Pancreatic Safety of Sitagliptin in the TECOS Study (original) (raw)
Clinical Care/Education/Nutrition/Psychosocial Research| September 14 2016
1University of North Carolina School of Medicine, Chapel Hill, NC
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for the TECOS Study Group
2Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, U.K.
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for the TECOS Study Group
3Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
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for the TECOS Study Group
3Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
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for the TECOS Study Group
3Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
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for the TECOS Study Group
4Pontificia Universidad Javeriana, Hospital Universitario San Ignacio, Bogotá, Colombia
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for the TECOS Study Group
5Centre Region CINVEC, Viña del Mar, Chile
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for the TECOS Study Group
6University Specialized Hospital for Active Treatment in Endocrinology, Medical University, Sofia, Bulgaria
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for the TECOS Study Group
7E. Wolfson Medical Center, Holon, Israel
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for the TECOS Study Group
8St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
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for the TECOS Study Group
9The George Washington University Biostatistics Center, Rockville, MD
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for the TECOS Study Group
10Merck & Co., Inc., Kenilworth, NJ
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for the TECOS Study Group
11Toronto Centre for Liver Disease, Division of Gastroenterology, University of Toronto Health Network, Toronto, Ontario, Canada
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for the TECOS Study Group
3Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
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for the TECOS Study Group
2Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, U.K.
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for the TECOS Study Group
Diabetes Care 2017;40(2):164–170
Citation
John B. Buse, M. Angelyn Bethel, Jennifer B. Green, Susanna R. Stevens, Yuliya Lokhnygina, Pablo Aschner, Carlos Raffo Grado, Tsvetalina Tankova, Julio Wainstein, Robert Josse, John M. Lachin, Samuel S. Engel, Keyur Patel, Eric D. Peterson, Rury R. Holman; for the TECOS Study Group, Pancreatic Safety of Sitagliptin in the TECOS Study. _Diabetes Care 1 February 2017; 40 (2): 164–170. https://doi.org/10.2337/dc15-2780
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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.
Clinical trial reg. no. NCT00790205, clinicaltrials.gov.
See accompanying articles, pp. 161 and 284.
© 2017 by the American Diabetes Association.
2017
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