Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: what a clinician should know on disproportionality analysis of spontaneous reporting systems

Raschi, E.; Poluzzi, E.; Salvo, F.; Pariente, A.; De Ponti, F.; Marchesini, G.; Moretti, U.

doi:10.1016/j.numecd.2018.02.014

Cited by 119Pharmacovigilance and Adverse Drug ReactionsDiabetes Treatment and ManagementPharmaceutical industry and healthcare

Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: what a clinician should know on disproportionality analysis of spontaneous reporting systems

Raschi, E., Poluzzi, E., Salvo, F., Pariente, A., De Ponti, F., Marchesini, G., Moretti, U.·2018·Nutrition, Metabolism and Cardiovascular Diseases

DOI 10.1016/j.numecd.2018.02.014

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Abstract

Sodium-glucose co-transporter-2 inhibitors (SGLT2-Is) have consistently demonstrated a clinically significant reduction of cardiovascular mortality. However, their safety in clinical practice is still incompletely characterized, and post-marketing monitoring is required considering the expected increase in clinical use. Different analyses of international spontaneous reporting systems, known as disproportionality analyses (DAs), have highlighted the occurrence of ketoacidosis, amputations, acute renal failure and skin toxicity. In this viewpoint, we critically appraise these pharmacovigilance data on SGLT2-Is, with the aim of supporting clinicians in proper interpretation of these studies, and discussing their risk-benefit profile. To this aim, we offer a broad perspective on basic technical aspects subtending DAs of spontaneous reporting databases (describing peculiarities of the Food and Drug Administration Adverse Event Reporting System), their common and evolving uses, key pitfalls in presenting study results (in terms of "risk" or "association") and relevant strategies to account for major confounders. This will also facilitate reviewers and editors in proper evaluation of DAs, and prompt pharmacovigilance experts in converging towards a set of minimum requirements in standardization of design, performance and reporting of DAs. A consensus on quality assessment of DAs will finally establish their transferability to clinical practice. It is anticipated that DAs cannot be used per se as a standalone approach to assess a drug-related risk and cannot replace clinical judgment in the individual patient.

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Thromboembolic Events with Cyclin-Dependent Kinase 4/6 Inhibitors in the FDA Adverse Event Reporting System
Raschi, E., Fusaroli, M., Ardizzoni, A., Poluzzi, E., & Ponti, F. D. (2021) · Cancers · doi:10.3390/cancers13081758 · Cited by 45 · see citing works
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Pharmacovigilance assessment of the association between Fournier’s gangrene and other severe genital adverse events with SGLT-2 inhibitors
Fadini, G. P., Sarangdhar, M., Ponti, F. D., Avogaro, A., & Raschi, E. (2019) · BMJ Open Diabetes Research & Care · doi:10.1136/bmjdrc-2019-000725 · Cited by 44 · see citing works
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The real-world safety profile of sodium-glucose co-transporter-2 inhibitors among older adults (≥ 75 years): a retrospective, pharmacovigilance study
Goldman, A., Fishman, B., Twig, G., Raschi, E., Cukierman‐Yaffe, T., Moshkovits, Y., Pomerantz, A., Ben‐Zvi, I., Dankner, R. S., & Maor, E. (2023) · Cardiovascular Diabetology · doi:10.1186/s12933-023-01743-5 · Cited by 42 · see citing works
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The association between GLP-1 receptor agonist and diabetic ketoacidosis in the FDA adverse event reporting system
Yang, Z., Yu, M., Mei, M., Chen, C., Lv, Y., Xiang, L., & Li, R. (2022) · Nutrition Metabolism and Cardiovascular Diseases · doi:10.1016/j.numecd.2021.10.003 · Cited by 37 · see citing works
Hyperglycaemic disorders associated with PCSK9 inhibitors: a real-world, pharmacovigilance study
Goldman, A., Raschi, E., Cukierman‐Yaffe, T., Dankner, R. S., Shouval, R., Shechter, M., Ben‐Zvi, I., Gerstein, H. C., & Maor, E. (2021) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwab209 · Cited by 37 · see citing works
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Skin cancers under Janus kinase inhibitors: A World Health Organization drug safety database analysis
Jalles, C., Lepelley, M., Mouret, S., Charles, J., Leccia, M. ‐., & Trabelsi, S. (2022) · Therapies · doi:10.1016/j.therap.2022.04.005 · Cited by 36 · see citing works
Post-marketing safety concerns with lecanemab: a pharmacovigilance study based on the FDA Adverse Event Reporting System database
Xing, X., Zhang, X., Wang, K., Wang, Z., Feng, Y., Li, X., Hua, Y., Zhang, L., & Dong, X. (2025) · Alzheimer s Research & Therapy · doi:10.1186/s13195-024-01669-4 · Cited by 36 · see citing works
Drug-induced systemic lupus erythematosus: should immune checkpoint inhibitors be added to the evolving list?
