Turk Kardiyol Dern Ars. 2013; 41(5): 406-417 | DOI: 10.5543/tkda.2013.60052

Efficacy and safety of valsartan and amlodipine single-pill combination in hypertensive patients (PEAK study)

Pınar Kızılırmak¹, Mehmet Berktaş², Mehmet Rıdvan Yalçın³, Bülent Boyacı^3
1Novartis Pharmaceuticals, Istanbul
²Yeditepe University, Pharmacoeconomics and Pharmacoepidemiology Research Center, Istanbul
³Department of Cardiology, Gazi University Faculty of Medicine, Ankara

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.

Keywords: Adult, amlodipine, angiotensin II receptor antagonist, blood pressure; body mass index; hypertension/epidemiology; risk factors; Turkey/epidemiology; valsartan.

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