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Background: Obstructive sleep apnea (OSA) is associated with increased cardiovascular risk. This study aim to assess differences in changes in arterial stiffness of two groups of patients, defined as having daytime sleepiness or not, after continuous positive airway pressure (CPAP) treatment.Methods: A selected cohort of consecutive male patients, under 65 years old, with moderate to severe OSA and without great number of comorbidities was studied. The diagnosis was confirmed by home respiratory poligraphy. Sleepiness was considered with an Epworth Sleepiness Scale (ESS) > 10. An ambulatory blood pressure (BP) monitoring and carotid-femoral pulse wave velocity (cf-PWV) measurements were performed, before and after four months under CPAP. Compliant patients, sleepy and non-sleepy, were compared using linear mixed effects regression models. A further stratified analysis was performed with non-sleepy patients.Results: Thirty-four patients were recruited, with mean age 55.2 (7.9) years, 38.2% were sleepy, 79.4% with hypertension, 61.8% with metabolic syndrome and 82.4% with dyslipidaemia. In univariable analysis, cf-PWV was strongly related to systolic BP parameters and age, but also to antihypertensive drugs (p = 0.030), metabolic syndrome (p = 0.025) and daytime sleepiness (p = 0.004). Sleepy patients had a more severe OSA, with AHI 44.8 (19.0) vs 29.7 (15.7) events/h (p = 0.018), but sleep study parameters were not associated with cf-PWV values. On multivariable regression, a significant interaction between time (CPAP) and sleepiness (p = 0.033) was found. There was a weak evidence of a cf-PWV reduction after CPAP treatment (p = 0.086), but the effects of treatment differed significantly between groups, with no changes in non-sleepy patients, while in sleepy patients a significant decrease was observed (p = 0.012). Evaluating non-sleepy patients group under CPAP therapy, results showed that both higher pulse pressure (p = 0.001) and lower LDL-cholesterol levels (p = 0.015) at baseline were associated to higher cf-PWV changes.Conclusions: Patients with daytime sleepiness had a more severe OSA and presented a greater arterial stiffness improvement after CPAP therapy, independently from age and BP. Besides sleepiness, cf-PWV reduction after CPAP therapy was mainly associated to CV risk factors, and less to sleep study parameters.Trial Registration: Clinicaltrials.gov NCT02273089 23.10.2014 retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: A post-hoc analysis was performed on the data from a 54 weeks phase III study (ClinicalTrials.gov identifier: NCT00923091) to measure changes in the health-related quality of life (HRQoL) of 2,690 patients aged =18 with moderate-to-severe hypertension who received one of six doses of olmesartan/amlodipine/hydrochlorothiazide (OLM/ AML/HCTZ), using the MINICHAL and EQ-5D instruments. Methods: Descriptive statistics were used to assess blood pressure and HRQoL scores over the study period. Analysis of covariance (ANCOVA) was used to identify those factors that could possibly have influenced HRQoL. Linear regression was used to assess the relationship between changes in blood pressure and HRQoL scores. Results: Patients' baseline MINICHAL mood and somatic domains scores were 5.5 and 2.6. Over the study period HRQoL improved as both MINICHAL scores decreased by 31-33%. Patients' baseline EQ-5D index and VAS scores were 0.9 and 73.4 respectively, increasing by 6% and 12% over the study period. Patients' QALY gain over the 54 weeks study period was estimated to be 0.029 QALYs. The ANCOVA showed that changes in patients' HRQoL was likely to have been influenced by patients' achievement of blood pressure control, the amount of concomitant medication and patients' last used dosage strength of antihypertensive. Linear regression showed that blood pressure improvement may have been associated with improved HRQoL. Conclusions: This study showed that OLM/AML/HCTZ reduced blood pressure and significantly increased blood pressure control whilst improving patients' HRQoL. Achieving blood pressure control, amount of concomitant medication and dosage strength of antihypertensive impacted on patients' HRQoL. [ABSTRACT FROM AUTHOR]

Objective: To evaluate physicians' attitudes and adherence to the use of risk scores in the primary prevention of cardiovascular disease (CVD).Design and Methods: A cross-sectional survey of 2056 physicians involved in the primary prevention of CVD. Participants included cardiologists (47%), general practitioners (42%), and endocrinologists (11%) from several geographical regions: Brazil (n = 968), USA (n = 381), Greece (n = 275), Chile (n = 157), Venezuela (n = 128), Portugal (n = 42), The Netherlands (n = 41), and Central America (Costa Rica, Panama, El Salvador and Guatemala; n = 64).Results: The main outcome measure was the percentage of responses on a multiple-choice questionnaire describing a hypothetical asymptomatic patient at intermediate risk for CVD according to the Framingham Risk Score. Only 48% of respondents reported regular use of CVD risk scores to tailor preventive treatment in the case scenario. Of non-users, nearly three-quarters indicated that 'It takes up too much of my time' (52%) or 'I don't believe they add value to the clinical evaluation' (21%). Only 56% of respondents indicated that they would prescribe lipid-lowering therapy for the hypothetical intermediate-risk patient. A significantly greater proportion of regular users than non-users of CVD risk scores identified the need for lipid-lowering therapy in the hypothetical patient (59 vs. 41%; p < 0.0001).Conclusions: Based on a survey conducted in a 'real-world' setting, risk scores are generally not used by a majority of physicians to guide primary prevention in asymptomatic persons at intermediate risk for CVD. Appropriate prescribing of lipid-lowering therapy in such patients is equally neglected. Changing physicians' attitudes towards the use of CVD risk scores is one of several challenges that need to be addressed to reduce the world-wide burden of CVD. [ABSTRACT FROM AUTHOR]