Raschi, E., Antonazzo, I. C., Poluzzi, E., & Ponti, F. D. (2019) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2019-215819 · Cited by 34 · see citing works
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Cardiovascular Toxicities of Antiangiogenic Tyrosine Kinase Inhibitors: A Retrospective, Pharmacovigilance Study
Goldman, A., Bomze, D., Dankner, R. S., Fourey, D., Boursi, B., Arad, M., & Maor, E. (2021) · Targeted Oncology · doi:10.1007/s11523-021-00817-2 · Cited by 32 · see citing works
Neurological Adverse Events Associated With Esketamine: A Disproportionality Analysis for Signal Detection Leveraging the FDA Adverse Event Reporting System
Guo, H., Wang, B., Yuan, S., Wu, S., Liu, J., He, M., & Wang, J. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.849758 · Cited by 31 · see citing works
Liver injury with drugs used for multiple sclerosis: A contemporary analysis of the FDA Adverse Event Reporting System
Antonazzo, I. C., Poluzzi, E., Forcesi, E., Riise, T., Bjørnevik, K., Baldin, E., Muratori, L., Ponti, F. D., & Raschi, E. (2018) · Multiple Sclerosis Journal · doi:10.1177/1352458518799598 · Cited by 29 · see citing works
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Myopathy with DPP-4 inhibitors and statins in the real world: investigating the likelihood of drug–drug interactions through the FDA adverse event reporting system
Antonazzo, I. C., Poluzzi, E., Forcesi, E., Salvo, F., Pariente, A., Marchesini, G., Ponti, F. D., & Raschi, E. (2019) · Acta Diabetologica · doi:10.1007/s00592-019-01378-7 · Cited by 27 · see citing works
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Sex differences in adverse drug reactions: Are women more impacted?
Lacroix, C., Maurier, A., Largeau, B., Destère, A., Thillard, E.-M., Drici, M., Micallef, J., & Jonville‐Béra, A. ‐. (2022) · Therapies · doi:10.1016/j.therap.2022.10.002 · Cited by 27 · see citing works
Kidney Injury Following Ibuprofen and Acetaminophen: A Real-World Analysis of Post-Marketing Surveillance Data
Shao, Q.-H., Yin, X., Liu, H., Zhao, B., Huang, J., & Li, Z. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.750108 · Cited by 25 · see citing works
Concomitant use of statins and sodium‐glucose co‐transporter 2 inhibitors and the risk of myotoxicity reporting: A disproportionality analysis
Gravel, C. A., Krewski, D. R., Mattison, D. R., Momoli, F., & Douros, A. (2023) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.15711 · Cited by 25 · see citing works
Serious adverse events with tedizolid and linezolid: pharmacovigilance insights through the FDA adverse event reporting system
Gatti, M., Fusaroli, M., Raschi, E., Moretti, U., Poluzzi, E., & Ponti, F. D. (2021) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2021.1956461 · Cited by 21 · see citing works
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Glucagon-like peptide 1 receptor agonists and the potential risk of pancreatic carcinoma: a pharmacovigilance study using the FDA Adverse Event Reporting System and literature visualization analysis
Cao, M., Pan, C., Tian, Y., Wang, L., Zhao, Z., & Zhu, B. (2023) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-023-01556-2 · Cited by 38 · see citing works
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study
Fusaroli, M., Salvo, F., Bernardeau, C., Idris, M., Dolladille, C., Pariente, A., Poluzzi, E., Raschi, E., & Khouri, C. (2023) · Drug Safety · doi:10.1007/s40264-023-01329-w · Cited by 21 · see citing works
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Observational research on sodium glucose co‐transporter‐2 inhibitors: A real breakthrough?
