Saxagliptin efficacy and safety in patients with type 2 diabetes receiving concomitant statin therapy

To examine whether concomitant statin therapy affects glycemic control with saxagliptin 2.5 and 5mg/d in patients with type 2 diabetes mellitus (T2DM).

Efficacy and safety were analyzed post hoc for pooled data from 9 saxagliptin randomized, placebo-controlled trials with a primary 24-week treatment period (4 monotherapy, 2 add-on to metformin, 1 each add-on to a sulfonylurea, thiazolidinedione, or insulin±metformin). Safety was also assessed in an 11-study, 24-week pool and an extended 20-study pool, which included 9 additional 4- to 52-week randomized studies. Comparisons were performed for patient groups defined by baseline statin use.

Saxagliptin produced greater mean reductions in glycated hemoglobin than placebo, with no interaction between treatment and baseline statin use (P=0.47). In patients receiving saxagliptin 2.5 and 5mg and placebo, the proportion of patients with ≥1 adverse event (AE) was 78.1%, 64.0%, and 63.2%, respectively, in patients with any statin use and 70.6%, 57.9%, and 55.0% in patients with no statin use. Serious AEs, deaths, and symptomatic confirmed hypoglycemia (fingerstick glucose ≤50mg/dL) were few and similar, irrespective of baseline statin use.

Saxagliptin improves glycemic control and is generally well tolerated in patients with T2DM, irrespective of concomitant statin therapy.