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Safety
of Anti-Anginal Drug Ranolazine is Confirmed, But Drug Does
Not Reduce Major Cardiac Events in ACS Patients Although Drug Missed Its End Points, Safety Profile May Suggest Use in a Broader Patient Population for Relief of Angina |
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The dual problems of angina and ischemia have taken center stage recently in the field of cardiology, most recently at the March annual meeting of the American College of Cardiology, where the MERLIN-TIMI 36 results were initially presented. The big news from the ACC, however, was the COURAGE trial, which showed that in low risk patients with stable angina, the addition of angioplasty or stenting (PCI) to "optimal medical therapy" did not prolong life or prevent heart attacks -- although there was a significant initial reduction in angina with PCI. However, an under-reported result of the study was that 25% of the patients in both groups still had significant angina at the end of five years: a signal that for 1 in 4 patients there is a need to provide additional forms of therapy, beyond current medical regimens or revascularization. Ranolazine was approved a little more than a year ago as a treatment for angina in patients who did not respond adequately to other medications or treatments. Although it was the first new anti-anginal drug in twenty years, it has been used mostly as a secondary therapy because of concerns that smaller studies showed an association between ranolazine and prolongation of the QT interval (an electrocardiographic measurement that may indicate increased risk of arrhythmia). However, the MERLIN (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes)-TIMI 36 trial studied 6,560 patients and found no safety issues relating to arrhythmic events -- in fact, possibly the opposite: one measure showed a clinically significant reduction in arrhythmic readings measured on Holter monitors. David A. Morrow, M.D., M.P.H., of Brigham and Women's Hospital and Harvard Medical School, Boston, and his colleagues led a multinational randomized trial comparing ranolazine to placebo. The primary end point (cardiovascular death, heart attack, or recurrent ischemia) occurred in 21.8 percent of the patients in the ranolazine group, compared with 23.5 percent of the patients in the placebo group. The major secondary end point (cardiovascular death, heart attack, or severe recurrent ischemia) occurred in 18.7 percent of the patients in the ranolazine group compared with 19.2 percent of the patients in the placebo group. Failure of therapy (including cardiovascular death, heart attack, recurrent ischemia, hospitalization for new or worsening heart failure) occurred at similar rates in both groups. The risk of recurrent ischemia was reduced in the ranolazine group (13.9 percent) compared with the placebo group (16.1 percent). The authors write:
In an accompanying editorial, titled "Does Ranolazine Have a Place in the Treatment of Acute Coronary Syndromes?", L. Kristin Newby, M.D., M.H.S., and Eric D. Peterson, M.D., M.P.H., of Duke University Medical Center, Durham, N.C. state:
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