Raschi, E., Poluzzi, E., Fadini, G. P., Marchesini, G., & Ponti, F. D. (2018) · Diabetes Obesity and Metabolism · doi:10.1111/dom.13468 · Cited by 21 · see citing works
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Drug-induced Kounis syndrome: A matter of pharmacovigilance
Raschi, E., Affini, L. F., Antonazzo, I. C., Diemberger, I., Poluzzi, E., & Ponti, F. D. (2018) · International Journal of Cardiology · doi:10.1016/j.ijcard.2018.07.119 · Cited by 21 · see citing works
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Serious adverse events with novel beta-lactam/beta-lactamase inhibitor combinations: a large-scale pharmacovigilance analysis
Gatti, M., Raschi, E., & Ponti, F. D. (2021) · European Journal of Clinical Microbiology & Infectious Diseases · doi:10.1007/s10096-020-04149-3 · Cited by 20 · see citing works
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COVID-19 Vaccination as a Trigger of IgA Vasculitis: A Global Pharmacovigilance Study
Ramdani, Y., Largeau, B., Jonville‐Béra, A. ‐., Maillot, F., & Audemard‐Verger, A. (2022) · The Journal of Rheumatology · doi:10.3899/jrheum.220629 · Cited by 20 · see citing works
Pharmacovigilance Evaluation of the Association Between DPP-4 Inhibitors and Heart Failure: Stimulated Reporting and Moderation by Drug Interactions
Fadini, G. P., Sarangdhar, M., & Avogaro, A. (2018) · Diabetes Therapy · doi:10.1007/s13300-018-0408-2 · Cited by 20 · see citing works
Calcitonin gene-related peptide antagonists in pregnancy: a disproportionality analysis in VigiBase®
Noseda, R., Bedussi, F., Gobbi, C., Ceschi, A., & Zecca, C. (2024) · The Journal of Headache and Pain · doi:10.1186/s10194-024-01715-4 · Cited by 19 · see citing works
Atrial arrhythmias following CAR‐chimeric antigen receptor T‐cell therapy: Incidence, risk factors and biomarker profile
Shouval, R., Goldman, A., Flynn, J. R., El‐Moghraby, A., Rehman, M., Devlin, S. M., Corona, M., Landego, I., Lin, R. J., Scordo, M., et al. (2024) · British Journal of Haematology · doi:10.1111/bjh.19497 · Cited by 19 · see citing works
Adrenal Insufficiency with Anticancer Tyrosine Kinase Inhibitors Targeting Vascular Endothelial Growth Factor Receptor: Analysis of the FDA Adverse Event Reporting System
Raschi, E., Fusaroli, M., Giunchi, V., Repaci, A., Pelusi, C., Mollica, V., Massari, F., Ardizzoni, A., Poluzzi, E., Pagotto, U., et al. (2022) · Cancers · doi:10.3390/cancers14194610 · Cited by 21 · see citing works
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The reporting of disproportionality analysis in pharmacovigilance: spotlight on the READUS-PV guideline
Fusaroli, M., Salvo, F., Khouri, C., & Raschi, E. (2024) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1488725 · Cited by 18 · see citing works
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The Changing Face of Drug-induced Adrenal Insufficiency in the Food and Drug Administration Adverse Event Reporting System
Raschi, E., Fusaroli, M., Massari, F., Mollica, V., Repaci, A., Ardizzoni, A., Poluzzi, E., Pagotto, U., & Di Dalmazi, G. (2022) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgac359 · Cited by 17 · see citing works
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Polypharmacology of clinical sodium glucose co‐transport protein 2 inhibitors and relationship to suspected adverse drug reactions
