisa Cohen, Barry Collins, Gildred Colon Vega, Angel Comulada-Rivera, Gregorio Cortes-Maisonet, Matthew Davis, Jose de Souza, Cyrus Desouza, Mary Dinnan, Bobbi Duffy-Hidalgo, Barbara Dunn, Julia Dunn, Marshall Elman, James Felicetta, Stuart Finkelstein, David Fitz-Patrick, Hermes Florez, Alan Forker, Wayne Fowler, Sonja Fredrickson, Zachary Freedman, Brooke Gainey Narron, Kristin Gainey-Ferree, Michael Gardner, Christian Gastelum, Stephen Giddings, Eve Gillespie, Michael Paul Gimness, Gary Goldstein, Maria Gomes, Nelson Gomez, Timothy Gorman, Ketan Goswami, Arthur Graves, Scott Hacking, Charles Hall, Lenita Hanson, Sherman Harman, David Heber, Robert Henry, Janette Hiner, Irl Hirsch, Priscilla Hollander, Thomas Hooker, Barry Horowitz, Laura Hoste, Loli Huang, Minh Huynh, Dan Hyman, Soha Idriss, Ali Iranmanesh, Dennis Karounos, Moti Kashyap, Lois Katz, William Kaye, Yevgeniy Khaiton, Romesh Khardori, Timothy Kitchen, Andrew Klein, Wendi Knffem, Mikhail Kosiborod, Nicola Kreglinger, Davida Kruger, Anubhav Kumar, Ivan Laboy, Patricia Larrabee, Laura Larrick, Donna Lawson, Mike Ledet, James Lenhard, James Levy, George Li, Zhaoping Li, David Lieb, April Limcolioc, Jane Lions-Patterson, Daniel Lorber, Daniel Lorch, Michael Lorrello, Peter Lu, Kathryn Jean Lucas, Siu-Ling Ma, Michael MacAdams, Michelle Magee, Alexander Magno, Aparna Reddy Mahakala, Jennifer Marks, Anthony McCall, William McClanahan, Carole McClary, Lydia Melendez, John Melish, Deanna Michaud, Christopher Miller, Neil Miller, Pablo Mora, Marriyam Moten, Sunder Mudaliar, Gregory Myrick, Puneet Narayan, Mike Nassif, Karena Neri, Tabitha Newton, Patricia Niblack, Philip Nicol, Ebenezer Nyenwe, A. Ola Odugbesan, Yolanda Okorocha, Ramón Ortiz Carrasquillo, Kwame Osei, Coromoto Palermo, Hiren Patel, Krishna Patel, Cindy Pau, Michael Perley, Sanford Plevin, Elena Plummer, Richard Powell, Mohammed Qintar, Rex Rawls, John Reyes-Castano, Lillian Reynolds, Robert Richards, Julio Rosenstock, Caroline Rowe, Jahandar Saleh, Sony Sam, Alfredo Sanchez, Donald Sander, Bruce Sanderson, Virginia Savin, Elizabeth Seaquist, Jayendra Shah, Serena Shi, Vijay Shivaswamy, Tammi Shlotzhauer, David Shore, Bobbie Skukowski, Kyaw Soe, Vesna Solheim, Joseph Soufer, Helmut Steinberg, Jaime Steinsapir, Phillip Tarkington, Debra Thayer, Stephen Thomson, James Thrasher, Joseph Tibaldi, Jeff Tjaden, Oberto Tores, Dace Trence, Subbulaxmi Trikudanathan, Jagdeesh Ullal, Gabriel Uwaifo, Anthony Vo, Kenny Vu, Damandeep Walia, Karen Weiland, Fred Whitehouse, Thomas Wiegmann, Kathleen Wyne, Alan Wynne, Kevin Yuen, Joel Zaretzky, James Zebrack, Franklin Zieve, William Zigrang, and Everest

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Recombinant Fusion Proteins, Placebo-controlled study, Glucagon-Like Peptides, 030204 cardiovascular system & hematology, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Medicine, Albuminuria, Humans, Hypoglycemic Agents, Diabetic Nephropathies, 030212 general & internal medicine, Renal replacement therapy, Aged, Intention-to-treat analysis, business.industry, Hazard ratio, General Medicine, Middle Aged, medicine.disease, Immunoglobulin Fc Fragments, Diabetes Mellitus, Type 2, Creatinine, Dulaglutide, Female, business, medicine.drug, Kidney disease, Glomerular Filtration Rate
Abstract

Digital, Background: Two glucagon-like peptide-1 (GLP-1) receptor agonists reduced renal outcomes in people with type 2 diabetes at risk for cardiovascular disease. We assessed the long-term effect of the GLP-1 receptor agonist dulaglutide on renal outcomes in an exploratory analysis of the REWIND trial of the effect of dulaglutide on cardiovascular disease. Methods: REWIND was a multicentre, randomised, double-blind, placebo-controlled trial at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo and followed up at least every 6 months for outcomes. Urinary albumin-to-creatinine ratios (UACRs) and estimated glomerular filtration rates (eGFRs) were estimated from urine and serum values measured in local laboratories every 12 months. The primary outcome (first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes), secondary outcomes (including a composite microvascular outcome), and safety outcomes of this trial have been reported elsewhere. In this exploratory analysis, we investigate the renal component of the composite microvascular outcome, defined as the first occurrence of new macroalbuminuria (UACR >33·9 mg/mmol), a sustained decline in eGFR of 30% or more from baseline, or chronic renal replacement therapy. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01394952. Findings: Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). At baseline, 791 (7·9%) had macroalbuminuria and mean eGFR was 76·9 mL/min per 1·73 m2 (SD 22·7). During a median follow-up of 5·4 years (IQR 5·1-5·9) comprising 51 820 person-years, the renal outcome developed in 848 (17·1%) participants at an incidence rate of 3·5 per 100 person-years in the dulaglutide group and in 970 (19·6%) participants at an incidence rate of 4·1 per 100 person-years in the placebo group (hazard ratio [HR] 0·85, 95% CI 0·77-0·93; p=0·0004). The clearest effect was for new macroalbuminuria (HR 0·77, 95% CI 0·68-0·87; p, Ciencias Médicas y de la Salud

