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Positive Phase IV Results for Ranexa (Ranolazine) in Angina Patients With Diabetes

Drug lowers angina frequency versus placebo (March 10)

Results from a phase IV study have shown that the addition of ranolazine (Ranexa, Gilead Sciences) to background antianginal therapy in chronic angina patients with type 2 diabetes significantly reduced the frequency of weekly angina episodes compared with placebo and background antianginal therapy.

The findings were presented at the 62nd Annual Scientific Session of the American College of Cardiology, held in San Francisco, California, and were published online in the Journal of the American College of Cardiology.

Chronic angina — the most common symptom of coronary artery disease (CAD) — can be a debilitating heart condition. Angina typically manifests as recurrent pain or tightness in the chest during exertion or emotional stress. Patients with diabetes have more extensive CAD and a propensity for greater angina burden compared with patients without diabetes.

In the phase IV TERISA (Type 2 Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) trial, 927 patients were randomly assigned to receive ranolazine (500 mg twice-daily, up-titrated to 1,000 mg twice-daily on day 8; n = 462) or matching placebo (n = 465) in addition to background antianginal therapy for 8 weeks.

During weeks 2 to 8, the average weekly angina frequency was significantly lower with ranolazine versus placebo (3.8 vs. 4.3 episodes, respectively; P = 0.008), as was weekly sublingual nitroglycerin use (1.7 vs. 2.1 doses, respectively; P = 0.003).

Ranexa (ranolazine) is an extended-release tablet approved for the treatment of chronic angina. The drug may be used in combination with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin receptor blockers.

Ranexa was initially approved in the U.S. in January 2006. In 2008, the U.S. indication was expanded to include first-line treatment for chronic angina. Ranexa is not indicated for the treatment of diabetes.

Source: Gilead Sciences; March 10, 2013.

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