Matharu, K. S., Chana, K., Ferro, C. J., & Jones, A. M. (2021) · Pharmacology Research & Perspectives · doi:10.1002/prp2.867 · Cited by 17 · see citing works
Evaluation of four machine learning models for signal detection
Dauner, D. G., Leal, E., Adam, T. J., Zhang, R., & Farley, J. F. (2023) · Therapeutic Advances in Drug Safety · doi:10.1177/20420986231219472 · Cited by 16 · see citing works
Anti-tumor Necrosis Factor-Alpha Therapy and Hypoglycemia: A Real-World Pharmacovigilance Analysis
Zhou, Y., Xie, W., Wang, L., Zhu, X., Liu, L., Liu, L., Zhu, S., & Wang, L. (2022) · Drug Safety · doi:10.1007/s40264-022-01210-2 · Cited by 16 · see citing works
PCSK9 Monoclonal Antibodies: New Developments and Their Relevance in a Nucleic Acid–Based Therapy Era
Gouni‐Berthold, I., Schwarz, J., & Berthold, H. K. (2022) · Current Atherosclerosis Reports · doi:10.1007/s11883-022-01053-3 · Cited by 16 · see citing works
Angiotensin-converting enzyme and dipeptidyl peptidase-4 inhibitor–induced angioedema: A disproportionality analysis of the WHO pharmacovigilance database
Lepelley, M., Khouri, C., Lacroix, C., & Bouillet, L. (2020) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2020.03.015 · Cited by 16 · see citing works
Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France
de Germay, S., Singier, A., Salvo, F., Pariente, A., & on behalf of the French Pharmacovigilance Network (2023) · Drug Safety · doi:10.1007/s40264-023-01359-4 · Cited by 14 · see citing works
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The safety of available treatment options for short bowel syndrome and unmet needs
Pironi, L., Raschi, E., & Sasdelli, A. S. (2021) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2021.1940947 · Cited by 13 · see citing works
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New Adverse Drug Reaction Signals from 2017 to 2021—Genuine Alerts or False Alarms?
Loke, Y. K., Mattishent, K., & Navaneetharaja, N. (2024) · Pharmacy · doi:10.3390/pharmacy12010033 · Cited by 13 · see citing works
The risk of worsening of myasthenia by cardiovascular medication as reflected by reporting frequency
Trillenberg, P., Katalinic, A., Thern, J., & Graf, T. (2021) · European Journal of Neurology · doi:10.1111/ene.14996 · Cited by 12 · see citing works
Association between voriconazole-induced visual hallucination and dopamine in an analysis of the food and drug administration (FDA) adverse event reporting system database
Kato, H., Shiraishi, C., Hagihara, M., Mikamo, H., & Iwamoto, T. (2024) · Scientific Reports · doi:10.1038/s41598-024-63504-y · Cited by 12 · see citing works
Crystal nephropathy and amoxicillin: insights from international spontaneous reporting systems
Gatti, M., Fusaroli, M., Raschi, E., Capelli, I., Poluzzi, E., & Ponti, F. D. (2021) · Journal of Nephrology · doi:10.1007/s40620-021-01191-y · Cited by 12 · see citing works
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Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database
de Filippis, R., Kane, J. M., Arzenton, E., Moretti, U., Raschi, E., Trifirò, G., Barbui, C., Fazio, P. D., Gastaldon, C., & Schoretsanitis, G. (2024) · Drug Safety · doi:10.1007/s40264-024-01431-7 · Cited by 11 · see citing works
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Disproportionality analysis of Raynaud’s phenomenon associated with calcitonin gene-related peptide inhibitors using the Food and Drug Administration adverse event reporting system
