Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension

Clin Exp Hypertens. 2015;37(3):260-6. doi: 10.3109/10641963.2014.954712. Epub 2014 Oct 1.

Abstract

Japanese patients with uncontrolled essential hypertension received single-blind losartan 50 mg/hydrochlorothiazide 12.5 mg (L50/H12.5) for 8 weeks. Patients whose blood pressure (BP) remained uncontrolled were randomized double-blind to fixed-dose losartan 50 mg/hydrochlorothiazide 12.5 mg/amlodipine 5 mg (L50/H12.5/A5) or L50/H12.5 for 8 weeks followed by open-label L50/H12.5/A5 for 44 weeks. Adverse events were assessed. After 8 weeks, diastolic and systolic BP were reduced significantly more with L50/H12.5/A5 versus L50/H12.5 (both p < 0.001). Mean changes in diastolic and systolic BP were sustained for 44 weeks. L50/H12.5/A5 was well-tolerated and improved BP significantly versus L50/H12.5 in Japanese patients with uncontrolled essential hypertension.

Trial registration: ClinicalTrials.gov NCT01299376.

Keywords: Amlodipine; Japanese; hydrochlorothiazide; losartan.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Amlodipine* / administration & dosage
  • Amlodipine* / adverse effects
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / adverse effects
  • Blood Pressure / drug effects*
  • Drug Combinations
  • Drug Monitoring / methods
  • Essential Hypertension
  • Female
  • Humans
  • Hydrochlorothiazide* / administration & dosage
  • Hydrochlorothiazide* / adverse effects
  • Hypertension* / diagnosis
  • Hypertension* / drug therapy
  • Hypertension* / physiopathology
  • Japan
  • Losartan* / administration & dosage
  • Losartan* / adverse effects
  • Male
  • Middle Aged
  • Treatment Outcome

Substances

  • Antihypertensive Agents
  • Drug Combinations
  • Hydrochlorothiazide
  • Amlodipine
  • Losartan

Associated data

  • ClinicalTrials.gov/NCT01299376