title: Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension.
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/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.
authors.affiliation: Emory University, Atlanta, GA 30349, USA. kferdinand@abcardio.org
authors.forename: Keith C
authors.initials: KC
authors.lastname: Ferdinand
authors.forename: Richard
authors.initials: R
authors.lastname: Weitzman
authors.forename: Marc
authors.initials: M
authors.lastname: Israel
authors.forename: Joleen
authors.initials: J
authors.lastname: Lee
authors.forename: Das
authors.initials: D
authors.lastname: Purkayastha
authors.forename: Edgar A
authors.initials: EA
authors.lastname: Jaimes
mesh_terms: D000577:Amides / Q000008:administration & dosage* / Q000009:adverse effects; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044383:Black People; D001794:Blood Pressure / Q000187:drug effects*; D004311:Double-Blind Method; D004338:Drug Combinations; D016903:Drug Monitoring; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D005650:Fumarates / Q000008:administration & dosage* / Q000009:adverse effects; D006630:Hispanic or Latino; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage* / Q000009:adverse effects; D006973:Hypertension / Q000188:drug therapy* / Q000208:ethnology* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D004338:Drug Combinations; D005650:Fumarates; D006852:Hydrochlorothiazide; D017311:Amlodipine; C446481:aliskiren