Abstract
This 12-month, double-blind, placebo-controlled study randomized 205 ulcerative colitis patients in remission to placebo or controlled-release mesalamine at 4 g/day for 12 months. Patients were stratified to either pancolitis or left-sided disease, based on previous diagnosis. Maintenance of remission was defined as a sigmoidoscopic index of <5, less than five stools per day, and the absence of rectal bleeding. A significantly greater number of patients maintained remission on mesalamine 4 g/day than on placebo at each of five study visits, following the first one-month visit (P<0.05). The estimated 12-month remission rates for the mesalamine group were 64% (38% for placebo, P=0.0004). Baseline subgroups (disease location, time since last flare of active disease, and previous response to oral/rectal steroids or sulfasalazine) did not influence remission rates. Treatment-related adverse events were rare. Controlled-release mesalamine is a safe and efficacious single agent for maintaining remission of ulcerative colitis.
Original language | English (US) |
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Pages (from-to) | 296-304 |
Number of pages | 9 |
Journal | Digestive diseases and sciences |
Volume | 40 |
Issue number | 2 |
DOIs | |
State | Published - Feb 1995 |
Keywords
- 5-aminosalicylic acid
- controlled-release mesalamine capsules
- recurrence
- remission maintenance
- ulcerative colitis
ASJC Scopus subject areas
- Physiology
- Gastroenterology