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Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies

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Li, L., Shen, J., Bala, M. M., Busse, J. W., Ebrahim, S., Vandvik, P. O., Rios, L. P., Malaga, G. +4 more·2014·BMJ
DOI 10.1136/bmj.g2366PMC PMC3987051
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Abstract

OBJECTIVE: To investigate the risk of pancreatitis associated with the use of incretin-based treatments in patients with type 2 diabetes mellitus. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov. ELIGIBILITY CRITERIA: Randomised and non-randomised controlled clinical trials, prospective or retrospective cohort studies, and case-control studies of treatment with glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors in adults with type 2 diabetes mellitus compared with placebo, lifestyle modification, or active anti-diabetic drugs. DATA COLLECTION AND ANALYSIS: Pairs of trained reviewers independently screened for eligible studies, assessed risk of bias, and extracted data. A modified Cochrane tool for randomised controlled trials and a modified version of the Newcastle-Ottawa scale for observational studies were used to assess bias. We pooled data from randomised controlled trials using Peto odds ratios, and conducted four prespecified subgroup analyses and a post hoc subgroup analysis. Because of variation in outcome measures and forms of data, we describe the results of observational studies without a pooled analysis. RESULTS: 60 studies (n=353,639), consisting of 55 randomised controlled trials (n=33,350) and five observational studies (three retrospective cohort studies, and two case-control studies; n=320,289) were included. Pooled estimates of 55 randomised controlled trials (at low or moderate risk of bias involving 37 pancreatitis events, raw event rate 0.11%) did not suggest an increased risk of pancreatitis with incretins versus control (odds ratio 1.11, 95% confidence interval 0.57 to 2.17). Estimates by type of incretin suggested similar results (1.05 (0.37 to 2.94) for GLP-1 agonists v control; 1.06 (0.46 to 2.45) for DPP-4 inhibitors v control). Analyses according to the type of control, mode, duration of treatment, and individual incretin agents suggested no differential effect by subgroups, and sensitivity analyses by alternative statistical modelling and effect measures did not show important differences in effect estimates. Three retrospective cohort studies (moderate to high risk of bias, involving 1466 pancreatitis events, raw event rate 0.47%) also did not suggest an increased risk of pancreatitis associated with either exenatide (adjusted odds ratios 0.93 (0.63 to 1.36) in one study and 0.9 (0.6 to 1.5) in another) or sitagliptin (adjusted hazard ratio 1.0, 0.7 to 1.3); a case-control study at moderate risk of bias (1003 cases, 4012 controls) also suggested no significant association (adjusted odds ratio 0.98, 0.69 to 1.38). Another case-control study (1269 cases, 1269 controls) at moderate risk of bias, however, suggested that the use of either exenatide or sitagliptin was associated with significantly increased odds of acute pancreatitis (use within two years v no use, adjusted odds ratio 2.07, 1.36 to 3.13). CONCLUSIONS: The available evidence suggests that the incidence of pancreatitis among patients using incretins is low and that the drugs do not increase the risk of pancreatitis. Current evidence, however, is not definitive, and more carefully designed and conducted observational studies are warranted to definitively establish the extent, if any, of increased risk.

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  • The absence of any strong association with pancreatitis for GLP-1RAs has been corroborated by numerous large real-world observational studies of patients with T2D.

    “The absence of any strong association with pancreatitis for GLP‐1RAs has been corroborated by numerous large real‐world observational studies of patients with T2D already a decade ago. 99 , 100”

    From Real‐world evidence on the utilization, clinical and comparative effectiveness, and adverse effects of newer <scp>GLP</scp> ‐ <scp>1RA</scp> ‐based weight‐loss therapies (2025) · cites this paper as [100]

    The Results and Discussion (page unavailable in our copy) describe five large real-world observational studies in patients with type 2 diabetes; four found no increased pancreatitis risk, including studies of the GLP-1 agonist exenatide. But one case-control study found significantly increased odds with exenatide or sitagliptin, and the review rates the observational studies at moderate to high risk of bias. The claim therefore overstates how consistently these studies corroborated an absence of association for GLP-1RAs. (LLM, conf=0.87)

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Authors
Li, L., Shen, J., Bala, M. M., Busse, J. W., Ebrahim, S., Vandvik, P. O., Rios, L. P., Malaga, G., Wong, E., Sohani, Z., Guyatt, G. H., & Sun, X.
Affiliations
  • Sichuan University (CN)
  • Huzhou Normal University (CN)
  • McMaster University (CA)
  • Hospital for Sick Children (CA)
  • Innlandet Hospital Trust (NO)
  • Hospital Clínico FUSAT (CL)
  • University of British Columbia (CA)
  • Hubei University of Medicine (CN)
Corresponding author
Sun, X.
ORCID
Venue
BMJ
Publisher
BMJ
Published
2014-04-15
Volume
348
Issue
apr15 2
Pages
g2366-g2366
ISSN
1756-1833 (ISSN-L)
DOI
10.1136/bmj.g2366
PMC
PMC3987051
OpenAlex
W1983616459
Cited by
254
References
10
Citations by year
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FWCI
6.79
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • BMJ (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Jagiellonian University Repository (Jagiellonian University) (submittedVersion, cc-by-nc-nd)
  • Homo Politicus (Academy of Humanities and Economics in Lodz) (submittedVersion, cc-by-nc-nd)
  • HighWire Press Open Archive (submittedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
  • Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
Keywords
pancreatitis, type 2 diabetes, incretin-based therapy, GLP-1 receptor agonists, DPP-4 inhibitors, drug safety, adverse drug reactions, risk of bias, subgroup analysis, treatment duration, observational studies, risk of bias assessment tools, Newcastle-Ottawa Scale, Cochrane risk of bias tool
MeSH terms
Glucagon-Like Peptide-1 Receptor, Clinical Trials as Topic, Diabetes Mellitus, Type 2, Humans, Hypoglycemic Agents, Pancreatitis, Randomized Controlled Trials as Topic, Receptors, Glucagon, Incretins, Dipeptidyl-Peptidase IV Inhibitors

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