Published
2019

46. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial

Author

Hertzel C Gerstein, Helen M Colhoun, Gilles R Dagenais, Rafael Diaz, Mark Lakshmanan, Prem Pais, Jeffrey Probstfield, Jeffrey S Riesmeyer, Matthew C Riddle, Lars Rydén, Denis Xavier, Charles Messan Atisso, Leanne Dyal, Stephanie Hall, Purnima Rao-Melacini, Gloria Wong, Alvaro Avezum, Jan Basile, Namsik Chung, Ignacio Conget, William C Cushman, Edward Franek, Nicolae Hancu, Markolf Hanefeld, Shaun Holt, Petr Jansky, Matyas Keltai, Fernando Lanas, Lawrence A Leiter, Patricio Lopez-Jaramillo, Ernesto German Cardona Munoz, Valdis Pirags, Nana Pogosova, Peter J Raubenheimer, Jonathan E Shaw, Wayne H-H Sheu, Theodora Temelkova-Kurktschiev, Mercedes Abella, Andrea Alebuena, Sandra Almagro, Eduardo Amoroso, Paula Anadon, Elizabeth Andreu, Guillermo Aristimuño, Maria Arzadun, Maria Barbieri, Raul Barcudi, Ines Bartolacci, Gabriel Bolobanich, Anselmo Bordonava, Miguel Bustamante Labarta, Betina Bustos, Alberto Caccavo, Alejandra Camino, Maria Cantero, Maria Carignano, Luis Cartasegna, Marcela Cipullo, Víctor Commendatore, Victoria Conosciuto, Osvaldo Costamagna, Claudia Crespo, Jose Cuello, Carlos Cuneo, Sandra Cusimano, Sofia Dean, Claudio Dituro, Andrea Dominguez, Miguel Farah, Alberto Fernandez, Florencia Fernandez, Adriana Ferrari, Patricia Flammia, Jose Fuentealba, Karina Beatriz Gallardo, Celso Garcia, Ruben Garcia Duran, Marcelo Garrido, Rodolfo Gavicola, Claudio Gerbaudo, Graciela Gilli, Ana Paula Giotto, Pedro Godoy Bolzán, Oscar Gomez Vilamajo, Fernando Guerlloy, Cristian Guridi, Narcisa Gutierrez Garrido, Eduardo Hasbani, Sonia Hermida, Miguel Hominal, Adrian Hrabar, Adrián Ingaramo, Alejandra Izzicupo, Mario Krynski, Mariana Lagrutta, Paulina Lanchiotti, Maria Langhe, Veronica Leonard, Javier Llanos, Ricardo Lopez Santi, Jorge Lowenstein, Cecilia Luquez, Ignacio Mackinnon, Melina Mana, Sara Manzur, Javier Marino, Carolina Martella, Roger Martinez, Re Matias, Javier Matkovich, Monica Meritano, Oscar Montaña, María Mulazzi, Juan Ochoa, Gustavo Paterlini, María Pelagagge, Maria Elena Peralta Lopez, Aldo Prado, Lorena Pruyas, Martín Racca, Carola Ricotti, Carolina Rodriguez, Mariano Romero Vidomlansky, Ricardo Ronderos, Ana Laura Sadowski, Jorgelina Sala, Alejandro Sánchez, Andrea Santoro, Lilia Schiavi, Mariano Sein, Virginia Sernia, Leonardo Serra, Maximiliano Sicer, Tomas Smith, Leonardo Soso, Georgina Sposetti, Andrea Steinacher, Jorge Stival, Jorge Tedesco, Hugo Tonin, Mauro Tortolo, Maria Ulla, Julio Vallejos, Marisa Vico, Luciana Virgillito, Virginia Visco, Daniel Vogel, Florencia Waisman, César Zaidman, Noemi Zucchiatti, Imran Badshah, Neale Cohen, Peter Colman, David Colquhoun, Timothy Davis, Spiros Fourlanos, Greg Fulcher, Jane Hamlyn, Cilla Haywood, Samantha Hocking, Maeve Huchinson, William Jeffries, Mervyn Kyl, Clement Lo, PeakMann Mah, Ashley Makepeace, Dolly Marope, Natalie Nanayakkar, Alison Nankervis, Neil Palmer, Barbara Palolus, Satish Pillai, Sarah Price, Joseph Proietto, Anne Reutens, Natassia Rodrigo, Abdul Sheikh, Greg Smith, Michelle So, Georgia Soldatos, Bronwyn Stuckey, Priya Sumithran, Helena Teede, Parind Vora, Lyn Williams, Eduardo Abib, Christiani Adão Poço, Érica Ferreira Alves, Janaina Andreatta Bernardi Barea, Livia Avezum Oliveira, Denise Ludovico da Costa de Castro, Ivan Correa da Cruz, Midiã Costa, Ivan Cruz, Sidney Cunha, Marco Antonio Vieira Da Silva, Renata de Carvalho Camara Bona, Bruna de Paula, Freddy Eliaschewitz, Guilherme Fazolli, Carlos Alberto Ferreira Filho, Jose Fortes, Cesar França, Denise Reis Franco, Paulo Roberto Genestreti, Flavio Giorgeto, Rodrigo Marques Gonçalves, Michele Elka Grossman, Ana Claudia Henrique Marcelino, Mauro Hernandes, Ana Horta, Cristiano Jaeger, Midia Kaneblai, Cecilia Kauffman Rutenberg, Jose Francisco Kerr Saraiva, Maria Angelica Lemos, Lilia Maia, Euler Roberto Manenti, Mariana Marques, Cynthia Melissa Valerio, Rodrigo Moreira, Flávia Mothé, Osana Maria Mouco, Philip Moura, José Carlos Moura Jorge, Carlos Nakashima, Marcelo Nakazone, Thiago Napoli, Cristiane Nunes, Joao Eduardo Nunes Salles, Karla Oliveira, Marcela Oliveira, Gracielly de Souza Pantano, Fabio Petri, Leonardo Piazza, Andreia Carla Pires, Patricia Pizzato, Sergio Prata, Dalton Precoma, Rafael Rech, Gilmar Reis, Heleno Reis, Elisabete Resende, Jose Ribas Fortes, Sylka Rodovalho, Fabio Rossi dos Santos, Joao Eduardo Salles, Célia Regina Sampaio, Thiago Santos, Vanessa Santos dos Santos, Tulio Silva e Quadros, Daniel Silveira, Katia Nunes Siqueira, M Teireira, Marcelo Uehara, C Valerio, Henrique Vianna, Maria Helena Vidotti, Guilherme de Lima Visconti, Maria Teresa Zanella, Viktoriya Andreeva, Radoslav Borisov, Nikolay Botushanov, Georgi Dimitrov, Kameliya Dimova, Tsvetan Dragoychev, Valentina Grigorova, Valentina Gushterova, Ivaylo Ivanov, Tatyana Kocelova, Dimo Kurktschiev, Milena Miletieva, Neli Nenkova-Gugusheva, Ralitsa