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CV event and death risk with rosiglitazone similar to pioglitazone
31 August 2010
MedWire News: Patients taking rosiglitazone have a similar risk for acute myocardial infarction (AMI), acute heart failure (AHF), and all-cause mortality as patients taking pioglitazone, US researchers suggest.
Previous studies have reported that rosiglitazone increases the risk for AMI compared with other thiazolidinediones (TZDs) and hypoglycemic agents, and as a result, additional warnings and restrictions were issued against rosiglitazone by the US Food and Drug Administration (FDA) in July 2010.
However, Debra Wertz (HealthCore, Inc, Wilmington, Delaware) and team explain that their findings may help to rectify rosiglitazone’s current reputation as a high-risk drug.
They say: “Given that rosiglitazone is scheduled for review with the FDA later this year, it will be important for the FDA to have available all evidence for consideration at that time.”
Wertz et al assessed the occurrence of AMI, AHF, and all-cause mortality among 36,628 patients with diabetes who were newly treated with rosiglitazone (n=18,319) or pioglitazone (n=18,309) between 2001 and 2005.
During this period, 4.16% (602) and 4.14% (599) of patients treated with rosiglitazone and pioglitazone, respectively, had an AMI, AHF, or died.
After adjusting for confounding factors, such as age and gender, the team found very similar rates of adverse outcomes associated with each drug, with an event rate per 1000 person-years of 6.18 and 6.74 for AMI, 13.23 and 11.86 for AHF, and 11.44 and 11.22 for all-cause death, in patients taking rosiglitazone and pioglitazone, respectively.
In the journal Circulation: Cardiovascular Quality and Outcomes, the researchers say: “Besides its findings that rosiglitazone and pioglitazone have comparable risks, what distinguishes this latest study from other claims-based is its analysis of death records, which include out-of-hospital deaths.”
They add: “This study provides valuable results that contrast previously published observational data and adds to the body of evidence available for risk-benefit profile assessment of TZDs in the treatment of diabetes.”
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