Journal Article

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 trial

Ahn, Youngkeun, Cha, Kwang Soo, Choi, Dong‐Ju, Kim, Hyo‐Soo, Cho, Eun Joo, Kwon, Kihwan, Ihm, Sang‐Hyun, Kim, Seong Hwan, Lim, Sang‐Wook, Lee, Jae‐Hwan, Hyon, Min Su, Choi, So‐Yeon, Hwang, Jin‐Yong, Hong, Soon Jun, Kim, Young‐Hak, Shin, Jinho, Kim, Moo Hyun, Lee, Namho, Rhee, Moo‐Yong, Kang, Woong Chol, Yoo, Byung‐Su, Doh, Joon‐Hyung, Chang, Kiyuk, Kim, Woo‐Shik, Son, Jang Won, Hong, Seung Pyo

2023

Overview

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.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc,Wiley
• Subject: Aged / amlodipine / Amlodipine - adverse effects / Antihypertensives / blood pressure / chlorthalidone / Chlorthalidone - adverse effects / Clinical Trial / Clinical Trials / Diabetes / Diuretics / Drug dosages / Essential Hypertension / Female / Humans / Hypertension / Hypertension - drug therapy / Kidney diseases / Leukemia, Myeloid, Acute / Male / Middle Aged / telmisartan / Telmisartan - adverse effects / triple combination