Efficacy and safety of valsartan and amlodipine single-pill combination in hypertensive patients (PEAK study) [Turk Kardiyol Dern Ars]
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 Boyacı3
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.

How to cite this article
Pınar Kızılırmak, Mehmet Berktaş, Mehmet Rıdvan Yalçın, Bülent Boyacı. Efficacy and safety of valsartan and amlodipine single-pill combination in hypertensive patients (PEAK study). Turk Kardiyol Dern Ars. 2013; 41(5): 406-417

Corresponding Author: Pınar Kızılırmak, Türkiye
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