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.
Original statement
روزيغليتازون (أفانديا) رفع خطر احتشاء القلب 43% في تحليل نيسن التلوي لاثنتين وأربعين تجربة، فأصدرت FDA تحذيرها بالحدود السوداء، ثم جاءت تجربة RECORD لتؤكد مضاعفة خطر فشل القلب (HR 2.10).
verbatim according to source. Translation by the project; the Arabic wording is authoritative.
Translation
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.
Origin
- Source status
- Archive editors
- Attribution
- Archive editors (not Elawady)
- Origin
- https://eltayebat.com/rule/oral-diabetes-drugs/
- Attribution uncertainty
- Editorial narrative and study selection written by the archive operators.
- Claimed health effect
MI, heart failure
- Population concerned
Type 2 diabetes
- Geographic restriction by Elawady
none found
Scientific assessment
Mostly true – Correct at its core, but with limitations or minor inaccuracies.
Certainty of evidence: moderate – Further research may still affect the assessment.
1. What was claimed?
Rosiglitazone raises MI and doubles heart failure.
2. What is demonstrably correct?
Nissen & Wolski: MI OR 1.43 (1.03-1.98), CV death OR 1.64 (0.98-2.74, borderline) (A-ODD-01). RECORD: heart failure HR 2.10 (1.35-3.27), more fractures in women (A-ODD-02, I-ODD-13).
3. What is wrong or exaggerated?
RECORD found rosiglitazone non-inferior for cardiovascular hospitalisation or death (HR 0.99) and MI HR 1.14 (0.80-1.63), i.e. 'inconclusive' (I-ODD-13). Nissen's meta-analysis lacked patient-level data (A-ODD-01). The rosiglitazone history is an example of drug safety monitoring working, not proof that all diabetes drugs are harmful.
4. What remains unclear?
Exact MI risk.
5. Which studies support it?
A-ODD-01, A-ODD-02, I-ODD-13 (heart failure).
6. Which studies contradict it?
I-ODD-13 (MI inconclusive, overall CV non-inferior).
7. What applies to Germany and Europe?
Not available in the EU since 2010 (to be verified).
8. What is known about Egypt?
Availability in Egypt not verified.
9. What practical conclusion is appropriate?
Thiazolidinediones should not be used in heart failure; the MI question for rosiglitazone was never fully settled.
Assessment details
- Rationale for certainty of evidence
Heart-failure risk confirmed in a randomised trial (high certainty). MI signal from a meta-analysis of short trials (OR 1.43, borderline CI) was 'inconclusive' in RECORD; the archive's wording overstates the MI finding as established.
- Source quality
Archive editorial citing meta-analysis and RCT.
- Regional transferability
Rosiglitazone is no longer marketed in the EU (suspended by EMA in 2010; not fetched; verified: false).
- Regional scope of the claim
- general (biological/medical)
- Last reviewed
- 26 October 2026 provisional
Scientific evidence in detail
Overinterpreted – A real finding exists, but the claim draws more from it than the data allow (e.g. association taken as cause, animal data applied to humans, small effect presented as large).
Research question: Did rosiglitazone increase myocardial infarction by about 43% and double heart failure?
Research question in detail (PICO)
- Population
- Type 2 diabetes
- Intervention or exposure
- Rosiglitazone
- Comparison
- Other treatment/placebo
- Geographic scope
- universal biology
- Outcomes
- Myocardial infarction
- Heart failure
Study results as reported by the authors. Our assessment follows below.
What speaks for the claim?
Rosiglitazone and heart failure (RECORD)
Komajda M et al.. Eur Heart J 2010 · PMID 20118174 · DOI 10.1093/eurheartj/ehp604 Randomised controlled trialfull text, structured risk-of-bias assessmentRECORD RCT: heart failure doubled.
- Actual result
- HR 2.10 (1.35-3.27).
- Methodological quality
- high
- Relevance
- direct
- Limitations
- Open-label.
Re-analysis of rosiglitazone trials: heart failure confirmed, heart attacks uncertain
Wallach JD et al.. BMJ 2020 · PMID 32024657 · DOI 10.1136/bmj.l7078 Meta-analysisabstract checkednewly addedIPD meta-analysis: composite risk increased, driven by heart failure.
- Actual result
- Composite OR 1.33 (1.09-1.61); HF OR 1.54 (1.14-2.09).
- Methodological quality
- moderate
- Relevance
- direct
- Limitations
- Analytic sensitivity; correction.
What speaks against the claim?
