PMID- 26094251
OWN - NLM
STAT- MEDLINE
DCOM- 20160531
LR  - 20181113
IS  - 1876-4479 (Electronic)
IS  - 1873-9946 (Print)
IS  - 1873-9946 (Linking)
VI  - 9
IP  - 9
DP  - 2015 Sep
TI  - Budesonide MMX for the Induction of Remission of Mild to Moderate Ulcerative 
      Colitis: A Pooled Safety Analysis.
PG  - 738-46
LID - 10.1093/ecco-jcc/jjv101 [doi]
AB  - BACKGROUND AND AIMS: Cumulative safety and tolerability of budesonide MMX, a 
      once-daily oral corticosteroid for inducing mild to moderate ulcerative colitis 
      remission, was examined. METHODS: Data from three randomized, double-blind, 
      placebo-controlled, phase II or III studies [budesonide MMX 9 mg, 6 mg, or 3mg 
      for 8 weeks]; one phase II study [randomisation to budesonide MMX 9 mg or placebo 
      for 4 weeks, then open-label budesonide MMX 9 mg for 4 weeks]; and one open-label 
      study [budesonide MMX 9 mg for 8 weeks] were pooled. RESULTS: Patients randomised 
      to budesonide MMX 9 mg [n = 288], 6 mg [n = 254], or placebo [n = 293] had 
      similar rates of adverse events [AEs] [27.1%, 24.8%, and 23.9%, respectively] and 
      serious AEs [2.4%, 2.0%, and 2.7%, respectively]; treatment-related AEs and 
      serious AEs were reported by 11.8% and 13.5%, and 5.9% and 2.2%, respectively, of 
      patients receiving budesonide MMX 3mg [n = 17] or open-label budesonide MMX 9 mg 
      [n = 89]. Mean morning plasma cortisol concentrations were normal from baseline 
      to final visit across randomised groups; in patients receiving open-label 
      budesonide, mean cortisol concentration was 129.9 nmol/l after 4 weeks, returning 
      to normal concentrations at final visit. Budesonide MMX was not associated with 
      an overall increased risk for glucocorticoid-related adverse effects. 
      CONCLUSIONS: Budesonide MMX 9 mg was associated with normal mean cortisol 
      concentrations at final visit and an AE incidence comparable to placebo. Overall, 
      budesonide MMX was safe and well tolerated for inducing remission of patients 
      with mild to moderate ulcerative colitis.
CI  - Copyright (c) 2015 European Crohn's and Colitis Organisation (ECCO). Published by 
      Oxford University Press. All rights reserved. For permissions, please email: 
      journals.permissions@oup.com.
FAU - Lichtenstein, Gary R
AU  - Lichtenstein GR
AD  - Division of Gastroenterology, Department of Medicine, University of Pennsylvania, 
      Philadelphia, PA, USA grl@uphs.upenn.edu.
FAU - Travis, Simon
AU  - Travis S
AD  - Translational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK.
FAU - Danese, Silvio
AU  - Danese S
AD  - Instituto Clinico Humanitas, Milan, Italy.
FAU - D'Haens, Geert
AU  - D'Haens G
AD  - Academic Medical Center, Amsterdam, The Netherlands.
FAU - Moro, Luigi
AU  - Moro L
AD  - Cosmo Technologies Ltd, Dublin, Ireland.
FAU - Jones, Richard
AU  - Jones R
AD  - Cosmo Technologies Ltd, Dublin, Ireland.
FAU - Huang, Michael
AU  - Huang M
AD  - Santarus, Inc., San Diego, CA, USA.
FAU - Ballard, E David
AU  - Ballard ED
AD  - Santarus, Inc., San Diego, CA, USA.
FAU - Bagin, Robert
AU  - Bagin R
AD  - Santarus, Inc., San Diego, CA, USA.
FAU - Hardiman, Yun
AU  - Hardiman Y
AD  - Santarus, Inc., San Diego, CA, USA.
FAU - Collazo, Raul
AU  - Collazo R
AD  - Santarus, Inc., San Diego, CA, USA.
FAU - Sandborn, William J
AU  - Sandborn WJ
AD  - University of California San Diego, La Jolla, CA, USA.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20150620
PL  - England
TA  - J Crohns Colitis
JT  - Journal of Crohn's & colitis
JID - 101318676
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Biomarkers)
RN  - 51333-22-3 (Budesonide)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents/*therapeutic use
MH  - Biomarkers/blood
MH  - Budesonide/*therapeutic use
MH  - Colitis, Ulcerative/blood/*drug therapy
MH  - Drug Administration Schedule
MH  - Drug Monitoring
MH  - Female
MH  - Humans
MH  - Hydrocortisone/blood
MH  - *Induction Chemotherapy
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC4736820
OTO - NOTNLM
OT  - Budesonide MMX
OT  - safety
OT  - tolerability
OT  - ulcerative colitis
EDAT- 2015/06/22 06:00
MHDA- 2016/06/01 06:00
PMCR- 2015/06/20
CRDT- 2015/06/22 06:00
PHST- 2014/11/07 00:00 [received]
PHST- 2015/05/05 00:00 [accepted]
PHST- 2015/06/22 06:00 [entrez]
PHST- 2015/06/22 06:00 [pubmed]
PHST- 2016/06/01 06:00 [medline]
PHST- 2015/06/20 00:00 [pmc-release]
AID - jjv101 [pii]
AID - 10.1093/ecco-jcc/jjv101 [doi]
PST - ppublish
SO  - J Crohns Colitis. 2015 Sep;9(9):738-46. doi: 10.1093/ecco-jcc/jjv101. Epub 2015 
      Jun 20.