3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) are generally safe and well-tolerated drugs that are extensively used for the primary and secondary prevention of atherosclerotic cardiovascular events. Muscle and liver adverse reactions are the best recognized, while cutaneous side effects are exceedingly rare. We present the case of a 65-year-old woman with severe hypercholesterolemia, who developed generalized erythematous cutaneous lesions with pruritus, resembling lichen planus, months after starting treatment with simvastatin. The symptoms disappeared on withdrawal of simvastatin and reappeared within 3 months upon rechallenge with rosuvastatin. In addition to describing a rare adverse effect of statins, the authors also discuss the nutraceutical approach to the management of a statin-intolerant patient., Learning Points: Lichenoid drug eruption is an uncommon cutaneous adverse effect of several drugs, with very few cases associated with statins.A temporal relationship, dechallenge/rechallenge information, and the lack of confounding factors or alternative explanations support the suggestion of causality.Due to the lack of optimized alternative treatment options for statin-intolerant patients, the nutraceutical approach should be considered., Competing Interests: Conflicts of Interests: The Authors declare that there are no competing interests.

Reducing low-density lipoprotein cholesterol (LDL-C) levels using statins is associated with significant reductions in cardiovascular (CV) events in a wide range of patient populations. Although statins are generally considered to be safe, recent studies suggest they are associated with an increased risk of developing Type 2 diabetes (T2D). This led the US Food and Drug Administration (FDA) to change their labelling requirements for statins to include a warning about the possibility of increased blood sugar and HbA1c levels and the European Medicines Agency (EMA) to issue guidance on a small increased risk of T2D with the statin class. This review examines the evidence leading to these claims and provides practical guidance for primary care physicians on the use of statins in people with or at risk of developing T2D. Overall, evidence suggests that the benefits of statins for the reduction of CV risk far outweigh the risk of developing T2D, especially in individuals with higher CV risk. To reduce the risk of developing T2D, physicians should assess all patients for T2D risk prior to starting statin therapy, educate patients about their risks, and encourage risk-reduction through lifestyle changes. Whether some statins are more diabetogenic than others requires further study. Statin-treated patients at high risk of developing T2D should regularly be monitored for changes in blood glucose or HbA1c levels, and the risk of conversion from pre-diabetes to T2D should be reduced by intensifying lifestyle changes. Should a patient develop T2D during statin treatment, physicians should continue with statin therapy and manage T2D in accordance with relevant national guidelines., (Copyright © 2014. Published by Elsevier Ireland Ltd.)

Cholesterol drug lowering is a paradig on how to best apply clinical evidence to clinical practice. Considering the available options, it is essential that statins have a clear safety and tolerability profile and a favourable benefit/risk relationship. Intensive cholesterol drug lowering is not associated with deleterious consequences, dependent on a greater efficacy or on serious side effects. Statins are not hepatotoxic. Enzyme fluctuation is common in dyslipidemia. The risk of increased transaminases is directly and closely related to the dosage (and type of statin used). Minor changes in baseline liver profile are not regarded as contraindications to their use (in patients with a cardiovascular justifiable risk). Iterative monitoring of the liver profile is not necessary. The etiology of miotoxicity with statins is not completely clear. The risk of myopathy or rhabdomyolysis is not related to the absolute or percent change in the LDL-C (or with the achieved LDL-C value). The adverse effects of statins may depend on the physical and chemical characteristics of the molecule and its pharmacokinetic characteristics. On a pharmacovigilance strategy the patient also has his say. The sharing of a common goal makes the patient divide responsibilities with his Health Team, encouraging safer treatments and better cardiovascular prevention. The grounds for treatment and intensive effective reduction of dyslipidemias must be made through a better adherence to quality Health Programs and through improving treatment and achieved goals.

