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Evaluation of Ranolazine in Patients With Type 2 Diabetes Mellitus and Chronic Stable Angina: Results From the TERISA Randomized Clinical Trial
Study Questions:
What is the efficacy of ranolazine on weekly angina frequency in subjects with type 2 diabetes, coronary artery disease, and chronic stable angina who remain symptomatic despite treatment with up to two antianginal agents?
Methods:
The TERISA (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina) trial was an international, randomized, double-blind, placebo-controlled trial of patients with type 2 diabetes, coronary artery disease, and chronic stable angina on treatment with one or two antianginal agents. After a single-blind, 4-week placebo run-in (during which subjects were required to meet adherence and angina frequency criteria), patients were randomized to 8 weeks of ranolazine (target dose 1000 mg twice daily) or placebo. Primary outcome was the average weekly number of patient-reported anginal episodes over the last 6 weeks of the study.
Results:
The final analytic sample size was 927 patients (462 in the ranolazine arm, 465 in the placebo arm). Weekly angina frequency was significantly lower with ranolazine versus placebo (3.8 [3.6-4.1] vs. 4.3 [4.0-4.5] episodes, p = 0.008), as was the weekly sublingual nitroglycerin use (1.7 [1.6-1.9] vs. 2.1 [1.9-2.3] doses, p = 0.003). There was no difference in the incidence of serious adverse events between groups. The therapeutic superiority of ranolazine on reducing weekly angina frequency was more pronounced in patients with higher baseline glycosylated hemoglobin values.
Conclusions:
Compared to placebo and among patients with diabetes and chronic angina despite treatment with up to two antianginal agents, ranolazine reduced patient-reported angina episodes and sublingual nitroglycerin use over 6 weeks.
Perspective:
While TERISA has strength in its randomized trial design and single-blind placebo run-in period, the magnitude of absolute effect demonstrated with ranolazine was small. Overall, ranolazine resulted in 0.5 fewer angina episodes, compared to placebo. Although this difference met statistical significance, the clinical meaningfulness of this difference is questionable and probably doubtful. Nonetheless, the results of this short-term study confirm results of previous analyses, and add to the evidence that ranolazine may be particularly well suited to the growing population of diabetics with coronary artery disease and angina.
Keywords: Glycated Hemoglobin A, Incidence, Coronary Artery Disease, Cyclopentanes, Angina, Stable, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Piperazines, Nitroglycerin
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