medwireNews: Lymphoma patients at high risk for anthracycline-associated cardiac dysfunction may benefit from the prophylactic use of atorvastatin, suggests the phase 3 STOP-CA trial.
After 12 months of treatment, 9% of patients in the atorvastatin group experienced a decline in left ventricular ejection fraction (LVEF) of at least 10% from prior to chemotherapy to a final value of less than 55%, compared with 22% of those in the placebo group.
The between-group difference was significant and equated to an odds ratio (OR) of 2.9 in favor of atorvastatin, report Tomas Neilan, from Massachusetts General Hospital in Boston, USA, and team in JAMA.
Atorvastatin treatment was also associated with a significant improvement in the secondary endpoint relative to placebo, with 13% versus 29% experiencing a decline in LVEF of 5% or greater from before chemotherapy to a final value of less than 55% at the 12-month follow-up.
An exploratory analysis of incident heart failure at 24 months showed a numerically lower rate in the atorvastatin than placebo group, at 3% versus 6%, but the difference was not statistically significant.
The STOP-CA investigators enrolled 300 patients (mean age 50 years) with a new diagnosis of lymphoma who were scheduled to receive anthracycline-based chemotherapy into the double-blind study and randomly assigned them to receive atorvastatin 40 mg/day or placebo, with treatment starting before the first anthracycline infusion.
Reporting on the safety, they say that “[t]he study intervention was safe, with no serious study-related adverse effects, and had no significant effect on hemodynamic parameters such as blood pressure.”
There was no significant difference in the incidence of adverse events of special interest between the statin and placebo treatment arms, namely muscle pain, elevated liver enzymes, and renal failure at a respective 19% versus 14%, 18% versus 16%, and 1% versus 3%.
Neilan and colleagues summarize that “[t]hese data support the use of atorvastatin among patients being treated with anthracyclines, in whom prevention of cardiac systolic dysfunction is important.”
But they note that “broadly conflicting data exist on whether statins protect against anthracycline-associated cardiac dysfunction.”
The team continues: “Thus, a reasonable approach would be to continue statins among patients who are being treated with anthracyclines; consider statins in patients who have a borderline indication for statins for prevention of atherosclerotic cardiovascular disease; and among patients with no traditional indication for a statin, consider a statin in those who are at high risk of anthracycline-associated cardiotoxicity.”
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