TY - JOUR
T1 - Safety and efficacy of controlled-release mesalamine for maintenance of remission in ulcerative colitis
AU - Miner, Philip
AU - Hanauer, Stephen
AU - Robinson, Malcolm
AU - Schwartz, Jerrold
AU - Arora, Sanjeev
N1 - Copyright:
Copyright 2007 Elsevier B.V., All rights reserved.
PY - 1995/2
Y1 - 1995/2
N2 - 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.
AB - 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.
KW - 5-aminosalicylic acid
KW - controlled-release mesalamine capsules
KW - recurrence
KW - remission maintenance
KW - ulcerative colitis
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U2 - 10.1007/BF02065413
DO - 10.1007/BF02065413
M3 - Article
C2 - 7851193
AN - SCOPUS:0028804562
SN - 0163-2116
VL - 40
SP - 296
EP - 304
JO - Digestive diseases and sciences
JF - Digestive diseases and sciences
IS - 2
ER -