Pancheva, Maria Pavlova, Dimitar Raev, Vesela Spasova, Anastas Stoikov, Dimitar Troev, Todor Yanev, Mariana Yoncheva-Mihaylova, Alexander Abitbol, Buki Ajala, Abdullh Alguwaihes, Jean-Luc Ardilouze, Nahla Aris-Jilwan, Amel Arnaout, Ronnie Aronson, Nadeem Aslam, Sandra Babin, Jean-Patrice Bailargeon, Allan Bailey, Harpreet Bajaj, Christian Beauchesne, Sorin Beca, Andre Belanger, Alan Bell, Diego Bellabarba, Lori Berard, Brian Berenbaum, Vincent Bergeron, Joseph Berlingieri, Frédéric Bernier, Phoebe Bishara, David Blank, Ian Blumer, Suzanne Brault, Donald Breton, André Carpentier, James Cha, Prakash Chandra, Jean-Louis Chiasson, James R Conway, Ghyslaine Couture, Nathalie Couture, Gilles Dagenais, Dyotirmoy Datta, Giuseppe D'Ignazio, Richard Dumas, Didier Fay, Andre Frechette, Louise Frenette, Daisy Fung, Nathalie Gagnon, Meri Galter, Jean Garon, Jean Sebastien Gauthier, Christian Geadah, Jeremy Gilbert, Ronald Girard, Ronald Goldenberg, Loren David Grossman, Nikhil Gupta, Jean-Pierre Halle, Marie-France Hivert, Ghislaine Houde, Robyn Houlden, Irene Hramiak, Ted Jablonski, Akshay Jain Jain, Hasnain Khandwala, Munish Khosla, C Lachance, Emilie Laflamme, Marie-France Langlois, Luc Larivee, Joanne Liutkus, Heather Lochnan, Saleem Malik, Charlotte McDonald, Pravinsagar Mehta, John Mihailidis, Alain Milot, Priya Narula, Patrice Nault, Arun Nayar, William Nisker, Gilles Ouellet, Jean Palardy, Minta Patel, Terri Paul, Sue Pedersen, Patrice Perron, Marie-Hélène Pesant, Paul Poirier, Marie-Claude Poulin, Zubin Punthakee, Waheed Rehman, Stuart Ross, P Sagar, Nouhad Saliba, Sam Sandler, Alicia Schiffrin, Robert Schlosser, Anila Seth-Sharma, Mark Sherman, David Sionit, Tharsan Sivakumar, Juan Soto, Eric St-Amour, Oren Steen, Jack Sussman, Adam Telner, Sheldon Tobe, David-Yaw Twum-Barima, Audrey Van Zanten, Nicole VanRossum, Jonathan Vecchiarelli, Rick Ward, John Wessengel, Stanley Weisnagel, Igor Wilderman, Vincent Woo, Natalia Yakubovich, Jean-Francois Yale, Zeina Yared, Monica Acevedo, Maria Loreto Aguirre, Andres Aizman, Maria Soledad Barroso, Leonardo Cobos, Alfredo Danin Vargas, Barbara Descalzi, Gonzalo Godoy, Elio Grumberg, Rodolfo Lahsen, Gladys Larenas, Eugenia Ortiz, Javier Paredes, Sergio Potthoff, Eva Retamal, Luis Rojas, Manuel Salgado, Claudio Santibanez, Carmen Solis, Benjamin Stokins, Jose Accini, Javier Acebedo, Lina Maria Agudelo Baena, Soraya Alarcon, Juliana Angel, Edgar Arcos, M Aroca Martinez, Leonor Atuesta, Jose Balaguera, Doris Ballestas, Sandra Isabel Barrera, Rosmy Barrios Reyes, Adolfo Bayona, Andres Bermudez, Diego Zarate Bernal, Marco Blanquicett, Victor Bravo, Wendy Bueno, Alvaro Burbano Delgado, Alberto Cadena, Andres Cadena, Sandra Caicedo, Carlos Celemin, Ricardo Consuegra, Cristhian Contreras Pimienta, Kelly Johenis Corredor, Carlos Cure, Lizeth Dayana De La Hoz Rueda, Erika Delgado, Sarahy Diaz, Marta Diego, Anabell Donado, William Encinales Sanabria, Juliana Escobar, Gillian Escorcia, Leonardo Forero, Laura Fuentes, Maria Garcia, Henry Garcia Lozada, Luis Garcia Ortiz, Angela Giraldo, Laura Gomez Gonzalez, Javier Granada, Corina Gutierrez, Natalia Henao, Edwin Hernandez, Olga Maria Herrera Uejbe, Juan Diego Higuera Cobos, Jaime Ibarra Gómez, Edwin Hernandez Jaimes, Monica Jaramillo, Nicolas Jaramillo, Carlos Jaramillo Gomez, Monica Jaramillo Sanchez, Ivonne Jarava Durán, Catalina Lopez Ceballos, Claudia Madrid, Elias María Amastha, Jennifer Mercado, Dora Ines Molina, Jessica Molina Soto, Carlos Montoya, Alexander Morales, Carolina Muñoz, Luis Alejandro Orozco, Oscar Osorio, Jorge Mario Palmera Sanchez, Adwar Peña, Jose Perez, Juan Perez Agudelo, Germán Pérez Amador, Carlos Pertuz, Irina Posada, Carlos Puerta, Adalberto Quintero, Diana Quiroz, Carmen Rendon, Alberto Reyes, Alvaro Reyes, Diana Ripoll, Carlos Rivera, Maria Rocha, Jose F Rodriguez, Kervis Asid Rodriguez Villanueva, Javier Emilio Rodriguez Zabala, Sindy Rojas, Maria Romero, Ricardo Rosero, Angelica Rocio Rosillo Cardenas, Lina Rueda, Gregorio Sanchez, Tatiana Sanchez, Arístides Sotomayor Herazo, Monica Suarez, Mariana Torres, Freddy Trujillo, Miguel Urina, Lazaro Van Strahlen, Carlos Velandia, Carolina Velasquez Guzman, Elizabeth Velazquez, Tatiana Vidal Prada, Juan Pablo Yepez Alvaran, Diego Zarate, Jana Andelova, Radka Benesova, Barbara Buzova, Vladimir Cech, Ida Chodova, Miroslav Choura, Antonin Dufka, Andrea Gamova, Jakub Gorgol, Tomas Hala, Hana Havlova, Dagmar Hlavkova, Petra Horanska, Juliana Ilcisin-Valova, Petra Jenickova, Ondrej Jerabek, Ilona Kantorova, Katerina Kolomaznikova, Iva Kopeckova, Miroslava Kopeckova, Karel Linhart, Tomas Linhart, Jan Malecha, Emilia Malicherova, Dana Neubauerova, Martina Oznerova, Radan Partys, Eva Pederzoliova, Maria Petrusova, Vera Prymkova, Eva Racicka, Ida Reissova, Eva Roderova, Libor Stanek, Alena Striova, Dana Svarcova, Petr Svoboda, Emilia Szeghy Malicharova, Jan Urge, Ladislav Vesely, Bedich Wasserburger, Hilde