Rosiglitazone for Active Ulcerative Colitis: A Randomized Placebo-Controlled Trial

James D. Lewis*, Gary R. Lichtenstein, Julius J. Deren, Bruce E. Sands, Stephen B. Hanauer, Jeffrey A. Katz, Bret Lashner, Daniel H. Present, Shaokun Chuai, Jonas H. Ellenberg, Lisa Nessel, Gary D. Wu

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

175 Scopus citations

Abstract

Background & Aims: Thiazolidinedione ligands for the gamma subtype of peroxisome proliferator-activated receptors (PPARγ), widely used to treat type 2 diabetes mellitus, have been proposed as novel therapies for ulcerative colitis (UC). Methods: This multicenter, randomized, double-blind, placebo-controlled clinical trial compared the efficacy of rosiglitazone (Avandia; GlaxoSmithKline, Philadelphia, PA) 4 mg orally twice daily vs placebo twice daily for 12 weeks in 105 patients with mild to moderately active UC. Disease activity was measured with the Mayo score. The primary end point was clinical response (≥2-point reduction) at week 12. Clinical remission (Mayo score ≤2), endoscopic remission, and quality of life were secondary outcomes. Results: After 12 weeks of therapy, 23 patients (44%) treated with rosiglitazone and 12 patients (23%) treated with placebo achieved clinical response (P = .04). Remission was achieved in 9 patients (17%) treated with rosiglitazone and 1 patient (2%) treated with placebo (P = .01). Endoscopic remission was uncommon in either treatment arm (8% rosiglitazone vs 2% placebo; P = .34). Clinical improvement was evident as early as 4 weeks after beginning treatment (P = .049). Quality of life was improved significantly at week 8 (P = .01), but not at week 4 (P = .48) or week 12 (P = .14). Serious adverse events were rare. Conclusions: Rosiglitazone was efficacious in the treatment of mild to moderately active UC.

Original languageEnglish (US)
Pages (from-to)688-695
Number of pages8
JournalGastroenterology
Volume134
Issue number3
DOIs
StatePublished - Mar 2008

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Fingerprint

Dive into the research topics of 'Rosiglitazone for Active Ulcerative Colitis: A Randomized Placebo-Controlled Trial'. Together they form a unique fingerprint.

Cite this