David D Dore1, John D Seeger2, K Arnold Chan3. 1. Brown University, Box G-121-7, 121 South Main Street, Providence, RI 02912, USA. 2. OptumInsight Epidemiology, Waltham, MA; Division of Pharmacoepidemiology and Pharmacoeconomics, Harvard Medical School/Brigham and Women's Hospital, Boston, MA, USA; Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA. 3. OptumInsight Epidemiology, Waltham, MA; Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA.
Abstract
OBJECTIVES: As part of a regulatory postmarketing commitment, we assessed the risk of claims for thyroid and pancreatic cancer among users of exenatide using an active drug safety surveillance system. METHODS: This active surveillance assessment used cohort methodology and commercial health insurance claims data to identify initiators of exenatide and propensity score-matched initiators of metformin or glyburide between June 2005 and September 2009, with up to 1 year of follow up through December 2009. The primary analysis estimated absolute and relative risk (RR) of inpatient or outpatient claims with diagnosis codes for thyroid neoplasm (benign or malignant) or pancreatic malignancies after exclusion of patients with a history of the same diagnosis at baseline. RESULTS: Among the matched comparison cohorts (N ≈ 32,800 each), there were 37 claims-suggested thyroid malignancies among exenatide initiators and 26 among metformin or glyburide initiators [RR 1.4; 95% confidence interval (CI) 0.8-2.4]. This association was attenuated when limited to inpatient thyroid cancer claims (RR 0.9; CI 0.3-2.6). Exenatide use was not associated with an increased risk of benign thyroid neoplasm (RR 0.7; CI 0.3-1.7), or pancreatic cancer (RR 0.8; CI 0.5-1.6). CONCLUSIONS: Use of exenatide was associated with a modestly higher incidence of inpatient and outpatient claims, but not inpatient claims for thyroid malignancies. Exenatide was not associated with higher risk of benign thyroid neoplasm or pancreatic cancer. Misclassification of outcomes and exposure, and residual confounding remain limitations of this analysis to be considered when interpreting the results. We have initiated a formal epidemiologic investigation to explore these relationships.
OBJECTIVES: As part of a regulatory postmarketing commitment, we assessed the risk of claims for thyroid and pancreatic cancer among users of exenatide using an active drug safety surveillance system. METHODS: This active surveillance assessment used cohort methodology and commercial health insurance claims data to identify initiators of exenatide and propensity score-matched initiators of metformin or glyburide between June 2005 and September 2009, with up to 1 year of follow up through December 2009. The primary analysis estimated absolute and relative risk (RR) of inpatient or outpatient claims with diagnosis codes for thyroid neoplasm (benign or malignant) or pancreatic malignancies after exclusion of patients with a history of the same diagnosis at baseline. RESULTS: Among the matched comparison cohorts (N ≈ 32,800 each), there were 37 claims-suggested thyroid malignancies among exenatide initiators and 26 among metformin or glyburide initiators [RR 1.4; 95% confidence interval (CI) 0.8-2.4]. This association was attenuated when limited to inpatient thyroid cancer claims (RR 0.9; CI 0.3-2.6). Exenatide use was not associated with an increased risk of benign thyroid neoplasm (RR 0.7; CI 0.3-1.7), or pancreatic cancer (RR 0.8; CI 0.5-1.6). CONCLUSIONS: Use of exenatide was associated with a modestly higher incidence of inpatient and outpatient claims, but not inpatient claims for thyroid malignancies. Exenatide was not associated with higher risk of benign thyroid neoplasm or pancreatic cancer. Misclassification of outcomes and exposure, and residual confounding remain limitations of this analysis to be considered when interpreting the results. We have initiated a formal epidemiologic investigation to explore these relationships.
Entities:
Keywords:
active safety surveillance; exenatide; pancreatic cancer; safety signal; thyroid cancer
Authors: D D Dore; G L Bloomgren; M Wenten; C Hoffman; C R Clifford; S G Quinn; D K Braun; R A Noel; J D Seeger Journal: Diabetes Obes Metab Date: 2011-06 Impact factor: 6.577
Authors: Laurent Azoulay; Kristian B Filion; Robert W Platt; Matthew Dahl; Colin R Dormuth; Kristin K Clemens; Madeleine Durand; David N Juurlink; Laura E Targownik; Tanvir C Turin; J Michael Paterson; Pierre Ernst Journal: BMJ Date: 2016-02-17