Effectiveness and tolerability of fixed-dose combination enalapril plus nitrendipine in hypertensive patients: results of the 3-month observational, post-marketing, multicentre, prospective CENIT study.

BACKGROUND AND OBJECTIVE: Monotherapy with any class of antihypertensive drug effectively controls blood pressure (BP) in only about 50% of patients. Consequently, the majority of patients with hypertension require combined therapy with two or more medications. This study aimed to evaluate the effectiveness (systolic BP [SBP]/diastolic BP [DBP] control) and tolerability of the fixed-dose combination enalapril/nitrendipine 10 mg/20 mg administered as a single daily dose in hypertensive patients. METHODS: This was a post-authorization, multicentre, prospective, observational study conducted in primary care with a 3-month follow-up. Patients throughout Spain with uncontrolled hypertension (> or =140/90 mmHg for patients without diabetes mellitus, or > or =130/85 mmHg for patients with diabetes) on monotherapy or with any combination other than enalapril + nitrendipine, or who were unable to tolerate their previous antihypertensive therapy, were recruited. Change from previous to study treatment was according to usual clinical practice. BP was measured once after 5 minutes of rest in the sitting position. Therapeutic response was defined as follows: 'controlled' meant controlled BP (<140/90 mmHg for nondiabetic patients, or <130/85 mmHg for diabetic patients); 'response' meant controlled BP, or a decrease in SBP of > or =20 mmHg and in DBP of > or =10 mmHg. The main laboratory test parameters were documented at baseline and after 3 months. Patients aged >65 years, with diabetes, with isolated systolic hypertension (ISH; SBP > or =140 mmHg for patients without diabetes, SBP > or =130 mmHg for patients with diabetes) and who were obese (body mass index [BMI] > or =30 kg/m2) were analysed separately. RESULTS: Of 6537 patients included, 5010 and 6354 patients were assessed in effectiveness and tolerability analyses, respectively. In the tolerability analysis population, there were 3023 men (47.6%) and 3321 women (52.4%). The mean (+/- SD) age of the tolerability analysis group was 62.8 (+/- 10.7) years. A total of 71.1% of the patients presented at least one clinical cardiovascular risk factor other than hypertension, with the most frequent being dyslipidaemia (42.3%), obesity (29.2%) and diabetes (23.9%). After 3 months of treatment, SBP and DBP showed mean (+/- SD) decreases of 26.5 (+/- 14.4) mmHg and 14.9 (+/- 9.0) mmHg, respectively, and 73.0% of patients responded to treatment while 40.9% achieved BP control (70.8%/36.1% in 2658 patients aged >65 years; 61.7%/46.8% in 1521 patients with diabetes; 55.3%/44.2% in 731 patients with ISH; 72.0%/36.4% in 1762 obese patients). Adverse events were reported in 10.8% of patients (n = 689). During the follow-up period, ten patients died and seven patients had serious adverse events; in no case was a causal relationship attributed to the study product. CONCLUSIONS: The rate of SBP/DBP control achieved demonstrates the effectiveness of the fixed-dose enalapril/nitrendipine 10 mg/20 mg combination administered as a single daily dose in patients with essential hypertension not adequately controlled with monotherapy or with any combination other than enalapril + nitrendipine. The proportion and type of adverse events reported were as expected and have already been described for both components of the enalapril/nitrendipine 10 mg/20 mg combination. These results confirm the effectiveness of a strategy based on a fixed-dose enalapril/nitrendipine 10 mg/20 mg combination in reducing BP and achieving BP control goals.

[Factors predictive of cardiovascular disease in patients with type-2 diabetes and hypercholesterolemia. ESODIAH study]. / Factores predictivos del riesgo de enfermedad cardiovascular en los pacientes con diabetes tipo 2 e hipercolesterolemia. Estudio ESODIAH.

INTRODUCTION AND OBJECTIVES: We investigated the pattern of cardiovascular disease and the factors that predict such disease in outpatients with type-2 diabetes and hypercholesterolemia. METHODS: This prospective open observational study included outpatients of both sexes (mean age 62 [8] years) with type-2 diabetes and hypercholesterolemia. Clinical manifestations of cardiovascular disease (e.g., angina, myocardial infarction, stroke and peripheral arterial disease), glucose and HbA1c levels, and cardiovascular risk factors were recorded every 4 months throughout the 2-year follow-up period. Overall, 838 patients completed follow-up. RESULTS: During follow-up, 81 patients (9.6%) presented with a cardiovascular event, nine of which were fatal. Cardiovascular events were more frequent in patients with a history of an ischemic condition than in those without: 58 of 258 (22.5%) and 23 of 579 (4%), respectively (P<.01). Previous angina or myocardial infarction was the strongest predictor of cardiovascular risk (relative risk [RR]=4.08, 95% confidence interval [CI] 2.39-6.95), followed by previous stroke (RR=2.96, 95% CI 1.26-6.93), high low-density lipoprotein (LDL)-cholesterol level > or =135 mg/dL (RR=2.79, 95% CI 1.56-5.01), peripheral arterial disease (RR=2.44, 95% CI 1.27-4.68), a high HbA1c level (RR=2.08, 95% CI 1.22-3.57), and obesity (RR=1.69, 95% CI 1.0-2.86). CONCLUSIONS: The incidence of cardiovascular disease in this southern European population of patients with type-2 diabetes and hypercholesterolemia was high. A history of an ischemic condition and a high LDL-cholesterol level during follow-up were the strongest predictors of cardiovascular disease.