Lee, N., Ok, J. H., Rhee, S., & Kim, Y. (2025) · Scientific Reports · doi:10.1038/s41598-025-87421-w · Cited by 12 · see citing works
The real-world safety of sacubitril / valsartan among older adults (≥75): A pharmacovigilance study from the FDA data
Lerman, T. T., Greenberg, N., Fishman, B., Goldman, A., Talmor‐Barkan, Y., Bauer, M., Goldberg, I., Goldberg, E., Kornowski, R., Krause, I., et al. (2023) · International Journal of Cardiology · doi:10.1016/j.ijcard.2023.131613 · Cited by 11 · see citing works
Relationship between adverse drug reactions to antibacterial agents and the Klebsiella pneumoniae carbapenemase-producing (KPC) Klebsiella pneumoniae outbreak: insight from a pharmacovigilance study
Gatti, M., Raschi, E., & Ponti, F. D. (2019) · BMC Pharmacology and Toxicology · doi:10.1186/s40360-019-0364-0 · Cited by 11 · see citing works
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Cardiac and metabolic safety profile of antipsychotics in youths: A WHO safety database analysis
Merino, D., Gérard, A. O., Destère, A., Saidessalam, H., Askenazy-Gittard, F., Montastruc, F., Drici, M., & Thümmler, S. (2024) · Psychiatry Research · doi:10.1016/j.psychres.2024.115786 · Cited by 10 · see citing works
Post‐marketing safety concerns with nirmatrelvir: A disproportionality analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System
Zhuang, W., Xu, J., Wu, Y., Yang, J., Lin, X., Liao, Y., Wan, J., Weng, L., & Lin, W. (2023) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.15783 · Cited by 11 · see citing works
Bisphosphonates-related tendinopathies and ligament disorders: Cases analysis from the U.S. Food and Drug Administration adverse event reporting system
Ji, L.-H., Zhao, C., Wang, Y., & Fu, Z.-H. (2023) · Bone · doi:10.1016/j.bone.2023.116919 · Cited by 9 · see citing works
Anaplastic lymphoma kinase tyrosine kinase inhibitor‐induced hepatic failure in lung cancer patients: A study of signal mining and analysis of the FDA adverse event reporting system database
Zhou, Z., Wang, C., Ying, L., Jin, M., Zhang, F., & Shi, D. (2021) · Journal of Clinical Pharmacy and Therapeutics · doi:10.1111/jcpt.13404 · Cited by 9 · see citing works
Stevens-Johnson Syndrome Following Vancomycin and Linezolid: A Real-World Analysis of Post-Marketing Surveillance Data
Ni, M., Yin, X., Hu, W., Zeng, N., Zhao, B., & Li, Z. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.872854 · Cited by 9 · see citing works
Spotlight commentary: The value of spontaneous reporting systems to detect (the lack of) clinically relevant drug–drug interactions in clinical practice
Raschi, E., Poluzzi, E., & Ponti, F. D. (2023) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.15780 · Cited by 9 · see citing works
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Safety of Monoclonal Antibodies Inhibiting PCSK9 in Pregnancy: Disproportionality Analysis in VigiBase®
Noseda, R., Bedussi, F., Panchaud, A., & Ceschi, A. (2024) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.3269 · Cited by 8 · see citing works
Adverse events of guselkumab in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system
Xiang, D., Chen, W., Fu, Z., Wu, X., Gao, P., & Wu, Y. F. (2023) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2023.2223956 · Cited by 7 · see citing works
Can glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors help in mitigating the risk of atrial fibrillation in patients with diabetes?
