PMID- 26563167
OWN - NLM
STAT- MEDLINE
DCOM- 20160510
LR  - 20181113
IS  - 1573-2568 (Electronic)
IS  - 0163-2116 (Print)
IS  - 0163-2116 (Linking)
VI  - 61
IP  - 1
DP  - 2016 Jan
TI  - Long-Term Benefit of Mesalamine Granules for Patients Who Achieved 
      Corticosteroid-Induced Ulcerative Colitis Remission.
PG  - 221-9
LID - 10.1007/s10620-015-3866-7 [doi]
AB  - BACKGROUND: Patients with ulcerative colitis (UC) who achieve remission with 
      corticosteroids often relapse after tapering or discontinuation; alternative 
      treatments limiting steroid exposure and UC relapse would be beneficial. It 
      remains uncertain whether patients with corticosteroid-induced remission 
      experience benefit with mesalamine granules (MG), a locally acting 
      aminosalicylate extended-release capsule formulation for maintenance of UC 
      remission in adults. AIMS: Efficacy and safety of MG 1.5 g once daily was 
      evaluated in patients with UC in corticosteroid-induced remission. METHODS: Data 
      from patients with previous corticosteroid use to achieve baseline UC remission 
      were analyzed from two 6-month randomized, double-blind, placebo-controlled 
      trials and a 24-month open-label extension (OLE). Six-month relapse-free rates 
      were assessed using the revised Sutherland Disease Activity Index. UC-related 
      adverse events (AEs) were recorded during the 30 months. RESULTS: Included were 
      158 steroid-treated patients in UC remission (MG, n = 105; placebo, n = 53) and 
      74/105 MG-treated patients who continued MG in the OLE. A significantly larger 
      percentage of patients remained relapse-free at 6 months with MG (77.1 %) versus 
      placebo (54.7 %; P = 0.006), with a 55 % reduction in relapse risk (hazard ratio 
      [HR] 0.45; 95 % CI 0.25-0.79). There was a similar (49.2 %) reduction in risk of 
      UC-related AEs at 6 months (HR 0.51; 95 % CI 0.31-0.84; P = 0.009) that was 
      sustained during the OLE. CONCLUSIONS: MG 1.5 g once daily administered for 
      maintenance of corticosteroid-induced remission was associated with low risk of 
      relapse and UC-related AEs. CLINICALTRIALS.GOV: NCT00744016, NCT00767728, and 
      NCT00326209.
FAU - Lichtenstein, Gary R
AU  - Lichtenstein GR
AD  - Division of Gastroenterology, Hospital of the University of Pennsylvania, 
      University of Pennsylvania School of Medicine, 7th Floor Perelman Center, Room 
      753, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA. 
      grl@uphs.upenn.edu.
FAU - Gordon, Glenn L
AU  - Gordon GL
AD  - Center for Digestive and Liver Diseases, Mexico, MO, USA.
FAU - Zakko, Salam
AU  - Zakko S
AD  - Connecticut Gastroenterology Institute and Clinical Research Foundation, Bristol, 
      CT, USA.
FAU - Murthy, Uma
AU  - Murthy U
AD  - Syracuse VA Medical Center, Syracuse, NY, USA.
FAU - Sedghi, Shahriar
AU  - Sedghi S
AD  - Gastroenterology Associates of Central Georgia, LLC, Macon, GA, USA.
FAU - Pruitt, Ron
AU  - Pruitt R
AD  - Nashville Medical Research Institute, The Maria Nathanson Center at Saint Thomas 
      Hospital, Nashville, TN, USA.
FAU - Barrett, Andrew C
AU  - Barrett AC
AD  - Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, 
      USA.
FAU - Bortey, Enoch
AU  - Bortey E
AD  - Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, 
      USA.
FAU - Paterson, Craig
AU  - Paterson C
AD  - Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, 
      USA.
FAU - Forbes, William P
AU  - Forbes WP
AD  - Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, 
      USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00326209
SI  - ClinicalTrials.gov/NCT00744016
SI  - ClinicalTrials.gov/NCT00767728
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20151112
PL  - United States
TA  - Dig Dis Sci
JT  - Digestive diseases and sciences
JID - 7902782
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Powders)
RN  - 4Q81I59GXC (Mesalamine)
SB  - IM
MH  - Adrenal Cortex Hormones/*administration & dosage/adverse effects
MH  - Adult
MH  - Anti-Inflammatory Agents/*administration & dosage/adverse effects
MH  - Clinical Trials, Phase III as Topic
MH  - Colitis, Ulcerative/diagnosis/*drug therapy
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Female
MH  - Gastrointestinal Agents/*administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Mesalamine/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Multicenter Studies as Topic
MH  - Powders
MH  - Randomized Controlled Trials as Topic
MH  - Recurrence
MH  - Remission Induction
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC4700064
OTO - NOTNLM
OT  - Inflammatory bowel diseases
OT  - Mesalamine
OT  - Remission
OT  - Steroids
OT  - Ulcerative colitis
EDAT- 2015/11/14 06:00
MHDA- 2016/05/11 06:00
PMCR- 2015/11/12
CRDT- 2015/11/14 06:00
PHST- 2015/04/11 00:00 [received]
PHST- 2015/09/03 00:00 [accepted]
PHST- 2015/11/14 06:00 [entrez]
PHST- 2015/11/14 06:00 [pubmed]
PHST- 2016/05/11 06:00 [medline]
PHST- 2015/11/12 00:00 [pmc-release]
AID - 10.1007/s10620-015-3866-7 [pii]
AID - 3866 [pii]
AID - 10.1007/s10620-015-3866-7 [doi]
PST - ppublish
SO  - Dig Dis Sci. 2016 Jan;61(1):221-9. doi: 10.1007/s10620-015-3866-7. Epub 2015 Nov 
      12.