Table 2.
Summary of controlled trials of modified release mesalamine for maintenance of remission in ulcerative colitis
| Study author | Number randomized | Treatment arm | Comparator arm | Remission | Comments |
|---|---|---|---|---|---|
| Mesalamine Study Group31 | n = 264 | Mesalamine 1.6 g or 0.8 g for 6 months | Placebo | 70% (1.6 g) 63% (0.8 g) 48% (placebo) |
Intention to treat analysis Both doses superior to placebo |
| Riley35 | n = 100 | Mesalamine 0.8–1.6 g for 48 weeks | Sulfasalazine 2–4 g | 62% (Mes) 61% (SSZ) |
Treatment equivalence demonstrated |
| d’Albasio32 | n = 69 | Mesalamine 1.6 g with twice weekly 5-ASA enema for 12 months | Mesalamine 1.6 g | 61% (combo) 31% (oral) |
Combination therapy superior to oral mesalamine alone |
| Courtney36 | n = 100 | Mesalamine 1.2 g for 12 months | Olsalazine 1 g | 54% (Mes) 76% (Ols) |
Olsalazine superior to mesalamine |
| Green37 | n = 99 | Mesalamine 1.2 g for 12 months | Balsalazide 3.0 g | 58% (Mes) 58% (Bal) |
Treatment equivalence demonstrated |
| Prantera41 | n = 331 | Mesalamine 2.4 g for 12 months | MMX 5-ASA 2.4 g | 66% (Mes) 68% (MMX) |
Treatment equivalence demonstrated |
Abbreviations: Mes, mesalamine; Bal, balsalazide; SSZ, sulfasalazine; Ols, olsalazine; MMX, multimatrix formulation.