Cited by 28Pharmacovigilance and Adverse Drug ReactionsDiabetes Treatment and ManagementMetabolism, Diabetes, and Cancer

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance

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Dore, David D., Seeger, John D., Chan, K. Arnold·2012·Therapeutic Advances in Drug Safety

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.

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Crossref · 10.1177/2042098612446473

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  • Five observational studies included analyses considering different lag times for outcome assessment, while two studies provided distinct information differentiating between thyroid cancer in general and MTC.

    “In addition, five studies included analyses considering different lag times for outcome assessment, while two studies provided distinct information differentiating between thyroid cancer in general and MTC.25,38,51–53”
  • The potential for residual confounding and the role of surveillance bias are important considerations that have not been thoroughly assessed.

    “Similarly, the potential for residual confounding (e.g., limited evaluation of specific risk factors for thyroid cancer such as obesity, neck radiation, and family history of thyroid cancer) and the role of surveillance bias (e.g., clinicians might be more likely to do a thyroid exam or ultrasound on patients taking GLP-1 RA) are important considerations that have been not thoroughly assessed.25,”
  • Two observational studies and a study based on two U.S. administrative databases did not highlight a significant increased risk of thyroid cancer with exenatide.

    “Furthermore, two observational studies, as well as a study based on two U.S. administrative databases did not highlight a significant increased risk of thyroid cancer with exenatide [130,131].”

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Authors
Dore, D. D., Seeger, J. D., & Chan, K. A.
Affiliations
  • Brown University (US)
  • Brigham and Women's Hospital (US)
  • Harvard University (US)
Venue
Therapeutic Advances in Drug Safety
Published
2012-05-15
Volume
3
Issue
4
Pages
157-164
ISSN
  • 2042-0986 (ISSN-L)
  • 2042-0994
OpenAlex
W2170608522
Cited by
28
References
15
Citations by year
2026: 3 · 2025: 5 · 2024: 5 · 2022: 4 · 2021: 1 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 3 · 2015: 2 · 2014: 1 · 2013: 1
FWCI
1.80
Type
journal article
Language
en
Open access
Locations
  • Therapeutic Advances in Drug Safety (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Metabolism, Diabetes, and Cancer
Keywords
exenatide, thyroid cancer, pancreatic cancer, drug safety, adverse drug reactions, metformin, glibenclamide, type 2 diabetes, health insurance claims, residual confounding, outcome misclassification

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