Rosiglitazone for Active Ulcerative Colitis: A Randomized Placebo-Controlled Trial
| Autor: | Gary D. Wu, Bruce E. Sands, Bret A. Lashner, Lisa Nessel, Stephen B. Hanauer, Jeffrey Katz, Gary R. Lichtenstein, Julius J. Deren, Shaokun Chuai, James D. Lewis, Jonas H. Ellenberg, Daniel H. Present |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Anti-Inflammatory Agents Placebo-controlled study Administration Oral Placebo Severity of Illness Index Gastroenterology Drug Administration Schedule law.invention Rosiglitazone Double-Blind Method Gastrointestinal Agents Randomized controlled trial law Internal medicine medicine Clinical endpoint Humans Sigmoidoscopy Gastrointestinal agent Hepatology business.industry Patient Selection Colonoscopy Middle Aged medicine.disease Ulcerative colitis United States Surgery Clinical trial Treatment Outcome Quality of Life Colitis Ulcerative Female Thiazolidinediones business medicine.drug |
| Zdroj: | Gastroenterology. 134:688-695 |
| ISSN: | 0016-5085 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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