Original articleEffect of Once- or Twice-Daily MMX Mesalamine (SPD476) for the Induction of Remission of Mild to Moderately Active Ulcerative Colitis
Section snippets
Participants
Eligible male and female patients aged ≥18 years with newly diagnosed or relapsing (relapsed ≤6 weeks before baseline) mild to moderately active UC (score of 4–10 on a modified version of the Sutherland UC–disease activity index16 (UC-DAI) (Table 1), with a sigmoidoscopy score ≥1 and a Physician’s Global Assessment (PGA) score ≤2 with compatible histology, were enrolled in the study.
Patients were excluded from the study if they had: severe UC defined by PGA >2; current relapse lasting >6 weeks;
Results
The study was conducted between September 2003 and January 2005. Two hundred eighty patients were randomized from 52 centers in Australia (n = 3), the Czech Republic (n = 16), India (n = 71), Mexico (n = 18 [this country group also included 1 center in Costa Rica]), New Zealand (n = 12), Romania (n = 11), the Ukraine (n = 78), and the USA (n = 71). Ten patients underwent forced randomization (5 in each of the SPD476 2.4 g/day given twice daily and SPD476 4.8 g/day given once daily groups).
Discussion
This study demonstrates that MMX mesalamine, given once or twice daily, was efficacious for the induction of clinical and endoscopic remission of mild to moderately active UC. Significantly more patients receiving either dose of MMX mesalamine achieved clinical and endoscopic remission than those receiving placebo (P < .01). Approximately 1 in 3 patients in both MMX mesalamine groups achieved clinical and endoscopic remission compared with 1 in 8 in the placebo group (a 2.3-fold to 2.6-fold
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Supported by Shire Pharmaceuticals Inc. Gary Lichtenstein, Michael Kamm, and William Sandborn have served as consultants for Shire and have participated in continuing medical education events indirectly sponsored by Shire Pharmaceuticals Inc. Andrew Lyne, Kristen H. Lees, and Raymond Joseph are employees of Shire Pharmaceuticals. Gary Lichtenstein has received honoraria and research support from Shire Pharmaceuticals, Proctor and Gamble, Salix Pharmaceuticals, and Axcan Pharmaceuticals.