An Open-Label Trial of the PPAR γ Ligand Rosiglitazone for Active Ulcerative Colitis

Lewis, James D.; Lichtenstein, Gary R.; Stein, Robert B.; Deren, Julius J.; Judge, Thomas A.; Fogt, Franz; Furth, Emma E.; Demissie, E. J.; Hurd, Linda B.; Su, Chinyu G.; Keilbaugh, Sue A.; Lazar, Mitchell A.; Wu, Gary D.
December 2001
American Journal of Gastroenterology;Dec2001, Vol. 96 Issue 12, p3323
Academic Journal
OBJECTIVES: Previous research has demonstrated that ligands for the γ subtype of peroxisome proliferator-activated receptors (PPARs) reduce Inflammation in two different murine models of colitis. This study was designed to examine the potential efficacy of rosiglitazone, a ligand for the 7 subtype of PPARs as a therapy for active ulcerative colitis. METHODS: Fifteen patients with mild to moderately active ulcerative colitis despite therapy with 5-aminosalicylic acid compounds were enrolled in an open-label study of rosiglitazone (4 mg b.i.d. p.o.) for 12 wk. Thirteen of 15 patients were receiving concomitant therapy with corticosteroids and/or immunomodulator medications. Disease activity was measured with the Disease Activity Index. RESULTS: After 12 wk of therapy, four patients (27%) had achieved clinical remission, of whom three (20%) also had an endoscopic remission. Pour additional patients (27%) had a clinical response without achieving remission. Two patients were hospitalized with worsened disease activity, and one patient was withdrawn for nephrotic syndrome. CONCLUSIONS: These data suggest that ligands for the γ subtype of PPARs may represent a novel therapy for ulcerative colitis. A double blind, placebo-controlled, randomized trial is warranted.


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