Thotamgari, S. R., Grewal, U. S., Sheth, A. R., Babbili, A., & Dominic, P. S. (2022) · Cardiovascular Endocrinology & Metabolism · doi:10.1097/xce.0000000000000265 · Cited by 7 · see citing works
Thrombotic microangiopathy associated with anticancer and immune system targeting drugs: New insights from real‐world data using the WHO pharmacovigilance database
Largeau, B., Thoreau, B., Grangé, S., Jonville‐Béra, A. ‐., & Halimi, J. (2023) · Journal of Internal Medicine · doi:10.1111/joim.13703 · Cited by 7 · see citing works
Signal of potentially protective drug–drug interactions from spontaneous reporting systems: proceed with caution
Antonazzo, I. C., Poluzzi, E., Forcesi, E., Salvo, F., Pariente, A., Marchesini, G., Ponti, F. D., & Raschi, E. (2019) · Acta Diabetologica · doi:10.1007/s00592-019-01441-3 · Cited by 7 · see citing works
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Exploring the potential association between stimulant or atomoxetine use and suicidal or self-injurious behaviors in children with attention deficit hyperactivity disorder: real-world insights from the FAERS database
Liu, J., Xue, L., Zeng, F., Ying, L., Zhu, Y., Zhou, J., Zhang, J., & Chen, H. (2025) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-025-02694-w · Cited by 5 · see citing works
Dental Disorders Reported to the FDA Adverse Event Reporting System in Association with Buprenorphine: An Analysis by Ingredient Composition and Route of Administration
Woods, R. H. (2023) · Current Drug Safety · doi:10.2174/1574886318666230731151447 · Cited by 5 · see citing works
Reduced reporting of neuropsychiatric adverse events with tumor necrosis factor alpha inhibitors for hidradenitis suppurativa: caution before concluding for risk reduction
Raschi, E., Salvo, F., Plaça, M. L., Poluzzi, E., & Ponti, F. D. (2020) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/jdv.16379 · Cited by 5 · see citing works
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In-silico approaches to assessing multiple high-level drug-drug and drug-disease adverse drug effects
Xu, X., Riviere, J. E., Raza, S., Gedara, N. I. M., Ramachandran, R. A., Tell, L. A., Wyckoff, G. J., & Jaberi‐Douraki, M. (2024) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2023.2299337 · Cited by 6 · see citing works
Impact of Bariatric Surgery on Medication Efficacy: an Analysis of World Health Organization Pharmacovigilance Data
Guigui, A., Betry, C., Khouri, C., & Borel, A. (2021) · Obesity Surgery · doi:10.1007/s11695-021-05258-4 · Cited by 5 · see citing works
Reduced neuropsychiatric events as “beneficial reactions” to drugs: Seek associations with caution
Raschi, E., Poluzzi, E., & Ponti, F. D. (2019) · Brain Behavior and Immunity · doi:10.1016/j.bbi.2019.11.011 · Cited by 5 · see citing works
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Severe cutaneous adverse reactions associated with second-generation androgen receptor antagonists in prostate cancer patients
Liu, J., Liu, X., Zeng, H., Tong, Y., Chen, Z., & Dong, Z. (2025) · PLoS ONE · doi:10.1371/journal.pone.0325448 · Cited by 4 · see citing works
Investigating Sodium-Glucose Cotransporter 2 Inhibitors Versus Other Glucose-Lowering Drugs on Ventricular Arrhythmias or Sudden Cardiac Death Using the US FDA Adverse Event Reporting System
Xu, B., Zhang, T., Kang, B., Yang, X., Li, S., Chen, J., He, Z., & Zhou, J. (2024) · Cardiovascular Drugs and Therapy · doi:10.1007/s10557-024-07653-2 · Cited by 4 · see citing works
Thromboembolism adverse event profiles of thrombopoietin receptor agonists: a real-world, pharmacovigilance study
