Meta-analysisindependent cross-checkabstract only checked I-ODD-12 standard review
Fournier gangrene in SGLT2 trials
Fournier's gangrene and sodium-glucose co-transporter-2 inhibitors: A meta-analysis of randomized controlled trials.
Overview
Silverii GA et al.. Diabetes Obes Metab 2020 · PMID 31637829 · DOI 10.1111/dom.13900
Across 84 trials Fournier gangrene was not more frequent, but cases were too few to be sure.
Does the study support the specific claim? No · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
SGLT2 inhibitors and Fournier gangrene
- How was the study done?
Meta-analysis of 84 RCTs
- How many people, animals or samples were studied?
42,415 SGLT2i vs 27,158 comparators; Type 2 diabetes in RCTs
- What was actually found?
OR 0.41 (n.s.).
- How large was the observed effect?
MH-OR 0.41 (0.09-1.82)
- What do the results mean in everyday life?
Very rare; no confirmed excess.
- What are the study's limitations?
Very few events; FG not systematically adjudicated
- What does it say about Elawady's specific claim?
Limits C-ODD-08.
- Do the results apply to Germany and Europe?
Multinational trial including European sites or directly applicable to EU practice.
- What can explicitly not be concluded from this study?
Exclude risk.
Scientific in-depth review
1. Full reference
- Authors
- Silverii GA et al.
- Journal
- Diabetes Obes Metab
- Year
- 2020
- Identifier
- PMID 31637829 DOI 10.1111/dom.13900
- Verification
- verified – PubMed efetch 2026-10-25 (this agent)
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract
2. Research question
SGLT2 inhibitors and Fournier gangrene
3. Study design and population
- Study design
- Meta-analysis – Meta-analysis of 84 RCTs
- Population
Type 2 diabetes in RCTs
- Country
International
- Period
RCTs to 2019
- Sample size
42,415 SGLT2i vs 27,158 comparators
- Inclusion and exclusion criteria
As described in the abstract; details not available in abstract.
4. Methods and endpoints
- Exposure / intervention
SGLT2 inhibitors
- Comparator
Placebo/active
- Endpoints
Fournier gangrene; abscess, cellulitis, erysipelas
- Statistical methods
Mantel-Haenszel OR
5. Actual results
- Results
FG MH-OR 0.41 (0.09-1.82); abscess 0.94; cellulitis 0.90; erysipelas 0.89; few events, wide CIs.
- Absolute risks
not reported
- Authors' conclusion
No difference observed; cannot rule out increase due to few events.
6. Strengths
- All RCTs
7. Weaknesses
- Very few events
- FG not systematically adjudicated
8. Risk of bias
- Orienting tool
- AMSTAR 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Sparse data.
9. Assessment of the statistical interpretation
Imprecise null.
10. Relevance to the specific claim
Limits C-ODD-08.
11. Independent contrary findings
12. Transferability to Germany and Europe
Multinational trial including European sites or directly applicable to EU practice.
13. Overall methodological judgement
Imprecise null.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | some concerns |
| Precision of results | low |
| Directness | direct |
| Reproducibility | unknown |
| Consistency with the overall evidence | mixed |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
None beyond those stated.
15. Linked fact checks
- Every major class of glucose-lowering drug (metformin, sulfonylureas, thiazolidinediones, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 agonists) carries a documented signal of serious harm in the peer-reviewed literature. – Studies contradicting or limiting the claim
- SGLT2 inhibitors are associated with Fournier gangrene: the FDA identified 55 cases in six years versus only 19 with all other diabetes drugs over 35 years. – Studies contradicting or limiting the claim