Gilead reports positive data from Phase 4 TERISA study of Ranexa

10th March 2013 (Last Updated March 10th, 2013 18:30)

Gilead Sciences Ranexa (ranolazine) has reduced angina frequency in the Phase 4 Type 2 Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina (TERISA) study conducted in chronic angina patients with type 2 diabetes.

Gilead Sciences' Ranexa ranolazine has reduced angina frequency in the phase 4 type 2 diabetes evaluation of ranolazine in a study on subjects with chronic stable angina (TERISA), which was conducted on chronic angina patients with type 2 diabetes.

The study reports that the addition of ranolazine to background antianginal therapy reduced angina frequency as compared to placebo and background antianginal therapy.

The TERISA study lead author, St. Luke's Mid America Heart Institute cardiologist and the University of Missouri associate professor of medicine Mikhail Kosiborod said that there is a need for effective therapeutic strategies against angina in patients with diabetes.

"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," Kosiborod added.

"The study reports that the addition of ranolazine to background antianginal therapy reduced angina frequency as compared to placebo and background antianginal therapy."

Subsequent to a single-blind, four-week placebo run-in phase, 927 patients were randomised with ranolazine or a corresponding placebo besides background antianginal therapy for eight weeks.

The number of angina episodes and sublingual nitroglycerin doses taken by patients on a daily basis has been documented using an electronic diary.

According to the data, the average weekly angina frequency was considerably lower with ranolazine against placebo, as was weekly sublingual nitroglycerin use.

The study noted a similar serious adverse event profile and discontinuation rate due to adverse events between the ranolazine and placebo groups.

Non-serious adverse events include nausea, dizziness and constipation.