Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: A single-blind randomized controlled trial

Paolo Gionchetti, Agesilao D'Arienzo, Fernando Rizzello, Francesco Manguso, Roberto Maieron, Pier Enrico Lecis, Daniela Valpiani, Gaetano Iaquinto, Vito Annese, Antonio Balzano, Guido Varoli, Massimo Campieri, Raffaele Bennato, Maurizio Zilli, Franco Costan Biedo, Bastianello Germana, Antonio Bove, Giovanni Lombardi, Luigi Pasquale, Angelo AndriulliGiuseppe D'Albasio, Siro Bagnoli, Salvatore Adamo, Serena Desideri, Giorgio Benedetti, Renato Sablich, Gabriele Riegler, Luigi Caserta, Marco Belletta, Antonio Benedetti, Francesco Ridolfi, Adriano Blasi, Gaetano Inserra, Alberto Prada, Oscar Ferrau, Santi Turiano, Pietro Loriga, Alessandro Muscas, Raimondo Murgia, Enrico Colombo, Eugenio Canevelli, Giorgio Menardo, Franco Dagnino, Fabio Monica, Massimo Giordano, Iliana Torelli, Davide Lo Cuoco, Erica Villa, Giampiero Rigo, Angela Bertani, Claudia Cremonini, Giorgio Minoli, Gianmichele Meucci, Massimo Cattoni

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

Goals: Therapy for active ulcerative colitis (UC) usually involves rectal formulations of corticosteroids (CS), which are characterized by the risk of systemic steroid-related adverse effects. Background: To compare the efficacy and safety of the topically acting CS beclomethasone dipropionate (BDP) versus mesalamine (5-ASA) in the treatment of active UC. Study: Patients with mild to moderate distal active UC were randomized to a 6-week treatment with BDP 3 mg enema o.d. or 5-ASA 1 g enema daily in a single-blind, multicenter, parallel-group, controlled study. The primary efficacy variable was the decrease in Disease Activity Index (DAI) score. Safety variables were adrenal function, monitoring of adverse events, vital signs, and laboratory parameters. Results: A total of 217 patients were enrolled and treated with BDP (n = 111) or 5-ASA (n = 106). A significant decrease in the DAI score (P <0.05) was observed in both treatment groups, with a clinical remission rate of 36.7% in the BDP group and of 29.2% in the 5-ASA group. Both treatments were well tolerated. No changes from baseline in morning cortisol levels were observed in the BDP group. Conclusions: BDP administered as a rectal enema over a 6-week treatment period was efficacious and safe in patients with active UC, without interference with pituitary adrenal axis.

Original languageEnglish
Pages (from-to)291-297
Number of pages7
JournalJournal of Clinical Gastroenterology
Volume39
Issue number4
DOIs
Publication statusPublished - Apr 2005

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Beclomethasone
Mesalamine
Ulcerative Colitis
Randomized Controlled Trials
Enema
Adrenal Cortex Hormones
Therapeutics
Safety
Vital Signs
Hydrocortisone
Steroids

Keywords

  • Beclomethasone
  • Mesalamine
  • Topical therapy
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine : A single-blind randomized controlled trial. / Gionchetti, Paolo; D'Arienzo, Agesilao; Rizzello, Fernando; Manguso, Francesco; Maieron, Roberto; Lecis, Pier Enrico; Valpiani, Daniela; Iaquinto, Gaetano; Annese, Vito; Balzano, Antonio; Varoli, Guido; Campieri, Massimo; Bennato, Raffaele; Zilli, Maurizio; Biedo, Franco Costan; Germana, Bastianello; Bove, Antonio; Lombardi, Giovanni; Pasquale, Luigi; Andriulli, Angelo; D'Albasio, Giuseppe; Bagnoli, Siro; Adamo, Salvatore; Desideri, Serena; Benedetti, Giorgio; Sablich, Renato; Riegler, Gabriele; Caserta, Luigi; Belletta, Marco; Benedetti, Antonio; Ridolfi, Francesco; Blasi, Adriano; Inserra, Gaetano; Prada, Alberto; Ferrau, Oscar; Turiano, Santi; Loriga, Pietro; Muscas, Alessandro; Murgia, Raimondo; Colombo, Enrico; Canevelli, Eugenio; Menardo, Giorgio; Dagnino, Franco; Monica, Fabio; Giordano, Massimo; Torelli, Iliana; Cuoco, Davide Lo; Villa, Erica; Rigo, Giampiero; Bertani, Angela; Cremonini, Claudia; Minoli, Giorgio; Meucci, Gianmichele; Cattoni, Massimo.

In: Journal of Clinical Gastroenterology, Vol. 39, No. 4, 04.2005, p. 291-297.

