Abstract

Objectives: We determined the relationships between glycemia at randomization, concurrent anti-diabetic therapy and change in hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) in patients with diabetes mellitus (DM) receiving standard treatment for DM and randomized to ranolazine or placebo within the MERLIN-TIMI 36 (MERLIN) study. Ranolazine is a novel first-in class drug approved for treating angina pectoris.

Research Design and Methods: Randomization and 4-month glycemic and anti-diabetes drug usage data from MERLIN were analyzed using Spotfire and SAS version 9.1 software.

Results: In patients with DM and HbA1c of ≥8-10% at randomization (n=171) there was an absolute HbA1c reduction in the ranolazine group of 1.2% (95%CI: −1.4 to −1.0) and the placebo (n=182) adjusted decrease in HbA1c by ranolazine was 0.59% (95%CI: −0.99 to −0.20, p<0.001). In patients with FPG 150-400 mg/dl at randomization, ranolazine (n=131) compared to placebo (n=147) reduced FPG by 25.7 mg/dl (95%CI: −43.3 to −8.1, p=0.001). When changes in either HbA1c or FPG were correlated to HbA1c or FPG at randomization the slopes were significantly steeper for ranolazine than placebo (HbA1c, p=0.046; FPG, p<0.001), indicating that lowering of HbA1c and FPG by ranolazine is related to hyperglycemia at randomization. Ranolazine, compared to placebo, was not associated with serious hypoglycemic events, significant changes in concurrent anti-diabetic therapy or dependent on a history of angina.

Conclusion: Ranolazine, when added to concurrent anti-diabetes treatment, lowers FPG and HbA1c in patients with cardiovascular disease and poorly controlled DM.