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

 Soon Jun Hong  ;  Ki-Chul Sung  ;  Sang-Wook Lim  ;  Seok-Yeon Kim  ;  Weon Kim  ;  Jinho Shin  ;  Sungha Park  ;  Hae-Young Kim  ;  Moo-Yong Rhee 
 DRUG DESIGN DEVELOPMENT AND THERAPY, Vol.14 : 5735-5746, 2020-12 
Journal Title
Issue Date
amlodipine ; blood pressure ; chlorthalidone ; combination therapy ; hypertension ; losartan ; low-dose
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.

Trial registration: ClinicalTrials.gov identifier NCT03897868.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Park, Sung Ha(박성하) ORCID logo https://orcid.org/0000-0001-5362-478X
Won, Dongju(원동주) ORCID logo https://orcid.org/0000-0002-0084-0216
Choi, Jong Rak(최종락) ORCID logo https://orcid.org/0000-0002-0608-2989
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