Randomised controlled trialindependent cross-checkabstract only checked★ key study I-ODD-13 in-depth review
RECORD: rosiglitazone heart outcomes
Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial.
Overview
Home PD et al.. Lancet 2009 · PMID 19501900 · DOI 10.1016/S0140-6736(09)60953-3
Overall heart outcomes were not worse, but heart failure doubled; heart-attack effect unclear.
Does the study support the specific claim? Partly · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
CV outcomes of add-on rosiglitazone
- How was the study done?
Multicentre open-label RCT (RECORD main results)
- How many people, animals or samples were studied?
4,447; Type 2 diabetes on metformin or SU, HbA1c 7.9%
- What was actually found?
Non-inferior CV; HF HR 2.10.
- How large was the observed effect?
HR 0.99 primary
- What do the results mean in everyday life?
Avoid in heart failure.
- What are the study's limitations?
Open-label; Manufacturer funded; Low event rates
- What does it say about Elawady's specific claim?
Supports HF part, limits MI part of C-ODD-09; limits C-ODD-05.
- Do the results apply to Germany and Europe?
European trial.
- What can explicitly not be concluded from this study?
Settle MI risk.
Scientific in-depth review
1. Full reference
- Authors
- Home PD et al.
- Journal
- Lancet
- Year
- 2009
- Identifier
- PMID 19501900 DOI 10.1016/S0140-6736(09)60953-3
- Verification
- verified – PubMed efetch 2026-10-25 (this agent)
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Funded by GlaxoSmithKline.
2. Research question
CV outcomes of add-on rosiglitazone
3. Study design and population
- Study design
- Randomised controlled trial – Multicentre open-label RCT (RECORD main results)
- Population
Type 2 diabetes on metformin or SU, HbA1c 7.9%
- Country
Europe and Australasia
- Period
Mean 5.5 years
- Sample size
4,447
- Inclusion and exclusion criteria
As described in the abstract; details not available in abstract.
4. Methods and endpoints
- Exposure / intervention
Rosiglitazone add-on
- Comparator
Metformin + sulfonylurea
- Endpoints
CV hospitalisation or CV death
- Statistical methods
Cox; non-inferiority margin 1.20
5. Actual results
- Results
Primary 321 vs 323 (HR 0.99, 0.85-1.16), non-inferior; CV death HR 0.84 (0.59-1.18); MI HR 1.14 (0.80-1.63); stroke 0.72; HF HR 2.10 (1.35-3.27); more fractures mainly in women.
- Absolute risks
not reported
- Authors' conclusion
Rosiglitazone increases HF and some fractures; MI data inconclusive; no increase in overall CV morbidity or mortality.
6. Strengths
- RCT
- Long follow-up
7. Weaknesses
- Open-label
- Manufacturer funded
- Low event rates
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Open-label; industry.
9. Assessment of the statistical interpretation
MI CI wide.
10. Relevance to the specific claim
Supports HF part, limits MI part of C-ODD-09; limits C-ODD-05.
11. Independent contrary findings
12. Transferability to Germany and Europe
European trial.
13. Overall methodological judgement
Confirms HF, not MI.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | some concerns |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | partly replicated |
| 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
- Rosiglitazone (Avandia) raised myocardial infarction risk by 43% (Nissen meta-analysis), leading to an FDA black-box warning, and RECORD confirmed a doubling of heart failure. – Studies with mixed or unclear results