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CV Therapeutics' Anti-Ischemic Agent Ranexa(R) Significantly Reduces HbA1c and Other Markers of Diabetes in MERLIN TIMI-36
Date:11/6/2007

IN 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.

Potential Diabetes Mechanism

Substantial published data suggest that the anti-ischemic effects of Ranexa result from the drug's activity to inhibit the late sodium current in cardiac cells. Preclinical work to identify the potential mechanism of action of Ranexa in diabetes has shown that ranolazine increased glucose stimulated insulin secretion in pancreatic islets. In separate experiments using preclinical models of insulin resistance, ranolazine also improved glucose homeostasis.

These data could illustrate an underlying potential first in class mechanism of action for the statistically significant reductions in HbA1c levels observed with Ranexa in cardiovascular patients with diabetes from the Phase 3 CARISA (n=189 with angina and diabetes) and MERLIN TIMI-36 (n=2,220 with acute coronary syndromes and diabetes) clinical trials.

In CARISA (Combination Assessment of Ranolazine in Stable Angina), Ranexa reduced HbA1c levels by an average of up to 0.7 percentage points in angina patients with diabetes. The reduction in HbA1c was not associated with increased hypoglycemia.

The Company plans to submit data from these new preclinical experiments for publication later this year.

About CV Therapeutics

CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular c
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SOURCE CV Therapeutics, Inc.
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