Caution in the interpretation of safety and efficacy differences in clinical trials comparing aminosalicylates for ulcerative colitis [3]

American Journal of Gastroenterology

Volumn 98, Issue 1, 2003, Pages 215-216

  Hanauer, Stephen B ^a  

^a UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

5 ACETAMIDOSALICYLIC ACID; AMINOSALICYLIC ACID DERIVATIVE; BALSALAZIDE; MESALAZINE;

CLINICAL TRIAL; DISEASE SEVERITY; DOSE RESPONSE; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; HUMAN; LETTER; PRIORITY JOURNAL; RECTUM HEMORRHAGE; STATISTICAL ANALYSIS; ULCERATIVE COLITIS;

EID: 0037253856     PISSN: 00029270     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1572-0241.2003.07205.x     Document Type: Letter

References (8)

1. Levine DS, Riff DS, Pruitt R, et al. A randomized, double blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative colitis. Am J Gastroenterol 2002;97:1398-407.
2. Pruitt R, Hanson J, Safdj M, et al. Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute ulcerative colitis. Gastroenterology 2000;118:A756 (abstract).
3. A phase III randomized, placebo-controlled, double-blind, dose response comparison of Colazide 4.5 g and 6.75 g daily vs placebo in patients with active mild to moderate ulcerative colitis. Colazide (balsalazide disodium) UK Monograph.
4. Green JRB, Lobo AJ, Holdsworth CD, et al. Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. Gastroenterology 1998;114:15-22.
5. Farrell RJ, Peppercorn MA. Equimolar doses of balsalazide and mesalamine: Are we comparing apples and oranges? Am J Gastroenterol 2002;97:1283-5.
6. Sandborn WJ, Hanauer SB. Comparable systemic absorption of 5-ASA and N-AC-5-ASA from U.S. Asacol and Colazal. Submitted to Am J Gastroenterol, June 2002.
7. Sandborn WJ, Hanauer SB. The pharmacokinetic profiles of oral 5 ASA formulations used in the management of ulcerative colitis: A systematic review. Aliment Pharmacol Ther. In press.
8. Riley SA, Tavares IA, Bennett A, et al. Delayed-release mesalazine (5-aminosalicylic acid): Coat dissolution and excretion in ileostomy subjects. Gastroenterol 1988;94:A377 (abstract).