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Clinical Diabetes 25:123-124, 2007
DOI: 10.2337/diaclin.25.4.123
© 2007 by the American Diabetes Association
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Landmark Study

Rosiglitazone Appears to Be Associated With an Increased Risk of Cardiovascular Events

Michael Pignone, MD, MPH

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   STUDY
 
Nissen S, Wolski K: Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 356:2457 -2471, 2007, erratum[Abstract/Free Full Text]N Engl J Med357 : 100,2007[Free Full Text]


   SUMMARY
 
Design. Systematic review and meta-analysis of randomized trials of rosiglitazone compared with placebo or other active therapy that were at least 24 weeks in duration and that measured cardiovascular events.

Methods. The authors performed a literature search, including databases maintained by the U.S. Food and Drug Administration (FDA) and the manufacturer of rosiglitazone. Available studies were abstracted to identify incident myocardial infarctions and cardiovascular deaths. Data from included trials were combined using a fixed-effects model to estimate summary odds ratios for incidence of myocardial infarction and cardiovascular death.

Results. The authors identified 42 trials that met their inclusion criteria. These trials studied > 27,000 patients and ranged in duration from 24 to 208 weeks. Most trials enrolled middle-aged patients with moderately elevated hemoglobin A1c (A1C) levels. There were 86 total myocardial infarctions in the rosiglitazone arms of the included studies and 72 in the control-group arms; 39 deaths from cardiovascular causes occurred in the rosiglitazone-assigned patients versus 22 in the control groups. The risk of myocardial . . . [Full Text of this Article]


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Copyright © 2007 by the American Diabetes Association.