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Thursday, July 8, 2010

Article Most Likely to Change Clinical Practice - Week Ending July 7, 2010

Rosiglitazone Associated with Increased Stroke, Heart Failure, and Death Compared to Pioglitazone in Elderly Patients 
The thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos) have become popular drugs for type 2 diabetes in recent years for their potential to improve glycemic control by increasing insulin sensitivity. Concern over the safety of rosiglitazone was raised by a 2007 meta-analysis of 42 trials associating the drug with increased risk of myocardial infarction (MI) and cardiovascular death (N Engl J Med 2007 Jun 14;356(24):2457).

A new, large cohort study compared the safety of rosiglitazone vs. pioglitazone in 227,571 elderly patients  (mean age 74 years) with diabetes who began taking 1 of the 2 drugs between July 2006 and June 2009. During a follow-up period of up to 3 years, there were 8,667 events of MI, stroke, heart failure, or death. The incidence rate per 100 person-years for the composite of these outcomes was significantly higher for rosiglitazone than for pioglitazone (9.1 vs. 7.42, p < 0.05) (level 2 [mid-level] evidence). The number needed to harm (NNH), calculated as the number of patients treated for 1 year to generate 1 excess event, was 60 for the composite outcome. Rosiglitazone was also associated with increased incidence rates of stroke (1.27 vs. 0.95, p < 0.05, NNH 313), heart failure (3.94 vs. 3, p < 0.05, NNH 106), and death (2.85 vs. 2.4, p < 0.05, NNH 222). Incidence rates of acute MI were not significantly different (1.83 vs. 1.63) (JAMA 2010 Jun 28 early online).

Also recently published was an update of the 2007 meta-analysis with 14 additional trials comparing treatment with vs. without rosiglitazone. Rosiglitazone was associated with increased risk of MI (odds ratio 1.28, 95% CI 1.02-1.63), but there was no significant difference in cardiovascular death (Arch Intern Med 2010 Jun 28 early online).

For more information, see the Rosiglitazone topic in DynaMed.
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