Efficacy and safety of amlodipine/valsartan/hydrochlorothiazide single pill combination in Egyptian patients with hypertension uncontrolled on any dual therapy: an observational study

Curr Med Res Opin. 2020 Apr;36(4):537-544. doi: 10.1080/03007995.2020.1719394. Epub 2020 Feb 4.

Abstract

Objective: Hypertension is a serious health problem in Egypt, with prevalence rate of 17% as reported in 2015. Despite receiving treatment, many do not achieve blood pressure (BP) control. The current study aimed to evaluate the efficacy and tolerability of amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) single pill combination (SPC) in patients with hypertension from Egypt, who were uncontrolled on any dual therapy.Methods: In this prospective, open label, multicenter, 12-week observational, cohort study, two doses of Aml/Val/HCTZ (5/160/12.5 mg or 10/160/25 mg) SPC were used to evaluate mean change in BP after 12 weeks (primary endpoint). Safety assessments included presence and intensity of ankle edema and other adverse events (AEs).Results: Data were collected from 1080 patients who were treated according to the routine medical practice across 47 centers in Egypt. Significant reduction in systolic and diastolic BP (SBP/DBP) was observed from 165.5 ± 12.83/100.8 ± 7.03 mmHg at baseline to 129.7 ± 8.35/80.6 ± 5.25 mmHg after 12 weeks of treatment (p < .0001). Majority of patients (76.85%) reached the BP goal of <140/90 mmHg. The most commonly reported AE was ankle edema (10.92%).Conclusions: Aml/Val/HCT SPC significantly reduced BP and was well tolerated in Egyptian patients with hypertension not controlled on any previous dual therapy.

Keywords: Compliance; Egypt; efficacy; hypertension; safety; triple therapy.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Amlodipine, Valsartan Drug Combination / administration & dosage*
  • Amlodipine, Valsartan Drug Combination / adverse effects
  • Antihypertensive Agents / therapeutic use*
  • Drug Combinations
  • Edema / chemically induced
  • Female
  • Humans
  • Hydrochlorothiazide / administration & dosage*
  • Hypertension / drug therapy*
  • Male
  • Middle Aged
  • Prospective Studies

Substances

  • Amlodipine, Valsartan Drug Combination
  • Antihypertensive Agents
  • Drug Combinations
  • Hydrochlorothiazide