Phase II study of the safety and efficacy of a 5-lipoxygenase inhibitor in patients with ulcerative colitis.
We examined the effects of an inhibitor of 5-lipoxygenase (A-64077) in 11 patients with mild to moderately active ulcerative colitis (UC). Treatment was a daily oral dose of 800 mg for 28 days. Physicians global rating (scale 1-50) included stool characteristics, rectal bleeding, abdominal and rectal pain, urgency, and general well being; sigmoidoscopic evaluation (scale 1-15) included mucosal vascular pattern, erythema, granularity/ulcerations, friability, and exudate. All of the patients experienced a decrease in discomfort of their disease, and the gross appearance in the sigmoidoscopy improved in eight of them, but were not accompanied by histologic improvement. No significant side effects occurred. A long-term controlled double-blind and dose-effect trial using 5-lipoxygenase inhibitors is needed which may lead to a new therapeutic approach in UC.
Collawn
C
C
Instituto Nacional de la Nutrición Salvador Zubirán, Mexico City, Mexico.
Rubin
P
P
Perez
N
N
Bobadilla
J
J
Cabrera
G
G
Reyes
E
E
Borovoy
J
J
Kershenobich
D
D
D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D006918:Hydroxyurea / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016859:Lipoxygenase Inhibitors / Q000627:therapeutic use*; D008297:Male; D012812:Sigmoidoscopy
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016859:Lipoxygenase Inhibitors; C063449:zileuton; D006918:Hydroxyurea