The therapeutic efficnecy of ranolazine in comparison with conventional therapy in diabetic individuals with ischemic heart disease; a randomized clinical trial

Abstract

Introduction: Patients with diabetes mellitus (DM) have higher risk of coronary artery disease (CAD) and angina than the general population. Objectives: We sought to assess the impact of ranolazine as an antianginal agent to diminish hemoglobin A1c (Hb A1c) level in diabetic individuals under treatment with metformin and gliclazide. Patients and Methods: This study was a randomized parallel-group clinical trial to compare the therapeutic effects of ranolazine versus conventional treatment in patients with concomitant T2DM and stable angina. TERISA (type 2 diabetes mellitus evaluation of ranolazine in subjects with chronic stable angina) was employed to assess the efficiency of ranolazine in lowering the frequency of angina attacks. The study was performed on diabetic patients with symptomatic angina under treatment with either sublingual nitroglycerin or up to two types of antianginal agents. The patients in the intervention group received 1000 mg ranolazine twice a day while patients in the control group were administrated with conventional treatment. Reduction in baseline Hb A1c level was determined at 4 and 8 weeks after the interventions. Results: Ranolazine therapy resulted in up to 15% absolute reduction in Hb A1c level in diabetic patients who had baseline HbA1c level >7%. Ranolazine was more efficient in reducing Hb A1c in patients with poorly controlled disease (i.e. HbA1c>8%, P=0.017). Ranolazine did not affect the glycemic status of patients concomitantly treated with antidiabetic therapy (P=0.560). Conclusion: Concurrent administration of ranolazine along with anti-diabetic treatments (i.e. metformin and gliclazide) was safe to reduce the level of HbA1c in patients with poorly controlled diabetes and stable angina.