Data mining study on adverse events of tirzepatide based on FAERS database

References

• Coskun T, Sloop KW, Loghin C, et al. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: from discovery to clinical proof of concept. Mol Metab. 2018;18:3–14. doi: 10.1016/j.molmet.2018.09.009
   PubMed Web of Science ®Google Scholar
• Jensen TL, Brønden A, Karstoft K, et al. The body weight reducing effects of tirzepatide in people with and without type 2 diabetes: a review on efficacy and adverse effects. Patient Prefer Adherence. 2024;18:373–382. doi: 10.2147/PPA.S419304
   PubMed Web of Science ®Google Scholar
• World Obesity Federation. World obesity atlas. 2023. Available from: https://data.worldobesity.org/publications/?cat=19
   Google Scholar
• Koliaki C, Dalamaga M, Liatis S. Update on the obesity epidemic: after the sudden rise, is the upward trajectory beginning to flatten? Curr Obes Rep. 2023;12(4):514–527. doi: 10.1007/s13679-023-00527-y
   PubMed Web of Science ®Google Scholar
• Baena-Díez JM, Peñafiel J, Subirana I, et al. Risk of cause-specific death in individuals with diabetes: a competing risks analysis. Diabetes Care. 2016;39(11):1987–1995. doi: 10.2337/dc16-0614
   PubMed Web of Science ®Google Scholar
• Khan MAB, Hashim MJ, King JK, et al. Epidemiology of type 2 diabetes - global burden of disease and forecasted trends. J Epidemiol Glob Health. 2020;10(1):107–111. doi: 10.2991/jegh.k.191028.001
   PubMed Web of Science ®Google Scholar
• Ye J, Wu Y, Yang S, et al. The global, regional and national burden of type 2 diabetes mellitus in the past, present and future: a systematic analysis of the global burden of disease study 2019. Front Endocrinol (Lausanne). 2023;14:1192629. doi: 10.3389/fendo.2023.1192629
   PubMed Web of Science ®Google Scholar
• Magliano DJ, Boyko EJ. Committee IDFDAtes. IDF diabetes atlas. Vol. 2021. Brussels: International Diabetes Federation © International Diabetes Federation; 2021.
   Google Scholar
• Sun B, Willard FS, Feng D, et al. Structural determinants of dual incretin receptor agonism by tirzepatide. Proc Natl Acad Sci U S A. 2022;119(13):e2116506119. doi: 10.1073/pnas.2116506119
   PubMed Web of Science ®Google Scholar
• Bailey CJ. Tirzepatide: a new low for bodyweight and blood glucose. Lancet Diabetes Endocrinol. 2021;9(10):646–648. doi: 10.1016/S2213-8587(21)00217-5
   PubMed Web of Science ®Google Scholar
• Nauck MA, D’Alessio DA. Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. Cardiovasc Diabetol. 2022;21(1):169. doi: 10.1186/s12933-022-01604-7
   PubMed Web of Science ®Google Scholar
• Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534–545. doi: 10.1001/jama.2022.0078
   PubMed Web of Science ®Google Scholar
• Frífrías JP, Davies MJ, Rosenstock J, et al. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503–515. doi: 10.1056/NEJMoa2107519
   PubMed Web of Science ®Google Scholar
• Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205–216. doi: 10.1056/NEJMoa2206038
   PubMed Web of Science ®Google Scholar
• Frias JP, Nauck MA, Van J, et al. Efficacy and tolerability of tirzepatide, a dual glucose-dependent insulinotropic peptide and glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled study to evaluate different dose-escalation regimens. Diabetes Obes Metab. 2020;22(6):938–946. doi: 10.1111/dom.13979
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Wysham C, FríFríAs JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143–155. doi: 10.1016/S0140-6736(21)01324-6
   PubMed Web of Science ®Google Scholar
• Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583–598. doi: 10.1016/S0140-6736(21)01443-4
   PubMed Web of Science ®Google Scholar
• Garvey WT, Frias JP, Jastreboff AM, et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023;402(10402):613–626. doi: 10.1016/S0140-6736(23)01200-X
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Frífrías JP, Rodbard HW, et al. Tirzepatide vs insulin lispro added to basal insulin in type 2 diabetes: the SURPASS-6 randomized clinical trial. JAMA. 2023;330(17):1631–1640. doi: 10.1001/jama.2023.20294
   PubMed Web of Science ®Google Scholar
• Bezin J, Gouverneur A, Pénichon M, et al. GLP-1 receptor agonists and the risk of thyroid cancer. Diabetes Care. 2023;46(2):384–390. doi: 10.2337/dc22-1148
   PubMed Web of Science ®Google Scholar
• Ahmad SR. Adverse drug event monitoring at the food and drug administration. J Gen Intern Med. 2003;18(1):57–60. doi: 10.1046/j.1525-1497.2003.20130.x
   PubMed Web of Science ®Google Scholar
