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Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis.

Garg R, Chen W, Pendergrass M - Diabetes Care (2010)

Bottom Line: A retrospective cohort study of a large medical and pharmacy claims database was performed.Data for 786,656 patients were analyzed.The limitations of this observational claims-based analysis cannot exclude the possibility of an increased risk.

View Article: PubMed Central - PubMed

Affiliation: Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA.

ABSTRACT

Objective: Cases of acute pancreatitis have been reported in association with exenatide, sitagliptin, and type 2 diabetes without use of these medications. It remains unknown whether exenatide or sitagliptin increase the risk of acute pancreatitis.

Research design and methods: A retrospective cohort study of a large medical and pharmacy claims database was performed. Data for 786,656 patients were analyzed. Cox proportional hazard models were built to compare the risk of acute pancreatitis between diabetic and nondiabetic subjects and between exenatide, sitagliptin, and control diabetes medication use.

Results: Incidence of acute pancreatitis in the nondiabetic control group, diabetic control group, exenatide group, and sitagliptin group was 1.9, 5.6, 5.7, and 5.6 cases per 1,000 patient years, respectively. The risk of acute pancreatitis was significantly higher in the combined diabetic groups than in the nondiabetic control group (adjusted hazard ratio 2.1 [95% CI 1.7-2.5]). Risk of acute pancreatitis was similar in the exenatide versus diabetic control group (0.9 [0.6-1.5]) and sitagliptin versus diabetic control group (1.0 [0.7-1.3]).

Conclusions: Our study demonstrated increased incidence of acute pancreatitis in diabetic versus nondiabetic patients but did not find an association between the use of exenatide or sitagliptin and acute pancreatitis. The limitations of this observational claims-based analysis cannot exclude the possibility of an increased risk.

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Kaplan-Meier curve of acute pancreatitis in exenatide, sitagliptin, and diabetes control groups.
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Figure 2: Kaplan-Meier curve of acute pancreatitis in exenatide, sitagliptin, and diabetes control groups.

Mentions: Figure 1 shows the Kaplan-Meier curve of time to acute pancreatitis in patients with diabetes compared with that in nondiabetic control patients. In the Cox proportional hazard model that controlled for diabetes, age, preexisting pancreatic disease, alcohol intake, biliary stone disease, and chronic disease score, patients with diabetes were 2.1 times more likely to have a claim for acute pancreatitis than patients without diabetes (Table 2). Figure 2 shows the Kaplan-Meier curve of time to acute pancreatitis in the diabetic subgroups. In the Cox proportional hazards model for the diabetic subgroups, acute pancreatitis was not significantly higher in the exenatide and sitagliptin groups compared with that in the diabetic control group (Table 3). The sensitivity analysis indicated that extending follow-up beyond 30 days of running out of the index medication did not significantly affect the results.


Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis.

Garg R, Chen W, Pendergrass M - Diabetes Care (2010)

Kaplan-Meier curve of acute pancreatitis in exenatide, sitagliptin, and diabetes control groups.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2963493&req=5

Figure 2: Kaplan-Meier curve of acute pancreatitis in exenatide, sitagliptin, and diabetes control groups.
Mentions: Figure 1 shows the Kaplan-Meier curve of time to acute pancreatitis in patients with diabetes compared with that in nondiabetic control patients. In the Cox proportional hazard model that controlled for diabetes, age, preexisting pancreatic disease, alcohol intake, biliary stone disease, and chronic disease score, patients with diabetes were 2.1 times more likely to have a claim for acute pancreatitis than patients without diabetes (Table 2). Figure 2 shows the Kaplan-Meier curve of time to acute pancreatitis in the diabetic subgroups. In the Cox proportional hazards model for the diabetic subgroups, acute pancreatitis was not significantly higher in the exenatide and sitagliptin groups compared with that in the diabetic control group (Table 3). The sensitivity analysis indicated that extending follow-up beyond 30 days of running out of the index medication did not significantly affect the results.

Bottom Line: A retrospective cohort study of a large medical and pharmacy claims database was performed.Data for 786,656 patients were analyzed.The limitations of this observational claims-based analysis cannot exclude the possibility of an increased risk.

View Article: PubMed Central - PubMed

Affiliation: Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA.

ABSTRACT

Objective: Cases of acute pancreatitis have been reported in association with exenatide, sitagliptin, and type 2 diabetes without use of these medications. It remains unknown whether exenatide or sitagliptin increase the risk of acute pancreatitis.

Research design and methods: A retrospective cohort study of a large medical and pharmacy claims database was performed. Data for 786,656 patients were analyzed. Cox proportional hazard models were built to compare the risk of acute pancreatitis between diabetic and nondiabetic subjects and between exenatide, sitagliptin, and control diabetes medication use.

Results: Incidence of acute pancreatitis in the nondiabetic control group, diabetic control group, exenatide group, and sitagliptin group was 1.9, 5.6, 5.7, and 5.6 cases per 1,000 patient years, respectively. The risk of acute pancreatitis was significantly higher in the combined diabetic groups than in the nondiabetic control group (adjusted hazard ratio 2.1 [95% CI 1.7-2.5]). Risk of acute pancreatitis was similar in the exenatide versus diabetic control group (0.9 [0.6-1.5]) and sitagliptin versus diabetic control group (1.0 [0.7-1.3]).

Conclusions: Our study demonstrated increased incidence of acute pancreatitis in diabetic versus nondiabetic patients but did not find an association between the use of exenatide or sitagliptin and acute pancreatitis. The limitations of this observational claims-based analysis cannot exclude the possibility of an increased risk.

Show MeSH
Related in: MedlinePlus