Evaluation of the dose-response relationship of amlodipine and losartan combination in patients with essential hypertension: An 8-week, randomized, double-blind, factorial, phase II, multicenter study

Chang Gyu Park, Ho Joong Youn, Shung Chull Chae, Joo Young Yang, Moo Hyun Kim, Taek Jong Hong, Cheol Ho Kim, Jae Joong Kim, Bum Kee Hong, Jin Won Jeong, Si Hoon Park, Jun Kwan, Young Jin Choi, Seung Yun Cho

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Despite recommendations for more intensive treatment and the availability of several effective treatments, hypertension remains uncontrolled in many patients. Objective: The aim of this study was to determine the dose-response relationship and assess the efficacy and safety of amlodipine or losartan monotherapy and amlodipine camsylate/losartan combination therapy in patients with essential hypertension. Methods: This was an 8-week, randomized, double-blind, factorial design, phase II, multicenter study conducted in outpatient hospital clinics among adult patients aged 18-75 years with essential hypertension. At screening, patients received placebo for 2-4 weeks. Eligible patients (n = 320) were randomized to one of eight treatment groups: amlodipine 5mg or 10 mg, losartan 50mg or 100 mg, amlodipine camsylate/losartan 5mg/50 mg, 5mg/100 mg, 10 mg/50 mg, or 10 mg/100 mg. Main Outcome Measures: The assumption of strict superiority was estimated using the mean change in sitting diastolic blood pressure (DBP) at 8 weeks. Safety was monitored through physical examinations, vital signs, laboratory test results, ECG, and adverse events. Results: The reduction in DBP at 8 weeks was significantly greater in patients treated with the combination therapies compared with the respective monotherapies for all specified comparisons except amlodipine camsylate/losartan 10 mg/100mg versus amlodipine 10 mg. The incidence of adverse events in the group of patients treated with the amlodipine camsylate/losartan 10 mg/50 mg combination tended to be higher than for any other group (27.9%, 12/43); however, the effect was not statistically significant. Conclusion: Combination amlodipine camsylate/losartan (5 mg/50 mg, 5mg/100mg and 10 mg/50 mg) resulted in significantly greater BP lowering compared with amlodipine or losartan monotherapy, and was determined to be generally safe and tolerable in patients with essential hypertension.

Original languageEnglish
Pages (from-to)35-47
Number of pages13
JournalAmerican Journal of Cardiovascular Drugs
Volume12
Issue number1
DOIs
Publication statusPublished - 2012 Feb 1

Keywords

  • amlodipine
  • hypertension
  • losartan.

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Pharmacology (medical)

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