Wasserburgerova, Emil Zahumensky, Vaclav Zamrazil, Hasan Alawi, Ernestos Anastasiadis, Elisabeth Axthelm, Tasso Bieler, Christina Buhrig, Elizaveta Degtyareva, Frank Dellanna, Karl-Michael Derwahl, Stephan Diessel, Barbara Dogiami, Kirsten Dorn-Weitzel, Monika Ernst, Grit Faulmann, Baerbel Fetscher, Thomas Forst, Gabriele Freyer-Lahres, Klaus Funke, Xenia Ganz, Christiane Gleixner, Christoph Hanefeld, Sven Heinrichs, Stephanie Helleberg, Elena Henkel, Gerd Ruediger Hetzel, Caren Hoffmann, Frohmut Jacob, Stephan Jacob, Franziska John, Antonius Jonczyk, Wolfram Kamke, Christiane Klein, Martina Kleinhardt, Werner Kleophas, Christine Kosch, Kristin Kreutzmann, Achim Kühn, Young Hee Lee-Barkey, Alexander Lier, Sarah Maatouk, Joachim Minnich, Michael Mitry, Ilona Muessig, Diana Nicula, Martina Niemann, Joerg Nothroff, Petra Ott, Andreas Pfuetzner, Andreas Pfützner, Frank Pistrosch, Wildgard Pohl, Zdenka Prochazkova, Marlena Retkowska, Heiko Rosin, Daniela Sachsenheimer, Holger Samer, Mazin Sanuri, Axel Schaefer, Frank Schaper, Erik-Delf Schulze, Marita Schulze, Martina Schumann, Thomas Segiet, Veronika Sowa, Hans-Detlev Stahl, Franziska Steinfeldt, Madlen Teige, Bjoern Trieb, Diethelm Tschoepe, Peter Uebel, Bernd Warken, Ingo Weigmann, Klaus Weyland, Klara Wilhelm, Timea Balo, Miklos Balsay, Ilona Bende, Katalin Bezzegh, Zita Birkus, Barbara Buday, Melinda Csomai, Laszlo Deak, Eniko Dezso, Peter Faludi, M Faluvegi, Ilona Fazekas, Agota Feher, Csaba Fejer, Ervin Finta, Agnes Fulcz, Zsolt Gaal, Mihaly Gurzo, Krisztina Hati, Gabriella Herczeg, Ildiko Jozsef, Marta Juhasz, Katalin Keltai, Laszlo Koranyi, Eniko Kulcsar, Krisztina Kun, Andrea Laczko, Botond Literáti-Nagy, Izabella Mezo, Margit Mileder, I Moricz, Károly Nagy, Bela Nagybaczoni, Csaba Nemeth, Agnes Oze, Jozsef Pauer, Eva Peterfai, Bela Polocsanyi, Ferenc Poor, István Reiber, Csaba Salamon, Julia Sebestyen, Ildiko Torok, Marianna Tuu, Andrea Varga, Viktor Vass, Chul Min Ahn, Chulwoo Ahn, Park ByungWon, Hyuk-Jae Chang, Kiyuk Chang, Eui-Young Choi, Han Seok Choi, Jin-Wook Chung, Bum- Kee Hong, Young Joon Hong, Min Su Hyon, Myung Ho Jeong, Shinae Kang, Byeong-Keuk Kim, Ji-Hyun Kim, Ju Han Kim, Kee-Sik Kim, Moo Hyun Kim, Pum-Joon Kim, Soon-Kil Kim, Yong-Seok Kim, Young Kwon Kim, Yoon Seok Koh, Hyuck Moon Kwon, Byoung Kwon Lee, Byung-Wan Lee, Jin Bae Lee, Myoung-Mook Lee, Young-Mee Lim, Pil Ki Min, Jong Sung Park, Jongsuk Park, Keun Ho Park, Sungha Park, Wook Bum Pyun, Se Joong Rim, Dong-Ryeol Ryu, Hong-Seog Seo, Ki Bae Seung, Dong-Ho Shin, Doo Sun Sim, Young Won Yoon, Ilze Andersone, Kristine Babicka, Inga Balcere, Roberts Barons, Inguna Capkovska, Kristine Geldnere, Inese Grigane, Baiba Jegere, Ilze Lagzdina, Lija Mora, Sigita Pastare, Rota Ritenberga, Janina Romanova, Inta Saknite, Natalja Sidlovska, Jelena Sokolova, Sandra Steina, Iveta Strizko, Dace Teterovska, Brigita Vizina, Lina Barsiene, Gintare Belozariene, Laura Daugintyte-Petrusiene, Nijole Drungiliene, Nijole Garsviene, Ala Grigiene, Vytautas Grizas, Virginija Jociene, Dalia Kalvaitiene, Jugeta Kaupiene, Jurate Kavaliauskiene, Dalia Kozloviene, Ilona Lapteva, Birute Maneikiene, Jolanta Marcinkeviciene, Vaidilija Markauskiene, Salomeja Meiluniene, Almantas Norkus, Rita Norviliene, Vladimiras Petrenko, Ruta Radzeviciene, Gintare Sakalyte, Gediminas Urbonas, Skaiste Urbutiene, Donatas Vasiliauskas, Dzilda Velickiene, Carlos Aguilar, Marco Alcocer, Juan Antonio Avalos-Ramirez, Ramiro Banda-Elizondo, Rubria Bricio-Ramirez, Karla Cardenas Mejia, Francisco Cavazos, Jesus Chapa, Erika Cienfuegos, Astrid De la Peña, Gilberto de la Peña Topete, Manuel Odin De los Rios Ibarra, Daniel Elias, Claudia Flores-Moreno, Pedro Garcia Hernandez, Luis Gerardo Gonzalez, Rosa Linda Guerra Moya, Arturo Guerra-Lopez, Raymundo Hernandez Baylon, Carolina Herrera Colorado, Marisol Herrera-Marmolejo, Neri Islas-Palacios, Esteban Lopez, Fernando Lopez, Agustin Lopez Alvarado, Rosa Isela Luna Ceballos, Enrique Morales Villegas, Gualberto Moreno-Virgen, Rosa Linda Parra Perez, Sara Pascoe Gonzalez, Irving Peralta-Cantu, Roopa Previn, Rosa Ramirez, Rubria Ramirez, Maria Guadalupe Ramos Zavala, Monica Rodriguez, Rocio Salgado-Sedano, Ana Claudia Sanchez-Aguilar, Edith Santa Rosa Franco, Leobardo Sauque-Reyna, Rodrigo Suarez Otero, Ivonne Torres, Enrique Velarde-Harnandez, Juan Villagordoa, Efrain Villeda-Espinoza, Jorge Vital-Lopez, Cristian Jair Zavala- Bello, John Baker, Elaine Barrington-Ward, Thomas Brownless, Richard Carroll, Simon Carson, Michelle Choe, Andrew Corin, Brian Corley, Richard Cutfield, Neelam Dalaman, Paul Dixon, Paul Drury, Keith Dyson, Chris Florkowski, Monica Ford, William Frengley, Colin Helm, Colin Katzen, Jane Kerr, Manish Khanolkar, David Kim, Renata Koops, Jeremy Krebs, Robert Leikis, Kwan Low, Alison Luckey, Richard Luke, Susan Macaulay, Rodney Marks, Catherine McNamara, Dean Millar-Coote, Steven Miller, Naomi Mottershead, James