A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease.

A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Research Abstract Details 

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A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Abstract Text:

David M Hockenbery,Scott Cruickshank,Timothy C Rodell,Ted Gooley,Friedrich Schuening,Scott Rowley,Donald David,Mark Brunvand,Brian Berryman,Sunil Abhyankar,Michelle Bouvier,George B McDonald,

We tested the hypothesis that oral beclomethasone dipropionate (BDP) would control gastrointestinal graft-versus-host disease (GVHD) in patients with anorexia, vomiting, and diarrhea. Patients were randomized to prednisone for 10 days and either oral BDP 8 mg/d (n = 62) or placebo (n = 67) tablets for 50 days. At study day 10, prednisone was rapidly tapered while continuing study drug. On an intent-to-treat basis, the risk of GVHD-treatment failure was reduced for the BDP group at study day 50 (hazard ratio [HR] 0.63, 95% confidence interval [CI] 0.35-1.13) and at 30 days follow-up (HR 0.55, 95% CI 0.32-0.93). Among patients eligible for prednisone taper at study day 10, the risk of GVHD-treatment failure was significantly reduced at both study days 50 and 80 (HR 0.39 and 0.38, respectively). By day 200 after transplantation, 5 patients randomized to BDP had died compared with 16 deaths on placebo, a 67% reduction in the hazard of mortality (HR 0.33, P = .03). In 47 recipients of unrelated and HLA-mismatched stem cells, mortality at transplantation day 200 was reduced by 91% in the BDP group compared with placebo (HR 0.09, P = .02). The survival benefit was durable to 1 year after randomization. Oral BDP prevents relapses of gastrointestinal GVHD following tapering of prednisone; survival is statistically significantly better among patients receiving BDP.

A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Publishing Authors By Initials

DM Hockenbery,S Cruickshank,TC Rodell,T Gooley,F Schuening,S Rowley,D David,M Brunvand,B Berryman,S Abhyankar,M Bouvier,GB McDonald,

For similar diagnosis: prognosis: treatment outcome research abstracts see: diagnosis: prognosis: treatment outcome research

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A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Journal Published:

PUBLICATION TYPE: Research Support, U.S. Gov't,

Journal: Blood

VOLUME: 109

Page Numbers: 4557-63

Journal Abbreviation:

ISSN: 0006-4971

DAY: 23

MONTH: 01

YEAR: 2007

A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Information

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LANGUAGE: eng

NlmUniqueID: 7603509

A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Keywords Mesh Terms:

KEYWORDS: Treatment Outcome

MESH TERMS: pharmacology

Chemical & Substance for Abstract: A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Information

Substance Name: Prednisone

Registry Number: 53-03-2

Grant and Affiliation Information for A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease.

AFFILIATION: Fred Hutchinson Cancer Research Center, University of Washington, School of Medicine, Seattle, WA 98109-1024, USA. dhockenb@fhcrc.org

Country: United States

AGENCY: United States FDA

GRANT: FD-R 02599

ACRONYM: FD

MEDLINETA: Blood

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