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 language | English |
|---|---|
| Pages (from-to) | 35-47 |
| Number of pages | 13 |
| Journal | American Journal of Cardiovascular Drugs |
| Volume | 12 |
| Issue number | 1 |
| DOIs | |
| State | Published - 2012 |
Bibliographical note
Funding Information:This study was supported by Hanmi Pharmaceutical Ltd, Korea, who provided funding and participated in the study design, data management and analysis, and review of the manuscript. The authors wish to thank Dr Mary E. Hanson of Merck for assistance in the preparation of the manuscript, although she did not fulfill all the criteria for authorship. The authors have no conflicts of interest to declare.
Keywords
- amlodipine
- hypertension
- losartan.