Comparative Efficacy and Safety Profile of Amlodipine 5 mg/Losartan 50 mg Fixed-Dose Combination and Amlodipine 10 mg Monotherapy in Hypertensive Patients Who Respond Poorly to Amlodipine 5 mg Monotherapy: An 8-Week, Multicenter, Randomized, Double-Blind Phase III Noninferiority Study
- Authors
- Kang, Seok-Min; Youn, Jong-Chan; Chae, Shung Chull; Park, Chang Gyu; Yang, Joo Young; Kim, Moo Hyun; Hong, Taek Jong; Kim, Cheol Ho; Kim, Jae Joong; Shin, Dong Gu; Jung, Jin Won; Yoon, Jung Han; Park, Si Hoon; Kwon, Jun; Cho, Seung Yun
- Issue Date
- 12월-2011
- Publisher
- ELSEVIER
- Keywords
- amlodipine; hypertension; losartan
- Citation
- CLINICAL THERAPEUTICS, v.33, no.12, pp.1953 - 1963
- Indexed
- SCIE
SCOPUS
- Journal Title
- CLINICAL THERAPEUTICS
- Volume
- 33
- Number
- 12
- Start Page
- 1953
- End Page
- 1963
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/111116
- DOI
- 10.1016/j.clinthera.2011.11.007
- ISSN
- 0149-2918
- Abstract
- Background: The number of hypertensive patients achieving treatment targets is not ideal with therapies that engage a single mechanism of action, and combination therapies using different mechanisms of action can increase drug efficacy in a synergistic way. Objective: This noninferiority study compared the clinical efficacy and safety profile of fixed-dose combination of amlodipine/losartan 5/50 mg and amlodipine 10 mg monotherapy in essential hypertensive patients who respond poorly to amlodipine 5 mg monotherapy. Methods: This was a double-blind, multicenter, randomized trial of hypertensive patients (N = 185) aged >=.18 years taking amlodipine 5 mg during the run-in treatment period but failed to achieve sitting diastolic blood pressure (DBP) <90 mm Hg. After randomization into the amlodipine/losartan 5/50 mg fixed-dose combination group (n = 92) and the amlodipine 10 mg monotherapy group (n = 93), treatment was maintained without dose escalation for 8 weeks. The noninferiority margin was prespecified as 4 mm Hg after 8 weeks of treatment for the difference of the average change in DBP between treatments. The primary efficacy evaluation of noninferiority was tested using a confidence interval approach with a 97.5% 1-sided lower confidence limit using the average difference in DBP measured at baseline and 8 weeks. Results: After 8 weeks, the DBP of both groups decreased from baseline by 8.9 (6.1) and 9.4 (7.5) mm Hg, respectively (difference = -0.5 [6.9] mm Hg, 95% CI: -2.5 to 1.5). Secondary end points of reductions in DBP after 4 weeks (-8.1 [6.7] vs -9.9 [7.3] mm Hg, difference = -1.8 mm Hg, 95% CI: -3.9 to 0.2) and sitting systolic blood pressure after 4 (-10.2 [11.8] vs -12.8 [10.2] mm Hg, difference = -2.6 mm Hg, 95% CI: -5.9 to 0.6) and 8 weeks (-12.2 [11.0] vs -13.4 [11.3] mm Hg, difference = -1.2 mmHg, 95% CI: -4.4 to 2.1) were comparable between the 2 treatment groups. There were 38 adverse events in 20 patients (21.7%) in the amlodipine/losartan 5/50 mg fixed-dose combination group and 31 in 24 patients (26.1%) in the amlodipine 10 mg monotherapy group; most were mild. There were 7 adverse events in 6 patients (6.5%) related to treatment in the fixed-dose combination group and 13 in 10 patients (10.9%) in the monotherapy group (P = 0.30). Conclusions: Fixed-dose combination amlodipine/losartan 5/50 mg was not inferior in terms of reductions in DBP after 8 weeks of treatment and had comparable safety profile to amlodipine 10 mg in patients who did not respond to amlodipine 5 mg monotherapy. ClinicalTrials.gov identifier: NCT00940667. (Clin Ther. 2011;33:1953-1963) (C) 2011 Elsevier HS Journals, Inc. All rights reserved.
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