An investigation on the association between sodium glucose co-transporter 2 inhibitors use and acute pancreatitis: A VigiBase study.
SGLT2i
VigiBase
acute pancreatitis
diabetes
disproportionality analysis
drug induced pancreatitis
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
10 2021
10 2021
Historique:
revised:
03
06
2021
received:
07
05
2021
accepted:
11
06
2021
pubmed:
23
6
2021
medline:
24
12
2021
entrez:
22
6
2021
Statut:
ppublish
Résumé
To characterize acute pancreatitis (AP) related to sodium glucose co-transporter 2 inhibitors and to investigate this relationship through disproportionality analysis in an international pharmacovigilance database. We analyzed all AP reports for canagliflozin, dapagliflozin and/or empagliflozin from the WHOs Global adverse drug reactions database VigiBase® up to July 2019. We characterized the patients, reporters, and reactions, and we present the proportional reporting ratio (PRR) and information component (IC) for each of the gliflozins. AP cases were reports containing at least one of 11 previously selected preferred terms. Gliflozin exposure was considered for all reports with at least one gliflozin as suspected/ interacting drug. Of the 19 834 180 individual case safety reports in VigiBase, in 600 reports containing 618 AP group reactions, gliflozins were suspected/ interacting drugs. Men were affected in 52.3% of the cases and 59.6% of the patients were in the 45-64 years age group. The reporters were in 417 cases healthcare professionals. Most of the reactions were reported for canagliflozin (59.7%), followed by empagliflozin (21%) and dapagliflozin (19.2%) and were serious (98.6%). Most of the reactions' outcomes (84% of the patients) were favorable. Ketoacidosis was frequently associated with the AP (21.3%). Significant PRR and IC were found for pancreatitis and pancreatitis acute for all three gliflozins, pancreatitis necrotizing for canagliflozin and empagliflozin and pancreatitis relapsing for empagliflozin. Most of the AP cases were serious and with favorable outcome. We identified possible alternative causes for AP, like concomitant medication, hypertriglyceridemia, and cholelithiasis and a frequent association with ketoacidosis. We found a significant association between AP and the use of canagliflozin, dapagliflozin, and empagliflozin that would need further investigation.
Substances chimiques
Sodium-Glucose Transporter 2 Inhibitors
0
Symporters
0
Sodium
9NEZ333N27
Glucose
IY9XDZ35W2
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1428-1440Informations de copyright
© 2021 John Wiley & Sons Ltd.
Références
Davies MJ, D'Alessio DA, Fradkin J, et al. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of diabetes (EASD). Diabetologia. 2018;61(12):2461-2498. https://doi.org/10.1007/s00125-018-4729-5
Zaccardi F, Webb DR, Htike ZZ, Youssef D, Khunti K, Davies MJ. Efficacy and safety of sodium-glucose co-transporter-2 inhibitors in type 2 diabetes mellitus: systematic review and network meta-analysis. Diabetes Obes Metab. 2016;18(8):783-794. https://doi.org/10.1111/dom.12670
Kohler S, Zeller C, Iliev H, Kaspers S. Safety and tolerability of Empagliflozin in patients with type 2 diabetes: pooled analysis of phase I-III clinical trials. Adv Ther. 2017;34(7):1707-1726. https://doi.org/10.1007/s12325-017-0573-0
CHMP. SGLT2 Inhibitors Article 20 - PRAC Assessment Report (for Publication) 2016. www.ema.europa.eu/contact.
European Medicines Agency. SGLT2 Inhibitors: Information on Potential Risk of Toe Amputation to Be Included in Prescribing Information www.ema.europa.eu/contact 2017.
U.S. Food and Drug Administration. FDA Revises Label of Diabetes Drug Canagliflozin (Invokana, Invokamet) to Include Updates on Bone Fracture Risk and New Information on Decreased Bone Mineral Density Safety Announcement https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-revises-label-diabetes-drug-canagliflozin-invokana-invokamet 2015.
U.S. Food and Drug Administration. FDA Revises Labels of SGLT2 Inhibitors for Diabetes to Include Warnings about Too Much Acid in the Blood and Serious Urinary Tract Infections https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-labels-sglt2-inhibitors-diabetes-include-warnings-about-too-much-acid-blood-and-serious 2015.
U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA Strengthens Kidney Warnings for Diabetes Medicines Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR) https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-strengthens-kidney-warnings-diabetes-medicines-canagliflozin 2016.
