Rosiglitazone increased risk for serious CV events

When compared with pioglitazone, rosiglitazone prescription led to an increased risk for stroke, heart failure and all-cause mortality in patients aged 65 years and older, according to study findings.

The study consisted of a nationwide, observational, retrospective, inception cohort of 227,571 patients aged 65 years and older (mean age, 74.4 years) who began treatment with rosiglitazone (Avandia, GlaxoSmithKline) or pioglitazone (Actos, Takeda) through a Medicare Part D prescription drug plan from July 2006 to June 2009. All patients underwent follow-up up to 3 years after thiazolidinedione initiation. The individual endpoints of acute myocardial infarction, stroke, HF and all-cause mortality were the main outcome measures.

During the study period, researchers recorded 8,667 endpoints. The adjusted HR for rosiglitazone vs. pioglitazone was 1.06 (95% CI, 0.96-1.18) for acute MI; 1.27 (95% CI, 1.12-1.45) for stroke; 1.25 (95% CI, 1.16-1.34) for HF; and 1.14 (95% CI, 1.05-1.24) for all-cause mortality. For the composite of acute MI, stroke, HF or death, the adjusted HR was 1.18 (95% CI, 1.12-1.23) with the attributable risk for the composite endpoint being 1.68 (95% CI, 1.27-2.08) excess events per 100 person years of treatment with rosiglitazone vs. pioglitazone.

David N. Juurlink, MD, PhD, with the department of medicine, Sunnybrook Health Science Centre, Toronto, wrote in an accompanying editorial that although he did not regard the findings as being novel, the study’s strengths included that it was large, rigorously conducted and exceptionally timely.

“Accumulating concerns about rosiglitazone make it difficult to advance a cogent argument regarding why, exactly, a patient might want to receive the drug or why a physician would choose to prescribe it when there is an available and quite possibly safer alternative,” Juurlink wrote.

Graham DJ. JAMA. 2010;304:doi:10:1001/jama.2010.920.