OBJECTIVETo determine the incidence of pancreatitis and pancreatic cancer in the SAVOR-TIMI 53 trial.
RESEARCH DESIGN AND METHODSA total of 16,492 type 2 diabetic patients ‡40 years old with established cardiovascular (CV) disease or CV risk factors were randomized to saxagliptin or placebo and followed for 2.1 years. Outcome measures were investigator reported with blinded expert adjudication of total pancreatitis (acute and chronic) and reported cases of pancreatic cancer. No differences in time to event onset, concomitant risk factors for pancreatitis, investigatorreported causality from study medication or disease severity, and outcome were found between treatment arms. The investigators reported 5 and 12 cases of pancreatic cancer in the saxagliptin and placebo arms, respectively ], P = 0.09).
RESULTS
Trial investigators reported
CONCLUSIONSIn the SAVOR-TIMI 53 trial, within 2.1 years of follow-up, risk for pancreatitis in type 2 diabetic patients treated with saxagliptin was low and apparently similar to placebo, with no sign of increased risk for pancreatic cancer. Further studies are needed to completely resolve the pancreatic safety issues with incretin-based therapy.