For high-risk patients with implantable cardioverter-defibrillators (ICDs), ranolazine does not significantly reduce the risk of ventricular tachycardia (VT) or ventricular fibrillation (VF) requiring appropriate ICD therapy, or death. The study was published in the Journal of the American College of Cardiology. Researchers randomized high-risk ICD patients with ischemic or nonischemic cardiomyopathy to 1,000 mg ranolazine twice daily (510 patients) or placebo (502 patients).

The researchers found that 37% of patients experienced the primary endpoint (VT or VF requiring appropriate ICD therapy, or death). In 39.6% of patients receiving placebo and 49.6% of patients receiving ranolazine, the blinded study drug was discontinued (P = 0.001).

ICD Therapies

For ranolazine versus placebo, the hazard ratio was 0.84 (95% confidence interval, 0.67 to 1.05; P = 0.117) for VT, VF, or death. Patients randomized to ranolazine had a marginally significant lower risk of ICD therapies for recurrent VT or VF in a pre-specified secondary analysis (hazard ratio, 0.7; 95 percent confidence interval, 0.51 to 0.96; P = 0.028).

Ranolazine

Ranolazine did not significantly reduce the incidence of the first VT or VF or death. However, the study was underpowered to detect a difference in the primary endpoint. Several authors disclosed financial ties to pharmaceutical companies, including Gilead Sciences, which manufactures ranolazine and provided funding for the study.

Treatment

In high-risk ICD patients, treatment with ranolazine did not significantly reduce the incidence of the first VT or VF or death. However, the study was underpowered to detect a difference in the primary endpoint.

In prespecified secondary endpoint analyses, ranolazine administration was associated with a significant reduction in recurrent VT or VF requiring ICD therapy without evidence for increased mortality.