Safety and mortality with rosiglitazone versus pioglitazone

January 01, 0001

Safety and mortality with rosiglitazone versus pioglitazone

There has been sometimes fierce debate on the safety of the antidiabetic thiazolidinedione medication rosiglitazone. These US researchers examined the risk of serious cardiovascular events using rosiglitazone compared with pioglitazone, the other thiazolidinedione marketed in the United States. They retrospectively looked at a nationwide inception cohort of 227 571 Medicare beneficiaries aged 65 years or older who D prescription drug plan from July 2006-June 2009 and who underwent follow-up for up to 3 years after thiazolidinedione initiation.

The researchers report: "A total of 8667 end points were observed during the study period. The adjusted hazard ratio for rosiglitazone compared with pioglitazone was 1.06 for AMI, 1.27 for stroke, 1.25 for heart failure, 1.14 for death, and 1.18 for the composite of AMI, stroke, heart failure, or death. The attributable risk for this composite end point was 1.68 excess events per 100 person-years of treatment with rosiglitazone compared with pioglitazone. The corresponding number needed to harm was 60 treated for 1 year."

The researchers concluded: "Compared with prescription of pioglitazone, prescription of rosiglitazone was associated with an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI, stroke, heart failure, or all-cause mortality in patients 65 years or older."

This study raises significant concerns about the safety of rosiglitazone

For the full abstract, click here.

JAMA 304(4): 411-418, 28 July 2010
© 2010 the American Medical Association
Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone. David J. Graham, Rita Ouellet-Hellstrom, Thomas E. MaCurdy, et al.

Category: K. Circulatory, T. Endocrine/Metabolic/Nutritional. Keywords: rosiglitazone, pioglitazone, cardiovascular events, mortality, safety, retrospective cohort, journal watch.
Synopsis edited by Dr Paul Schaefer, Toledo, Ohio. Posted on Global Family Doctor 10 August 2010

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.