U.S. Food and Drug Administration. FDA Warns about Rare Occurrences of a Serious Infection of the Genital Area with SGLT2 Inhibitors for Diabetes https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrences-serious-infection-genital-area-sglt2-inhibitors-diabetes 2018.
U.S. Food and Drug Administration. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) | FDA https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/april-june-2016-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event 2016.
Crockett SD, Wani S, Gardner TB, et al. American Gastroenterological Association Institute guideline on initial management of acute pancreatitis. Gastroenterology. 2018;154(4):1096-1101. https://doi.org/10.1053/j.gastro.2018.01.032
Jones MR, Morgan Hall O, Kaye AM, David Kaye A. Drug-Induced Acute Pancreatitis: A Review.; 2014.
Urushihara H, Taketsuna M, Liu Y, et al. Increased risk of acute pancreatitis in patients with type 2 diabetes: an observational study using a Japanese hospital database. PLoS One. 2012;7(12):1-8. https://doi.org/10.1371/journal.pone.0053224
Chowdhary M, Kabbani AA, Chhabra A. Canagliflozin-induced pancreatitis: a rare side effect of a new drug. Ther Clin Risk Manag. 2015;11:991-994. https://doi.org/10.2147/TCRM.S86641
Cheungpasitporn W, Srivali N, Thongprayoon C, Ungprasert P. Acute pancreatitis in the use of canagliflozin: a rare side-effect of the novel therapy for type 2 diabetes mellitus. J Basic Clin Pharm. 2015;6(3):101. https://doi.org/10.4103/0976-0105.160753
Verma R. Canagliflozin-Associated Acute Pancreatitis. Am J Ther. 2016;973:972-973.
Gutch M, Bhattacharya A, Kumar S, Pahan RK, Singh RS. Dapagliflozin induced pancreatitis. Int J Med Public Heal. 2018;8(1):45-47. https://doi.org/10.5530/ijmedph.2018.1.10
Patel KM, Pikas E, George T. Drug-induced necrotizing pancreatitis with a focus on Canagliflozin. Am J Ther. 2017;24(4):e496. https://doi.org/10.1097/MJT.0000000000000561
Sujanani SM, Elfishawi MM, Zarghamravanbaksh P, Castillo FJC, Reich DM. Dapagliflozin-induced acute pancreatitis: a case report and review of literature. Case Rep Endocrinol. 2020;2020:1-4. https://doi.org/10.1155/2020/6724504
Badwal K, Tariq T, Peirce D. Dapagliflozin-associated Euglycemic diabetic ketoacidosis in a patient presenting with acute pancreatitis. Case Rep Endocrinol. 2018;2018:1-4. https://doi.org/10.1155/2018/6450563
Sharma V, K Viswam S, Ravindra Reddy N, Chacko S, Bellapu A. PDB111 Empagliflozin induced pancreatitis: a disproportionality analysis in USFDA adverse event reporting system database. Value Heal. 2019;22:S592-S593. https://doi.org/10.1016/j.jval.2019.09.993
Tang H, Yang K, Li X, Song Y, Han J. Pancreatic safety of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. Pharmacoepidemiol Drug Saf. 2020;29(2):161-172. https://doi.org/10.1002/pds.4943
Yabe D, Yasui A, Ji L, et al. Safety and tolerability of empagliflozin in east Asian patients with type 2 diabetes: pooled analysis of phase I-III clinical trials. J Diabetes Investig. 2019;10(2):418-428. https://doi.org/10.1111/jdi.12910
Yuan Z, DeFalco F, Wang L, et al. Acute pancreatitis risk in type 2 diabetes patients treated with canagliflozin versus other antihyperglycemic agents: an observational claims database study. Curr Med Res Opin. 2020;36:1-1. https://doi.org/10.1080/03007995.2020.1761312
Ueda P, Svanström H, Melbye M, et al. Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study. BMJ. 2018;363(2016):k4365. https://doi.org/10.1136/bmj.k4365
Lindquist M. VigiBase, the WHO global ICSR database system: basic facts. Drug Inf J. 2008;42(5):409-419. https://doi.org/10.1177/009286150804200501
UMC | VigiBase https://www.who-umc.org/vigibase/vigibase/. 2020.
