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Pancreatic safety of sitagliptin in the TECOS Study
- Source :
- Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid, Diabetes Care
- Publication Year :
- 2017
- Publisher :
- American Diabetes Association, 2017.
-
Abstract
- 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.
- Subjects :
- Male
medicine.medical_specialty
Endocrinology, Diabetes and Metabolism
030209 endocrinology & metabolism
030204 cardiovascular system & hematology
Placebo
Gastroenterology
Sitagliptin Phosphate
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Risk Factors
Pancreatic cancer
Internal medicine
Internal Medicine
medicine
Humans
Aged
Proportional Hazards Models
Advanced and Specialized Nursing
Dipeptidyl-Peptidase IV Inhibitors
business.industry
Hazard ratio
Clinical Care/Education/Nutrition/Psychosocial Research
Middle Aged
16. Peace & justice
medicine.disease
3. Good health
Surgery
Pancreatic Neoplasms
Treatment Outcome
Diabetes Mellitus, Type 2
Pancreatitis
Cardiovascular Diseases
Sitagliptin
Relative risk
Acute Disease
Acute pancreatitis
Female
business
Follow-Up Studies
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid, Diabetes Care
- Accession number :
- edsair.doi.dedup.....a153cf96a50affda936502f6c5d00919