( to continue on ranolazine inthe ROLE ...)JACC Publishes Long-Term Safety and Tolerability Data from,Ranolazine Open Label Experience (ROLE) Program,Health

to continue on ranolazine in the ROLE program suggests they were perceiving a benefit from ranolazine. It is also comforting that the long term ROLE data show favorable safety and tolerability over an average follow up period of nearly three years," said Michael Koren, M.D., CEO of the Jacksonville Center for Clinical Research and principal investigator of the ROLE program.

Study Details

Patients with severe functional impairment from angina who completed either the MARISA or CARISA trial, and who elected to participate in the long- term, open label ROLE program, were enrolled at 123 sites in 12 countries. Physicians titrated patients to the optimal dose of Ranexa between 500mg and 1000mg twice daily. Safety and tolerability assessments included vital signs, electrocardiograms, laboratory tests and adverse event reporting.

Data were available and analyzed from a total of 2,372 patient-years of follow-up from the 942 patients exposed to ranolazine in MARISA, CARISA and the ROLE program, incorporating 2,233 patient-years of Ranexa treatment exposure. Mortality in the ROLE program was compared against a Duke Treadmill Score (DTS) predictive model and other contemporary cohorts of high risk heart disease patients. When extending observations to all patients exposed to ranolazine in the double-blind trials preceding the ROLE program, annual mortality was 2.8 percent, compared with greater than five percent, as predicted by DTS.

About Angina

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.

About CV Therapeutics

CV Therapeutics, Inc
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