Dijkstra L, Garling M, Foraita R, Pigeot I. Adverse drug reaction or innocent bystander? A systematic comparison of statistical discovery methods for spontaneous reporting systems. Pharmacoepidemiol Drug Saf. 2020;29(4):396-403. https://doi.org/10.1002/pds.4970
Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol. 1998;54(4):315-321. https://doi.org/10.1007/s002280050466
Slattery J, Alvarez Y, Hidalgo A. Choosing thresholds for statistical signal detection with the proportional reporting ratio. Drug Saf. 2013;36(8):687-692. https://doi.org/10.1007/s40264-013-0075-1
Salem JE, Manouchehri A, Moey M, et al. Cardiovascular toxicities associated with immune checkpoint inhibitors: an observational, retrospective, pharmacovigilance study. Lancet Oncol. 2018;19(12):1579-1589. https://doi.org/10.1016/S1470-2045(18)30608-9
Chatila AT, Bilal M, Guturu P. Evaluation and management of acute pancreatitis. World J Clin Cases. 2019;7(9):1006-1020. https://doi.org/10.12998/wjcc.v7.i9.1006
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of diabetes. Diabetologia. 2015;58(3):429-442. https://doi.org/10.1007/s00125-014-3460-0
Kumar P, Sakwariya A, Sultania AR, Dabas R. Hypertriglyceridemia-induced acute pancreatitis with diabetic ketoacidosis: a rare presentation of type 1 diabetes mellitus. J Lab Phys. 2017;9(04):329-331. https://doi.org/10.4103/jlp.jlp_53_17
Shemesh E, Zafrir B. Hypertriglyceridemia-related pancreatitis in patients with type 2 diabetes: links and risks. Diabetes, Metab Syndr Obes Targets Ther. 2019;12:2041-2052. https://doi.org/10.2147/DMSO.S188856
Nair S, Yadav D, Pitchumoni CS. Association of diabetic ketoacidosis and acute pancreatitis: observations in 100 consecutive episodes of DKA. Am J Gastroenterol. 2000;95(10):2795-2800. https://doi.org/10.1111/j.1572-0241.2000.03188.x
Yanoff L FDA Introductory Remarks Endocrinologic and Metabolic Drugs Advisory Committee Meeting.; 2019. https://www.fda.gov/media/121276/download.
Wang Y, Attar BM, Hinami K, et al. Concurrent diabetic ketoacidosis in hypertriglyceridemia-induced pancreatitis: how does it affect the clinical course and severity scores? Pancreas. 2017;46(10):1336-1340. https://doi.org/10.1097/MPA.0000000000000937
Kabadi UM. Pancreatic ketoacidosis (kabadi syndrome) mimicking diabetic ketoacidosis. Endocr Pract. 2015;21(10):1184-1185. https://doi.org/10.4158/1934-2403-21.10.1184
Nassar TI, Qunibi WY. AKI associated with acute pancreatitis. Clin J Am Soc Nephrol. 2019;14(7):1106-1115. https://doi.org/10.2215/CJN.13191118
Gad MM. Roberto Simons-Linares ORCID number C. is aggressive intravenous fluid resuscitation beneficial in acute pancreatitis? A meta-analysis of randomized control trials and cohort studies conflict-of-interest statement. World J Gastroenterol. 2020;26(10):1098-1106. https://doi.org/10.3748/wjg.v26.i10.1098
Devani K, Charilaou P, Radadiya D, Brahmbhatt B, Young M, Reddy C. Acute pancreatitis: trends in outcomes and the role of acute kidney injury in mortality- a propensity-matched analysis. Pancreatology. 2018;18(8):870-877. https://doi.org/10.1016/j.pan.2018.10.002
European Medicines Agency. Minutes of PRAC Meeting on 26-29 October 2020; 2020. www.ema.europa.eu/contact.
eCFR - Code of Federal Regulations. https://www.ecfr.gov/cgi-bin/text-idx?SID=77821c5f7ae204cd5251ed82639d876a&mc=true&node=se21.5.314_180&rgn=div8. 2020.
Uppsala Monitoring Centre. Guideline for using VigiBase data in studies. 2016;2(9):1-9. http://www.who-umc.org/graphics/28461.pdf.
Fadini GP, Bonora BM, Avogaro A. SGLT2 inhibitors and diabetic ketoacidosis: data from the FDA adverse event reporting system. Diabetologia. 2017;60(8):1385-1389. https://doi.org/10.1007/s00125-017-4301-8