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Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): Data from randomized controlled trials.
Diabetes Obes Metab. 2017 09; 19(9):1233-1241.DO

Abstract

AIM

Glucagon-like peptide 1 receptor agonists (GLP1-RA) have been associated with an increased risk of pancreatitis and pancreatic cancer. Prior meta-analyses of randomized controlled trials failed to show any significant increase of risk; however, those meta-analyses did not include the recently published cardiovascular outcome trials (CVOT) with GLP1-RA, which provide a substantial additional body of data. The aim of the present meta-analysis is to assess the effect of GLP1-RA on pancreatitis, pancreatic cancers and cholelithiasis.

MATERIALS AND METHODS

A Medline search for GLP-1 receptor agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide or semaglutide) was performed, collecting all randomized clinical trials with a duration >11 weeks, enrolling patients with type 2 diabetes and comparing a GLP-1 receptor agonist with placebo or any other non-GLP-1 receptor agonist drug.

RESULTS

Of the 113 trials fulfilling inclusion criteria, 13 did not report information on pancreatitis, whereas 72 reported no events in all treatment groups. The incidence of pancreatitis and pancreatic cancer with GLP1-RA was not significantly different from that observed in comparator arms (MH-OR [95% CI] 0.93 [0.65-1.34], P = .71, and 0.94 [0.52-1.70], P = .84, respectively), whereas, a significantly increased risk of cholelithiasis (MH-OR [95% CI] 1.30 [1.01-1.68], P = .041) was detected.

CONCLUSIONS

Presently available data confirm the safety of GLP-1 receptor agonists for pancreatitis. Conversely, therapy with those drugs is associated with an increased risk of cholelithiasis, which deserves further investigation.

Authors+Show Affiliations

Department of Diabetology, Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.Department of Diabetology, Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.Diabetology Unit, Osperdale San Donato Arezzo, Arezzo, Italy.Department of Diabetology, Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.Diabetology Unit, Osperdale San Donato Arezzo, Arezzo, Italy. Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.Diabetology Unit, Osperdale San Donato Arezzo, Arezzo, Italy. Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.Department of Diabetology, Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28244632

Citation

Monami, Matteo, et al. "Safety Issues With Glucagon-like Peptide-1 Receptor Agonists (pancreatitis, Pancreatic Cancer and Cholelithiasis): Data From Randomized Controlled Trials." Diabetes, Obesity & Metabolism, vol. 19, no. 9, 2017, pp. 1233-1241.
Monami M, Nreu B, Scatena A, et al. Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): Data from randomized controlled trials. Diabetes Obes Metab. 2017;19(9):1233-1241.
Monami, M., Nreu, B., Scatena, A., Cresci, B., Andreozzi, F., Sesti, G., & Mannucci, E. (2017). Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): Data from randomized controlled trials. Diabetes, Obesity & Metabolism, 19(9), 1233-1241. https://doi.org/10.1111/dom.12926
Monami M, et al. Safety Issues With Glucagon-like Peptide-1 Receptor Agonists (pancreatitis, Pancreatic Cancer and Cholelithiasis): Data From Randomized Controlled Trials. Diabetes Obes Metab. 2017;19(9):1233-1241. PubMed PMID: 28244632.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): Data from randomized controlled trials. AU - Monami,Matteo, AU - Nreu,Besmir, AU - Scatena,Alessia, AU - Cresci,Barbara, AU - Andreozzi,Francesco, AU - Sesti,Giorgio, AU - Mannucci,Edoardo, Y1 - 2017/06/20/ PY - 2017/01/14/received PY - 2017/02/23/revised PY - 2017/02/23/accepted PY - 2017/3/1/pubmed PY - 2018/5/8/medline PY - 2017/3/1/entrez KW - GLP-1 analogue KW - meta-analysis SP - 1233 EP - 1241 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 19 IS - 9 N2 - AIM: Glucagon-like peptide 1 receptor agonists (GLP1-RA) have been associated with an increased risk of pancreatitis and pancreatic cancer. Prior meta-analyses of randomized controlled trials failed to show any significant increase of risk; however, those meta-analyses did not include the recently published cardiovascular outcome trials (CVOT) with GLP1-RA, which provide a substantial additional body of data. The aim of the present meta-analysis is to assess the effect of GLP1-RA on pancreatitis, pancreatic cancers and cholelithiasis. MATERIALS AND METHODS: A Medline search for GLP-1 receptor agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide or semaglutide) was performed, collecting all randomized clinical trials with a duration >11 weeks, enrolling patients with type 2 diabetes and comparing a GLP-1 receptor agonist with placebo or any other non-GLP-1 receptor agonist drug. RESULTS: Of the 113 trials fulfilling inclusion criteria, 13 did not report information on pancreatitis, whereas 72 reported no events in all treatment groups. The incidence of pancreatitis and pancreatic cancer with GLP1-RA was not significantly different from that observed in comparator arms (MH-OR [95% CI] 0.93 [0.65-1.34], P = .71, and 0.94 [0.52-1.70], P = .84, respectively), whereas, a significantly increased risk of cholelithiasis (MH-OR [95% CI] 1.30 [1.01-1.68], P = .041) was detected. CONCLUSIONS: Presently available data confirm the safety of GLP-1 receptor agonists for pancreatitis. Conversely, therapy with those drugs is associated with an increased risk of cholelithiasis, which deserves further investigation. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/28244632/Safety_issues_with_glucagon_like_peptide_1_receptor_agonists__pancreatitis_pancreatic_cancer_and_cholelithiasis_:_Data_from_randomized_controlled_trials_ L2 - https://doi.org/10.1111/dom.12926 DB - PRIME DP - Unbound Medicine ER -