• Jiao XF, Pu L, Lan S, et al. Adverse drug reaction signal detection methods in spontaneous reporting system: a systematic review. Pharmacoepidemiol Drug Saf. 2024;33(3):e5768. doi: 10.1002/pds.5768
   PubMed Web of Science ®Google Scholar
• Xiang S, Shen R, Xiang J, et al. A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for Bruton’s tyrosine kinase inhibitors (BTKis) single and its combination therapy. Expert Opin Drug Saf. 2024 Mar;23(5):627–636. doi: 10.1080/14740338.2024.2327507
   PubMed Web of Science ®Google Scholar
• Ventola CL. Big data and pharmacovigilance: data mining for adverse drug events and interactions. P T. 2018;43(6):340–351. doi: 10.1093/bib/bbx010
   PubMedGoogle Scholar
• International Council for Harmonisation. [cited 2024 Jan 18]. Available from: https://www.meddra.org/
   Google Scholar
• Ang PS, Chen Z, Chan CL, Tai BC. Data mining spontaneous adverse drug event reports for safety signals in Singapore - a comparison of three different disproportionality measures. Expert Opin Drug Saf. 2016;15(5):583–590. doi: 10.1517/14740338.2016.1167184
   PubMed Web of Science ®Google Scholar
• Harpaz R, DuMouchel W, LePendu P, et al. Performance of pharmacovigilance signal-detection algorithms for the FDA adverse event reporting system. Clin Pharmacol Ther. 2013;93(6):539–546. doi: 10.1038/clpt.2013.24
   PubMed Web of Science ®Google Scholar
• van Puijenbroek EP, Bate A, Leufkens HGM, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002;11(1):3–10. doi: 10.1002/pds.668
   PubMed Web of Science ®Google Scholar
• Cornelius VR, Sauzet O, Evans SJ. A signal detection method to detect adverse drug reactions using a parametric time-to-event model in simulated cohort data. Drug Saf. 2012;35(7):599–610. doi: 10.2165/11599740-000000000-00000
   PubMed Web of Science ®Google Scholar
• Tanaka H, Tani A, Onoda T, et al. Hypoxia-inducible factor prolyl hydroxylase inhibitors and hypothyroidism: an analysis of the Japanese pharmacovigilance database. In Vivo. 2024;38(2):917–922. doi: 10.21873/invivo.13519
   PubMed Web of Science ®Google Scholar
• Permana H, Yanto TA, Hariyanto TI. Efficacy and safety of tirzepatide as novel treatment for type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials. Diabetes Metab Syndr. 2022;16(11):102640. doi: 10.1016/j.dsx.2022.102640
   PubMed Web of Science ®Google Scholar
• Tan B, Pan XH, Chew HSJ, et al. Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Int J Obes (Lond). 2023;47(8):677–685. doi: 10.1038/s41366-023-01321-5
   PubMed Web of Science ®Google Scholar
• Mishra R, Raj R, Elshimy G, et al. Adverse events related to Tirzepatide. J Endocr Soc. 2023;7(4):bvad016. doi: 10.1210/jendso/bvad016
   PubMed Web of Science ®Google Scholar
• Patel H, Khunti K, Rodbard HW, et al. Gastrointestinal adverse events and weight reduction in people with type 2 diabetes treated with tirzepatide in the SURPASS clinical trials. Diabetes Obes And Metab. 2024;26(2):473–481. doi: 10.1111/dom.15333
   PubMed Web of Science ®Google Scholar
• Zeng Q, Xu J, Mu X, et al. Safety issues of tirzepatide (pancreatitis and gallbladder or biliary disease) in type 2 diabetes and obesity: a systematic review and meta-analysis. Front Endocrinol (Lausanne). 2023;14:1214334. doi: 10.3389/fendo.2023.1214334
   PubMed Web of Science ®Google Scholar
• He L, Wang J, Ping F, et al. Association of glucagon-like peptide-1 receptor agonist use with risk of gallbladder and biliary diseases: a systematic review and meta-analysis of randomized clinical trials. JAMA Intern Med. 2022;182(5):513–519. doi: 10.1001/jamainternmed.2022.0338
   PubMed Web of Science ®Google Scholar
• Gomez Casanovas J, Bartl M, Blesset A, et al. Abstract #1402779: a case of possible tirzepatide-induced pancreatitis. Endocr Pract. 2023;29(5, Supplement):S13. doi: 10.1016/j.eprac.2023.03.034
   Google Scholar
• Zhou J, Zheng Y, Xu B, et al. Exploration of the potential association between GLP-1 receptor agonists and suicidal or self-injurious behaviors: a pharmacovigilance study based on the FDA adverse event reporting system database. BMC Med. 2024;22(1):65. doi: 10.1186/s12916-024-03274-6
   PubMed Web of Science ®Google Scholar
• Chen W, Cai P, Zou W, et al. Psychiatric adverse events associated with GLP-1 receptor agonists: a real-world pharmacovigilance study based on the FDA adverse event reporting system database. Front Endocrinol (Lausanne). 2024;15:1330936. doi: 10.3389/fendo.2024.1330936
   PubMed Web of Science ®Google Scholar