The Journal of Clinical Hypertension (Sep 2023)

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

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

DOI
https://doi.org/10.1111/jch.14707
Journal volume & issue
Vol. 25, no. 9
pp. 817 – 827

Abstract

Read online

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.

Keywords