Comparison of efficacy and safety between third-dose triple and third-dose dual antihypertensive combination therapies in patients with hypertension.

Abstract

We compared the efficacy and safety of third-standard-dose triple and third-standard-dose dual antihypertensive combination therapies in patients with mild to moderate hypertension. This was a phase II multicenter, randomized, double-blind, parallel-group trial. After a 4-week placebo run-in period, 245 participants were randomized to the third-dose triple combination (ALC group; amlodipine 1.67mg + losartan potassium 16.67mg + chlorthalidone 4.17mg) or third-dose dual combination (AL group; amlodipine 1.67mg + losartan potassium 16.67mg, LC group; losartan potassium 16.67mg + chlorthalidone 4.17mg, AC group; amlodipine 1.67mg + chlorthalidone 4.17mg) therapy groups and followed up for 8weeks. The mean systolic blood pressure (BP) reduction was -18.3±13.2, -13.0±13.3, -16.3±12.4, and -13.8±13.2mmHg in the ALC, AL, LC, and AC groups, respectively. The ALC group showed significant systolic BP reduction compared to the AL and AC groups at weeks 4 (P=.010 and P=.018, respectively) and 8 (P=.017 and P=.036, respectively). At week 4, the proportion of systolic BP responders was significantly higher in the ALC group (42.6%) than in the AL (22.0%), LC (23.3%), and AC (27.1%) groups (P=.013, P=.021, and P=.045, respectively). At week 8, the proportion of systolic and diastolic BP responders was significantly higher in the ALC group (59.7%) than in the AL (39.3%) and AC (42.4%) groups (P=.022 and P=.049, respectively) at week 8. Third-standard-dose triple antihypertensive combination therapy demonstrated early effective BP control compared to third-standard-dose dual combination therapies, without increasing adverse drug reactions in patients with mild-to-moderate hypertension.