Efficacy of ranolazine in patients with chronic angina observations from the randomized, double-blind, placebo-controlled MERLIN-TIMI (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Segment Elevation Acute Coronary Syndromes) 36 Trial. SR Wilson, BM Scirica, E Braunwald, SA Murphy, E Karwatowska-Prokopczuk, JL Buros, BR Chaitman, DA Morrow J Am Coll Cardiol 2009 4;53(17):1510-6
| Posted on |
Aug 10, 2009 |
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Ranolazine is a unique anti-anginal medication that does not affect BP or heart rate. It was approved by the FDA in 2006 for relief of symptoms in patients with chronic stable angina. The MERLIN-TIMI 36 trial was a multi-national, randomized, double-blind, placebo-controlled, parallel-group trial of ranolazine in patients with history of recent non-ST-segment elevation myocardial infarction (MI). The pre-specified primary endpoint for the study was a composite of cardiovascular (CV) death, MI, or recurrent ischemia. In the overall study population, ranolazine did not lead to a reduction in this primary endpoint. However, in the current post-hoc analysis that examined the 3565 (54%) of patients with a history of chronic stable angina prior to entry in the study, ranolazine did demonstrate a 14% reduction in the primary endpoint. This effect was driven almost entirely by reduction in recurrent ischemia , with no significant effect on CV death or MI. Importantly, there was no difference in the incidence of major safety issues with ranolazine treatment, despite its use with other medications commonly used post-MI. Previous reports have also suggested that ranolazine modestly lowers HgbA1C in patients with diabetes—although it is not indicated for that use. Of course, as a post-hoc, sub-group analysis, these results should be treated with some healthy skepticism, but they are consistent with other previous studies that have demonstrated decreased symptoms in patients with chronic stable angina. In sum, it appears that ranolazine is a safe and well tolerated option for control of chest patin in patients with chronic angina, but since it does not reduce CV death or risk of MI, it has no role in patients with established CAD with minimal or no chronic anginal symptoms. –Michael J. Bloch, M.D.
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