Citation: Cook CV, Castro JC, Schmidt RE, et al. Diabetes care in hospitalized noncritically ill patients: More evidence for clinical inertia and negative therapeutic momentum. J Hosp Med. 2007;2:203-211.
Background: Although beta-blockers improve symptoms and survival in adults with heart failure, little is known about these medications in children and adolescents. Treatment recommendations in children and adolescents with heart failure usually must be extrapolated from the results of clinical trials conducted in adults.
Study design: A multicenter, randomized, double-blind placebo controlled study.
Setting: 26 U.S. hospitals.
Synopsis: 161 children and adolescents with symptomatic systolic heart failure on conventional heart failure medications were randomized in a 1:1:1 ratio to twice-daily dosing with placebo, low-dose carvedilol (Coreg) or high-dose carvedilol for eight months. Patients were determined to have a response of worsened, improved, or unchanged, based on variables involving a change in New York Heart Association class, hospitalization requiring IV medications, or withdrawal from the study for treatment failure or lack of therapeutic response.
Carvedilol had no significant effect on the primary end points above, although there may have been some difference in benefit based on ventricular morphology. Because fewer patients overall experienced worsening of their heart failure than expected and because of the high rate of spontaneous improvement seen, the study may have been underpowered. Randomized clinical trials in pediatrics are exceedingly rare, and trials that are done routinely have study populations far smaller than this one.
Bottom Line: Carvedilol has not been shown to benefit children and adolescents with symptomatic systolic heart failure.
Citation: Shaddy RE, Boucek MM, Hsu DT, et al. Carvedilol for children and adolescents with heart failure: a randomized controlled trial. JAMA. 2007; 298(10):1171-1179. TH