RESUMEN
OBJECTIVE: Deterioration in ventricular function is often observed in patients treated with anthracyclines for cancer. There is a paucity of evidence on interventions that might provide cardio-protection. We investigated whether prophylactic use of carvedilol can prevent doxorubicin-induced cardiotoxicity and whether any observed effect is dose related. METHODS: A prospective, randomized, double-blind study in patients treated with doxorubicin, comparing placebo (nâ¯=â¯38) with different doses of carvedilol [6.25â¯mg/day (nâ¯=â¯41), 12.5â¯mg/day (nâ¯=â¯38) or 25â¯mg/day (nâ¯=â¯37)]. The primary endpoint was the measured change in left ventricular ejection fraction (LVEF) from baseline to 6 months. RESULTS: LVEF decreased from 62⯱â¯5% at baseline to 58⯱â¯7% at 6-months (pâ¯=â¯0.002) in patients assigned to placebo but no statistically significant changes were observed in any of the 3 carvedilol groups. At 6 months, only one of 116 patients (1%) assigned to carvedilol had an LVEFâ¯<â¯50% compared to four of the 38 assigned to placebo (11%), (pâ¯=â¯0.013). No significant differences were noted between carvedilol and placebo in terms of the development of diastolic dysfunction, clinically overt heart failure or death. CONCLUSIONS: Carvedilol might prevent deterioration in LVEF in cancer patients treated with doxorubicin. This effect may not be dose related within the studied range.