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Ranolazine in Patients with Acute Coronary Syndromes

A randomized trial found no benefit in acute onset of coronary artery disease, but some benefit in chronic recurrent angina.

Ranolazine, a novel antianginal agent that is thought to block intracellular sodium and calcium overload in cardiac ischemia, was FDA-approved in 2006 for the treatment of chronic angina. In this multinational randomized trial — which was funded by the manufacturer of ranolazine and included company employees on the study team — 6560 patients (mean age, 64) with acute coronary syndromes (ACS [unstable angina or non–ST-elevation myocardial infarction]) were treated acutely with intravenous ranolazine followed by 1000 mg of oral ranolazine or placebo twice daily. Patients also received usual ACS treatment, including percutaneous interventions in 32% and coronary artery bypass surgery in 8%. Median follow-up was approximately 1 year.

There was no difference in the incidence of the primary endpoint of cardiovascular death, myocardial infarction, or recurrent angina (roughly 23% in both groups). A barely significant trend toward a reduction in recurrent ischemia was observed in the ranolazine group (14% vs. 16%), and risks for syncope (3.3% vs. 2.3%) and QTc prolongation (0.9% vs. 0.3%) were significantly increased in the ranolazine group.

Comment: These data do not support the use of ranolazine in patients with acute coronary syndromes, but they do indicate some efficacy for its use in chronic recurrent angina refractory to standard therapies. According to the prescribing information for ranolazine, the drug should be reserved for patients who have not adequately responded to other antianginal drugs (e.g., ß-blockers, nitrates) and is contraindicated in patients with QT prolongation, patients with hepatic disease, and patients taking CYP3A inhibitors (e.g., diltiazem).

— Thomas L. Schwenk, MD

Published in Journal Watch General Medicine April 26, 2007

Citation(s):

Morrow DA et al. Effects of ranolazine on recurrent cardiovascular events in patients with non–ST-elevation acute coronary syndromes: The MERLIN-TIMI 36 randomized trial. JAMA 2007 Apr 25; 297:1775-83.

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