Safety and efficacy of a new 3.3 g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis: a multicenter, randomized, double-blind, placebo-controlled study.
OBJECTIVE
To evaluate the safety and efficacy of a new twice-daily balsalazide disodium 1.1 g tablet dosing regimen (6.6 g/day, three tablets twice daily) for the treatment of mild-to-moderately-active ulcerative colitis (UC).


METHODS
In a double-blind, multicenter study patients with symptoms of acute UC and a baseline Modified Mayo Disease Activity Index (MMDAI) score between 6 and 10, inclusive, with a subscale rating of > or =2 for both rectal bleeding and mucosal appearance were randomized to receive 3.3 g of balsalazide or placebo tablets twice daily for 8 weeks. The primary end point was the proportion of patients achieving clinical improvement (> or =3 point improvement in MMDAI) and improvement in rectal bleeding (> or =1 point improvement) at 8 weeks. Safety assessments were conducted from baseline through 2-weeks post-treatment.


RESULTS
A total of 249 patients (166 balsalazide, 83 placebo) received at least 1 dose of study medication. The mean MMDAI score at baseline was 7.9; 62% of patients had a score > or =8.0 (moderate disease). A significantly larger proportion of patients achieved clinical improvement and improvement in rectal bleeding in the balsalazide group vs. the placebo group (55 vs. 40%, P=0.02). The most common adverse events reported were worsening of UC and headache; both were reported more often in the placebo group.


CONCLUSIONS
Balsalazide disodium 1.1 g tablets administered as 3.3 g twice daily are effective, well tolerated and significantly better than placebo for improving signs and symptoms of mild-to-moderately-active UC. This new formulation with a reduced pill and dosing burden offers the potential to improve convenience and compliance in patients with active UC.
Scherl
Ellen J
EJ
Weill Cornell Physicians, New York, NY, USA.
Pruitt
Ronald
R
Gordon
Glenn L
GL
Lamet
Mark
M
Shaw
Audrey
A
Huang
Shirley
S
Mareya
Shadreck
S
Forbes
William P
WP
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000473:pathology / Q000517:prevention & control; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage*; D008875:Middle Aged; D010659:Phenylhydrazines / Q000008:administration & dosage*; D011446:Prospective Studies; D012007:Rectum; D012720:Severity of Illness Index; D012812:Sigmoidoscopy; D013607:Tablets; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010659:Phenylhydrazines; D013607:Tablets; D019804:Mesalamine; C038637:balsalazide