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Juan José Soler-Cataluña,1,2 Arturo Huerta,3 Pere Almagro,4 Diego González-Segura,5 Borja G Cosío6 On behalf of the CLAVE Study Investigators1Department of Pneumology, Hospital Arnau de Vilanova-Lliria, Valencia, Spain; 2Medicine Department, València University and CIBERES, Valencia, Spain; 3Pulmonary and Critical Care Division, Clínica Sagrada Família, Barcelona, Spain; 4Internal Medicine Department, Mutua Terrassa University Hospital, Terrassa, Spain; 5Medical Advisor, Chiesi SAU, Barcelona, Spain; 6Department of Pneumology, H. Universitari Son Espases Hospital-IdISBa and CIBERES, Palma de Mallorca, SpainCorrespondence: Juan José Soler-Cataluña, Department of Pneumology Arnau de Vilanova-Lliria, C/San Clemente 12, Valencia, 46015, Spain, Email jjsoler@telefonica.netIntroduction: According to the Global Initiative for chronic obstructive lung disease (GOLD), when a treatment is not achieving an appropriate response it should be switched taking into account the predominant treatable trait to target (dyspnea or exacerbations). The objective of the present study was to investigate the lack of clinical control according to the target and medication groups.Materials and Methods: This was a post-hoc analysis of the CLAVE study, an observational, cross-sectional, multicenter study which evaluated the clinical control, and related-factors, in a cohort of 4801 patients with severe chronic obstructive pulmonary disease (COPD). The primary endpoint was the percentage of uncontrolled patients defined as COPD Assessment Test (CAT) > 16 or presence of exacerbations in the last 3 months despite receiving long-acting beta2-agonist (LABA) and/or long-acting antimuscarinic antagonist (LAMA) with or without inhaled corticosteroids (ICS). Secondary objectives included the description of sociodemographic and clinical characteristics of patients by therapeutic group and the identification of characteristics potentially associated with the lack of control of COPD including low adherence measured by the test to adherence to inhalers (TAI).Results: In the dyspnea pathway, lack of clinical control was of 25.0% of patients receiving LABA or LAMA in monotherapy, 29.5% by those with LABA + LAMA, 38.3% with LABA + ICS and 37.0% with triple therapy (LABA + LAMA + ICS). In the exacerbation pathway, percentages were 87.1%, 76.7%, 83.3%, and 84.1%, respectively. Low physical activity and high Charlson comorbidity index were independent factor of non-control in all therapeutic groups. Additional factors were lower post-bronchodilator FEV1 and poor adherence to inhalers.Conclusion: There are still room for improvement in COPD control. From the pharmacological perspective, every step in treatment have a pool of uncontrolled patients in which a step-up could be considered according to a trait to target strategy.Keywords: COPD, control, target, dyspnea, comorbidities, treatment

Juan José Soler-Cataluña,1 Pere Almagro,2 Arturo Huerta,3 Diego González-Segura,4 Borja G Cosío5 On behalf of the CLAVE study Investigators1Department of Pneumology, Hospital Universitari Arnau de Vilanova and CIBERES, Valencia, Spain; 2Multimorbidity Patients Unit. Internal Medicine Department, H. Mutua Terrassa University Hospital, Terrassa, Barcelona, Spain; 3Emergency Department – Medicine and Pulmonary Section, H. Clínic de Barcelona, Barcelona, Spain; 4Medical Department, Chiesi SAU, Barcelona, Spain; 5Department of Pneumology, H. Universitari Son Espases Hospital-IdISBa and CIBERES, Palma de Mallorca, Balearic Islands, SpainCorrespondence: Juan José Soler-CataluñaDepartment of Pneumology, H. Universitari Arnau de Vilanova, C/San Clemente 12, Valencia 46015, SpainTel + 973 24 81 00Email jjsoler@telefonica.netBackground: Clinical control in chronic obstructive pulmonary disease (COPD) has not been completely characterized. A proposal of clinical control criteria (CCC) has been recently defined and validated as a tool for determining control, but there is scarce information on patients with severe COPD.Objective: To evaluate clinical control in severe COPD using the CCC.Patients and Methods: The study design was observational, multicenter, cross-sectional study involving 4801 patients with severe COPD in Spain. Clinical control was defined according to clinical impact (dyspnea grade, use of rescue treatment in last week, sputum color, and daily physical activity) and stability (exacerbations in last 3 months and patient’s perception about health status). Clinical control of COPD was alternatively evaluated with the COPD assessment test (CAT) and the presence of exacerbations in the last 3 months.Results: According to CCC, 61.0% of patients had low clinical impact, and 41.4% showed clinical stability. Overall, 29.9% of patients had both low clinical impact and stability (controlled), whereas 70.1% showed high clinical impact and/or no clinical stability (non-controlled). COPD control was also assessed by using only the definition of CAT≤ 16 and no exacerbations in the last 3 months. Results obtained with this definition were similar to those obtained by CCC, and the concordance between both definitions was high (Kappa index = 0.698).Conclusion: By using the CCC, approximately only one third of patients with severe COPD were considered as controlled. Physical activity, adherence to inhalers, age, post-bronchodilator FEV1, age-adjusted Charlson comorbidity index, and healthcare level were independent factors associated with COPD control.Keywords: COPD, control, clinical, exacerbations, criteria, CAT