Factores predictivos del riesgo de enfermedad cardiovascular en los pacientes con diabetes tipo 2 e hipercolesterolemia. Estudio ESODIAH / Factors Predictive of Cardiovascular Disease in Patients With Type-2 Diabetes and Hypercholesterolemia. ESODIAH Study

Introducción y objetivos. Evaluar el patrón y los factores predictivos de enfermedad cardiovascular (ECV) en los pacientes ambulatorios con diabetes tipo 2 e hipercolesterolemia. Métodos. Estudio prospectivo, abierto y observacional en el que se incluyó a pacientes de ambos sexos (62 ± 8 años) con diabetes tipo 2 e hipercolesterolemia. Se registraron las manifestaciones clínicas de ECV, incluidos la angina, el infarto de miocardio, el ictus y la enfermedad arterial periférica; la glucosa, la hemoglobina glucosilada (HbA1c) y los factores de riesgo cardiovascular se evaluaron cada 4 meses durante un período de seguimiento de 2 años, que fue completado por 838 pacientes. Resultados. En total, 81 pacientes (9,6%) presentaron un episodio de ECV y 9 fallecieron durante el seguimiento. La ECV fue más frecuente en los pacientes con historia previa de enfermedad isquémica que en los pacientes sin ella (58 de 258 [22,5%] frente a 23 de 579 [4%], respectivamente; p < 0,01). La angina o el infarto de miocardio previos fueron los predictores más potentes del riesgo cardiovascular (riesgo relativo [RR] = 4,08; intervalo de confianza [IC] del 95%, 2,39-6,95), seguidos del ictus previo (RR = 2,96; IC del 95%, 1,26-6,93), el exceso de colesterol unido a lipoproteínas de baja densidad (cLDL) (≥ 135 mg/dl) (RR = 2,79; IC del 95%, 1,56-5,01), la arteriopatía periférica (RR = 2,44; IC del 95%, 1,27-4,68), el exceso de HbA1c (RR = 2,08; IC del 95%, 1,22-3,57) y la obesidad (RR = 1,69; IC del 95%, 1,0-2,86). Conclusiones. La incidencia de ECV en esta población de pacientes del sur de Europa con diabetes tipo 2 e hipercolesterolemia es elevada. El hecho de haber presentado un episodio isquémico previo y el exceso de cLDL durante el seguimiento son los predictores más potentes del riesgo de presentar futuros episodios de ECV

Introduction and objectives. We investigated the pattern of cardiovascular disease and the factors that predict such disease in outpatients with type-2 diabetes and hypercholesterolemia. Methods. This prospective open observational study included outpatients of both sexes (mean age 62 [8] years) with type-2 diabetes and hypercholesterolemia. Clinical manifestations of cardiovascular disease (e.g., angina, myocardial infarction, stroke and peripheral arterial disease), glucose and HbA1c levels, and cardiovascular risk factors were recorded every 4 months throughout the 2-year follow-up period. Overall, 838 patients completed follow-up. Results. During follow-up, 81 patients (9.6%) presented with a cardiovascular event, nine of which were fatal. Cardiovascular events were more frequent in patients with a history of an ischemic condition than in those without: 58 of 258 (22.5%) and 23 of 579 (4%), respectively (P<.01). Previous angina or myocardial infarction was the strongest predictor of cardiovascular risk (relative risk [RR]=4.08, 95% confidence interval [CI] 2.39-6.95), followed by previous stroke (RR=2.96, 95% CI 1.26-6.93), high low-density lipoprotein (LDL)-cholesterol level ≥135 mg/dL (RR=2.79, 95% CI 1.56-5.01), peripheral arterial disease (RR=2.44, 95% CI 1.27-4.68), a high HbA1c level (RR=2.08, 95% CI 1.22-3.57), and obesity (RR=1.69, 95% CI 1.0-2.86). Conclusions. The incidence of cardiovascular disease in this southern European population of patients with type-2 diabetes and hypercholesterolemia was high. A history of an ischemic condition and a high LDL-cholesterol level during follow-up were the strongest predictors of cardiovascular disease