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Open Access Highly Accessed Research article

Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study

Sung-Hae Kim1, Kyu-Hyung Ryu1*, Nam-Ho Lee2, Jin-Ho Kang3, Woo-Shik Kim4, Sang-Weon Park5, Hae-Young Lee6, Jae-Joong Kim7, Young-Keun Ahn8 and Soon-Yong Suh9

Author Affiliations

1 Department of Cardiology, Konkuk University School of Medicine, Seoul, Korea

2 Cardiology Department, Hallym University Kangnam Sacred Heart Hospital, Gyeonggi, Korea

3 Cardiology Department, Kangbuk Samsung Hospital, Seoul, Korea

4 Cardiovascular Medicine Department, KyungHee University Medical Center, Seoul, Korea

5 Cardiology Department, Korea University Anam Hospital, Seoul, Korea

6 Cardiology Department, Seoul National University Hospital, Seoul, Korea

7 Department of Cardiology, Asan Medical Center, Seoul, Korea

8 Cardiology Department, Chonnam National University Hospital, Gwangju, Korea

9 Gachon University Gil Medical Center, Incheon, Korea

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BMC Research Notes 2011, 4:461  doi:10.1186/1756-0500-4-461

Published: 28 October 2011

Abstract

Background

The objective of this trial was to compare the blood-pressure lowering efficacy of amlodipine/losartan combination with amlodipine monotherapy after 6 weeks of treatment in Korean patients with stage 2 hypertension.

Results

In this multi-center, double-blind, randomized study, adult patients (n = 148) with stage 2 hypertension were randomized to amlodipine 5 mg/losartan 50 mg or amlodipine 5 mg. After 2 weeks, patients with systolic blood pressure (SBP) > 140 mmHg were titrated to amlodipine 10 mg/losartan 50 mg or amlodipine 10 mg. After 4 weeks of titration, hydrochlorothiazide 12.5 mg could be optionally added to both groups. The change from baseline in SBP was assessed after 6 weeks. The responder rate (defined as achieving SBP < 140 mmHg or DBP < 90 mmHg) was also assessed at 2, 6 and 8 weeks as secondary endpoints. Safety and tolerability were assessed through adverse event monitoring and laboratory testing. Baseline demographics and clinical characteristics were generally similar between treatment groups. Least-square mean reduction in SBP at 6 weeks (primary endpoint) was significantly greater in the combination group (36.5 mmHg vs. 31.6 mmHg; p = 0.0117). The responder rate in SBP (secondary endpoints) was significantly higher in the combination group at 2 weeks (52.1% vs. 33.3%; p = 0.0213) but not at 6 weeks (p = 0.0550) or 8 weeks (p = 0.0592). There was no significant difference between groups in the incidence of adverse events.

Conclusion

These results demonstrate that combination amlodipine/losartan therapy provides an effective and generally well-tolerated first line therapy for reducing blood pressure in stage 2 hypertensive patients.

Trial Registration

ClinicalTrials.gov: NCT01127217

Keywords:
hypertension; amlodipine; losartan