title: Comparative efficacy and safety of amlodipine/benazepril combination therapy and amlodipine monotherapy in severe hypertension.
abstract: This multicentre, double-blind, trial in subjects with severe hypertension compared the efficacy and tolerability of two parallel drug regimens: A/B (amlodipine/benazepril: 5/20 or 10/40 mg daily, if necessary) with A (amlodipine: 5 or 10 mg daily, if necessary). The principal dependent variable was the proportion of patients achieving goal blood pressures (BP<140/90 mm Hg or BP<130/80 mm Hg in diabetes or chronic kidney disease) in the two groups within 6 weeks. In the 259 randomized subjects, BP control rates were higher with A/B at 2, 4 and 6 weeks (10.5, 22, and 33.6%, respectively) compared with A (5.7, 16, and 25.8 %, respectively). Corresponding trended BP reductions from baseline at 2, 4 and 6 weeks were about 5 mm Hg greater with A/B (-21+/-16, -26+/-17 and -30+/-17 mm Hg, respectively, compared with A (-16+/-17, -23+/-18 and 25+/-19 mm Hg, respectively, P<0.01). Both regimens were well tolerated; incidences of peripheral oedema at weeks 4 and 6 were similar (A/B: 13 and 20% versus A: 20 and 22%, P=not significant). We conclude that titration of amlodipine and benazepril in single-pill combinations is more effective than titration of amlodipine alone for rapid BP control in patients with severe hypertension.
authors.affiliation: Department of Medicine, State University of New York at Buffalo, 462 Grider St, Buffalo, NY 14215, USA. jizzo@buffalo.edu
authors.forename: J L
authors.initials: JL
authors.lastname: Izzo
authors.forename: D
authors.initials: D
authors.lastname: Purkayastha
authors.forename: D
authors.initials: D
authors.lastname: Hall
authors.forename: R J
authors.initials: RJ
authors.lastname: Hilkert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001552:Benzazepines / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D048909:Diabetes Complications / Q000188:drug therapy; D004359:Drug Therapy, Combination; D004487:Edema / Q000139:chemically induced; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007674:Kidney Diseases / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D001552:Benzazepines; D017311:Amlodipine; C044946:benazepril