In patients with poorly controlled diabetes and cardiovascular disease, ranolazine significantly reduced A1C by a placebo-adjusted 0.59% (95% CI -0.99 to -0.20; P<0.001).
RCT
randomized
Does ranolazine reduce A1C and fasting plasma glucose in hyperglycemic patients with non-ST elevation acute coronary syndrome?
Ranolazine significantly lowers A1C and fasting plasma glucose when added to standard antidiabetic therapy in patients with poorly controlled diabetes and cardiovascular disease.
Mean Difference: -0.59 (95% CI -0.99–-0.2)
p-value: p=< 0.001
OBJECTIVE: We determined the relationships between glycemia at randomization, concurrent antidiabetic therapy, and change in A1C and fasting plasma glucose (FPG) in patients with diabetes receiving standard treatment for diabetes 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 antidiabetes drug usage data from MERLIN were analyzed using Spotfire and SAS version 9.1 software. RESULTS: In patients with diabetes and A1C of >or=8-10% at randomization (n = 171), there was an absolute A1C reduction in the ranolazine group of 1.2% (95% CI -1.4 to -1.0), and the placebo-adjusted (n = 182) decrease in A1C by ranolazine was 0.59% (95% CI -0.99 to -0.20, P < 0.001). In patients with FPG of 150-400 mg/dl at randomization, ranolazine (n = 131) compared with placebo (n = 147) reduced FPG by 25.7 mg/dl (95% CI -43.3 to -8.1, P = 0.001). When changes in either A1C or FPG were correlated to A1C or FPG at randomization, the slopes were significantly steeper for ranolazine than placebo (A1C, P = 0.046; FPG, P < 0.001), indicating that lowering of A1C and FPG by ranolazine is related to hyperglycemia at randomization. Ranolazine, compared with placebo, was not associated with serious hypoglycemic events, associated with significant changes in concurrent antidiabetic therapy, or dependent on a history of angina. CONCLUSIONS: Ranolazine, when added to concurrent antidiabetes treatment, lowers FPG and A1C in patients with cardiovascular disease and poorly controlled diabetes.
Chisholm et al. (Wed,) conducted a rct in Hyperglycemia and Non-ST Elevation Acute Coronary Syndrome. Ranolazine vs. Placebo was evaluated on Placebo-adjusted decrease in A1C in patients with baseline A1C ≥8-10% (MD -0.59%, 95% CI -0.99 to -0.20, p=< 0.001). In patients with poorly controlled diabetes and cardiovascular disease, ranolazine significantly reduced A1C by a placebo-adjusted 0.59% (95% CI -0.99 to -0.20; P<0.001).