Gilead Sciences Inc. announced data from the Phase 4 TERISA (Type 2 Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) study, which demonstrated that the addition of ranolazine to background antianginal therapy in chronic angina patients with type 2 diabetes significantly reduced the frequency of weekly angina episodes compared to placebo and background antianginal therapy. Results were presented today during the American College of Cardiology's 62nd Annual Scientific Session (ACC.13) in San Francisco and were published online ahead of print in the Journal of the American College of Cardiology.
Ranexa (ranolazine) is indicated for the treatment of chronic angina. Ranexa is not indicated for the treatment of diabetes and should not be considered a treatment for diabetes.
Chronic angina, the most common symptom of coronary artery disease, can be a debilitating heart condition. Angina typically manifests as recurrent pain or tightness in the chest upon exertion or emotional stress. Patients with diabetes have more extensive coronary artery disease and a propensity for greater angina burden compared to patients without diabetes.
"Given the high prevalence of angina in patients with diabetes, there is a need for effective therapeutic strategies in this difficult-to-treat population," said Mikhail Kosiborod, MD, Associate Professor of Medicine at the University of Missouri, Kansas City, cardiologist at St. Luke's Mid America Heart Institute and lead author of the TERISA study. "Although the safety and efficacy profile of ranolazine is well established, this is the first study to prospectively evaluate the antianginal effectiveness of ranolazine in patients with chronic angina and concurrent type 2 diabetes."
Following a single-blind, four-week placebo run-in phase, 927 randomized patients received ranolazine (twice-daily 500 mg up-titrated to twice-daily 1,000 mg on Day 8) (n=462) or matching placebo (n=465) in addition to background antianginal therapy for eight weeks. Patients were asked to document the number of angina episodes and sublingual (under the tongue) nitroglycerin doses taken on a daily basis using an electronic diary.
During weeks 2-8, average weekly angina frequency was significantly lower with ranolazine versus placebo (3.8 [3.6-4.1] versus 4.3 [4.0-4.5] episodes, P=0.008), as was weekly sublingual nitroglycerin use (1.7 [1.6-1.9] versus 2.1 [1.9-2.3] doses, P=0.003).
The rate of serious adverse events and the rate of discontinuations due to adverse events were similar between the ranolazine and placebo groups. Notable non-serious adverse events included nausea, reported in 17 ranolazine and two placebo patients; dizziness, reported in 17 ranolazine and six placebo patients; and constipation, reported in eight ranolazine and two placebo patients; see below for important safety information.
Date: March 10, 2013
Source: Gilead Sciences Inc.