PMID- 12042891
OWN - NLM
STAT- MEDLINE
DCOM- 20020731
LR  - 20131121
IS  - 0931-041X (Print)
IS  - 0931-041X (Linking)
VI  - 17
IP  - 5
DP  - 2002 May
TI  - Beta-blocker/thiazide combination for treatment of hypertensive children: a 
      randomized double-blind, placebo-controlled trial.
PG  - 345-50
AB  - 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.
FAU - Sorof, Jonathan M
AU  - Sorof JM
AD  - Division of Pediatric Nephrology and Hypertension, Medical School, University of 
      Texas-Houston, 6431 Fannin Street, Room 3.124, Houston, TX 77030, USA. 
      jonathan.m.sorof@uth.tmc.edu
FAU - Cargo, Paul
AU  - Cargo P
FAU - Graepel, Jay
AU  - Graepel J
FAU - Humphrey, David
AU  - Humphrey D
FAU - King, Eileen
AU  - King E
FAU - Rolf, Clyde
AU  - Rolf C
FAU - Cunningham, Robert J
AU  - Cunningham RJ
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Pediatr Nephrol
JT  - Pediatric nephrology (Berlin, Germany)
JID - 8708728
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Diuretics)
RN  - 0 (Drug Combinations)
RN  - 0 (Placebos)
RN  - 0 (Sodium Chloride Symporter Inhibitors)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - Y41JS2NL6U (Bisoprolol)
SB  - IM
MH  - Adolescent
MH  - Adrenergic beta-Antagonists/administration & dosage/*therapeutic use
MH  - Bisoprolol/administration & dosage/*therapeutic use
MH  - Blood Pressure/drug effects
MH  - Child
MH  - Diuretics
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Hydrochlorothiazide/administration & dosage/*therapeutic use
MH  - Hypertension/*drug therapy/physiopathology
MH  - Male
MH  - Placebos
MH  - Single-Blind Method
MH  - Sodium Chloride Symporter Inhibitors/administration & dosage/*therapeutic use
MH  - Treatment Failure
EDAT- 2002/06/04 10:00
MHDA- 2002/08/01 10:01
CRDT- 2002/06/04 10:00
PHST- 2002/06/04 10:00 [pubmed]
PHST- 2002/08/01 10:01 [medline]
PHST- 2002/06/04 10:00 [entrez]
AID - 10.1007/s00467-002-0851-0 [doi]
PST - ppublish
SO  - Pediatr Nephrol. 2002 May;17(5):345-50. doi: 10.1007/s00467-002-0851-0.