Carvedilol did not reduce the incidence of early onset of LVEF reduction compared to placebo (14.5% vs 13.5%; p=1.0), but resulted in a significant reduction in troponin levels.
RCT (n=200)
double-blind
randomized
Does carvedilol prevent cardiotoxicity in patients with HER2-negative breast cancer and normal LVEF referred for anthracycline chemotherapy?
In patients with HER2-negative breast cancer receiving anthracyclines, carvedilol did not prevent early LVEF reduction but significantly reduced troponin levels and diastolic dysfunction.
Absolute Event Rate: 14.5% vs 13.5%
p-value: p=1.0
BACKGROUND: Anthracycline (ANT) chemotherapy is associated with cardiotoxicity. Prevention with β-blockers remains controversial. OBJECTIVES: This prospective, randomized, double-blind, placebo-controlled study sought to evaluate the role of carvedilol in preventing ANT cardiotoxicity. METHODS: The authors randomized 200 patients with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction (LVEF) referred for ANT (240 mg/m RESULTS: Primary endpoint occurred in 14 patients (14.5%) in the carvedilol group and 13 patients (13.5%) in the placebo group (p = 1.0). No differences in changes of LVEF or B-type natriuretic peptide were noted between groups. A significant difference existed between groups in troponin I levels over time, with lower levels in the carvedilol group (p = 0.003). Additionally, a lower incidence of diastolic dysfunction was noted in the carvedilol group (p = 0.039). A nonsignificant trend toward a less-pronounced increase in LV end-diastolic diameter during the follow-up was noted in the carvedilol group (44.1 ± 3.64 mm to 45.2 ± 3.2 mm vs. 44.9 ± 3.6 mm to 46.4 ± 4.0 mm; p = 0.057). CONCLUSIONS: In this largest clinical trial of β-blockers for prevention of cardiotoxicity under contemporary ANT dosage, the authors noted a 13.5% to 14.5% incidence of cardiotoxicity. In this scenario, carvedilol had no impact on the incidence of early onset of LVEF reduction. However, the use of carvedilol resulted in a significant reduction in troponin levels and diastolic dysfunction. (Carvedilol Effect in Preventing Chemotherapy-Induced Cardiotoxicity CECCY; NCT01724450).
Ávila et al. (2018) conducted an RCT in HER2-negative breast cancer (n=200). carvedilol vs. placebo was evaluated on early onset of LVEF reduction (cardiotoxicity) (p=1.0). Carvedilol did not reduce the incidence of early onset of LVEF reduction compared to placebo (14.5% vs 13.5%; p=1.0), but resulted in a significant reduction in troponin levels.