Efficacy and safety of standard dose triple combination of telmisartan 80mg/amlodipine 5mg/chlorthalidone 25mg in primary hypertension: A randomized, double-blind, active-controlled, multicenter phase 3 trial.

Abstract

The authors evaluated the efficacy, safety, and characteristics of patients who respond well to standard dose triple combination therapy including chlorthalidone 25mg with telmisartan 80mg plus amlodipine 5mg in hypertensive patients. This is a multicenter, double-blind, active-controlled, phase 3, randomized trial. Patients are randomized to triple combination (telmisartan 40mg/amlodipine 5mg/chlorthalidone 12.5mg, TEL/AML/CHTD group) or dual combination (telmisartan 40mg/amlodipine 5mg, 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±10.7years, male=78.3%) were randomized to the study. The baseline MSSBPs/diastolic BPs were 149.9±12.2/88.5±10.4mm Hg. After 8weeks treatment, the change of MSSBPs at week 8 are -19.1±14.9mm Hg (TEL/AML/CHTD) and -11.4±14.7mm 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≥65years 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 80mg/amlodipine 5mg/chlorthalidone 25mg is efficacious and safe in treatment of primary hypertension. Target BP achievement with triple therapy would be facilitated in female or old age.