Reid, Narcisa Robertson, Ian Rosen, David Rowe, Ole Schmiedel, Russell Scott, Jeffrey Sebastian, Davitt Sheahan, Victoria Stiebel, Ian Ternouth, Chris Tofield, Dirk Venter, Michael Williams, Miles Williams, Fiona Wu, Simon Young, Malgorzata Arciszewska, Anna Bochenek, Piotr Borkowski, Przemyslaw Borowy, Tomasz Chrzanowski, Edward Czerwinski, Marek Dwojak, Agnieszka Grodzicka, Izabela Janiec, Joanna Jaruga, Ewa Krystyna Jazwinska-Tarnawska, Krystyna Jedynasty, Danuta Juzwiak-Czapiewska, Jadwiga Karczewicz-Janowska, Jan Konieczny, Marek Konieczny, Marek Korol, Maciej Kozina, Ewa Krzyzagorska, Ewa Kucharczyk-Petryka, Roman Laz, Anna Majchrzak, Zdzislawa Mrozowska, Michal Mularczyk, Elzbieta Nowacka, Jadwiga Peczynska, Robert Petryka, Radoslaw Pietrzak, Dorota Pisarczyk-Wiza, Aleksandra Rozanska, Zofia Ruzga, Emilia Rzeszotarska, Malgorzata Sacha, Marzenna Sekulska, Anna Sidorowicz-Bialynicka, Teresa Stasinska, Agnieszka Strzelecka-Sosik, Teresa Swierszcz, Katarzyna Miroslawa Szymkowiak, Olga Turowska, Krystyna Wisniewska, Maciej Wiza, Iwona Wozniak, Katarzyna Zelazowska, Bernadetta Ziolkowska-Gawron, Danuta Zytkiewicz-Jaruga, Adrian Albota, Carmina Alexandru, Rodica Avram, Cornelia Bala, Diana Barbonta, Roxana Barbu, Daniela Braicu, Nicoleta Calutiu, Doina Catrinoiu, Anca Cerghizan, Alina Ciorba, Anca Craciun, Rodica Doros, Livia Duma, Ancuta Dumitrache, Ioana Ferariu, Anca Ferician Moza, Alexandrina Ghergan, Gheorghe Ghise, Mariana Graur, Mihaela Gribovschi, Bogdan Mihai, Laura Mihalache, Madalina Mihalcea, Nicoleta Mindrescu, Magdalena Morosanu, Andrea Morosoanu, Maria Mota, Anca Moza, Valerica Nafornita, Narcisa Natea, Simona Nicodim, Cristina Nita, Adriana Onaca, Mircea Onaca, Cristina Pop, Lavinia Pop, Amorin Popa, Alexandrina Popescu, Luchiana Pruna, Gabriela Roman, Mihaela Rosu, Alexandra Sima, Doina Sipciu, Carmen Narcisa Sitterli-Natea, Iosif Szilagyi, Minodora Tapurica, Adrian Tase, Adriana-Carmen Tutescu, Luminita Vanghelie, Ioana Verde, Adrian Vlad, Mihaela Zarnescu, Roman Akhmetov, Irina Allenova, Irina Avdeeva, Oksana Baturina, Irina Biserova, Nikolay Bokovin, Irina Bondar, Natalia Burova, Galina Chufeneva, Elena Chumachek, Marina Demidova, Alexander Demin, Vera Drobysheva, Irina Egorova, Lev Esenyan, Ekaterina Gelig, Sergey Gilyarevsky, Maria Golshmid, Arseniy Goncharov, Anastasia Gorbunova, Ivan Gordeev, Vera Gorelysheva, Tatiana Goryunova, Irina Grebenshchikova, Roman Ilchenko, Maria Ivannikova, Saule Karabalieva, Juliya Karpeeva, Elena Khaykina, Zhanna Kobalava, Irina Kononenko, Oxana Korolik, Anna Korshunova, Victor Kostenko, Irina Krasnopevtseva, Ludmila Krylova, Polina Kulkova, Irina Kuzmina, Alla Ledyaeva, Sergey Levashov, Natalia Lokhovinina, Vadim Lvov, Narine Martirosyan, Sergey Nedogoda, Rostislav Nilk, Yulia Osmolovskaya, Alexey Panov, Olga Paramonova, Ekaterina Pavlova, Elena Pekareva, Nina Petunina, Svetlana Ponamareva, Galina Reshedko, Alla Salasyuk, Malvina Sepkhanyan, Alexandr Serebrov, Olesya Shabelnikova, Andrey Skvortsov, Olga Smirnova, Oxana Spiridonova, Svetlana Strogova, Evgeny Taratukhin, Sergey Tereschenko, Lubov Trukhina, Olga Tsarkova, Vera Tsoma, Farid Tumarov, Natalya Tyan, Tatiana Tyurina, Svetlana Villevalde, Elena Yankovaya, Ludmila Zarutskaya, Elena Zenkova, Aysha Badat, Frederik Bester, Suzanne Blignaut, Dirk Blom, Susan Booysen, Warren Boyd, Brigitte Brice, Susan Brown, Lesley Burgess, Reina Cawood, Kathleen Coetzee, Hillet Conradie, Tanja Cronje, Douwe de Jong, Graham Ellis, Shaunagh Emanuel, Ingrid Engelbrecht, Sharne Foulkes, Done Fourie, Gilbert Gibson, Thirumani Govender, Sumayah Hansa, Allana Colleen Hemus, Firzana Hendricks, Marshall Heradien, Chantelle Holmgren, Zaheer Hoosain, Emile Horak, Johannes Howard, Ignatius Immink, E. Janari, Daksha Jivan, Karl Klusmann, Weik Labuschagne, Yen-yu Lai, Gulam Latiff, J. Lombaard, Hanlie Lottering, Ronel Meeding, Shirley Middlemost, Haroon Mitha, Ismail Mitha, Sandile Mkhwanazi, Rajendran Moodley, Almeri Murray, Dany Musungaie, Yasmin Osman, Kirsten Peacey, Larisha Pillay-Ramaya, Catharina Pretorius, Hans Prozesky, Mahomed Sarvan, E Scholtz, Attila Sebesteny, Bianca Skinner, Michael Skriker, M Smit, Anna-Marie Stapelberg, Nicolaas Swanepoel, Dorothea Urbach, Dina van Aswegen, Francois van Zyl, Louis Van Zyl, Esme Venter, Shahid Wadvalla, Jeffrey Wing, Karen Wolmarans, Cristina Abreu, Pilar Aguilà, Eva Aguilera, Nuria Alonso, Carmen Alvarez, Priscila Cajas, Jose Carlos Castro, Roger Codinachs, Jose Contreras, Maria Jose Coves, Carmen Fajardo, Juan Carlos Ferrer, Neus Font, Mar Garcia, Maria Apolonia Gil, Fernando Gomez, Lluis Alberto Gomez, Jose Gonzalbez, Jose Luis Griera, Luís Masmiquel, Didac Mauricio, Silvia Narejos Perez, Juana Ana Nicolau, Olga Noheda Contreras, Josefina Olivan, Josefina Olivares, Emilio Ortega, Silvia Pellitero, Salvador Pertusa, Ferran Rius, Irene Rodriguez, Carlos Sánchez-Juan, Dolores Santos, Berta Soldevila, David Subias, Manel