Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study

被引:20
|
作者
Hong, Soon Jun [1 ]
Sung, Ki-Chul [2 ]
Lim, Sang-Wook [3 ]
Kim, Seok-Yeon [4 ]
Kim, Weon [5 ]
Shin, Jinho [6 ]
Park, Sungha [7 ]
Kim, Hae-Young [8 ,9 ]
Rhee, Moo-Yong [10 ,11 ]
机构
[1] Korea Univ, Coll Med, Cardiovasc Ctr, Dept Cardiol,Anam Hosp, Seoul, South Korea
[2] Sungkyunkwan Univ, Gangbuk Samsung Hosp, Dept Cardiol, Coll Med, Seoul, South Korea
[3] CHA Univ, Cardiac Ctr, CHA Bundang Med Ctr, Cardiol Div, Seongnam, South Korea
[4] Seoul Med Ctr, Dept Cardiol, Seoul, South Korea
[5] Kyung Hee Univ, Med Ctr, Dept Internal Med, Seoul, South Korea
[6] Hanyang Univ, Dept Internal Med, Div Cardiol, Coll Med, Seoul, South Korea
[7] Yonsei Univ, Severance Hosp, Dept Cardiol, Coll Med, Seoul, South Korea
[8] Korea Univ, Grad Sch, Coll Hlth Sci, Dept Hlth Policy & Management, Seoul, South Korea
[9] Korea Univ, Grad Sch, Dept Hlth Care Sci, Seoul, South Korea
[10] Dongguk Univ, Cardiovasc Ctr, Ilsan Hosp, Goyang Si, Gyeonggi, South Korea
[11] Dongguk Univ, Coll Med, Gyeongju Si, Gyeongbuk, South Korea
来源
DRUG DESIGN DEVELOPMENT AND THERAPY | 2020年 / 14卷
关键词
hypertension; blood pressure; combination therapy; low-dose; amlodipine; losartan; chlorthalidone; METAANALYSIS; AMLODIPINE; EFFICACY; EVENTS; SAFETY; AGENTS;
D O I
10.2147/DDDT.S286586
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Purpose: We evaluated the dose-responsiveness, efficacy, and safety of low-dose triple antihypertensive combination therapies in patients with mild-to-moderate hypertension. Patients and Methods: After a 1 to 2-week placebo run-in period, 248 patients were randomized to the half-dose triple combination (amlodipine 2.5 mg + losartan 25 mg + chlorthalidone 6.25 mg), third-dose triple combination (amlodipine 1.67 mg + losartan 16.67 mg + chlorthalidone 4.17 mg), quarter-dose triple combination (amlodipine 1.25 mg + losartan 12.5 mg + chlorthalidone 3.13mg), amlodipine 10mg, amlodipine 5mg, losartan 100mg, and placebo groups for 8 weeks. The primary outcome was the mean change in systolic blood pressure (SBP) from baseline to week 8. Results: The placebo-corrected SBP reductions of the half-dose, third-dose, quarter-dose combination, amlodipine 10 mg, amlodipine 5 mg and losartan 100 mg treatments were -17.2, -19.5, -14.9, -18.5, -11.3 and -9.9 mmHg, respectively. The BP control and response rates were significantly higher in the half-dose, third-dose, and quarter-dose combination groups than in the placebo group (all p < 0.01). Despite no intergroup differences in study drug-related adverse events, ankle circumference increased significantly in the amlodipine group compared to those in the combination treatment groups. The quarter-dose combination, amlodipine 5 mg, and losartan 100 mg groups showed similar SBP reduction and BP response rates. The SBP reduction and BP response rate in the third-dose and half-dose combination groups were not significantly different from those in the amlodipine 10 mg group but superior to those in the losartan 100 mg group. Conclusion: Low-dose triple combination therapies could be effective as antihypertensive therapies.
引用
收藏
页码:5735 / 5746
页数:12
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