Background: Chronic obstructive pulmonary disease (COPD) frequently coexists with other chronic diseases, namely comorbidities. They negatively impact prognosis, exacerbations and quality of life in COPD patients. However, no studies have been performed to explore the impact of these comorbidities on COPD clinical control criteria., Research Question: Determine the relationship between individualized comorbidities and COPD clinical control criteria., Study Design and Methods: Observational, multicenter, cross-sectional study performed in Spain involving 4801 patients with severe COPD (< 50 predicted forced expiratory volume in the first second [FEV 1 %]). Clinical control criteria were defined by the combination of COPD assessment test (CAT) scores (≤16 vs ≥17) and exacerbations in the previous three months (none vs ≥1). Binary logistic regression adjusted by age and FEV 1 % was performed to identify comorbidities potentially associated with the lack of control of COPD. Secondary endpoints were the relationship between individualized comorbidities with COPD assessment test and exacerbations within the last three months., Results: Most frequent comorbidities were arterial hypertension (51.2%), dyslipidemia (36.0%), diabetes (24.9%), obstructive sleep apnea-hypopnea syndrome (14.9%), anxiety (14.1%), heart failure (11.6%), depression (11.8%), atrial fibrillation (11.5%), peripheral arterial vascular disease (10.4%) and ischemic heart disease (10.1%). After age and FEV 1 % adjustment, comorbidities related to lack of clinical control were cardiovascular diseases (heart failure, peripheral vascular disease and atrial fibrillation; p < 0.0001), psychologic disorders (anxiety and depression; all p < 0.0001), metabolic diseases (diabetes, arterial hypertension and abdominal obesity; all p < 0.001), sleep disorders (p < 0.0001), anemia (p = 0.015) and gastroesophageal reflux (p < 0.0001). These comorbidities were also related to previous exacerbations and COPD assessment test scores., Interpretation: Comorbidities are frequent in patients with severe COPD, negatively impacting COPD clinical control criteria. They are related to health-related quality of life measured by the COPD assessment test. Our results suggest that comorbidities should be investigated and treated in these patients to improve their clinical control., Take-Home Points: Study question: What is the impact of comorbidities on COPD clinical control criteria?, Results: Among 4801 patients with severe COPD (27.5% controlled and 72.5% uncontrolled), after adjustment by age and FEV 1 %, comorbidities related to lack of clinical control were cardiovascular diseases (heart failure, peripheral vascular disease and atrial fibrillation; p < 0.0001), psychologic disorders (anxiety and depression; p < 0.0001), metabolic diseases (diabetes, arterial hypertension and abdominal obesity; p < 0.001), obstructive sleep apnea-hypopnea syndrome (p < 0.0001), anaemia (p = 0.015) and gastroesophageal reflux (p < 0.0001), which were related to previous exacerbations and COPD assessment test scores., Interpretation: Comorbidities are related to health-related quality of life measured by the COPD assessment test scores and history of exacerbations in the previous three months., (© 2023. The Author(s).)