Terns, Carlos Trescoli, Judith Vilaplana, Alicia Villanueva, Jaan Albo, Kjell Antus, Mattias Axelsson, Lisa Bergström, Emil Binsell-Gerdin, Kurt Boman, Fabian Botond, Annika Dotevall, Anna Graipe, C Jarnet, Jessica Kaminska, Anders Kempe, Michael Korhonen, Carina Linderfalk, Bo Liu, Karl Ljungstroem, Karl Ljungström, Lennart Malmqvist, Linda Mellbin, Thomas Mooe, Peter Nicol, Anders Norrby, Ake Ohlsson, Annika Rosengren, Jan Saaf, Staffan Salmonsson, Olof Strandberg, Karl-Axel Svensson, Bengt-Olov Tengmark, Georgios Tsatsaris, Anders Ulvenstam, Peter Vasko, Chwen-Tzuei Chang, Hsin-Mei Chang, Jung-Fu Chen, To-Pang Chen, Ming-Min Chung, Chia-Po Fu, Te-Lin Hsia, Shih-Che Hua, Ming-Chun Kuo, Chia-ln Lee, I-Te Lee, Kae-Woei Liang, Shih Yi Lin, Chieh-Hsiang Lu, Wen-Ya Ma, Dee Pei, Feng-Chih Shen, Ching-Chieh Su, Shuo-Wei Su, Tsai-Sung Tai, Wan-Ni Tsai, Yi-Ting Tsai, Shih-Chen Tung, Jun-Sing Wang, Hui-I Yu, Ahmed Al-Qaissi, Vijayaraman Arutchelvam, Stephen Atkin, Simon Au, Myint Myint Aye, Stephen Bain, Cristina Bejnariu, Patrick Bell, Deepak Bhatnagar, Rudy Bilous, Neil Black, Ursula Brennan, Barbara Brett, Jana Bujanova, Elaine Chow, Andrew Collier, Amanda Combe, Christopher Courtney, Hamish Courtney, James Crothers, Patrick Eavis, Jackie Elliott, Salvatore Febbraro, Jim Finlayson, Rajiv Gandhi, Sharon Gillings, Jonathan Hamling, Roy Harper, Tim Harris, Kahal Hassan, Simon Heller, Alison Jane, Zeeshan Javed, Tim Johnson, Stephen Jones, Adele Kennedy, David Kerr, Brian Kilgallon, Judith Konya, John Lindsay, Lina Lomova-Williams, Helen Looker, David MacFarlane, Sandra Macrury, Iqbal Malik, Rory McCrimmon, Douglas McKeith, John McKnight, Biswa Mishra, Racha Mukhtar, Ciara Mulligan, Maurice O'Kane, Tolu Olateju, Ian Orpen, Tristan Richardson, Desmond Rooney, Shorsha Bae Ross, Thozhukat Sathyapalan, Naveen Siddaramaiah, Lee Euan Sit, Jeffrey Stephens, Frances Turtle, Ammar Wakil, Emma Walkinshaw, Asem Ali, Robert Anderson, Richard Arakaki, Omar Aref, Mehrdad Kevin Ariani, David Arkin, Salomon Banarer, George Barchini, Arti Bhan, Kelley Branch, Donald Brautigam, Stephen Brietzke, Maridez Brinas, Yudit Brito, Casey Carter, Kimberely Casagni, Sabina Casula, Simon Chakko, Seth Charatz, Dale Childress, Lisa Chow, Malgorzata Chustecka, Subha Clarke, Lisa Cohen, Barry Collins, Gildred Colon Vega, Angel Comulada-Rivera, Gregorio Cortes-Maisonet, Matthew Davis, Jose de Souza, Cyrus Desouza, Mary Dinnan, Bobbi Duffy-Hidalgo, Barbara Dunn, Julia Dunn, Marshall Elman, James Felicetta, Stuart Finkelstein, David Fitz-Patrick, Hermes Florez, Alan Forker, Wayne Fowler, Sonja Fredrickson, Zachary Freedman, Brooke Gainey Narron, Kristin Gainey-Ferree, Michael Gardner, Christian Gastelum, Stephen Giddings, Eve Gillespie, Michael Paul Gimness, Gary Goldstein, Maria Gomes, Nelson Gomez, Timothy Gorman, Ketan Goswami, Arthur Graves, Scott Hacking, Charles Hall, Lenita Hanson, Sherman Harman, David Heber, Robert Henry, Janette Hiner, Irl Hirsch, Priscilla Hollander, Thomas Hooker, Barry Horowitz, Laura Hoste, Loli Huang, Minh Huynh, Dan Hyman, Soha Idriss, Ali Iranmanesh, Dennis Karounos, Moti Kashyap, Lois Katz, William Kaye, Yevgeniy Khaiton, Romesh Khardori, Timothy Kitchen, Andrew Klein, Wendi Knffem, Mikhail Kosiborod, Nicola Kreglinger, Davida Kruger, Anubhav Kumar, Ivan Laboy, Patricia Larrabee, Laura Larrick, Donna Lawson, Mike Ledet, James Lenhard, James Levy, George Li, Zhaoping Li, David Lieb, April Limcolioc, Jane Lions-Patterson, Daniel Lorber, Daniel Lorch, Michael Lorrello, Peter Lu, Kathryn Jean Lucas, Siu-Ling Ma, Michael MacAdams, Michelle Magee, Alexander Magno, Aparna Reddy Mahakala, Jennifer Marks, Anthony McCall, William McClanahan, Carole McClary, Lydia Melendez, John Melish, Deanna Michaud, Christopher Miller, Neil Miller, Pablo Mora, Marriyam Moten, Sunder Mudaliar, Gregory Myrick, Puneet Narayan, Mike Nassif, Karena Neri, Tabitha Newton, Patricia Niblack, Philip Nicol, Ebenezer Nyenwe, A. Ola Odugbesan, Yolanda Okorocha, Ramón Ortiz Carrasquillo, Kwame Osei, Coromoto Palermo, Hiren Patel, Krishna Patel, Cindy Pau, Michael Perley, Sanford Plevin, Elena Plummer, Richard Powell, Mohammed Qintar, Rex Rawls, John Reyes-Castano, Lillian Reynolds, Robert Richards, Julio Rosenstock, Caroline Rowe, Jahandar Saleh, Sony Sam, Alfredo Sanchez, Donald Sander, Bruce Sanderson, Virginia Savin, Elizabeth Seaquist, Jayendra Shah, Serena Shi, Vijay Shivaswamy, Tammi Shlotzhauer, David Shore, Bobbie Skukowski, Kyaw Soe, Vesna Solheim, Joseph Soufer, Helmut Steinberg, Jaime Steinsapir, Phillip Tarkington, Debra Thayer, Stephen Thomson, James Thrasher, Joseph Tibaldi, Jeff Tjaden, Oberto Tores, Dace Trence, Subbulaxmi Trikudanathan, Jagdeesh Ullal, Gabriel Uwaifo, Anthony Vo, Kenny Vu, Damandeep Walia, Karen Weiland, Fred Whitehouse, Thomas Wiegmann, Kathleen Wyne, Alan Wynne, Kevin Yuen, Joel Zaretzky, James Zebrack, Franklin Zieve, William Zigrang, and Everest

