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.
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Springer Healthcare Limited. © Springer Healthcare Ltd;
2010
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BARI-2D results suggest rosiglitazone may not cause CV events