Efficacy and safety of standard dose triple combination of telmisartan 80 mg/amlodipine 5 mg/chlorthalidone 25 mg in primary hypertension: A randomized, double-blind, active-controlled, multicenter phase 3 trialopen access
- Authors
- Cho, Eun Joo; Kim, Moo Hyun; Kim, Young-Hak; Chang, Kiyuk; Choi, Dong-Ju; Kang, Woong Chol; Shin, Jinho; Kim, Seong Hwan; Lee, Namho; Son, Jang Won; Doh, Joon-Hyung; Kim, Woo-Shik; Hong, Soon Jun; Rhee, Moo-Yong; Ahn, Youngkeun; Lim, Sang-Wook; Hong, Seung Pyo; Choi, So-Yeon; Hyon, Min Su; Hwang, Jin-Yong; Kwon, Kihwan; Cha, Kwang Soo; Ihm, Sang-Hyun; Lee, Jae-Hwan; Yoo, Byung-Su; Kim, Hyo-Soo
- Issue Date
- Sep-2023
- Publisher
- WILEY
- Keywords
- amlodipine; blood pressure; chlorthalidone; telmisartan; triple combination
- Citation
- JOURNAL OF CLINICAL HYPERTENSION, v.25, no.9, pp 817 - 827
- Pages
- 11
- Journal Title
- JOURNAL OF CLINICAL HYPERTENSION
- Volume
- 25
- Number
- 9
- Start Page
- 817
- End Page
- 827
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/25593
- DOI
- 10.1111/jch.14707
- ISSN
- 1524-6175
1751-7176
- Abstract
- The authors evaluated the efficacy, safety, and characteristics of patients who respond well to standard dose triple combination therapy including chlorthalidone 25 mg with telmisartan 80 mg plus amlodipine 5 mg in hypertensive patients. This is a multicenter, double-blind, active-controlled, phase 3, randomized trial. Patients are randomized to triple combination (telmisartan 40 mg/amlodipine 5 mg/chlorthalidone 12.5 mg, TEL/AML/CHTD group) or dual combination (telmisartan 40 mg/amlodipine 5 mg, TEL/AML group) treatment and then dose up titration to TEL 80/AML5/CHTD25mg and TEL80/AML5, respectively. The primary endpoint is the change of mean sitting systolic blood pressure (MSSBP) at week 8. A Target BP achievement rate, a response rate, and the safety endpoints are also evaluated. Total 374 patients (mean age = 60.9 +/- 10.7 years, male = 78.3%) were randomized to the study. The baseline MSSBPs/diastolic BPs were 149.9 +/- 12.2/88.5 +/- 10.4 mm Hg. After 8 weeks treatment, the change of MSSBPs at week 8 are -19.1 +/- 14.9 mm Hg (TEL/AML/CHTD) and -11.4 +/- 14.7 mm Hg (TEL/AML) (p < .0001). The achievement rates of target BP (53.8% vs. 37.8%, p = .0017) and responder rate (54.8% vs. 35.6%, p = .0001) at week 8 were significantly higher in TEL/AML/CHTD. There are no serious adverse event and no one discontinued medication due to adverse event. Among the TEL 80/AML5/CHTD25mg treatment group, patients of female or age >= 65 years old showed higher rate of target BP achievement than relatively young male. (61.4 vs. 46.8%, p = .042) Our study showed standard dose triple combination of telmisartan 80 mg/amlodipine 5 mg/chlorthalidone 25 mg is efficacious and safe in treatment of primary hypertension. Target BP achievement with triple therapy would be facilitated in female or old age.
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