Introduction: Obesity is a chronic disease and a serious health problem that leads to increased prevalence of diabetes, hypertension, dyslipidemia and gallbladder disease., Objective: To evaluate the efficacy of orlistat for weight loss and improved lipid profile compared to placebo in obese patients with hypercholesterolemia, treated over a period of 6 months., Methodology: In a 6-month, multicenter (10 centers in Portugal), double-blind, parallel, placebo-controlled study, 166 patients, aged 18-65 years, body mass index (BMI) > or = 27 kg/m2, LDL cholesterol > 155 mg/dl, were randomized to a reduced calorie diet (600 kcal/day deficit) plus orlistat three times a day or placebo. Exclusion criteria included triglycerides > 400 mg/dl, severe cardiovascular disease, uncontrolled hypertension, type 1 or 2 diabetes under pharmacological treatment, and gastrointestinal or pancreatic disease., Results: The mean difference in weight from baseline was 5.9% (5.6 kg) in the orlistat group vs. 2.3% (2.2 kg) in the placebo group. In the orlistat group 49% of patients achieved 5-10% weight loss and 8.8% achieved > 10%. The orlistat group showed a significant reduction in total and LDL cholesterol, with similar changes for HDL in both treatment groups. The frequency of gastrointestinal adverse events was slightly higher in the orlistat group than in the placebo group, leading to discontinuation in 7 patients., Conclusion: Treatment with orlistat plus a reduced calorie diet for 6 months achieved significant reductions in weight, BMI and lipid parameters.

Background: Single-pill amlodipine/atorvastatin targets the two most common modifiable cardiovascular risk factors, hypertension and dyslipidaemia. We evaluated the clinical utility of this single pill to help patients across Europe and Canada achieve country-specific targets for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C)., Design: Two 16-week, open-label studies conducted in 122 study centres across the United Kingdom and Canada (JEWEL 1) and 113 centres across 11 European countries (JEWEL 2)., Methods: Patients with uncontrolled BP and controlled/uncontrolled LDL-C qualifying for treatment according to local governing guidelines were administered single-pill amlodipine/atorvastatin with appropriate lifestyle modification. Eight dosages of amlodipine/atorvastatin (5/10-10/80 mg) were titrated to achieve country-specific BP and LDL-C targets. The primary outcome was the percentage of patients reaching country-specific BP and LDL-C targets in 16 weeks., Results: Among 2245 patients enrolled in the studies (JEWEL 1, n = 1138; JEWEL 2, n = 1107), 62.9% in JEWEL 1 and 50.6% in JEWEL 2 achieved both country-specific BP and LDL-C goals. BP was reduced by 20.4/10.7 and 21.8/12.6 mmHg in JEWEL 1 and JEWEL 2, respectively, and reductions in LDL-C were 0.90 mmol/l (34.8 mg/dl) and 1.09 mmol/l (42.2 mg/dl), respectively. The most common adverse events were peripheral oedema (11.0%), joint swelling (2.9%) and headache (2.9%), of which, only oedema was linked to study treatment., Conclusion: Single-pill amlodipine/atorvastatin is an effective and well-tolerated treatment, which in a real-world setting helped more than half of the patients achieve both BP and LDL-C targets as recommended by local guidelines. Although fewer patients met their goals in JEWEL 2 than JEWEL 1, reductions in BP and LDL-C were slightly greater in JEWEL 2, suggesting that the observed differences are likely because of more stringent targets in Europe than in the UK/Canada.

Background: In order to prevent cardiovascular events, it is essential to effectively manage overall risk of cardiovascular disease. However, despite guideline recommendations to this effect, current management of the major, modifiable cardiovascular risk factors such as hypertension and dyslipidemia is disconnected and patient adherence to therapy is poor. This is particularly important for patients with multiple cardiovascular risk factors, who are often prescribed multiple medications. The JEWEL study program will investigate the use of single-pill amlodipine/atorvastatin as a strategy to improve management of these patients., Methods: The JEWEL program consists of two 16-week, international, open-label, multicenter, titration-to-goal studies in patients with hypertension and dyslipidemia. The 2 studies differ based on country of enrollment and certain tertiary endpoints, but the overall designs are very similar. Patients have been enrolled from 255 centers across Canada and 13 European countries. The study is designed to assess the efficacy, safety, and utility of amlodipine/atorvastatin single-pill therapy in a real-world setting. Patients will be initiated at a dose of amlodipine 5 mg/atorvastatin 10 mg, unless previously treated, and will be uptitrated as necessary. The primary efficacy parameter is the percentage of patients, at different levels of cardiovascular risk, achieving country-specific guideline-recommended target levels for blood pressure and lipids. A secondary analysis of efficacy measured attainment of the same single goal for blood pressure across all study participants (JEWEL I and II) and the same single goal for LDL-C across all study participants (JEWEL I and II). The program will utilize a newly developed questionnaire to gain better understanding of participants' beliefs and behaviors towards medical treatment of their multiple risk factors. Approximately 2850 patients will be enrolled in the program, which is due to be completed in August 2005., Conclusion: The JEWEL program will assess the effectiveness of a single pill (amlodipine/atorvastatin) in targeting the two principal risk factors for cardiovascular disease simultaneously to achieve nationally applicable treatment targets in a routine clinical practice setting.