Background and Objective: Blood pressure (BP) control has been extensively studied in patients attended in primary care but reports in the hospital setting, which includes referral units, are scarce. The aim was to evaluate the degree of BP control in hypertensive patients attended in referral units., Patients and Methods: We studied 1,550 hypertensive subjects (41.5% women) with a mean age of 64 (12) years, who were receiving antihypertensive drugs. The degree of BP control was estimated in a single visit by the proportion of patients with BP below 140/90 mm Hg., Results: BP was controlled in 653 patients (42%). In comparison, those whose BP was not controlled were more frequently women (odds ratio [OR] 1.57; 95% confidence interval [95%CI]: 1.23-1.99), obese (OR 1.28; 95%CI 1.00-1.63), smokers (OR 1.78; 95%CI 1.36-2.34), had left ventricular hypertrophy (OR 1.86; 95%CI 1.46-2.36) and elevated values of total serum cholesterol (OR 1.50; 95%CI 1.19-1.90) and triglycerides (OR 1.63; 95%CI 1.29-2.07). Therapeutical inertia was observed in 39% of uncontrolled patients. In a subgroup of patients who underwent ambulatory BP monitoring, discordance between measurements was only present in 23% (9.8 with isolated clinic hypertension and 13.1% with masked hypertension)., Conclusion: The degree of BP control in patients attended in referral units is estimated in 42% and has not been modified in the last decade. Although therapeutical effort and inertia have improved, this only compensates the increased risk and comorbidities of attended patients, making more difficult the control of BP values., (Copyright © 2012 Elsevier España, S.L. All rights reserved.)

Background: Clinical inertia, the failure of physicians to initiate or intensify therapy when indicated, is a major problem in the management of hypertension and may be more prevalent in elderly patients. Overcoming clinical inertia requires understanding its causes and evaluating certain factors, particularly those related to physicians., Objective: The objective of our study was to determine the rate of clinical inertia and the physician-reported reasons for it., Methods: An observational, cross-sectional, multi-center study was carried out in a primary care setting. We included 512 physicians, with a consecutive sampling of 1,499 hypertensive patients with clinical inertia., Main Outcome Measure: Clinical inertia was defined when physicians did not modify treatment despite knowing that the therapeutic target had not been reached. Clinical inertia was considered to be justified (JCI) when physicians provided an explanation for not intensifying treatment and as not justified (nJCI) when no reasons were given., Results: JCI was observed in 30.1 % (95 % CI 27.8-32.4) of patients (n = 451) and nJCI in 69.9 % (95 % CI 67.6-72.2) (n = 1,058). JCI was associated with higher blood pressure (BP) values (both systolic and diastolic) and diabetes (p = 0.012) than nJCI. nJCI was associated with patients having an isolated increase of systolic or diastolic or high borderline BP values or cardiovascular disease., Conclusion: Physicians provided reasons for not intensifying treatment in poorly controlled patients in only 30 % of instances. Main reasons for not intensifying treatment were borderline BP values, co-morbidity, suspected white coat effect, or perceived difficulty achieving target. nJCI was associated with high borderline BP values and cardiovascular disease.

Background and Objective: A large number of patients with cardiovascular risk exhibit metabolic syndrome and are attended by several specialists. There is no information about possible differences in the clinical characteristics and management of these patients by these specialists. The aim of the present study was to evaluate possible differences in clinical features, blood pressure control, therapeutic effort, and therapeutic inertia among medical specialities attending hypertensive patients with metabolic syndrome (MS)., Patients and Methods: Cross-sectional study carried out in 17 autonomous communities in Spain, in hypertensive patients with MS consecutively recruited in ambulatory units from departments of cardiology, internal medicine, endocrinology and nephrology. Demographic and clinical data, as well as blood pressure control were assessed. Therapeutic effort was defined as the proportion of patients using 3 or more antihypertensive drugs. Therapeutic inertia was defined as the proportion of patients without any change in antihypertensive treatment despite a lack of blood pressure control (values ≥ 140 and/or 90 mmHg)., Results: 2,453 patients (40% women) with a mean age of 64 (11) years were included in the study. We observed some differences in the specific MS components among specialities. Atherogenic dyslipidemia, defined as elevated triglycerides (97%) and/or HDL-cholesterol (61%) was more common in patients attended by cardiologists. Blood pressure control was better achieved by nephrologists (16-33%, depending on the criteria used), and it was accompanied by a greater therapeutical effort (59%). Therapeutical inertia in relation to antihypertensive treatment was more common among endocrinologists (56%)., Conclusions: Hypertensive patients with MS attended by different specialists have similar clinical features, although some differences are present, especially driven by more frequent lipid alterations among those attending cardiology departments. Nephrologists make a greater therapeutic effort and achieve a better blood pressure control. On the contrary, therapeutical inertia is higher among endocrinologists., (Copyright © 2010 Elsevier España, S.L. All rights reserved.)

