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Efficacy and safety of valsartan/amlodipine single-pill combination in patients with essential hypertension (PEAK LOW).
Turk Kardiyol Dern Ars ; 42(4): 339-48, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24899477


This study evaluated the efficacy as well as the safety and tolerability profile of low-dose valsartan/amlodipine (Val/Amlo) single-pill combination (SPC) (160/5 mg) in patients with essential hypertension in Turkey. STUDY


Adult patients with essential hypertension [systolic blood pressure (SBP)>140 mmHg and/or diastolic blood pressure (DBP)>90 mmHg], who were on low dose Val/Amlo (160/5 mg) SPC before enrollment and gave informed consent, were accepted for this multi-centric observational study performed at 30 sites. The absolute changes in SBP and DBP from baseline were the primary efficacy outcomes. Safety assessments consisted of recording all adverse events.


Of 381 patients enrolled, 327 completed the study; 39% were females. The mean age was 57.3±11.8 years. Median duration of hypertension was 38 months. Both SBP and DBP values showed reductions from 162.6±16.6 mmHg and 94.0±13.2 mmHg to 137.6±14.2 mmHg and 81.9±9.0 mmHg at 4th week and to 131.6±11.5 mmHg and 79.7±7.6 mmHg at 12th week, respectively. The control and response rates at the end of the study were 82.0% and 92.6%, respectively. Twelve patients (3.2%) experienced a total of 12 adverse events; there were no serious adverse events. The most common adverse event was edema (1.3%). Patient compliance was approximately 99%.


Low-dose (160/5 mg) Val/Amlo SPC is efficacous and has a good tolerability and safety profile for the management of essential hypertension in Turkey.





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 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: 2014 Tipo del documento: Artículo País de afiliación: Turquía