Rosiglitazone linked to increased CVD risk in elderly
MedWire News: Results from an observational study of elderly Medicare beneficiaries in the USA show that rosiglitazone treatment is associated with an increased risk for cardiovascular disease (CVD) events compared with treatment with pioglitazone.
The researchers followed-up 227,571 elderly individuals with diabetes, aged 65 years or older, who were treated with rosiglitazone (n=67,593) or pioglitazone (n=159,978) through a Medicare plan between July 2006 and June 2009 for a period of 3 years.
Incidence of stroke, heart failure (HF), and all-cause mortality were a significant 27%, 25%, and 14% higher in the rosiglitazone- compared with the pioglitazone-treated group, respectively. Incidence of acute myocardial infarction (AMI) was nonsignificantly different between the two groups.
In addition, rosiglitazone-treated patients were a significant 18% more likely to experience the composite endpoint of AMI, stroke, HF, or death than those treated with pioglitazone.
The team found that the attributable risk for the composite endpoint was 1.68 excess events per 100 person-years of treatment with rosiglitazone versus pioglitazone, with a corresponding number needed to harm of 60 treated for 1 year.
David Graham (US Food and Drug Administration [FDA], Silver Spring, Maryland, USA) presented the results at the American Diabetes Association 2010 Scientific Sessions held in Orlando, Florida, and they were simultaneously published in the Journal of the American Medical Association.
Writing in an accompanying editorial, David Juurlink (Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada) commented that the results of this report will undoubtedly contribute to FDA deliberations in an impending review regarding the safety of rosiglitazone, which are likely to conclude either with removal of rosiglitazone from the US market, or with a recommendation to wait for the results of the Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) trial.
In a published comment, the American Heart Association advised: "There still is currently not enough data to support the choice of a specific thiazolidinedione."
It said that a TZD should not be prescribed for diabetics with an expectation of achieving a reduction in risk for MI or stroke, and the rationale of choosing such a drug should be carefully discussed between patient and physician.
However, the Association added that patients who have achieved good glycemic control by taking a TZD should be able to continue with their medication.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010
By Helen Albert