Beta-blocker/thiazide combination for treatment of hypertensive children: a randomized double-blind, placebo-controlled trial

Pediatr Nephrol. 2002 May;17(5):345-50. doi: 10.1007/s00467-002-0851-0.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adrenergic beta-Antagonists / administration & dosage
  • Adrenergic beta-Antagonists / therapeutic use*
  • Bisoprolol / administration & dosage
  • Bisoprolol / therapeutic use*
  • Blood Pressure / drug effects
  • Child
  • Diuretics
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Hydrochlorothiazide / administration & dosage
  • Hydrochlorothiazide / therapeutic use*
  • Hypertension / drug therapy*
  • Hypertension / physiopathology
  • Male
  • Placebos
  • Single-Blind Method
  • Sodium Chloride Symporter Inhibitors / administration & dosage
  • Sodium Chloride Symporter Inhibitors / therapeutic use*
  • Treatment Failure

Substances

  • Adrenergic beta-Antagonists
  • Diuretics
  • Drug Combinations
  • Placebos
  • Sodium Chloride Symporter Inhibitors
  • Hydrochlorothiazide
  • Bisoprolol