San Francisco, CA—Ranolazine extended release (Ranexa) reduces the frequency of anginal episodes in patients with type 2 diabetes, and its effects are more pronounced in patients with poorer glycemic control, according to new data released at the 2013 American College of Cardiology annual meeting. Ranolazine is approved for the treatment of chronic angina, but it had not been studied specifically in patients with type 2 diabetes.
In the international Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina trial, 927 patients with type 2 diabetes, chronic stable angina, and coronary artery disease were randomized to ranolazine 1000 mg twice daily or to placebo for 8 weeks. Nearly all (96%) patients had hypertension, and 74% had a history of myocardial infarction. More than 80% were taking statins and angiotensin-converting enzyme inhibitors. At baseline, patients in the ranolazine group had a mean of 6.6 anginal episodes weekly, and those in the placebo group had a mean of 6.8 episodes.
Ranolazine had a modest effect in reducing angina frequency. From weeks 2 to 8, self-reported angina episodes were 4.3 weekly in the placebo group compared with 3.8 weekly in the ranolazine group (P = .008), reported Mikhail N. Kosiborod, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, MO.
The need for sublingual nitroglycerin was also lower in patients randomized to ranolazine (1.7 doses weekly) than in those receiving placebo (2.1 doses weekly).
The benefits of ranolazine were greater in patients with higher baseline hemoglobin (Hb) A1c levels. Previously, ranolazine was found to have glucose-lowering effects.
The superior effect of ranolazine was especially pronounced in patients with HbA1c >7%. “If the glucose-lowering action of ranolazine is confirmed in future studies, patients with diabetes and angina may derive a dual benefit from this drug,” said Dr Kosiborod.
A subgroup analysis by geographic region revealed that the frequency of angina was not different between the ranolazine and placebo arms among patients enrolled in Russia, Ukraine, and Belarus. Among the patients enrolled in other countries, ranolazine recipients experienced a significant reduction in the frequency of angina versus placebo (3.1 vs 4.1 episodes weekly; P = .002).
“The reasons for this geographic difference are not clear,” Dr Kosiborod said. “It wasn’t explained by differences in baseline characteristics but was driven by several sites located in Russia.”