PMID- 25869389
OWN - NLM
STAT- MEDLINE
DCOM- 20150720
LR  - 20181113
IS  - 1572-0241 (Electronic)
IS  - 0002-9270 (Linking)
VI  - 110
IP  - 5
DP  - 2015 May
TI  - Oral prolonged release beclomethasone dipropionate and prednisone in the 
      treatment of active ulcerative colitis: results from a double-blind, randomized, 
      parallel group study.
PG  - 708-15
LID - 10.1038/ajg.2015.114 [doi]
AB  - OBJECTIVES: Double-blind study comparing efficacy and safety of the topically 
      acting corticosteroid beclomethasone dipropionate (BDP) to prednisone (PD) in 
      patients with active, mild-to-moderate ulcerative colitis (UC). METHODS: Overall, 
      282 patients were randomized to receive BDP-prolonged release tablets 5 mg once 
      daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 
      40 mg once daily for the initial 2 weeks tapered of 10 mg every 2 weeks during 
      the 8-week study period. Efficacy end point was the non-inferiority of BDP vs. PD 
      in terms of Disease Activity Index (DAI) score <3 or reduction by at least 3 
      points for patients with a baseline DAI >/=7 at week 4. Safety end point was the 
      proportion of patients with steroid-related adverse events (AEs) and cortisol 
      <150 nmol/l at week 4. RESULTS: DAI response rates at week 4 were 64.6% and 66.2% 
      with BDP and PD, respectively, demonstrating non-inferiority of BDP vs. PD 
      (delta: -1.56; 95% confidence interval (CI) -13.00-9.88, P=0.78). Patients with 
      steroid-related AEs and cortisol <150 nmol/l at week 4 were 38.7% in the BDP 
      group and 46.9% in the PD group (P=0.17 between groups). No safety signals were 
      observed in both the groups. CONCLUSIONS: BDP was non-inferior to PD in the 
      treatment of active UC, with a good safety profile in both the groups.
FAU - Van Assche, Gert
AU  - Van Assche G
AD  - Department of Gastroenterology, UZ Gasthuisberg, Leuven, Belgium.
FAU - Manguso, Francesco
AU  - Manguso F
AD  - Division of Gastroenterology and Endoscopy, Cardarelli Hospital, Naples, Italy.
FAU - Zibellini, Marco
AU  - Zibellini M
AD  - Corporate Clinical Development, Chiesi Farmaceutici S.p.A., Parma, Italy.
FAU - Cabriada Nuno, Jose Luis
AU  - Cabriada Nuno JL
AD  - Hospital Galdakao, Barrio Labeaga, Vizcaya, Spain.
FAU - Goldis, Adrian
AU  - Goldis A
AD  - Policlinica Algomed, Centru Medical e Gastroenterologie, Medicina Interna si 
      Nefrologie, Timisoara, Romania.
FAU - Tkachenko, Evgeniy
AU  - Tkachenko E
AD  - St Petersburg State Medical Academy n.a. I.I. Mechnikov, St Petersburg, Russia.
FAU - Varoli, Guido
AU  - Varoli G
AD  - Corporate Clinical Development, Chiesi Farmaceutici S.p.A., Parma, Italy.
FAU - Kleczkowski, Dariusz
AU  - Kleczkowski D
AD  - Endoskopia B. Chrobrego 6/8 81-756, Sopot, Poland.
FAU - Annese, Vito
AU  - Annese V
AD  - Department of Gastroenterology, University Hospital Careggi, Florence, Italy.
FAU - D'Heygere, Francois
AU  - D'Heygere F
AD  - Department of Gastroenterology and Hepatology, AZ Groeninge, Kortrijk, Belgium.
FAU - Balzano, Antonio
AU  - Balzano A
AD  - Division of Gastroenterology and Endoscopy, Cardarelli Hospital, Naples, Italy.
CN  - BETA study participating centers
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150414
PL  - United States
TA  - Am J Gastroenterol
JT  - The American journal of gastroenterology
JID - 0421030
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Tablets, Enteric-Coated)
RN  - KGZ1SLC28Z (Beclomethasone)
RN  - VB0R961HZT (Prednisone)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
EIN - Am J Gastroenterol. 2015 Jun;110(6):943. PMID: 26052781
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents/*administration & dosage/adverse effects
MH  - Beclomethasone/*administration & dosage/adverse effects
MH  - Colitis, Ulcerative/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Hydrocortisone/blood
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Prednisone/*administration & dosage/adverse effects
MH  - Severity of Illness Index
MH  - Tablets, Enteric-Coated
MH  - Young Adult
EDAT- 2015/04/15 06:00
MHDA- 2015/07/21 06:00
CRDT- 2015/04/15 06:00
PHST- 2014/10/09 00:00 [received]
PHST- 2015/03/17 00:00 [accepted]
PHST- 2015/04/15 06:00 [entrez]
PHST- 2015/04/15 06:00 [pubmed]
PHST- 2015/07/21 06:00 [medline]
AID - ajg2015114 [pii]
AID - 10.1038/ajg.2015.114 [doi]
PST - ppublish
SO  - Am J Gastroenterol. 2015 May;110(5):708-15. doi: 10.1038/ajg.2015.114. Epub 2015 
      Apr 14.