Efficacy and safety of aliskiren-based dual and triple combination therapies in
US minority patients with stage 2 hypertension.
Author(s): Ferdinand KC, Weitzman R, Israel M, Lee J, Purkayastha D, Jaimes EA.
Affiliation(s): Emory University, Atlanta, GA 30349, USA. kferdinand@abcardio.org
Publication date & source: 2011, J Am Soc Hypertens. , 5(2):102-13
Minority patients with hypertension generally require combination therapy to
reach blood pressure (BP) goals. We examined the BP-lowering efficacy and safety
of combination aliskiren/amlodipine therapy in self-identified minority patients
in the United States with stage 2 hypertension and the impact of adding
hydrochlorothiazide (HCTZ) to this combination. In this 8-week double-blind
study, 412 patients were randomized to receive aliskiren/amlodipine (150/5 mg) or
amlodipine (5 mg) with forced titration up to aliskiren/amlodipine/HCTZ
(300/10/25 mg) or aliskiren/amlodipine (300/10 mg), respectively. Overall, mean
age was 55.2 years, mean body mass index was 32 kg/m(2), 62.3% were black, 28.2%
were Hispanic/Latino, and 69.1% had metabolic syndrome. Mean sitting systolic
blood pressure (MSSBP), the primary efficacy outcome, was reduced from 167.1 mm
Hg at baseline to 130.7 mm Hg at week 8 with aliskiren/amlodipine/HCTZ and from
167.4 mm Hg to 137.9 mm Hg with aliskiren/amlodipine (P < .0001 between groups).
At week 8, BP goal (<140/90 mm Hg) was achieved in 72.6% and 53.2% of patients in
the two treatment groups, respectively (P < .0001). Adverse events were
experienced by 34.2% and 40.2%, respectively. Combination aliskiren/amlodipine
therapy was effective in treating these high-risk patients but inclusion of HCTZ
provided greater antihypertensive efficacy. Both treatments were similarly well
tolerated.
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