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Incidence of Pancreatitis and Pancreatic Cancer in a Randomized Controlled

Featured Article :. Incidence of Pancreatitis and Pancreatic Cancer in a Randomized Controlled Multicenter Trial (SAVOR-TIMI 53) of the Dipeptidyl Peptidase-4 Inhibitor Saxagliptin.

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Incidence of Pancreatitis and Pancreatic Cancer in a Randomized Controlled

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  1. Featured Article: Incidence of Pancreatitis and Pancreatic Cancer in a Randomized Controlled Multicenter Trial (SAVOR-TIMI 53) of the Dipeptidyl Peptidase-4 Inhibitor Saxagliptin Itamar Raz, Deepak L. Bhatt, Boaz Hirshberg, Ofri Mosenzon, Benjamin M. Scirica, Amarachi Umez-Eronini, KyungAh Im, Christina Stahre, Alona Buskila, Nayyar Iqbal, Norton Greenberger, and Markus M. Lerch Diabetes Care Volume 37: 2435-2441 September, 2014

  2. STUDY OBJECTIVE • To determine the incidence of pancreatitis and pancreatic cancer in the SAVORTIMI 53 trial Raz I. et al. Diabetes Care 2014;37:2435-2441

  3. STUDY DESIGN AND METHODS • 16,492 type 2 diabetic patients ≥40 years old with cardiovascular (CV) disease or CV risk factors were randomized to saxagliptin or placebo • Patients were 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 Raz I. et al. Diabetes Care 2014;37:2435-2441

  4. RESULTS • Trial investigators reported 35 events of pancreatitis in each treatment arm in 63 patients • Adjudication confirmed pancreatitis in 24 patients (26 events) in the saxagliptin arm and 21 patients (25 events) in the placebo arm • Cases of definite acute pancreatitis were confirmed in 17 vs. 9, definite plus possible pancreatitis in 22 vs. 16, and chronic pancreatitis in 2 vs. 6 in the saxagliptin and placebo arms, respectively Raz I. et al. Diabetes Care 2014;37:2435-2441

  5. RESULTS • No differences were found between treatment arms in the following: • Time to event onset • Concomitant risk factors for pancreatitis • Investigator-reported causality from study medication or disease severity • Outcome • The investigators reported 5 and 12 cases of pancreatic cancer in the saxagliptin and placebo arms, respectively Raz I. et al. Diabetes Care 2014;37:2435-2441

  6. Raz I. et al. Diabetes Care 2014;37:2435-2441

  7. Raz I. et al. Diabetes Care 2014;37:2435-2441

  8. Raz I. et al. Diabetes Care 2014;37:2435-2441

  9. CONCLUSIONS • Risk for pancreatitis in type 2 diabetic patients treated with saxagliptin was low and apparently similar to placebo • There was no sign of increased risk for pancreatic cancer • Further studies are needed to completely resolve the pancreatic safety issues with incretin-based therapy Raz I. et al. Diabetes Care 2014;37:2435-2441

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