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The findings were presented today at the American Heart AssociationScientific Sessions in Orlando, Florida by Dr. David Morrow of the TIMI StudyGroup.
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In patients with diabetes treated with Ranexa in the study, at four monthsHbA1c had declined approximately 0.7 percentage points, from a starting meanbaseline of 7.5 to 6.8 percent, and 0.43 percentage points compared to placebo(p<0.001). Patients taking Ranexa were significantly more likely (p<0.001) toachieve the HbA1c treatment target of less than 7.0 percent, with 59 percentof diabetic patients on Ranexa achieving this target at four months.
Patients without diabetes at baseline who received Ranexa had a 32 percentreduction (p=0.003) in their risk of newly diagnosed hyperglycemia (as definedby having an HbA1c of greater than 6.0 percent or a new fasting glucose ofmore than 110mg/dL). Worsening hyperglycemia (defined as greater than a onepercent increase in HbA1c) was 37 percent less likely (p<0.001) in the Ranexatreated group and no increased hypoglycemia or weight gain were observed inRanexa patients compared to placebo.
"The results of the MERLIN TIMI-36 study confirm that ranolazine is a safeand effective anti-ischemic drug that also has favorable effects on arrhythmiaand HbA1c," Morrow said. "The reduction in HbA1c observed with ranolazine inthe MERLIN TIMI-36 study is especially striking because the effects wereobserved on top of multiple other anti-diabetic drugs used as part of standardtherapy."
In accordance with a special protocol assessment agreement between theU.S. Food and Drug Administration (FDA) and CV Therapeutics, the Companybelieves that data from the MERLIN TIMI-36 study could support expansion ofthe existing Ranexa indication to first line angina. In September 2007, theCompany submitted a supplemental new drug application to the FDA seeking a newindication for first line angina and a significant reduction in cautionarylanguage.
Ranexa is currently indicated for the treatment of chronic angina inpatients who have not achieved an adequate response with other antianginaldrugs, and should be used in combination with amlodipine, beta-blockers ornitrates.
Study Design
MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia inNon-ST Elevation Acute Coronary Syndromes) was a multi-national, double-blind,randomized, placebo-controlled, parallel-group clinical trial designed toevaluate the efficacy and safety of Ranexa during acute and long-termtreatment in 6,560 patients (3,279 received ranolazine, 3,281 receivedplacebo) with non-ST elevation ACS treated with standard therapy.
Within 48 hours of the onset of angina due to ACS, eligible hospitalizedpatients were enrolled in the study and randomized to receive intravenousRanexa or placebo, followed by long-term outpatient treatment with Ranexaextended-release tablets or placebo. All patients also received standardtherapy during both hospital-based and outpatient treatment. The doses ofRanexa extended-release tablets used in MERLIN TIMI-36 have been studied inprevious Phase 3 clinical trials.
Participants in the MERLIN TIMI-36 study received current standardtherapy, with approximately 96 percent of patients on aspirin, approximately89 percent on beta blockers and approximately 82 percent on statins.Approximately 59 percent of study participants received coronary angiographyduring their
