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[Rosiglitazone: no increase in cardiovascular mortality].
Ingrid M Jazet1, A Edo Meinders
1Leids Universitair Medisch Centrum, afd. Endocrinologie en Metabolisme/Algemene Interne Geneeskunde, Leiden, The Netherlands. i.m.jazet@lumc.nl
Nederlands Tijdschrift Voor Geneeskunde
|November 26, 2009
Summary
Rosiglitazone does not increase cardiovascular risks in type 2 diabetes patients, according to the RECORD and BARI 2D studies. It can be prescribed cautiously, avoiding patients with heart failure.
Area of Science:
- Cardiovascular outcomes research
- Diabetes mellitus pharmacotherapy
- Clinical trial analysis
Background:
- Previous meta-analyses suggested rosiglitazone may increase myocardial infarction risk.
- Prior studies lacked sufficient power and design for robust cardiovascular safety assessment.
- Concerns regarding rosiglitazone's cardiovascular safety profile persisted in clinical practice.
Purpose of the Study:
- To rigorously evaluate the cardiovascular safety of rosiglitazone in type 2 diabetes patients.
- To assess the impact of rosiglitazone on major adverse cardiovascular events (MACE).
- To provide evidence-based guidance on rosiglitazone prescribing for glycemic control.
Main Methods:
- The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes (RECORD) study prospectively assessed cardiovascular outcomes.
- RECORD involved a mean follow-up of 5.5 years comparing rosiglitazone plus metformin/sulfonylurea versus metformin/sulfonylurea alone.
- The Bypass Angioplasty revascularisation Investigation 2 Diabetes (BARI 2D) study also examined cardiovascular events in relevant patient populations.
Main Results:
- The RECORD study found no significant increase in cardiovascular hospitalisation or mortality with rosiglitazone.
- A non-significant increase in myocardial infarction was observed with rosiglitazone, without a corresponding rise in mortality.
- BARI 2D reported no increased risk of myocardial infarction or cardiovascular death with insulin-sensitising therapies, including rosiglitazone.
Conclusions:
- Rosiglitazone, when used according to indications, does not elevate cardiovascular risk in type 2 diabetes patients.
- The drug is considered safe for patients without pre-existing heart failure or elevated risk.
- These findings support the continued use of rosiglitazone under appropriate clinical supervision.
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