RECORD: rosiglitazone heart outcomes
Home PD et al.. Lancet 2009 · PMID 19501900 · DOI 10.1016/S0140-6736(09)60953-3 Randomised controlled trialabstract checkedRECORD: MI result inconclusive.
- Actual result
- MI HR 1.14 (0.80-1.63).
- Methodological quality
- high (RCT), imprecise for MI
- Relevance
- direct
- Limitations
- Open-label.
Re-analysis of rosiglitazone trials: heart failure confirmed, heart attacks uncertain
Wallach JD et al.. BMJ 2020 · PMID 32024657 · DOI 10.1136/bmj.l7078 Meta-analysisabstract checkednewly addedIPD MI estimate not significant and attenuated with summary data.
- Actual result
- MI OR 1.17 (0.92-1.51); with summary data 1.09 (0.88-1.35).
- Methodological quality
- moderate
- Relevance
- direct
What does the overall evidence say?
Editorial assessment based on the studies above – not itself a study result.
Which position is better supported?
Heart failure harm is established; the 43% MI figure from Nissen's 2007 meta-analysis is correctly quoted but later analyses (RECORD, IPD re-analysis) did not confirm a significant MI increase.
Why some studies weigh more
RCT and IPD evidence weigh more than the early summary-level meta-analysis.
Is a causal relationship established? Probable Established for heart failure (RCT); not established for MI.
Remaining uncertainty
MI risk size.
Justified conclusion
Mostly true; MI part overstated.
Why do studies seem to disagree?
Nissen (summary data, short trials) vs RECORD and IPD analyses: differing data sources and continuity corrections explain the attenuation.
Does this depend on the country?
- General biological effects
- Drug pharmacology and physiology are universal.
- Eating habits
- Prolonged fasting, Ramadan fasting and very-low-carbohydrate eating change the risk of hypoglycaemia and ketoacidosis with some drugs; relevant in Egypt and among Muslims in Europe.
- Origin of the food
- Not applicable.
- Contaminants
- Not applicable.
- National production conditions
- Not applicable (same active substances; generics widely used in Egypt).
- Legal rules
- Drug labels and warnings are set by FDA/EMA and national regulators; Egyptian labelling not reviewed.
- Actual monitoring data
- No Egypt-specific pharmacovigilance data were found for this outcome.
A regional difference that changes the conclusion is not supported by robust data.
Statistical re-check
- Crude vs stratified estimate – Crude proportions 2.31% vs 2.35% (RR 0.98) vs stratified OR 1.33: result depends on trial stratification and continuity corrections. recalculated
- CI symmetry – OR 1.43 (1.03-1.98) symmetric. recalculated
Certainty of the overall evidence (GRADE, simplified)
- Main outcome
- Heart failure with rosiglitazone
- Starting level
- high (randomised trials)
- Result
- moderate
Simplified assessment by a single reviewer, following the GRADE approach; not a formal GRADE panel. GRADE rates the body of evidence for one outcome, not individual studies.
Search strategy
Documented literature searches for this review (search strings in the original database syntax).
| Database | Date | Search | Looking for | Hits | Included |
|---|---|---|---|---|---|
| PubMed | 26 October 2026 | rosiglitazone[ti] AND (myocardial[tiab] OR cardiovascular[ti]) AND (meta-analysis[pt] OR "individual patient"[tiab]) AND 2010:2026[dp] | both directions | 8 |
Open questions
None practical.
How deeply was this checked?
4 linked studies: 1 checked in full text (1 of them with a structured risk-of-bias assessment), 3 on the basis of the abstract, 0 bibliographically only. No formal assessment with two independent reviewers and no independent human expert review has taken place yet.
Last scientific review: 26 October 2026
History of the verdict
In plain language
Rosiglitazone clearly increases the risk of heart failure, as a large trial confirmed. Whether it also increases heart attacks remained uncertain. The drug was withdrawn from the European market. Its story shows why drug safety is monitored after approval.
Studies on this claim
Studies supporting the claim (2)
-
Rosiglitazone and heart attacks: pooled trials
Nissen SE et al.. N Engl J Med 2007 · PMID 17517853 · DOI 10.1056/NEJMoa072761Meta-analysiscited by the Tayebat archiveabstract checked★ key studyPooling 42 trials suggested 43% more heart attacks; the increase in heart deaths was not statistically certain.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Effect of rosiglitazone on MI and CV death
- How was the study done?
Meta-analysis of 42 randomised trials (fixed effects, trial-level data)
- How many people, animals or samples were studied?
