Key result
Azilsartan medoxomil combined with amlodipine reduced 24-hour systolic blood pressure by approximately 25 mmHg, significantly greater than the 14 mmHg reduction seen with placebo plus amlodipine (P<0.001).
Why the study?
Does combining azilsartan medoxomil (40 or 80 mg) with amlodipine 5 mg reduce 24-h systolic blood pressure compared to amlodipine alone in patients with stage 2 hypertension?
RCT (n=566)
Double-blind
Randomized
Yes
Does combining azilsartan medoxomil (40 or 80 mg) with amlodipine 5 mg reduce 24-h systolic blood pressure compared to amlodipine alone in patients with stage 2 hypertension?
Absolute Event Rate: -24.8% vs -13.6%
p-value: p=<0.001
Combining azilsartan medoxomil with amlodipine 5 mg provides significantly greater blood pressure reduction than amlodipine alone in patients with stage 2 hypertension, while also reducing the incidence of peripheral edema.
Supports azilsartan-amlodipine combination for greater BP control in stage 2 hypertension; confirms additive efficacy of ARB plus CCB in RCTs.
OBJECTIVE: The aim of the study was to measure the effects on blood pressure (BP) of the angiotensin receptor blocker azilsartan medoxomil, in 40 and 80 mg doses, combined with 5 mg of the calcium channel blocker amlodipine and to compare these effects with placebo plus amlodipine 5 mg. METHODS: This was a randomized, controlled, double-blind study of 6 weeks' duration in 566 patients with stage 2 hypertension. The primary endpoint was 24-h systolic BP by ambulatory monitoring. RESULTS: The mean age of the participants was 58 years; men and women were equally represented, and baseline 24-h BP (153-154/93 mmHg) and clinic BP (165-166/94-95 mmHg) were similar across the three treatment groups. After 6 weeks, 24-h BP decreased by 25/15 mmHg in both the azilsartan medoxomil/amlodipine 40/5 and 80/5 mg groups. These reductions were each greater than the 14/8 mmHg decrease with placebo plus amlodipine 5 mg (P≤0.001 for both comparisons). All treatments were well tolerated, and adverse events did not increase with the azilsartan medoxomil doses. Edema or fluid retention was less common in both combination groups (2.6 and 2.7%) than with placebo plus amlodipine (7.6%). CONCLUSION: Coadministration of azilsartan medoxomil with amlodipine was well tolerated and led to meaningful additional BP reductions compared with placebo plus amlodipine.
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Weber et al. (2014) conducted an RCT in Stage 2 hypertension (n=566). Azilsartan medoxomil plus amlodipine vs. Placebo + 5 mg amlodipine was evaluated on Change from baseline to week 6 in 24-h systolic BP by ambulatory monitoring (p=<0.001). Azilsartan medoxomil combined with amlodipine reduced 24-hour systolic blood pressure by approximately 25 mmHg, significantly greater than the 14 mmHg reduction seen with placebo plus amlodipine (P<0.001).
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