Background: Some studies have described a large number of hypertensive patients who are followed by a primary care physician without achieving adequate blood pressure (BP) control but whose treatment nevertheless is not intensified. It is not known whether physicians are aware of this clinical inertia and what factors are associated with this problem., Objective: The aim of this study was to describe the factors associated with clinical inertia in hypertensive patients., Methods: This was an observational, cross-sectional, multicentre study conducted in a network of primary care centres and hospital hypertension units in Spain. Using a consecutive sampling approach, 512 physicians selected 5077 hypertensive patients in whom they suspected poor BP control after chart review. The main variables documented were BP control and cardiovascular risk according to European Society of Hypertension guidelines, changes in treatment after visit, type of treatment, and healthcare setting. A binomial logistic regression multivariate analysis, adjusted for physician, was performed., Results: Of the selected patients, 70.9% had poor BP control according to measurements taken in the physician's office, and in 1499 (42.1%) of those poorly controlled patients, treatment was not intensified (clinical inertia). Factors associated with clinical inertia were as follows: being seen at a primary care centre (p < 0.001), not having left ventricular hypertrophy (p < 0.001) or microalbuminuria (p < 0.001), taking fixed-dose (p = 0.049) or free-dose (p = 0.001) combination therapy, BP measured in other settings (nurse's office, patient's home) than the physician's office (p = 0.034) or the pharmacy (p = 0.019), older age (p = 0.032), and lower systolic (p < 0.001) and diastolic (p < 0.001) BP. Of the hypertensive patients with clinical inertia, 90.2% (95% CI 88.7, 91.7) had high cardiovascular risk., Conclusions: Clinical inertia was associated with a profile that included older age, lack of co-morbid conditions and being seen at a primary care centre.

Introduction and Objectives: The available information regarding blood pressure control in women is scarce. This study was aimed at assessing blood pressure control and predictors of a lack of blood pressure control in the primary care setting in a large sample of hypertensive women., Methods: Women aged 65 years or older with an established diagnosis of hypertension (≥ 6 months of evolution) were included in a cross-sectional, multicenter study. Blood pressure readings were taken following the current guidelines, and the value for each visit was the average of two separate measurements. Adequate blood pressure control was defined as < 140/90 mm Hg (< 130/80 mm Hg for diabetics)., Results: A total of 4274 hypertensive women (mean age: 73.6 years [6.1 years]) were included in the study; blood pressure was controlled in 29.8% (95% confidence interval: 28.4%-31.1%) of the study population. Combined therapy was administered in 67.6% of patients (46.3% with 2 drugs and 21.7% with 3 or more drugs). The most common organ damage was left ventricular hypertrophy (33.8%) and the most common associated condition was heart failure (19%). Poor blood pressure control was more frequent in patients with more cardiovascular risk factors, organ damage, and associated clinical conditions (P<.01). A more recent hypertension diagnosis, LDL-cholesterol > 115 mg/dl, monotherapy, obesity, and hemoglobin A(1c) ≥ 7% were associated with a lack of blood pressure control (P < .0001)., Conclusions: Only 3 in 10 hypertensive women aged ≥ 65 years monitored daily in the primary care setting achieved their blood pressure goals. A recent diagnosis of hypertension was the main predictor of poor blood pressure control., (Copyright © 2011 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.)