42 trials (116 screened); Type 2 diabetes in trials >24 weeks, mean age 56, HbA1c 8.2%
- What was actually found?
MI OR 1.43; CV death OR 1.64 (n.s.).
- How large was the observed effect?
OR 1.43 (1.03-1.98)
- What do the results mean in everyday life?
A real warning signal that changed drug regulation.
- What are the study's limitations?
No patient-level data; Rare events, fixed-effect model; Short trials not designed for CV outcomes
- What does it say about Elawady's specific claim?
- Do the results apply to Germany and Europe?
Rosiglitazone no longer marketed in EU (not verified).
- What can explicitly not be concluded from this study?
That all diabetes drugs raise heart attacks.
-
Rosiglitazone and heart failure (RECORD)
Komajda M et al.. Eur Heart J 2010 · PMID 20118174 · DOI 10.1093/eurheartj/ehp604Randomised controlled trialcited by the Tayebat archivefull text, structured risk-of-bias assessmentHeart failure doubled with rosiglitazone (2.6 extra cases per 1,000 patient-years), but overall heart deaths did not increase.
Does the study support the specific claim? Yes · Methodological quality: high · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Heart failure risk with rosiglitazone
- How was the study done?
Analysis of heart failure events in an open-label RCT (RECORD)
- How many people, animals or samples were studied?
4,447; Type 2 diabetes on metformin or SU, HbA1c 7.9%
- What was actually found?
HF HR 2.10.
- How large was the observed effect?
HR 2.10 (1.35-3.27)
- What do the results mean in everyday life?
Avoid in heart failure.
- What are the study's limitations?
Open-label; sponsored and analysed by the manufacturer (GSK); relatively few HF events (90).
- What does it say about Elawady's specific claim?
Supports C-ODD-09.
- Do the results apply to Germany and Europe?
European trial.
- What can explicitly not be concluded from this study?
Increased overall CV mortality.
No study in this group is marked as key.
Studies contradicting or limiting the claim (0)
No studies in this group.
Studies with mixed or unclear results (2)
-
RECORD: rosiglitazone heart outcomes
Home PD et al.. Lancet 2009 · PMID 19501900 · DOI 10.1016/S0140-6736(09)60953-3Randomised controlled trialindependent cross-checkabstract checked★ key studyOverall heart outcomes were not worse, but heart failure doubled; heart-attack effect unclear.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
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.
-
Re-analysis of rosiglitazone trials: heart failure confirmed, heart attacks uncertain
Wallach JD et al.. BMJ 2020 · PMID 32024657 · DOI 10.1136/bmj.l7078Meta-analysisindependent cross-checkabstract checked★ key studyHF OR 1.54; MI OR 1.17 (not significant).
HF confirmed (OR 1.54); MI OR 1.17 (0.92-1.51) not significant.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Re-examine rosiglitazone cardiovascular risk with patient-level data.
- How was the study done?
IPD and summary meta-analyses.
- How many people, animals or samples were studied?
21,156 patients with IPD.
- What was actually found?
Higher composite risk driven by heart failure; MI uncertain.
- How large was the observed effect?
Composite OR 1.33; HF OR 1.54; MI OR 1.17.
- What do the results mean in everyday life?
The heart-failure risk is real; the heart-attack risk remains unproven.
- What are the study's limitations?
Analytic sensitivity; correction.
- What does it say about Elawady's specific claim?
Partly supports the claim; 43% MI figure is not robust.
- Do the results apply to Germany and Europe?
Limited (drug withdrawn).
- What can explicitly not be concluded from this study?
A precise MI risk.
No study in this group is marked as key.
Regional context
Germany / EU
Not available in the EU since 2010 (to be verified).
Egypt
Availability in Egypt not verified.
What applies in my country?
General scientific assessment
Mostly true Heart-failure harm confirmed; heart-attack harm suggested but not settled.
This statement concerns biological or medical relationships. The scientific assessment above applies regardless of the country; country-specific food data do not change it.
References
- Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes.. Nissen SE et al.. N Engl J Med 2007 · PMID 17517853 · DOI 10.1056/NEJMoa072761
- Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial.. Komajda M et al.. Eur Heart J 2010 · PMID 20118174 · DOI 10.1093/eurheartj/ehp604
- Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial.. Home PD et al.. Lancet 2009 · PMID 19501900 · DOI 10.1016/S0140-6736(09)60953-3
- Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses.. Wallach JD et al.. BMJ 2020 · PMID 32024657 · DOI 10.1136/bmj.l7078