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Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis
Philip D Home1, Stuart J Pocock, Henning Beck-Nielsen
1Newcastle Diabetes Centre and Newcastle University, Newcastle upon Tyne, United Kingdom. philip.home@newcastle.ac.uk
The New England Journal of Medicine
|June 7, 2007
Summary
This study found rosiglitazone did not increase heart attack risk but was linked to more heart failure in type 2 diabetes patients. Further research is needed for definitive conclusions.
Area of Science:
- Cardiology
- Endocrinology
- Clinical Trials
Background:
- Concerns exist regarding rosiglitazone's cardiovascular risks in type 2 diabetes.
- A meta-analysis highlighted potential increased risks of myocardial infarction and cardiovascular death.
Purpose of the Study:
- To investigate the cardiovascular safety of rosiglitazone as an add-on therapy.
- To compare rosiglitazone versus a metformin plus sulfonylurea combination in type 2 diabetes patients.
Main Methods:
- An unplanned interim analysis of a randomized, multicenter, open-label trial.
- 4447 patients with type 2 diabetes inadequately controlled on metformin or sulfonylurea were studied.
- Primary endpoint: hospitalization or death from cardiovascular causes.
Main Results:
- Interim analysis showed no statistically significant difference in myocardial infarction or cardiovascular death between groups.
- A higher incidence of heart failure was observed in the rosiglitazone group (Hazard Ratio: 2.15).
- Limited statistical power due to short follow-up (mean 3.75 years).
Conclusions:
- Interim findings are inconclusive regarding rosiglitazone's effect on overall cardiovascular risk.
- No increased risk of death from cardiovascular or all causes was detected.
- Rosiglitazone is associated with an increased risk of heart failure; data on myocardial infarction risk remain insufficient.
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