Subjects
Male, medicine.medical_specialty, Recombinant Fusion Proteins, Population, Placebo-controlled study, Glucagon-Like Peptides, Myocardial Infarction, Type 2 diabetes, 030204 cardiovascular system & hematology, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Humans, Hypoglycemic Agents, 030212 general & internal medicine, education, Aged, education.field_of_study, business.industry, Semaglutide, Hazard ratio, General Medicine, Middle Aged, medicine.disease, Immunoglobulin Fc Fragments, Stroke, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Dulaglutide, Female, business, medicine.drug
Abstract

Digital, Background Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin A1c (HbA1c) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens of individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control. Methods This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer-generated random code with stratification by site. All investigators and participants were masked to treatment assignment. Participants were followed up at least every 6 months for incident cardiovascular and other serious clinical outcomes. The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01394952. Findings Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA1c 7·2% [IQR 6·6–8·1], 4589 [46·3%] women) were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). During a median follow-up of 5·4 years (IQR 5·1–5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (hazard ratio [HR] 0·88, 95% CI 0·79–0·99; p=0·026). All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80–1·01; p=0·067). 2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p, Ciencias Médicas y de la Salud

Published
2019

47. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry

Author

David R. Wood, Pedro Marques-Vidal, Nebojsa Lalic, Renata Cifkova, Catriona Jennings, S. Mancas, Costas Tsioufis, J. Badariene, Seppo Lehto, Aldo P. Maggioni, S Stoerk, Linda Mellbin, Peter U. Heuschmann, Piotr Jankowski, Dusko Vulic, Hosam Hasan-Ali, Zeljko Reiner, Jan Bruthans, Zlatko Fras, Vilnis Dzerve, J Crowley, Guy De Backer, Davor Milicic, Marina Dolzhenko, Nana Pogosova, Dragan Lovic, Johan De Sutter, Jaap W. Deckers, Dirk De Bacquer, Erkin M. Mirrakhimov, Kairat Davletov, Kornelia Kotseva, Lars Rydén, Diederick E. Grobbee, Almudena Castro Conde, Ana Abreu, Dan Gaita, Mirza Dilic, Delphine De Smedt, Andrejs Erglis, Carlos Aguiar, Arno W. Hoes, Nina Gotcheva, Rafael G. Oganov, Lâle Tokgözoğlu, Epidemiology, Vriendenkring VUB, Clinical sciences, and Cardiology

Subjects
cardiovascular risk factors, Male, Cardiac & Cardiovascular Systems, Heart disease, Epidemiology, medicine.medical_treatment, Health Status, EUROASPIRE, guidelines, lifestyle, secondary prevention, Risk Reduction Behavior, HSM CAR, Risk Factors, Secondary Prevention, ARTERY-DISEASE, Myocardial infarction, Diet / adverse effects, Registries, Cardiovascular Diseases / physiopathology, 1102 Cardiorespiratory Medicine and Haematology, Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use, Smoking / epidemiology, Smoking, Healthy Lifestyle, Middle Aged, PREVALENCE, Europe, Cardiovascular Diseases / diagnosis, Treatment Outcome, Cardiovascular Diseases, Cardiovascular Agents / therapeutic use, LDL Cholesterol Lipoproteins, Female, Europe / epidemiology, Cardiology and Cardiovascular Medicine, Life Sciences & Biomedicine, medicine.medical_specialty, Smoking / adverse effects, Cardiovascular risk factors, HEART-DISEASE, Risk Assessment, LOW-INCOME COUNTRIES, Life Style, Cardiovascular Diseases / prevention & control, Cardiovascular prevention, medicine, Journal Article, Humans, ddc:610, Risk factor, Aged, Cardiovascular Diseases / epidemiology, Science & Technology, Task force, business.industry, Cardiovascular Agents, SMOKING-CESSATION, Protective Factors, medicine.disease, Diet, EUROASPIRE Investigators, Cross-Sectional Studies, MYOCARDIAL-INFARCTION, CLINICAL-PRACTICE, Family medicine, Health Care Surveys, Cardiovascular System & Cardiology, Smoking cessation, Patient Compliance, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Sedentary Behavior, business, TASK-FORCE
Abstract

