Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension

• Published in: Journal of the American Society of Hypertension Vol. 5; no. 2; pp. 102 - 113
• Main Authors: Ferdinand, Keith C., MD, Weitzman, Richard, MD, Israel, Marc, PharmD, Lee, Joleen, BS, Purkayastha, Das, PhD, Jaimes, Edgar A., MD
• Format: Journal Article
• Language: English
• Published: United States 01.03.2011
• Subjects: African Continental Ancestry Group; Amides - administration & dosage; Amides - adverse effects; Amlodipine - administration & dosage; Amlodipine - adverse effects; Antihypertensive Agents - administration & dosage; Antihypertensive Agents - adverse effects; Blood Pressure - drug effects; Cardiovascular; Double-Blind Method; Drug Combinations; Drug Monitoring; Drug Synergism; Drug Therapy, Combination; Female; Fumarates - administration & dosage; Fumarates - adverse effects; Hispanic Americans; Humans; Hydrochlorothiazide - administration & dosage; Hydrochlorothiazide - adverse effects; Hypertension - drug therapy; Hypertension - ethnology; Hypertension - physiopathology; Male; Middle Aged; Treatment Outcome; Blacks; Hispanics; amlodipine; hydrochlorothiazide
• ISSN: 1933-1711
• DOI: 10.1016/j.jash.2011.01.006

Abstract 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/m2 , 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.