Carvedilol not beneficial for children and adolescents with heart failure

Clinical Question

Is carvedilol beneficial in the management of children and adolescents with heart failure?

Bottom Line

This study found no evidence for a benefit of carvedilol (Coreg) in the management of children and adolescents with heart failure. (LOE = 1b-)

Reference

Shaddy RE, Boucek MM, Hsu DT, et al, for the Pediatric Carvedilol Study Group. Carvedilol for children and adolescents with heart failure. A randomized controlled trial. JAMA 2007;298(10):1171-1179. [PMID:17848651]

Study Design

Randomized controlled trial (double-blinded)

Funding

Industry

Allocation

Uncertain

Setting

Outpatient (specialty)

Synopsis

The benefit of beta-blockade treatment for children and adolescents with heart failure is uncertain. These investigators identified 161 patients, 18 years or younger, with chronic symptomatic heart failure due to ventricular systolic dysfunction (ejection fraction < 40%). Causes of heart failure included dilated cardiomyopathy and congenital heart disease. All patients were receiving standard heart failure medications including angiotensin-converting enzyme inhibitors. Eligible patients randomly received (allocation concealment uncertain) twice-daily low-dose carvedilol (target dose = 0.2 mg/kg per dose if < 62.5 kg or 12.5 mg per dose if >= 62.5 kg), high-dose carvedilol (target dose = 0.4 mg/kg per dose or 25 mg per dose, respectively), or matched placebo. Individuals assessing outcomes remained masked to treatment group assignment. Complete follow-up occurred for 98% of patients for up to 4 years. Using intention-to-treat analysis, there were no significant differences between the treatment groups for all-cause mortality, hospitalization rates, or global assessment scores. In addition, no significant effect of age or sex on any outcomes was detected. The study was 90% powered to detect a clinically significant difference between the combined carvedilol groups and placebo.