Aims The aim of this study was to determine whether the Joint European Societies guidelines on secondary cardiovascular prevention are followed in everyday practice. Design A cross-sectional ESC-EORP survey (EUROASPIRE V) at 131 centres in 81 regions in 27 countries. Methods Patients (Results A total of 8261 patients (females 26%) were interviewed. Nineteen per cent smoked and 55% of them were persistent smokers, 38% were obese (body mass index ≥30 kg/m2), 59% were centrally obese (waist circumference: men ≥102 cm; women ≥88 cm) while 66% were physically active Conclusion A large majority of coronary patients have unhealthy lifestyles in terms of smoking, diet and sedentary behaviour, which adversely impacts major cardiovascular risk factors. A majority did not achieve their blood pressure, low-density lipoprotein cholesterol and glucose targets. Cardiovascular prevention requires modern preventive cardiology programmes delivered by interdisciplinary teams of healthcare professionals addressing all aspects of lifestyle and risk factor management, in order to reduce the risk of recurrent cardiovascular events.

Published
2019

48. Incidence of cardiovascular events in patients with stabilized coronary heart disease : the EUROASPIRE IV follow-up study

Author

Nana Pogosova, Dirk De Bacquer, Stefan Störk, Peter U. Heuschmann, Raphael Oganov, Andrzej Pajak, Mirza Dilic, Nina Gotcheva, Renata Cifkova, Delphine De Smedt, Andrejs Erglis, Dragan Lovic, Dan Gaita, Lale Tokgozoglu, Catriona Jennings, Lars Rydén, Philippe Amouyel, Bahira Shahim, Aleksandras Laucevičius, David R. Wood, Martin Stagmo, Guy De Backer, Martin Wagner, Evagoras Nicolaides, Kornelia Kotseva, Zeljko Reiner, Davor Miličić, Jan Bruthans, John A. Goudevenos, Almudena Castro Conde, Seppo Lehto, Viveca Gyberg, Johan De Sutter, David D. Moore, Jaap W. Deckers, Dusko Vulic, Maryna Dolzhenko, Zlatko Fras, Clinical sciences, Cardiology, Vriendenkring VUB, Imperial College Healthcare NHS Trust - CLRN Funding, and Imperial College Healthcare NHS Trust

Subjects
Male, EUROASPIRE Investigators, Epidemiology, Coronary Disease, 030204 cardiovascular system & hematology, 0302 clinical medicine, Risk Factors, Guidelines implementation, Medicine, 030212 general & internal medicine, Myocardial infarction, Stroke, Public, Environmental & Occupational Health, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Interna medicina, OUTCOMES, Incidence, Secondary prevention, Hazard ratio, Coronary heart disease, ASSOCIATION, Middle Aged, Europe, Cardiovascular Diseases, Cohort, Female, Life Sciences & Biomedicine, secondary prevention, medicine.medical_specialty, EUROPEAN GUIDELINES, 1117 Public Health and Health Services, 03 medical and health sciences, RISK-FACTOR, Internal medicine, Humans, Risk factor, Life Style, BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Internal Medicine, Aged, Science & Technology, business.industry, Proportional hazards model, PERIPHERAL ARTERIAL-DISEASE, MORTALITY, GLUCOSE-TOLERANCE TEST, medicine.disease, PREVENTION, Cross-Sectional Studies, MYOCARDIAL-INFARCTION, CLINICAL-PRACTICE, Heart failure, business, Follow-Up Studies, Kidney disease
Abstract

The EUROASPIRE surveys (EUROpean Action on Secondary Prevention through Intervention to Reduce Events) demonstrated that most European coronary patients fail to achieve lifestyle, risk factor and therapeutic targets. Here we report on the 2-year incidence of hard cardiovascular (CV) endpoints in the EUROASPIRE IV cohort. EUROASPIRE IV (2012-2013) was a large cross-sectional study undertaken at 78 centres from selected geographical areas in 24 European countries. Patients were interviewed and examined at least 6 months following hospitalization for a coronary event or procedure. Fatal and non-fatal CV events occurring at least 1 year after this baseline screening were registered. The primary outcome in our analyses was the incidence of CV death or non-fatal myocardial infarction, stroke or heart failure. Cox regression models, stratified for country, were fitted to relate baseline characteristics to outcome. Our analyses included 7471 predominantly male patients. Overall, 222 deaths were registered of whom 58% were cardiovascular. The incidence of the primary outcome was 42 per 1000 person-years. Comorbidities were strongly and significantly associated with the primary outcome (multivariately adjusted hazard ratio HR, 95% confidence interval): severe chronic kidney disease (HR 2.36, 1.44-3.85), uncontrolled diabetes (HR 1.89, 1.50-2.38), resting heart rate ≥ 75 bpm (HR 1.74, 1.30-2.32), history of stroke (HR 1.70, 1.27-2.29), peripheral artery disease (HR 1.48, 1.09-2.01), history of heart failure (HR 1.47, 1.08-2.01) and history of acute myocardial infarction (HR 1.27, 1.05-1.53). Low education and feelings of depression were significantly associated with increased risk. Lifestyle factors such as persistent smoking, insufficient physical activity and central obesity were not significantly related to adverse outcome. Blood pressure and LDL-C levels appeared to be unrelated to cardiovascular events irrespective of treatment. In patients with stabilized CHD, comorbid conditions that may reflect the ubiquitous nature of atherosclerosis, dominate lifestyle-related and other modifiable risk factors in terms of prognosis, at least over a 2-year follow-up period.

Published
2019

50. 155Effects of two different preventive counselling programs on selected psychosocial risk factors and quality of life in coronary patients with abdominal obesity

Author

Nana Pogosova, A O Salbieva, A I Yusubova, O Y Sokolova, Y M Yufereva, A K Ausheva, and A. Karpova

Subjects
medicine.medical_specialty, Quality of life (healthcare), business.industry, Family medicine, Medicine, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Psychosocial, Abdominal obesity
Published
2018

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