Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial.
OBJECTIVE
Thiazolidinedione ligands for the gamma subtype of peroxisome proliferator-activated receptors (PPARgamma), 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.
Lewis
James D
JD
Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA. lewisjd@mail.med.upenn.edu
Lichtenstein
Gary R
GR
Deren
Julius J
JJ
Sands
Bruce E
BE
Hanauer
Stephen B
SB
Katz
Jeffrey A
JA
Lashner
Bret
B
Present
Daniel H
DH
Chuai
Shaokun
S
Ellenberg
Jonas H
JH
Nessel
Lisa
L
Wu
Gary D
GD
D000284:Administration, Oral; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011788:Quality of Life; D000077154:Rosiglitazone; D012720:Severity of Illness Index; D012812:Sigmoidoscopy; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D000893:Anti-Inflammatory Agents; D005765:Gastrointestinal Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone