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Pancreatic Safety of Sitagliptin in the TECOS Study.

Publication ,  Journal Article
Buse, JB; Bethel, MA; Green, JB; Stevens, SR; Lokhnygina, Y; Aschner, P; Grado, CR; Tankova, T; Wainstein, J; Josse, R; Lachin, JM; Engel, SS ...
Published in: Diabetes Care
February 2017

OBJECTIVE: We evaluated the incidence of acute pancreatitis and pancreatic cancer in patients with type 2 diabetes and cardiovascular disease who were treated with sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i). RESEARCH DESIGN AND METHODS: In the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study, a cardiovascular safety study of sitagliptin, all suspected cases of acute pancreatitis and pancreatic cancer were collected prospectively for 14,671 participants during a median follow-up time of 3 years, and were adjudicated blindly. RESULTS: Baseline differences were minimal between participants confirmed to have no pancreatic events, acute pancreatitis, or pancreatic cancer. Among those participants randomized to receive sitagliptin, 23 (0.3%) (vs. 12 randomized to receive placebo [0.2%]) had pancreatitis (hazard ratio 1.93 [95% CI 0.96-3.88], P = 0.065; 0.107 vs. 0.056/100 patient-years), with 25 versus 17 events, respectively. Severe pancreatitis (two fatal) occurred in four individuals allocated to receive sitagliptin. Cases of pancreatic cancer were numerically fewer with sitagliptin (9 [0.1%]) versus placebo (14 [0.2%]) (hazard ratio 0.66 [95% CI 0.28-1.51], P = 0.32; 0.042 vs. 0.066 events/100 patient-years). Meta-analysis with two other DPP-4i cardiovascular outcome studies showed an increased risk for acute pancreatitis (risk ratio 1.78 [95% CI 1.13-2.81], P = 0.01) and no significant effect for pancreatic cancer (risk ratio 0.54 [95% CI 0.28-1.04], P = 0.07). CONCLUSIONS: Pancreatitis and pancreatic cancer were uncommon events with rates that were not statistically significantly different between the sitagliptin and placebo groups, although numerically more sitagliptin participants developed pancreatitis and fewer developed pancreatic cancer. Meta-analysis suggests a small absolute increased risk for pancreatitis with DPP-4i therapy.

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Published In

Diabetes Care

DOI

EISSN

1935-5548

Publication Date

February 2017

Volume

40

Issue

2

Start / End Page

164 / 170

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sitagliptin Phosphate
  • Risk Factors
  • Proportional Hazards Models
  • Pancreatitis
  • Pancreatic Neoplasms
  • Middle Aged
  • Male
  • Humans
  • Follow-Up Studies
 

Citation

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Buse, J. B., Bethel, M. A., Green, J. B., Stevens, S. R., Lokhnygina, Y., Aschner, P., … TECOS Study Group. (2017). Pancreatic Safety of Sitagliptin in the TECOS Study. Diabetes Care, 40(2), 164–170. https://doi.org/10.2337/dc15-2780
Buse, John B., M Angelyn Bethel, Jennifer B. Green, Susanna R. Stevens, Yuliya Lokhnygina, Pablo Aschner, Carlos Raffo Grado, et al. “Pancreatic Safety of Sitagliptin in the TECOS Study.Diabetes Care 40, no. 2 (February 2017): 164–70. https://doi.org/10.2337/dc15-2780.
Buse JB, Bethel MA, Green JB, Stevens SR, Lokhnygina Y, Aschner P, et al. Pancreatic Safety of Sitagliptin in the TECOS Study. Diabetes Care. 2017 Feb;40(2):164–70.
Buse, John B., et al. “Pancreatic Safety of Sitagliptin in the TECOS Study.Diabetes Care, vol. 40, no. 2, Feb. 2017, pp. 164–70. Pubmed, doi:10.2337/dc15-2780.
Buse JB, Bethel MA, Green JB, Stevens SR, Lokhnygina Y, Aschner P, Grado CR, Tankova T, Wainstein J, Josse R, Lachin JM, Engel SS, Patel K, Peterson ED, Holman RR, TECOS Study Group. Pancreatic Safety of Sitagliptin in the TECOS Study. Diabetes Care. 2017 Feb;40(2):164–170.

Published In

Diabetes Care

DOI

EISSN

1935-5548

Publication Date

February 2017

Volume

40

Issue

2

Start / End Page

164 / 170

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sitagliptin Phosphate
  • Risk Factors
  • Proportional Hazards Models
  • Pancreatitis
  • Pancreatic Neoplasms
  • Middle Aged
  • Male
  • Humans
  • Follow-Up Studies