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Oral Antidiabetic Agent Relieves Symptoms of Ulcerative Colitis: Presented at DDW

By Em Brown

WASHINGTON, DC -- May 29, 2007 -- An agent that increases insulin sensitivity and is commonly used to treat type 2 diabetes mellitus also appears to reduce symptoms of ulcerative colitis.

Rosiglitazone significantly reduces Disease Activity Index scores and increases quality of life in patients with ulcerative colitis, possibly through its anti-inflammatory effects on the gut, investigators reported in a presentation here at Digestive Disease Week (DDW).

Principal investigator James D. Lewis, MD, MSCE, assistant professor of medicine and senior scholar, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, presented the findings of a multicenter study on May 22^nd.

The study involved 105 patients with mild to moderate ulcerative colitis that was refractory to or intolerant of standard therapy with 5-aminosalicylic acid (5-ASA). The patients were randomized to rosiglitazone 4 mg or placebo twice daily for 12 weeks.

At baseline, patients had scores of 4 to 10 on the Disease Activity Index (DAI), indicating mild to moderate disease. Clinical response was defined as a reduction of 3 or more points on the DAI by week 12 and clinical remission as a reduction of 2 or more points on the DAI.

At week 12, a decrease of 2 or more points on DAI was observed in 44% of patients on rosiglitazone and in 23% of patients on placebo.

Clinical remission occurred in 17% of patients on active treatment and 2% of patients on placebo.

Stool frequency, bleeding rates, and the physician's global assessments all improved in patients on active therapy.

Endoscopic remission, with no evidence of mucosal activity, occurred in 8% of patients on active treatment and in 2% of patients on placebo. The numbers favored rosiglitazone numerically, but the difference was not statistically significantly.

"We saw a clinical response within 4 weeks" of beginning rosiglitazone therapy, Dr. Lewis said. Serious adverse events were "rare and did not differ between the placebo and rosiglitazone arms," he reported.
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For patients who do not respond to treatment with 5-ASA or cannot take this drug, "rosiglitazone is a novel second-line therapy," Dr. Lewis said.

The positive findings with rosiglitazone in the setting of ulcerative colitis were reported on the same day that a study reported in The New England Journal of Medicine showed that rosiglitazone increases the risk of myocardial infarction by 43%.

The FDA has issued an alert while the Journal report is investigated, but rosiglitazone remains on the market.

[Presentation title: A Randomized, Controlled Trial of the PPAR-Gamma for Acute Ulcerative Colitis. Abstract 639a]

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