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MERLIN-36: Ranolazine safety data could lead to expanded use
A topline analysis of unblinded data from the MERLIN TIMI-36 study of ranolazine showed that there were no adverse events in death or arrhythmias in patients assigned the drug.
However, ranolazine (Ranexa, CV Therapeutics Inc.) failed to meet the study’s primary efficacy endpoint in patients with acute coronary syndrome.
“Based on a written agreement with the FDA, the label is likely to expand to include front line angina, and cardiologists are likely to get a lot of comfort from this study’s safety data,” said John Bluth, a CV Therapeutics spokesperson.
“If it is approved I think it will be well received, but it depends on the details of the safety data,” said Udho Thadani, MD, professor of medicine in the cardiovascular section of Oklahoma University Health Sciences Center and member of the Cardiovascular Pharmacology section of the Today in Cardiology editorial board.
Confirming safety, efficacy
MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) was a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial. It was designed to evaluate the efficacy and safety of acute and long-term ranolazine treatment among patients with non-ST elevation ACS treated with standard therapy. The trial included about 6,500 patients. The composite endpoint was cardiovascular death, MI or recurrent ischemia.
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Within 48 hours of the onset of angina due to ACS, the researchers enrolled eligible hospitalized patients and randomly assigned IV ranolazine or placebo, followed by long-term outpatient treatment with ranolazine extended-release tablets or placebo. Patients were also assigned standard therapy during hospital-based and outpatient treatment. The researchers studied the doses of extended-release tablets in previous phase-3 clinical trials.
“We asked two questions. The first: Is the drug safe? The answer is clearly, yes. The second: Could this drug, which is effective in treating angina also be useful in treating ACS patients and reducing the composite endpoint? The answer is: No, not with statistical significance,” Bluth told Today in Cardiology.
Last year, the FDA approved ranolazine for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and it is used in combination with amlodipine, beta-blockers or nitrates. It has been prescribed more than 100,000 times since its launch last year, according to Bluth.
“Earlier studies show this drug is equally effective as beta-blockers, but the current indication is not for primary therapy because there were some safety issues, which were minimal,” Thadani said. “I think the dilemma is that there were no adverse trends. The significance of this finding needs to be confirmed pending the release of details of the safety and efficacy parameters. At the present time it would appear the drug will not be used in patients hospitalized with ACS.” – by Tara Grassia