Key result
Aliskiren plus amlodipine lowers SBP by an additional ~5 mmHg versus amlodipine alone.
Why the study?
Does aliskiren and amlodipine combination therapy reduce systolic blood pressure more than amlodipine monotherapy in African Americans with stage 2 hypertension?
RCT
double-blind
randomized
Yes
Does aliskiren and amlodipine combination therapy reduce systolic blood pressure more than amlodipine monotherapy in African Americans with stage 2 hypertension?
Absolute Event Rate: -34.1% vs -28.9%
p-value: p=<0.001
In African Americans with stage 2 hypertension, combination therapy with aliskiren and amlodipine provided greater blood pressure reduction than amlodipine monotherapy with similar tolerability.
Supports aliskiren-amlodipine combination over monotherapy for greater BP reduction in African Americans with stage 2 hypertension; extends RCT evidence to this population.
Objective: African Americans have a high prevalence of hypertension and, like other patients with hypertension, are unlikely to achieve blood pressure (BP) goals with monotherapy. This 8-week, prospective, multicenter, randomized, double-blind study compared efficacy and safety of a combination of aliskiren (A) and amlodipine (AML) to AML in African American men and women with systolic (S) BP >=160-<200 mmHg. Design and Methods: After a 1–4 week washout period, patients received A+AML 150/5 mg or AML 5 mg for 1 week. Then patients were force-titrated to A+AML 300/10 mg or AML 10 mg for 7 weeks. Results: Baseline mean sitting SBP [msSBP ± standard deviation] was 167.4 ± 8.2 mmHg; mean age was 52.8 ± 10.0 years; and mean body mass index was 33.8 ± 7.9 kg/m2 at randomization. The primary efficacy variable, change in msSBP at week 8, was greater with A+AML than with AML (−34.1 ± 1.14 vs -28.9 ± 1.12; P < 0.001) in the overall study population. Similar findings in favor of A+AML were observed in both men and women. Overall, the BP control (<140/90 mmHg) rate at week 8 was 57.3% with A+AML and 48.0% with AML (P = 0.051). Both treatment groups had similar adverse event rates (overall, 35.0% with A+AML, 32.7% AML); most common events were peripheral edema (7.7% with A+AML and 9.0% AML), headache, fatigue, and nausea. Conclusion: We concluded that the combination A+AML resulted in greater reductions in BP, with similar tolerability compared to AML monotherapy in African Americans with stage 2 hypertension.
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Black et al. (2010) conducted an RCT in stage 2 hypertension. Aliskiren + Amlodipine vs. Amlodipine 5 mg titrated to 10 mg was evaluated on change in mean sitting systolic blood pressure (msSBP) at week 8 (p=<0.001). Combination aliskiren and amlodipine resulted in a greater reduction in mean sitting systolic blood pressure at 8 weeks compared to amlodipine monotherapy (-34.1 vs -28.9 mmHg; P<0.001).
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