title: Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension.
abstract: Initial multiple drug therapy for hypertension achieves greater and quicker reductions and higher blood pressure (BP) control rates than monotherapy. This 8-week, prospective, multicenter, randomized, double-blind study compared the efficacy and safety of the initial combination of aliskiren/amlodipine with amlodipine monotherapy in African Americans with stage 2 hypertension. After a 1- to 4-week washout, patients received aliskiren/amlodipine 150/5 mg or amlodipine 5 mg for 1 week and then were force-titrated to aliskiren/amlodipine 300/10 mg or amlodipine 10 mg for 7 weeks. At week 8, greater reductions in mean sitting systolic BP were obtained with aliskiren/amlodipine (n = 220) than with amlodipine (n = 223) (least squares mean change [standard error of the mean], -34.1 [1.14] mm Hg vs -28.9 [1.12] mm Hg; P<.001). Ambulatory and central BP measures were consistent with clinic BP findings, although these were conducted in a small subset of patients (n = 94 in ambulatory BP monitoring substudy and n = 136 for central BP). More patients achieved goal BP (<140/90 mm Hg) with aliskiren/amlodipine than with amlodipine at week 8 (57.3% vs 48.0%; P = .051). Both treatment groups had similar adverse event rates (35.0% and 32.7%, respectively). The most common adverse events were peripheral edema (7.7% with aliskiren/amlodipine and 9.0% with amlodipine), headache, fatigue, and nausea. The combination of aliskiren/amlodipine reduced peripheral, ambulatory, and central BP more than amlodipine alone with similar tolerability in African Americans with stage 2 hypertension.
authors.affiliation: New York University, New York, NY, USA. hrbmd63@gmail.com
authors.forename: Henry R
authors.initials: HR
authors.lastname: Black
authors.forename: Myron H
authors.initials: MH
authors.lastname: Weinberger
authors.forename: Das
authors.initials: D
authors.lastname: Purkayastha
authors.forename: Joleen
authors.initials: J
authors.lastname: Lee
authors.forename: Kanaka
authors.initials: K
authors.lastname: Sridharan
authors.forename: Marc
authors.initials: M
authors.lastname: Israel
authors.forename: Robert
authors.initials: R
authors.lastname: Hilkert
authors.forename: Joseph
authors.initials: J
authors.lastname: Izzo
mesh_terms: D000328:Adult; D001741:Black or African American / Q000208:ethnology*; D000577:Amides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D017311:Amlodipine / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D018660:Blood Pressure Monitoring, Ambulatory; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004487:Edema / Q000139:chemically induced / Q000453:epidemiology; D005221:Fatigue / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D005650:Fumarates / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006261:Headache / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000208:ethnology* / Q000503:physiopathology; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000577:Amides; D005650:Fumarates; D017311:Amlodipine; C446481:aliskiren