Randomized, placebo-controlled trial of the PPAR ligand rosiglitazone for active ulcerative colitis
(21 May 2007: VIDYYA MEDICAL NEWS SERVICE) -- Currently, 5-aminosalicylic acid (5-ASA) is the most common treatment for ulcerative colitis (UC), a form of inflammatory bowel disease (IBD). However, not all patients respond to this treatment. Ligands to peroxisome proliferators-activated receptors (PPARy) – a type of therapy widely used to treat type-2 diabetes by lowering the body's resistance to insulin – has been proposed to have anti-inflammatory properties in the colon. This study aimed to determine the effectiveness of the PPARy ligand rosiglitazone (Avandia®) in patients with UC.
Researchers from the University of Pennsylvania in Philadelphia, Pa. led a multicenter, randomized, double-blind, placebo-controlled clinical trial of 105 patients with mild-to-moderately active UC. Patients who have not responded to or were intolerant of 5-ASA were given either 4mg of rosiglitazone or a placebo twice daily for 12 weeks. A Disease Activity Index (DAI) was used to measure the disease activity during the trial and efficacy was assessed by measuring clinical response, clinical remission, endoscopic remission and overall quality of life.
The team found that rosiglitazone was an effective treatment for mild-to-moderately active UC in patients who did not respond to 5-ASA. After 12 weeks of therapy, clinical response was achieved in 23 patients (44%) treated with rosiglitazone and 12 patients (23%) treated with placebo. Patients treated with rosiglitazone had higher rates of clinical remission, but not endoscopic remission. Furthermore, patients who took rosiglitazone also experienced improvement in endoscopic appearance, stool frequency, bleeding rates and the physician's global assessment. Clinical improvement was evident as early as four weeks. While the patients' quality of life was not improved at week four or 12, significant changes were seen at week eight.
"As physicians and scientists, we seek to provide patients with safe and effective treatment options," said James Lewis, M.D., M.S.C.E., of the University of Pennsylvania and lead author of this study. "With that goal in mind, the benefits observed with rosiglitazone in animal models of colitis led us to examine whether this commonly prescribed treatment for type-2 diabetes could relieve the symptoms of ulcerative colitis. This study suggests that rosiglitazone may be a safe and effective short-term therapy for selected patients with ulcerative colitis; however, further testing of maintenance therapy with rosiglitazone is needed."
Dr. Lewis will present this study on Tuesday, May 22, at 10:30 a.m. in Room 151.
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