COMPARISON OF THIRD-DOSE TRIPLE VERSUS THIRD-DOSE DUAL ANTIHYPERTENSIVE COMBINATION THERAPIES IN PATIENTS WITH ESSENTIAL HYPERTENSION DURING 8-WEEK FOLLOW-UP

초록

Objective We compared efficacy and safety of low-dose triple versus low-dose dual antihypertensive combination therapies in patients with essential hypertension. Design and method This trial was a multicenter, randomized, double-blind, parallel, phase II study. After a 4-week placebo run-in period, 243 patients were randomized to the third -dose triple combination (ALC group, amlodipine 1.67 mg + losartan potassium 16.67 mg + chlorthalidone 4.17 mg), 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), or (AC group, amlodipine 1.67 mg + chlorthalidone 4.17 mg) for 8 weeks. The primary outcome was to compare the mean changes in systolic blood pressure (SBP) from baseline to week 8. Results Baseline patient characteristics and blood pressure did not show significant differences among 4 groups. The mean SBP reductions of ALC group, AL group, LC group and AC group were -18.30 ± 13.23, -13.03 ± 13.30, -16.29 ± 12.36, and -13.80 ± 13.21 mmHg at week 8 from baseline, respectively. The ALC group showed significant SBP reductions in comparison to the AL and AC groups at week 4 (p = 0.0097 and p = 0.0179, respectively) and week 8 (p = 0.0170 and p = 0.0357, respectively). The mean diastolic blood pressure (DBP) reduction from baseline was significantly greater in the ALC group when compared to the AL group (-7.93 ± 7.05 and -4.95 ± 7.96 mmHg, respectively, p = 0.0307). The proportion of responders for SBP was significantly greater in the ALC group (42.6%) compared to the AL (22.0%), LC (23.3%) and AC (27.1%) groups (p = 0.0126, 0.0210 and 0.0445, respectively) at week 4. Furthermore, the proportion of responders for SBP and DBP was significantly greater in the ALC group (59.7%) compared to the AL (39.3%) and AC (42.4%) groups (p = 0.0222 and 0.0491, respectively) at Week 8. Study drug-related adverse reactions were rare and did not show significant differences among 4 study groups. Conclusions Low-dose triple antihypertensive combination therapy when compared to the low-dose dual combination therapies demonstrated early effective BP control without increasing adverse drug reactions in patients with essential hypertension during 8-week follow-up.