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Review: rosiglitazone increases risk of MI but does not differ from other drugs for CV death in type 2 diabetes

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In patients with type 2 diabetes, how does rosiglitazone (RGZ) compare with placebo or other drugs for cardiovascular (CV) outcomes?

Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356:2457–71.

Clinical impact ratings GP/FP/Primary care ★★★★★★★ Internal medicine ★★★★★★★ Cardiology ★★★★★★⋆ Endocrine ★★★★★⋆⋆


Embedded ImageData sources

US Food and Drug Administration (FDA) website; clinical trial registry of the drug manufacturer; and 2 large, recently published trials (Diabetes REduction Assessment with ramipril and rosiglitazone Medication [DREAM] trial and A Diabetes Outcome Prevention Trial [ADOPT]).

Embedded ImageStudy selection and assessment

randomised controlled trials (RCTs) that compared RGZ with placebo or other drugs (control) for >24 weeks and reported myocardial infarction (MI) or CV death as outcomes. 42 RCTs (n = 27 847, mean age 56 y) met the selection criteria.

Embedded ImageOutcomes

MI and CV death.


Meta-analysis showed that RGZ increased risk of MI more than placebo or other drugs, but groups did not differ for CV death (table).


Rosiglitazone increases risk of myocardial infarction and cardiovascular death in patients with type 2 diabetes.

View this table:
Rosiglitazone v placebo or other drugs (control) in type 2 diabetes*

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  • Sources of funding: Pfizer; AstraZeneca; Daiichi Sankyo; Roche; Takeda; Sanofi-Aventis; Eli Lilly.