Results from the TERISA trial, presented March 10 during ACC.13's Late Breaking Clinical Trials III session and simultaneously published in the Journal of the American College of Cardiology, suggest that ranolazine may help both angina and hemoglobin A1c levels in diabetes patients.

"There was a significant placebo effect observed in this trial, and ranolazine was additive," said Mikhail Kosiborod, MD, Saint Luke's Mid America Heart Institute, Kansas City, MO, presenting on behalf of the TERISA investigators. "This effect was observed early and persisted throughout the treatment phase of the trial."

A total of 949 patients with stable angina and type 2 diabetes were enrolled at 105 centers in 14 countries. After initial enrollment, all patients were given a four-week run-in phase with placebo to normalize angina episodes. After randomization, they were given either ranolazine (target dose 1000 mg bid) or a matching placebo for eight weeks. Patients had medical visits at two weeks and eight weeks, and a follow-up safety call two weeks after the treatment phase ended.

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The primary endpoint was the average weekly number of angina episodes from weeks two to eight of treatment. The key secondary endpoint was the average number of sublingual nitroglycerin doses from weeks two to eight. Both angina episodes and nitroglycerin use were recorded on an electronic diary with daily data transfer and 98 percent compliance.

Patients in the two groups were similar, with a mean duration of diabetes of about 7.5 years and HbA1c of 7.3. Similar numbers were on glucose-lowering medication insulin, statins, antiplatelet agents and ACE-I/ARBs.

Patients on ranolazine reported 3.8 angina episodes per week versus 4.3 for the placebo group, p=0.008. Ranolazine patients used 1.7 sublingual nitroglycerin doses per week versus 2.1 for placebo patients, p=0.003. An exploratory analysis also showed greater reductions in HbA1c for ranolazine versus placebo, with greater benefit for patients with higher baseline A1c levels. There were no statistically significant differences in side effects between the two groups.

"We found that ranolazine was more effective than placebo in reducing angina frequency and sublingual nitroglycerin use," Kosiborod said. "Future studies are needed to explore the potential dual effects of ranolazine on angina and glucose control."

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