Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide.
OBJECTIVE
To estimate risk and relative risk (RR) of acute pancreatitis among patients using incretin-based diabetes therapies (exenatide or sitagliptin) compared to patients treated with agents with established safety profiles (metformin or glyburide).


METHODS
The study population was derived from a large US commercial health insurance transaction database using an active drug safety surveillance system (i3 Aperio). This analysis is based on data from June 2005 through June 2008. Cohorts of exenatide and sitagliptin initiators were each matched to an equal number of metformin or glyburide (met/gly) initiators using propensity scores to reduce confounding in the comparison of outcomes during follow-up. Patients with claims suggesting pancreatic disease in the 6 months prior to cohort entry were excluded.


METHODS
Claims for hospitalizations associated with a primary diagnosis of acute pancreatitis (ICD-9 577.0).


RESULTS
There were 27 996 exenatide initiators and 16 276 sitagliptin initiators and approximately equal numbers of matched comparators. During follow-up of up to 1 year, acute pancreatitis occurred among 0.13% of patients treated with exenatide and 0.12% of patients treated with sitagliptin. The risk of acute pancreatitis was comparable for initiators of exenatide (RR 1.0; 95% confidence interval (CI) 0.6-1.7) and sitagliptin (RR 1.0; 95% CI 0.5-2.0) relative to the comparison cohorts.


CONCLUSIONS
These data do not provide evidence for an association of acute pancreatitis among initiators of exenatide or sitagliptin compared to met/gly initiators. These results are limited by the data available in an administrative, healthcare database.
Dore
David D
DD
i3 Drug Safety, 950 Winter Street, Waltham, MA 02451, USA. david.dore@i3drugsafety.com
Seeger
John D
JD
Arnold Chan
K
K
D000293:Adolescent; D000328:Adult; D016208:Databases, Factual; D000077270:Exenatide; D005260:Female; D005905:Glyburide / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007348:Insurance, Health; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010195:Pancreatitis / Q000139:chemically induced / Q000453:epidemiology*; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D011719:Pyrazines / Q000009:adverse effects / Q000627:therapeutic use*; D018570:Risk Assessment; D012449:Safety; D000068900:Sitagliptin Phosphate; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States / Q000453:epidemiology; D014688:Venoms / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
D007004:Hypoglycemic Agents; D010455:Peptides; D011719:Pyrazines; D014230:Triazoles; D014688:Venoms; D008687:Metformin; D000077270:Exenatide; D005905:Glyburide; D000068900:Sitagliptin Phosphate