Linked Life Data

12700955

Source:http://linkedlifedata.com/resource/pubmed/id/12700955

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2003-5-21
pubmed:abstractText
Essential hypertension in pediatric patients may require pharmacological treatment. There is a need for efficacious, safe, and well-tolerated antihypertensive agents with a once-a-day dosing regimen in children and adolescents. The aim of the trial was to evaluate the dose-response and tolerability of the dihydropyridine calcium channel blocker, felodipine extended-release tablets (felodipine ER), given once daily to pediatric patients with essential hypertension. A randomized double-blind, parallel-group, multi-center clinical study comparing felodipine ER (2.5, 5, or 10 mg once daily) and placebo was performed on pediatric patients with a baseline systolic (SBP) or diastolic blood pressure (DBP) above the 95th percentile for age, sex, and height. Of 133 randomized patients, 128 (96.2%) completed the 3 weeks of double-blind treatment. The study population included 50% children 6-12 years of age or Tanner stage <or=3, 39% black, and 40% female patients. All doses of felodipine ER and placebo decreased both SBP and DBP. The 5-mg dose of felodipine ER resulted in a significant decline in trough sitting, standing, and supine DBP (placebo-adjusted, -4.6, -5.06, and -5.05 mmHg, respectively, P<0.05) compared with placebo. However, there was no significant decline in SBP. The 2.5- and 10-mg doses showed no significant differences compared with placebo in lowering BP. The effect of felodipine ER was comparable in patient subgroups by age, race, and gender. The drug was well tolerated. The study failed to show a dose response of felodipine ER in pediatric patients with essential hypertension. This finding might be explained in part by the limitations of study design. The spectrum of side effects in pediatric patients was comparable with that in adults, except for a lower incidence of peripheral edema. Further studies are needed to clarify the role of felodipine ER in the management of children and adolescents with essential hypertension.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
0931-041X
pubmed:author
pubmed:issnType
Print
pubmed:volume
18
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
548-53
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed:year
2003
pubmed:articleTitle
Clinical trial of extended-release felodipine in pediatric essential hypertension.
pubmed:affiliation
Department of Pediatrics, Division of Nephrology, Schneider Children's Hospital of the North Shore-LIJ Health System, New Hyde Park, NY 11040, USA. trachtma@lij.edu
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Multicenter Study