Background and Objective: Guidelines recommend management of patients based not only on the degree of blood pressure elevation, but in total cardiovascular risk. The aim of the present study was to evaluate the distribution of cardiovascular risk categories in hypertensive patients without evidence of previous cardiovascular events, as well as the relative contribution of each factor responsible for this distribution., Patients and Methods: Cross-sectional, observational, and multicentre study in a cohort of 6,762 treated hypertensive patients, without evidence of previous cardiovascular events. Data responsible for cardiovascular risk stratification (additional cardiovascular risk factors and target organ damage) were collected. The presence of such factors, as well as changes in risk stratification due to individual removal were evaluated., Results: Most patients fulfilled criteria of high or very-high cardiovascular risk. Most frequently present factors were lipid alterations (73.6%) followed by advanced age (sex-adjusted) in 50.8% and abdominal obesity (31.7%). Regarding target organ damage, abnormalities in renal function (24.1%), left ventricular hypertrophy (16.4%) and microalbuminuria (10.7%) were the most frequently observed. A 29% of patients would reduce their cardiovascular risk categorization if lipid abnormalities were absent. In comparison, when other risk factors were removed from risk categorization, it affected less than 10% of patients., Conclusion: Most of the hypertensive subjects fall in high or very-high cardiovascular risk categories. Lipid abnormalities are the most frequent risk modificator and has the most important quantitative impact in risk categorization., (Copyright © 2010 Elsevier España, S.L. All rights reserved.)

Objective: To determine the proportion and clinical features of unrecognized heart failure (HF) in hypertensive women ≥65 years attended in Spain., Methods: A cross-sectional study carried out in primary healthcare setting. Patients were considered to present unrecognized clinical diagnosis of HF if they had not been previously diagnosed but fulfilled Framingham criteria for HF diagnosis., Results: Of 3500 patients, the proportion of unrecognized clinical HF was 26.3%. In comparison with women without HF, all cardiovascular risk factors were more prevalent in patients with unrecognized HF; the same was observed for target organ damage, being the most frequent left ventricular hypertrophy (LVH) (54.1% vs 15.5%, p<0.0001), and for the presence of cardiovascular disease, being the most common coronary heart disease (24.8% vs 9.8%, p<0.0001). Predictive factors associated with the presence of unrecognized HF were LVH (OR =4.84) and the presence of previous cardiovascular disease (OR =2.26) Blood pressure control was worse in patients with unrecognized HF (16.6% vs 33.9%, p <0.01)., Conclusions: More than a quarter of hypertensive women ≥65 years may have clinical data of unrecognized HF. Hypertensive women with unrecognized clinical HF have a worse clinical profile and worse BP control rates than those without HF.

Introduction: The control of overactive bladder (OAB) symptoms, without worsening voiding symptoms, has become an important therapeutic goal in the management of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia. The objective of the present study was to assess the prevalence of other associated LUTS in patients with OAB., Material and Methods: Epidemiological, observational, cross-sectional and multi-centre study, carried out at urology clinics/divisions throughout Spain. The sample included male patients older than 40 who came in for a urology consultation with filling symptoms compatible with OAB. Patient data were collected from the clinical history (demographic data, prostatic disease, other urological and concomitant diseases, OAB and other LUTS symptom data, diagnostic method and treatment data) and from the interview with the patient (I-PSS questionnaire)., Results: 1,754 patients were included in the study. Mean age (SD) of patients was 65.4 (9.7) years. 74.2% of patients presented a prostatic disease, mainly benign prostatic hyperplasia (90.6%); 8.4% had other urologic diseases and 67.4% had at least one concomitant disease relevant to OAB. 99% of all patients had had at least one urological diagnostic test, 78.4% had received some kind of drug to treat symptoms and 61.3% had taken hygiene or dietetic measures. Filling symptoms were more frequent (93.3%) than voiding symptoms (83.9%). Mean score in the I-PSS was 16.3 (5.6) points, symptoms scored as moderate in 1,153 patients (67.9%) and as severe in 463 patients (27.3%)., Conclusions: Most male patients aged over 40 years with OAB symptoms showed other LUTS which worsened their quality of life. Taking this high revalence into account, it seems necessary to manage these patients' diagnosis and treatment according to their symptoms.