Ranexa Significantly Reduces Cardiac Chest Pain Symptoms
CV Therapeutics announced that Ranexa (ranolazine extended release tablets) significantly reduced the risk of recurrent ischemia (p=0.002), worsening angina (p=0.048) and intensification of antianginal therapy (p=0.009) in angina patients (n=3,565) in the MERLIN- TIMI 36 study.
Additionally, Ranexa significantly improved all measures of exercise performance compared to placebo, including reductions in the time to onset of angina (p=0.002) and time to the onset of 1 mm ST segment depression (p=0.002), a signal of ischemia, in these MERLIN-TIMI 36 angina patients.
"MERLIN-TIMI 36 is the largest study of ranolazine in patients with established coronary artery disease," said David Morrow, M.D., MPH, of Brigham & Women's Hospital at Harvard Medical School and lead investigator of the MERLIN-TIMI 36 study. "This new subgroup analysis shows consistent safety and efficacy across a broader group of angina patients than those studied previously and reaffirms ranolazine as an option for treating chronic angina."
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.
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. Ranolazine had no effect on the risk of CV death or MI in the study.
Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. Approximately 8.9 million people in the United States have chronic angina, and 400,000 new cases are diagnosed annually, according to the American Heart Association. Ranexa has anti- ischemic effects which do not depend on changes in heart rate or blood pressure.