Fracture-Centred Skeletal Reporting Profiles of Glucose-Lowering Drug Classes in FAERS and JADER: Cross-Database and Regional Reporting-Context Analyses
- Design
- Pharmacovigilance · Hard outcome
- Match to healthy normal-weight adults aged 55–75
- Population unclear[Auto] Population characteristics not extractable from abstract (age/BMI not reported in abstract). Needs manual review.
- Could weight loss explain it?
- Unknown[Auto] Not addressed in abstract.
- Study tier
- Study tier 4[Auto] Hypothesis-generating design (auto-provisional).
- Assessment
- Version 1 · automatic, not yet reviewed by a person · Sep 20, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
[Auto, unreviewed; quoted from abstract conclusions] Skeletal reporting profiles varied by drug class, database, and reporting context. Apparent total-Asian elevations for several classes were predominantly Japan-driven and should not be interpreted as patient-level Asian fracture risk.
01Findings
What the study reported
- Drugs
- Class unspecified
- Primary outcome
- Not extracted
- Effect
- Not extracted
- 95% confidence interval
- Not extracted
- Follow-up
- 60 years
- Adverse events
- Not extracted
- Limitations
- Auto-classified from abstract only; effect estimates, adverse events and limitations not extracted. Requires manual review.
Who was studied
Study quality details
- Study design
- Pharmacovigilance analysis
- Sample size
- not extracted
- Randomization
- no
- Blinding
- not stated
- Comparator
- not stated
- Follow up duration
- 60 years
- Outcome type
- hard
- Replication
- not assessed (auto)
- Consistency with other evidence
- not assessed (auto)
- Population applicability
- UNKNOWN
- Statistical precision
- CI reported: 95% CI 1
- Risk of bias
- not assessed (auto)
- Funding conflicts
- no
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- National Natural Science Foundation of China; Anhui Provincial Natural Science Foundation; Health Commission of Anhui Province Research Project; Diabetes and Metabolism Research Fund; USTC Research Funds of the Double First-Class Initiative; Research Funds of the Centre for Leading Medicine and Advanced Technologies of IHM
- Industry funded
- No
- Manufacturer
- None identified
- Sponsor role
- no manufacturer funding identified
- Author conflicts
- not available in metadata
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[AIMS] To characterise fracture-centred skeletal adverse-event reporting across nine glucose-lowering drug classes and test whether regional differences persist after separating Japan from non-Japan Asian reporting contexts. [MATERIALS AND METHODS] We analysed FAERS and JADER reports, with fracture as the primary endpoint and reporting frequency per 10 000 mapped suspect reports. FAERS older age was harmonised to ≥ 60 years, with ≥ 65 and ≥ 70-year sensitivity analyses. Regional analyses separated Western, Japan, and non-Japan Asia; class-specific reporting odds were adjusted for age, sex, calendar year, and reporter type. Disproportionality analyses were supplementary. [RESULTS] The study included 15 473 015 FAERS and 1 037 161 JADER reports, including 202 881 and 10 678 fractures. Using final deduplicated FAERS denominators, fracture reporting was highest for insulin (126.08/10000), DPP-4 inhibitors (111.03) and sulfonylureas (103.76), whereas thiazolidinediones (152.54), SGLT2 inhibitors (115.14) and GLP-1 receptor agonists (112.15) were most prominent in JADER. Age was unavailable in 44.9% of unique FAERS suspect reports, but findings were stable across age thresholds. Japan accounted for 83.0%-92.9% of total-Asian fractures for thiazolidinediones, GLP-1 receptor agonists, SGLT2 inhibitors and DPP-4 inhibitors; corresponding non-Japan Asian RFRs were not clearly elevated. Insulin remained higher after excluding Japan (RFR 1.96, 95% CI 1.57-2.45). No class met FDR-positive fracture disproportionality criteria. [CONCLUSIONS] Skeletal reporting profiles varied by drug class, database, and reporting context. Apparent total-Asian elevations for several classes were predominantly Japan-driven and should not be interpreted as patient-level Asian fracture risk.