Thiazolidinedione ligands for the gamma subtype of peroxisome proliferator-activated receptors, widely used to treat type 2 diabetes mellitus, have been proposed as novel therapies for ulcerative colitis.
Dr James Lewis and colleagues from Pennsylvania, USA conducted a multicenter, randomized, double-blind, placebo-controlled clinical trial the efficacy of rosiglitazone in patients with ulcerative colitis.
The team assessed rosiglitazone 4 mg orally twice daily vs placebo twice daily for 12 weeks in 105 patients with mild to moderately active ulcerative colitis.
The team measured disease activity with the Mayo score.
|44% treated with rosiglitazone achieved clinical response|
The primary end point was clinical response at week 12.
Clinical remission, endoscopic remission, and quality of life were secondary outcomes.
The researchers found that after 12 weeks of therapy, 44% of patients treated with rosiglitazone and 23% of patients treated with placebo achieved clinical response.
Remission was achieved in 17% of patients treated with rosiglitazone and 2% treated with placebo.
The team found that endoscopic remission was uncommon in either treatment arm.
Clinical improvement was evident as early as 4 weeks after beginning treatment.
The researchers observed that quality of life was improved significantly at week 8, but not at week 4 or week 12.
Serious adverse events were rare.
Dr Lewis' team concluded, "Rosiglitazone was efficacious in the treatment of mild to moderately active ulcerative colitis."