Treatment of ulcerative colitis with balsalazide: Response to Editorial by Drs. Farrell and Peppercorn and Letter to the Editor by Dr. Hanauer [4]

American Journal of Gastroenterology

Volumn 98, Issue 1, 2003, Pages 216-219

  Johnson, Lorin K ^a   Pruitt, Ronald E ^b   Green, Johnathan R B ^c  

^a Salix a Division of Valeant Pharmaceuticals North America LLC   (United States)

^b Nashville Medical Research Institute   (United States)

^c CITY GENERAL HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

5 ACETAMIDOSALICYLIC ACID; BALSALAZIDE; MESALAZINE;

AREA UNDER THE CURVE; DOSE RESPONSE; DRUG FORMULATION; DRUG MARKETING; DRUG SOLUBILITY; HUMAN; LETTER; PRIORITY JOURNAL; SCORING SYSTEM; SIGMOIDOSCOPY; TREATMENT OUTCOME; ULCERATIVE COLITIS; UNITED KINGDOM; UNITED STATES;

EID: 0037253959     PISSN: 00029270     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1572-0241.2003.07204.x     Document Type: Letter

References (13)

1. Farrell RJ, Peppercorn MA. Equimolar doses of balsalazide and mesalamine: Are we comparing apples and oranges? Am J Gastroenterol 2002;97:1283-5.
2. Hanauer SB. Caution in the interpretation of safety and efficacy differences in clinical trials comparing aminosalicylates for ulcerative colitis. Am J Gastroenterol 2003;98:215-16.
3. 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.
4. Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharmaceut Technol 1996;6:64-74.
5. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 1987;317:1625-9.
6. Sninsky CA, Cort DH, Shanahan F, et al. Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis - A multicenter study. Ann Intern Med 1991;15:350-5.
7. New Drug Application 19-651 Medical Officer's Review. Food and Drug Administration, Rockville, MD. November 15, 1990:130-2.
8. US Pharmacopeia and National Formulary, Twenty-five. United States Pharmacopeial Convention, Inc., Rockville, MD. 2002:1087-8.
9. Hebden JM, Blackshaw PE, Perkins AC, et al. Limited exposure of the healthy distal colon to orally-dosed formulation is further exaggerated in active left-sided ulcerative colitis. Aliment Pharmacol Ther 2000;14:155-61.
10. 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.
11. Green JRB, Allen G, Jung D, Johnson LK. Comparative pharmacokinetic study of three different ulcerative colitis medications: Balsalazide, mesalamine and sulfasalazine (abstract). Gastroenterology 2001;118:A756.
12. 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.
13. Pruitt R, Hanson J, Safdi M, et al. Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute ulcerative colitis (abstract). Gastroenterology 2000;118:A756.