Key result
Third-dose triple combination therapy significantly reduced systolic blood pressure compared to dual combinations AL and AC at 8 weeks (-18.3 vs -13.0 and -13.8 mmHg; P=0.017 and P=0.036).
Why the study?
The study was conducted to compare the efficacy and safety of third-standard-dose triple versus third-standard-dose dual antihypertensive combination therapies in patients with mild to moderate hypertension.
Does third-dose triple antihypertensive combination therapy improve blood pressure reduction in patients with mild to moderate hypertension compared to third-dose dual combination therapies?
RCT (n=245)
double-blind
randomized
Yes
Does third-dose triple antihypertensive combination therapy improve blood pressure reduction in patients with mild to moderate hypertension compared to third-dose dual combination therapies?
p-value: P = .017 and P = .036
A third-standard-dose triple antihypertensive combination provides earlier and more effective blood pressure control than dual combinations without increasing adverse reactions in patients with mild-to-moderate hypertension.
May support low-dose triple as initial therapy in mild-moderate HTN; extends ultra-low-dose combination evidence pending Phase III.
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 1.67 mg + losartan potassium 16.67 mg + chlorthalidone 4.17 mg) or third-dose dual combination (AL group; amlodipine 1.67 mg + losartan potassium 16.67 mg, LC group; losartan potassium 16.67 mg + chlorthalidone 4.17 mg, AC group; amlodipine 1.67 mg + chlorthalidone 4.17 mg) therapy groups and followed up for 8 weeks. The mean systolic blood pressure (BP) reduction was -18.3 ± 13.2, -13.0 ± 13.3, -16.3 ± 12.4, and -13.8 ± 13.2 mmHg 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.
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Sung et al. (2023) conducted an RCT in mild to moderate hypertension (n=245). Third-dose triple combination therapy (ALC) vs. Third-dose dual combination therapies (AL, LC, AC) was evaluated on Mean systolic blood pressure reduction (p=P = .017 and P = .036). Third-dose triple combination therapy significantly reduced systolic blood pressure compared to dual combinations AL and AC at 8 weeks (-18.3 vs -13.0 and -13.8 mmHg; P=0.017 and P=0.036).
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