Key result
Third-standard-dose triple antihypertensive combination therapy significantly reduced systolic blood pressure at 8 weeks compared to amlodipine/losartan (MD -5.1 mmHg) and amlodipine/chlorthalidone (MD -4.5 mmHg) dual therapies.
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-standard-dose triple antihypertensive combination therapy improve blood pressure reduction compared to third-standard-dose dual combination therapies in patients with mild to moderate hypertension?
RCT (n=245)
Double-blind
1:1:1:1 ratio
Yes
Does third-standard-dose triple antihypertensive combination therapy improve blood pressure reduction compared to third-standard-dose dual combination therapies in patients with mild to moderate hypertension?
Mean Difference: -5.1 (95% CI -9.2–-0.9)
Absolute Event Rate: -18.3% vs -13%
p-value: p=0.017
A third-standard-dose triple antihypertensive combination pill provides earlier and greater blood pressure reduction than dual combinations without increasing adverse events in mild-to-moderate hypertension.
Supports low-dose triple therapy for greater BP reduction in mild-moderate hypertension; extends RCT evidence beyond dual combinations.
Purpose 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. Methods 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 after 8 weeks. Results 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 = 0.010 and p = 0.018, respectively) and 8 (p = 0.017 and p = 0.036, respectively). 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 = 0.013, p = 0.021 and p = 0.045, respectively) at week 4. 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 = 0.022 and p = 0.049, respectively) at week 8. Conclusion 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. Trial Registration NCT04959305
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Sung et al. (2022) conducted an RCT in Mild to moderate hypertension (n=245). Third-dose triple combination (amlodipine + losartan + chlorthalidone) vs. Third-dose dual combinations (amlodipine/losartan, losartan/chlorthalidone, or amlodipine/chlorthalidone) was evaluated on Mean change in sitting systolic blood pressure (SBP) from baseline to week 8 (MD -5.1, 95% CI -9.2 to -0.9, p=0.017). Third-standard-dose triple antihypertensive combination therapy significantly reduced systolic blood pressure at 8 weeks compared to amlodipine/losartan (MD -5.1 mmHg) and amlodipine/chlorthalidone (MD -4.5 mmHg) dual therapies.
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