Beta-blocker/thiazide combination for treatment of hypertensive children: a randomized double-blind,placebo-controlled trial |
| |
Authors: | Sorof Jonathan M Cargo Paul Graepel Jay Humphrey David King Eileen Rolf Clyde Cunningham Robert J |
| |
Affiliation: | (1) Division of Pediatric Nephrology and Hypertension, University of Texas, Houston, Medical School, 6431 Fannin Street, Room 3.124, Houston, TX 77030, USA e-mail: jonathan.m.sorof@uth.tmc.edu Tel.: +1-713-5005677, Fax: +1-713-5005680, US;(2) Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania, USA, US;(3) Procter and Gamble Pharmaceuticals, Cincinnati, Ohio, USA, US;(4) B & B Clinical Innovations, Kansas City, Missouri, USA, US;(5) Cleveland Clinic Foundation, Cleveland, Ohio, USA, US |
| |
Abstract: | Antihypertensive medications are used extensively in children despite a paucity of randomized, placebo-controlled trials. This study was among the first randomized, controlled pediatric antihypertensive medication trials, in which the combination drug bisoprolol fumarate/hydrochlorothiazide (B/HT) was compared with placebo. The study comprised a 2-week single-blind placebo screening period, a 6-week double-blind dose titration period, a 4-week double-blind dose maintenance period, and a 2-week double-blind dose-tapering period. One hundred and forty subjects were enrolled to achieve 94 randomized subjects treated either with B/HT (n=62) or placebo (n=32). B/HT induced significant reductions compared with placebo for average sitting systolic blood pressure (SiSBP) (9.3 vs. 4.9 mmHg, P<0.05) and sitting diastolic blood pressure (SiDBP) (7.2 vs. 2.7 mmHg, P<0.05). The placebo-subtracted BP reductions were greater in younger children and those with more-severe baseline hypertension. The percentage of subjects with BP less than the 90th percentile at study completion was 45% for B/HT and 34% for placebo (P=NS). Although the study demonstrated that B/HT reduced BP safely compared with placebo, the large placebo effect and failure of most subjects to achieve target BP control make it uncertain whether B/HT is appropriate first-line therapy for pediatric hypertension, particularly in adolescents with mild-to-moderate BP elevation. Received: 14 November 2001 / Revised: 3 January 2002 / Accepted: 4 January 2002 |
| |
Keywords: | Hypertension Clinical trial Placebo Blood pressure Antihypertensive agents |
本文献已被 PubMed SpringerLink 等数据库收录! |
|