title: Efficacy and safety of valsartan and amlodipine single-pill combination in hypertensive patients (PEAK study).
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Novartis Pharmaceuticals, İstanbul, Turkey. pkizilirmak@gmail.com
authors.forename: Pınar
authors.initials: P
authors.lastname: Kızılırmak
authors.forename: Mehmet
authors.initials: M
authors.lastname: Berktaş
authors.forename: Mehmet Rıdvan
authors.initials: MR
authors.lastname: Yalçın
authors.forename: Bülent
authors.initials: B
authors.lastname: Boyacı
mesh_terms: D000284:Administration, Oral; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D013777:Tetrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014421:Turkey; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000068756:Valsartan
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D013777:Tetrazoles; D017311:Amlodipine; D000068756:Valsartan; D014633:Valine