#34 Rosiglitazone – Reasonable Option or Regrettable Choice?
CLINICAL QUESTION
Is rosiglitazone a reasonable second or third line agent in the management of Type 2 Diabetes (DM2)?
BOTTOM LINE
Strong evidence supports increased cardiovascular risk, specifically MI, in Type 2 Diabetes patients receiving rosiglitazone. In the absence of any demonstrated patient-oriented benefits, there is no indication for its use.
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EVIDENCE
A 2007 meta-analysis (42 randomized controlled trials, 27,847 patients) first assessed the impact of rosiglitazone on cardiovascular (CV) outcomes in DM2 patients.
- Rosiglitazone caused a statistically significant increase in myocardial infarction (MI) over placebo or other drugs, Relative Risk Increase 43% (Confidence Interval (CI) 3%-97%). 1
- No difference in cardiovascular deaths.
- Some questioned the meta-analysis validity due to inclusion of low-quality studies and concern that analysis may have overestimated CV events.2
- 56 trials, 35,531 patients Odds Ratio 1.28 (CI 1.02-1.63), Number Needed to Harm (NNH) 52 over five years. 3
- 52 trials, 16,995 patients Odds Ratio 1.80 (CI 1.03-3.25). 4
- FDA analysis4 found the researchers’ management of some data potentially masked rosiglitazone harms.
- Rosiglitazone was approved based on its ability to improve glycemic control, without any evidence of improvement in patient-oriented outcomes.
- A systematic review reported a strong link between author’s views on rosiglitzone and financial conflicts of interest with manufacturer. 6
- The American Diabetes Association and the European Association for the Study of Diabetes released a consensus statement in 2009 recommending against the use of rosiglitazone in DM2. 7
- In 2013, the FDA relaxed restrictions on rosiglitazone based on re-analysis of the RECORD trial, despite remaining concerns on its safety. 8,9
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