Xu, X., Zhang, L., Zhang, X., Huang, W., Xie, L., & Ouyang, M. (2024) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2024.2416540 · Cited by 4 · see citing works
Interstitial lung disease following COVID-19 vaccination: a disproportionality analysis using the Global Scale Pharmacovigilance Database (VigiBase)
Lee, M., Lee, J. W., Lee, H. J., Lee, J., Choi, J. C., Gu, K.-M., & Jung, S. (2023) · BMJ Open Respiratory Research · doi:10.1136/bmjresp-2023-001992 · Cited by 4 · see citing works
Efficient Q-Value Zero-Leakage Protection Scheme in SRS Regularly Publishing Private Data
Cui, Z., Zhang, L., Wu, B., Zhao, Z., Mei, Z., & Wu, Z. (2019) · Tehnicki vjesnik - Technical Gazette · doi:10.17559/tv-20181218005415 · Cited by 4 · see citing works
Postmarketing Reports of Incomplete Dosing-Related Complications with Self-Injected PCSK9 Inhibitors: A Descriptive Study and Disproportionality Analysis
Woods, R. H. (2024) · BioDrugs · doi:10.1007/s40259-024-00664-3 · Cited by 3 · see citing works
Sexual Dysfunctions Associated with Proton Pump Inhibitors: Insights from VigiBase, the World Health Organization Pharmacovigilance Database
Crisafulli, S., Ciccimarra, F., Scapini, F., L’Abbate, L., Jannini, E. A., Martino, M. C. D., Giannetta, E., Mestres, J., Tuccori, M., & Trifirò, G. (2025) · Drug Safety · doi:10.1007/s40264-025-01626-6 · Cited by 3 · see citing works
Alice in wonderland syndrome: Down the rabbit hole of VigiBase®
Merino, D., Gérard, A. O., Chérikh, F., Lavrut, T., Thümmler, S., Askenazy-Gittard, F., Drici, M., & Montastruc, F. (2025) · Psychiatry Research · doi:10.1016/j.psychres.2025.116920 · Cited by 2 · see citing works
Sodium-glucose cotransporter-2 inhibitors and abnormal serum potassium: a real-world, pharmacovigilance study
Meng, Y., Zhao, S., Fan, X., Lv, Y., Xiang, L., & Li, R. (2024) · Journal of Cardiovascular Medicine · doi:10.2459/jcm.0000000000001646 · Cited by 2 · see citing works
Sorafenib‐Related Dermatologic Toxicity: A Comprehensive Evaluation Based on Disproportionality Analysis and Clinical Characteristics
Ding, Y., Wang, Z., Shu, Y., Tang, Y., & Zhang, Q. (2025) · Dermatologic Therapy · doi:10.1155/dth/1667726 · Cited by 1 · see citing works
Relationship Between Trimethoprim‐Sulfamethoxazole‐Induced Hepatotoxicity and Cytochrome Protein 450 2C9 Using Food and Drug Administration Adverse Event Reporting System Database
Kato, H., Shiraishi, C., Hagihara, M., Mikamo, H., & Iwamoto, T. (2026) · Journal of Clinical Pharmacy and Therapeutics · doi:10.1155/jcpt/8891620 · Cited by 1 · see citing works
Sexual Dysfunction with Antipsychotics: Emerging Clues from a Disproportionality Analysis of the World Health Organization VigiBase
Pavlidis, E. T., Siafis, S., Arzenton, E., Crisafulli, S., Raschi, E., Moretti, U., Isidori, A. M., Jannini, E. A., Trifirò, G., Seifritz, E., et al. (2026) · Drug Safety · doi:10.1007/s40264-026-01673-7 · Cited by 1 · see citing works
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Disproportionality analysis of pyoderma gangrenosum reporting to the FDA Adverse Event Reporting System in association with antirheumatic biologics
Woods, R. H. (2026) · Clinical Rheumatology · doi:10.1007/s10067-026-08237-1 · Cited by 1 · see citing works
Sodium-glucose cotransporter-2 inhibitors and cardiovascular safety profile: a pharmacovigilance analysis of the US food and drug administration adverse event reporting system
Zhang, L., Pan, C., Yang, X., Jiang, D., & Cao, M. (2023) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2023.2216453 · Cited by 1 · see citing works
Utilization of Big Data with a Focus on Administrative Claims Database
