Meta-analysiscited by the Tayebat archiveabstract only checked★ key study A-ODD-01 in-depth review

Rosiglitazone and heart attacks: pooled trials

Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes.

Overview

Nissen SE et al.. N Engl J Med 2007 · PMID 17517853 · DOI 10.1056/NEJMoa072761

Pooling 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

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?: Supports C-ODD-09, C-ODD-05.
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.

Effect of rosiglitazone on MI and CV death

Study design: Meta-analysis – Meta-analysis of 42 randomised trials (fixed effects, trial-level data)
Population: Type 2 diabetes in trials >24 weeks, mean age 56, HbA1c 8.2%
Country: International
Period: Trials to 2007
Sample size: 42 trials (116 screened)
Inclusion and exclusion criteria: As described in the abstract; details not available in abstract.

Results: MI OR 1.43 (1.03-1.98; P=0.03); CV death OR 1.64 (0.98-2.74; P=0.06).
Absolute risks: not reported in abstract
Authors' conclusion: Rosiglitazone associated with significant increase in MI and borderline increase in CV death; limited by lack of source data.

Borderline significance; sensitive to method.

Rosiglitazone no longer marketed in EU (not verified).

Important safety signal, partly confirmed (heart failure), MI uncertain.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	moderate
Risk of bias	some concerns
Precision of results	low
Directness	direct
Reproducibility	partly replicated
Consistency with the overall evidence	mixed
Regional transferability	high
Adequacy of the interpretation (by the archive)	essentially correct but incomplete

None beyond those stated.

Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.

What the archive says about the study: Nissen & Wolski meta-analysis of 42 trials: rosiglitazone raised MI risk 43% and cardiovascular mortality 64% - basis for FDA black-box warning.
A. What was actually studied?: Effect of rosiglitazone on MI and CV death
B. What did the authors find?: MI OR 1.43; CV death OR 1.64 (n.s.).
C. What conclusions do the authors themselves draw?: Rosiglitazone associated with significant increase in MI and borderline increase in CV death; limited by lack of source data.
D. What does the archive derive from it?: Used as example that a diabetes drug class causes heart attacks.
E. Is this derivation scientifically justified?: Numbers correct but CV death was not significant (P=0.06); RECORD later found MI 'inconclusive'. The 64% figure is presented as established although borderline.
Adequacy of the interpretation (by the archive): essentially correct but incomplete