PMID- 25168266 OWN - NLM STAT- MEDLINE DCOM- 20150824 LR - 20141202 IS - 1873-460X (Electronic) IS - 1056-8727 (Linking) VI - 28 IP - 6 DP - 2014 Nov-Dec TI - Saxagliptin efficacy and safety in patients with type 2 diabetes receiving concomitant statin therapy. PG - 887-93 LID - S1056-8727(14)00206-2 [pii] LID - 10.1016/j.jdiacomp.2014.07.006 [doi] AB - AIMS: To examine whether concomitant statin therapy affects glycemic control with saxagliptin 2.5 and 5mg/d in patients with type 2 diabetes mellitus (T2DM). METHODS: 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. RESULTS: 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