Yokoyama, S., & Hosomi, K. (2023) · YAKUGAKU ZASSHI · doi:10.1248/yakushi.22-00179-3 · Cited by 1 · see citing works
Safety of cardiovascular disease drugs approved between 2014 and 2021 in the US: a pharmacovigilance analysis
Park, T., & Hwang, M. J. (2024) · Expert Review of Cardiovascular Therapy · doi:10.1080/14779072.2024.2354255 · Cited by 1 · see citing works

Safety Profile of Sodium-Glucose Co-Transporter-2 Inhibitors: A Global Analysis of Pharmacovigilance Databases
Raschi, E., Parisotto, M., Forcesi, E., Marchesini, G., Ponti, F. D., & Poluzzi, E. (2017) · Clinical Therapeutics · doi:10.1016/j.clinthera.2017.05.121
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Adverse events with sodium-glucose co-transporter-2 inhibitors: A global analysis of international spontaneous reporting systems
Raschi, E., Parisotto, M., Forcesi, E., Plaça, M. L., Marchesini, G., Ponti, F. D., & Poluzzi, E. (2017) · Nutrition Metabolism and Cardiovascular Diseases · doi:10.1016/j.numecd.2017.10.008 · Cited by 47 · see citing works
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Active‐comparator restricted disproportionality analysis for pharmacovigilance signal detection studies of chronic disease medications: An example using sodium/glucose cotransporter 2 inhibitors
Alkabbani, W., & Gamble, J. (2021) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.15178 · Cited by 39 · see citing works
Safety of Sodium-Glucose Co-Transporter 2 Inhibitors
McGill, J. B., & Subramanian, S. (2019) · The American Journal of Medicine · doi:10.1016/j.amjmed.2019.08.006 · Cited by 37 · see citing works
SGLT2 inhibitors and diabetic ketoacidosis: data from the FDA Adverse Event Reporting System
Fadini, G. P., Bonora, B. M., & Avogaro, A. (2017) · Diabetologia · doi:10.1007/s00125-017-4301-8 · Cited by 242 · see citing works

Authors: Raschi, E., Poluzzi, E., Salvo, F., Pariente, A., De Ponti, F., Marchesini, G., & Moretti, U.
Affiliations: University of Bologna (IT)
Université de Bordeaux (FR)
University of Verona (IT)
Corresponding author: Poluzzi, E.
ORCID: Raschi, E.
Poluzzi, E.
Salvo, F.
Marchesini, G.
Moretti, U.
Venue: Nutrition, Metabolism and Cardiovascular Diseases
Publisher: Elsevier BV
Published: 2018-06
Volume: 28
Issue: 6
Pages: 533-542
ISSN: 0939-4753 (ISSN-L)
DOI: 10.1016/j.numecd.2018.02.014
OpenAlex: W2789922753
Cited by: 119
References: 50
Citations by year: 2026: 5 · 2025: 10 · 2024: 23 · 2023: 18 · 2022: 13 · 2021: 23 · 2020: 9 · 2019: 12 · 2018: 5
FWCI: 2.10
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Nutrition Metabolism and Cardiovascular Diseases (publishedVersion)
PubMed (publishedVersion)
HAL (submittedVersion)
Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
Oskar-Bordeaux (Universite de Bordeaux) (submittedVersion)
Funders: Institutional funds of the University of Bologna
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 › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords: SGLT2 inhibitors, pharmacovigilance, disproportionality analysis, spontaneous adverse event reporting, FDA Adverse Event Reporting System, drug safety, ketoacidosis, acute kidney injury, skin toxicity, amputation, risk-benefit assessment, confounding
MeSH terms: Clinical Decision-Making, Sodium-Glucose Transporter 2 Inhibitors, Diabetes Mellitus, Type 2, Humans, Risk Factors, Treatment Outcome, Adverse Drug Reaction Reporting Systems, Risk Assessment, Patient Selection, Pharmacovigilance

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Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: what a clinician should know on disproportionality analysis of spontaneous reporting systems

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