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DOC News    March 1, 2007
Volume 4 Number 3 p. 9
© 2007 American Diabetes Association

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DREAM Washout's Results Revealed

Bruce Goldfarb

Hopes that rosiglitazone (Avandia, GlaxoSmithKline) has a long-term effect on the progression to diabetes were dashed by the reporting of the DREAM (Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication) study washout results at the International Diabetes Federation (IDF) 19th World Diabetes Congress, held December 3–7, 2006, in Cape Town, South Africa.

At the end of the washout period, those taking rosiglitazone progressed to diabetes at the same rate as participants receiving placebo, according to researchers.

The DREAM trial revealed that therapy with rosiglitazone, when combined with a healthful diet and physical activity, reduced the risk of developing type 2 diabetes by 62% in people with pre-diabetes, compared with placebo. (DOC News, November 2006, page 1).

The results suggest that rosiglitazone delays progression to full-blown diabetes during treatment, but the effects do not persist when therapy is discontinued.

"The practical implication is that you can't stop the drug. If you stop the drug, you lose the benefit," says David Nathan, MD, director of the diabetes center at Massachusetts General Hospital in Boston and chairman of the Diabetes Prevention Program.

"I haven't been a big fan of rosiglitazone as a prevention owing to its expense, the edema, and heart failure. [DREAM washout results] don't surprise me, and it doesn't make me more or less a fan of rosiglitazone than I was before," Nathan says.

How the results of the DREAM washout phase will affect plans for changing the labeling or indications of the drug is unclear. GlaxoSmithKline did not respond to several requests for comment. {blacksquare}


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