Ranexa Significantly Reduces Ischemia In Women
Reducing Ischemia In Women
Analysis of data from 2,291 women who participated in the MERLIN TIMI-36 study showed a 29 percent reduction in the relative risk of recurrent ischemia in women receiving CV Therapeutics's Ranexa (ranolazine extended-release tablets) compared to placebo (p=0.002) after 12 months. No difference in symptomatic documented arrhythmias was observed in women between the ranolazine and placebo groups.
The data were presented today by Dr. Jessica Mega of the TIMI Study Group at the American Heart Association Scientific Sessions in Orlando, Florida.
"Women were very well represented in the MERLIN TIMI-36 study and these data provide important additional confirmation of the safety and efficacy we have seen with Ranexa in other clinical trials and in commercial use," said Louis G. Lange, CV Therapeutics chairman and chief executive officer.
According to the American Heart Association, cardiovascular disease is the leading cause of death among American women.
In accordance with a special protocol assessment agreement between the U.S. Food and Drug Administration (FDA) and CV Therapeutics, the Company believes that data from the MERLIN TIMI-36 study could support expansion of the existing Ranexa indication to first line angina. In September 2007, the Company submitted a supplemental new drug application to the FDA seeking a new indication for first line angina and a significant reduction in cautionary language.
Ranexa is currently indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates.
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 designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in 6,560 patients (3,279 received ranolazine, 3,281 received placebo) with non-ST elevation ACS treated with standard therapy.
Within 48 hours of the onset of angina due to ACS, eligible hospitalized patients were enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with Ranexa extended-release tablets or placebo. All patients also received standard therapy during both hospital-based and outpatient treatment. The doses of Ranexa extended-release tablets used in MERLIN TIMI-36 have been studied in previous Phase 3 clinical trials.
Participants in the MERLIN TIMI-36 study received current standard therapy, with approximately 96 percent of patients on aspirin, approximately 89 percent on beta blockers and approximately 82 percent on statins. Approximately 59 percent of study participants received coronary angiography during their initial hospitalization.
Previously published data from the MERLIN TIMI-36 study has shown that Ranexa was safe in this population of patients with coronary artery disease, which included nearly 1,100 patients with prior heart failure.