Association of sodium-glucose cotransporter 2 inhibitor treatment with risk of hospitalization for Fournier gangrene among men
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lars, will need to be covered somewhere.Without additional large financial authorizations, these costs will likely result in resource reductions from within the VA, leading to a diminution of capabilities for the system.This would be a bad outcome and ironically may lead to less choice for veterans.The purpose of a health care system should be to match its capabilities with the clinical needs of the patients it serves.To achieve this, the VA must transition from simply being a provider of care to a network coordinator of care.Although opening the aperture to private care, the VA's proposed access standards based on nonclinical criteria will not serve veterans' interests.We should not be using arbitrary administrative rules, such as drive times and wait times (that are not based on clinical evaluations), when it comes to people's health care.The system should be based on the individual clinical needs of the veteran.Veterans and their physicians (or other licensed heath care professionals), not government policy makers, must decide when and where the most appropriate care can and should be delivered.What is needed is a clinically integrated system that uses the best of the VA and the private sector.6 This integration can be achieved through building a system of care that offers clinically based decisions with coordinated care between the VA and private sector, transparency of outcomes, and competition based on quality and service.In addition, better predictive analytics for medical management, as well as enhanced efforts to empower veterans with better information about their own care plans, will be essential to improving the safety of the system.The VA's efforts to reform are necessary and good.Greater choice for veterans is also good.However, without the appropriate clinical safeguards, as this study by Thorpe and colleagues 2 demonstrates, unintended consequences are possible.It is essential that access standards be based on sound health policy.Our veterans deserve no less.
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Fournier gangrene is rare (about 1 in 10,000 patients) but serious and has been reported in FDA post-market safety reports.
“Among putative side effects of SGLT2 inhibitors, Fournier gangrene is rare (1 in 10,000 patients) but serious and has been reported in post–market approval safety reports to the FDA (93).”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [93]
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Cites
Negative Controls: A Tool for Detecting Confounding and Bias in Observational Studies
Lipsitch, M., Tchetgen Tchetgen, E., & Cohen, T. (2010) · Epidemiology · doi:10.1097/ede.0b013e3181d61eeb · Cited by 1,583 · see citing works
Fournier's Gangrene: Population Based Epidemiology and Outcomes
Sorensen, M. D., Krieger, J. N., Rivara, F. P., et al. (2009) · The Journal of Urology · doi:10.1016/j.juro.2009.01.034 · Cited by 319 · see citing works
Fournier Gangrene Associated With Sodium–Glucose Cotransporter-2 Inhibitors
Bersoff‐Matcha, S. J., Chamberlain, C. E., Cao, C., Kortepeter, C. M., & Chong, W. H. (2019) · Annals of Internal Medicine · doi:10.7326/m19-0085 · Cited by 240 · see citing works
Transparency and Reproducibility of Observational Cohort Studies Using Large Healthcare Databases.
Wang, S., Verpillat, P., Rassen, J. A., Patrick, A., Garry, E., & Bartels, D. (2015) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.329 · Cited by 198 · see citing works
Comparative risk of genital infections associated with sodium‐glucose co‐transporter‐2 inhibitors
Dave, C. V., Schneeweiß, S., & Patorno, E. (2018) · Diabetes Obesity and Metabolism · doi:10.1111/dom.13531 · Cited by 161 · see citing works
Self-citationA Contemporary Analysis of Fournier Gangrene Using the National Surgical Quality Improvement Program
Kim, S. Y., Dupree, J. M., Le, B. V., et al. (2015) · Urology · doi:10.1016/j.urology.2014.08.063 · Cited by 42 · see citing works
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Rangaswami, J., Bhalla, V., de Boer, I. H., Staruschenko, A., Sharp, J. A., Singh, R. R., Lo, K. B., Tuttle, K., Vaduganathan, M., Ventura, H., et al. (2020) · Circulation · doi:10.1161/cir.0000000000000920 · Cited by 192 · see citing works
Tuttle, K. R., Brosius, F. C., Cavender, M. A., Fioretto, P., Fowler, K. J., Heerspink, H. J. L., Manley, T., McGuire, D. K., Molitch, M. E., Mottl, A. K., et al. (2021) · Diabetes · doi:10.2337/dbi20-0040 · Cited by 123 · see citing works
Gonzalez, J., Bates, B. A., Setoguchi, S., Gerhard, T., & Dave, C. V. (2023) · Cardiovascular Diabetology · doi:10.1186/s12933-023-01784-w · Cited by 32 · see citing works
Self-citationWang, E., Patorno, E., Khosrow-Khavar, F., Crystal, S., & Dave, C. V. (2025) · Diabetologia · doi:10.1007/s00125-024-06321-2 · Cited by 14 · see citing works
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- Authors
- Dave, C. V., Schneeweiss, S., & Patorno, E.
- Affiliations
- Brigham and Women's Hospital (US)
- Corresponding author
- Dave, Chintan V.
- Venue
- JAMA Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2019-11-01
- Volume
- 179
- Issue
- 11
- Pages
- 1587
- ISSN
- 2168-6106 (ISSN-L)
- PMC
- PMC6724526
- OpenAlex
- W2972124212
- Cited by
- 44
- References
- 6
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 8 · 2023: 6 · 2022: 3 · 2021: 1 · 2020: 11 · 2019: 2
- FWCI
- 3.44
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Internal Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Brigham and Women's Hospital
- National Institute on Aging (K08AG055670)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Streptococcal Infections and Treatments
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- SGLT2 inhibitors, Fournier's gangrene, hospitalization risk, men, veterans, accessibility standards, care coordination
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