Efficacy and safety of carvedilol in infants with dilated cardiomyopathy: a preliminary report.

ABSTRACT

BACKGROUND: Carvedilol has proven to be beneficial in a majority of adult patients with congestive heart failure. Although the experience from adult patients may be extrapolated to older children, symptomatic infants remain a subset for whom dosage, safety and efficacy need to be established. The purpose of this study was to assess whether treatment with carvedilol is efficacious and safe for infants with dilated cardiomyopathy who do not show satisfactory clinical improvement despite treatment with conventional medications. METHODS AND RESULTS: Eight infants with dilated cardiomyopathy (ejection fraction <30%) who were symptomatic despite tailored treatment with decongestive medications, were enrolled in the study. Echocardiographic findings and heart failure symptom scores were analyzed before and after starting carvedilol. Patients were hospitalized and monitored for side-effects during up-titration of carvedilol. At a follow-up of 4.5+/-2.2 months, patients receiving carvedilol showed a significant improvement in the left ventricular ejection fraction (38.5+/-11% v. 24.4+/-5%), and heart failure symptom score (p<0.05). No adverse events related to carvedilol administration occurred. There were no deaths. CONCLUSIONS: Carvedilol is well tolerated in infants with dilated cardiomyopathy and there is significant improvement in their functional status. Optimal timing of starting therapy, dosage and long-term effects need to be investigated with multi-institutional trials.