At the European society of cardiology, AstraZeneca / Bristol-Myers and Takeda presented detailed analysis of the Cardiovascular (CV) outcome data from SAVOR-TIMI 53 and EXAMINE trial conducted on saxagliptin and alogliptin respectively. Both the studies concluded that saxagliptin and alogliptin are CV safe and comparable to other oral anti diabetes medications. The overall safety data on the drugs is very much comforting and should eliminate any physician concerns with regard to pancreatitis and pancreatic cancer.

The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)–Thrombolysis in Myocardial Infarction (TIMI) 53 trial was designed to evaluate the safety and efficacy of saxagliptin with respect to cardiovascular outcomes in patients with diabetes mellitus who are at risk for cardiovascular events. A total of 16,492 patients underwent randomization..

During a mean follow-up of 2.1 years, the primary endpoint of composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke occurred in 7.3% of patients assigned saxagliptin compared with 7.2% assigned placebo (HR=1.00; 95% CI, 0.89-1.12; P=.99 for superiority; P<.001 for noninferiority). The major secondary endpoint, a composite of CV death, MI, stroke and hospitalization for unstable angina, coronary revascularization or Heart failure(HF) occurred in 12.8% of patients assigned saxagliptin compared with 12.4% assigned placebo (HR=1.02; 95% CI, 0.94-1.11). Of note, the saxagliptin group had more hospitalizations for HF (3.5% vs. 2.8%; HR=1.27; 95% CI, 1.07-1.51). Reductions in blood glucose were also greater with saxagliptin, with mean reductions in HbA1c of 0.5% at 2 years in the saxagliptin group compared with 0.2% in the placebo group (P<.001). More patients assigned saxagliptin achieved or maintained goal HbA1c <7% (40% vs. 30.3%; P<.001). About 15% of patients in the saxagliptin group reported at least one hypoglycemic event compared with 13.4% of patients in the placebo group (P<.001). Additionally, saxagliptin was associated with reduced development and progession of microalbuminuria. Rates of pancreatitis were similar with saxagliptin and placebo (0.3% for both; P=.77). Five cases of pancreatic cancer were reported in the saxagliptin group compared with 12 in the placebo group. Premature discontinuation of the study drug occurred more in the placebo group (20.8% vs. 18.4%; P<.001).

Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) trial was designed to determine whether alogliptin is noninferior to placebo with respect to major cardiovascular events in patients with type 2 diabetes who are at very high cardiovascular risk — those with recent acute coronary syndromes. 5380 patients participated in the study. The primary end point occurred at similar rates in the alogliptin and placebo groups (in 11.3% and 11.8% of patients, respectively, after a median exposure of 18 months. The analysis of the principal secondary end point of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina showed no significant difference between the alogliptin group and the placebo group (12.7% and 13.4% of patients, respectively. By the end of the study period, the mean change of HbA1c from baseline was −0.33% in the alogliptin group and 0.03% in the placebo group. Alogliptin and placebo groups did not differ significantly with respect to the incidence of serious adverse events (33.6% and 35.5%, respectively; P=0.14). The incidences of acute and chronic pancreatitis were similar in the two groups; no cases were fatal. There were no significant between-group differences in the incidence of cancer, and there were no reports of pancreatic cancer.