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Pancreatic Safety of Sitagliptin in the TECOS Study.
- Source :
- Diabetes Care; Feb2017, Vol. 40 Issue 2, p164-170, 7p, 2 Charts, 2 Graphs
- Publication Year :
- 2017
-
Abstract
- <bold>Objective: </bold>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).<bold>Research Design and Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusions: </bold>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. [ABSTRACT FROM AUTHOR]
- Subjects :
- PANCREATIC tumors
PANCREATITIS
SITAGLIPTIN
CD26 antigen
CARDIOVASCULAR system
PANCREATITIS diagnosis
CARDIOVASCULAR diseases
COMPARATIVE studies
LONGITUDINAL method
RESEARCH methodology
MEDICAL cooperation
META-analysis
TYPE 2 diabetes
RESEARCH
RESEARCH funding
PROTEASE inhibitors
EVALUATION research
TREATMENT effectiveness
PROPORTIONAL hazards models
BLIND experiment
ACUTE diseases
DIAGNOSIS
Subjects
Details
- Language :
- English
- ISSN :
- 01495992
- Volume :
- 40
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- Diabetes Care
- Publication Type :
- Academic Journal
- Accession number :
- 120882244
- Full Text :
- https://doi.org/10.2337/dc15-2780