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Efficacy and safety of valsartan and amlodipine single-pill combination in hypertensive patients (PEAK study).
Turk Kardiyol Dern Ars ; 41(5): 406-17, 2013 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-23917006
ABSTRACT

OBJECTIVES:

This study was designed to assess the safety, compliance and efficacy of amlodipine (Aml) and valsartan (Val) single-pill combination (SPC) in a large hypertensive patient population. STUDY

DESIGN:

This is a non-interventional, observational, open label study conducted in 166 centers in Turkey with a 24-week follow-up period.

RESULTS:

Of the 1184 enrolled patients, two-thirds were female (62.2%). The mean age was 57.7±11.3 years, and 26.1% of the patients were older than 65 years. The majority of patients (82.3%) were overweight or obese. During the course of the study, 150 (12.7%) patients experienced a total of 174 adverse events (AEs). The overall mean (SD) compliance rate was determined to be 96.9 (0.2)%. The most commonly reported AE was edema, with a new-onset edema incidence of 6.7%. In the entire group, Aml/Val SPC significantly reduced both systolic and diastolic blood pressure (BP), with a reduction of 29.6±0.9 / 14.7±0.6 mmHg (for each, p<0.001).

CONCLUSION:

As a result of the low incidences of AEs and new-onset edema, the safety profile of Aml/Val SPC proved to be optimal. Aml/Val SPC reduced BP efficiently and met the needs of most patients to achieve the targets. Aml/Val SPC seems to be a beneficial option for effective BP control, which is a key factor influencing cardiovascular outcome.
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Texto completo: Disponible Colección: Bases de datos internacionales Base de datos: MEDLINE Asunto principal: Tetrazoles / Valina / Amlodipino / Hipertensión / Antihipertensivos Tipo de estudio: Ensayo clínico controlado Aspecto clínico: Pronóstico / Terapia Límite: Anciano / Femenino / Humanos / Masculino / Media edad País/Región como asunto: Asia Idioma: Inglés Revista: Turk Kardiyol Dern Ars Asunto de la revista: Cardiología Año: 2013 Tipo del documento: Artículo País de afiliación: Turquía