Research output: Contribution to journalArticle

Gionchetti, P, D'Arienzo, A, Rizzello, F, Manguso, F, Maieron, R, Lecis, PE, Valpiani, D, Iaquinto, G, Annese, V, Balzano, A, Varoli, G, Campieri, M, Bennato, R, Zilli, M, Biedo, FC, Germana, B, Bove, A, Lombardi, G, Pasquale, L, Andriulli, A, D'Albasio, G, Bagnoli, S, Adamo, S, Desideri, S, Benedetti, G, Sablich, R, Riegler, G, Caserta, L, Belletta, M, Benedetti, A, Ridolfi, F, Blasi, A, Inserra, G, Prada, A, Ferrau, O, Turiano, S, Loriga, P, Muscas, A, Murgia, R, Colombo, E, Canevelli, E, Menardo, G, Dagnino, F, Monica, F, Giordano, M, Torelli, I, Cuoco, DL, Villa, E, Rigo, G, Bertani, A, Cremonini, C, Minoli, G, Meucci, G & Cattoni, M 2005, 'Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: A single-blind randomized controlled trial', Journal of Clinical Gastroenterology, vol. 39, no. 4, pp. 291-297. https://doi.org/10.1097/01.mcg.0000155124.74548.61
Gionchetti, Paolo ; D'Arienzo, Agesilao ; Rizzello, Fernando ; Manguso, Francesco ; Maieron, Roberto ; Lecis, Pier Enrico ; Valpiani, Daniela ; Iaquinto, Gaetano ; Annese, Vito ; Balzano, Antonio ; Varoli, Guido ; Campieri, Massimo ; Bennato, Raffaele ; Zilli, Maurizio ; Biedo, Franco Costan ; Germana, Bastianello ; Bove, Antonio ; Lombardi, Giovanni ; Pasquale, Luigi ; Andriulli, Angelo ; D'Albasio, Giuseppe ; Bagnoli, Siro ; Adamo, Salvatore ; Desideri, Serena ; Benedetti, Giorgio ; Sablich, Renato ; Riegler, Gabriele ; Caserta, Luigi ; Belletta, Marco ; Benedetti, Antonio ; Ridolfi, Francesco ; Blasi, Adriano ; Inserra, Gaetano ; Prada, Alberto ; Ferrau, Oscar ; Turiano, Santi ; Loriga, Pietro ; Muscas, Alessandro ; Murgia, Raimondo ; Colombo, Enrico ; Canevelli, Eugenio ; Menardo, Giorgio ; Dagnino, Franco ; Monica, Fabio ; Giordano, Massimo ; Torelli, Iliana ; Cuoco, Davide Lo ; Villa, Erica ; Rigo, Giampiero ; Bertani, Angela ; Cremonini, Claudia ; Minoli, Giorgio ; Meucci, Gianmichele ; Cattoni, Massimo. / Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine : A single-blind randomized controlled trial. In: Journal of Clinical Gastroenterology. 2005 ; Vol. 39, No. 4. pp. 291-297.
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abstract = "Goals: Therapy for active ulcerative colitis (UC) usually involves rectal formulations of corticosteroids (CS), which are characterized by the risk of systemic steroid-related adverse effects. Background: To compare the efficacy and safety of the topically acting CS beclomethasone dipropionate (BDP) versus mesalamine (5-ASA) in the treatment of active UC. Study: Patients with mild to moderate distal active UC were randomized to a 6-week treatment with BDP 3 mg enema o.d. or 5-ASA 1 g enema daily in a single-blind, multicenter, parallel-group, controlled study. The primary efficacy variable was the decrease in Disease Activity Index (DAI) score. Safety variables were adrenal function, monitoring of adverse events, vital signs, and laboratory parameters. Results: A total of 217 patients were enrolled and treated with BDP (n = 111) or 5-ASA (n = 106). A significant decrease in the DAI score (P <0.05) was observed in both treatment groups, with a clinical remission rate of 36.7{\%} in the BDP group and of 29.2{\%} in the 5-ASA group. Both treatments were well tolerated. No changes from baseline in morning cortisol levels were observed in the BDP group. Conclusions: BDP administered as a rectal enema over a 6-week treatment period was efficacious and safe in patients with active UC, without interference with pituitary adrenal axis.",
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T1 - Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine

T2 - A single-blind randomized controlled trial

AU - Gionchetti, Paolo

AU - D'Arienzo, Agesilao

AU - Rizzello, Fernando

AU - Manguso, Francesco

AU - Maieron, Roberto

AU - Lecis, Pier Enrico

AU - Valpiani, Daniela

AU - Iaquinto, Gaetano

AU - Annese, Vito

AU - Balzano, Antonio

AU - Varoli, Guido

AU - Campieri, Massimo

AU - Bennato, Raffaele

AU - Zilli, Maurizio

AU - Biedo, Franco Costan

AU - Germana, Bastianello

AU - Bove, Antonio

AU - Lombardi, Giovanni

AU - Pasquale, Luigi

AU - Andriulli, Angelo

AU - D'Albasio, Giuseppe

AU - Bagnoli, Siro

AU - Adamo, Salvatore

AU - Desideri, Serena

AU - Benedetti, Giorgio

AU - Sablich, Renato

AU - Riegler, Gabriele

AU - Caserta, Luigi

AU - Belletta, Marco

AU - Benedetti, Antonio

AU - Ridolfi, Francesco

AU - Blasi, Adriano

AU - Inserra, Gaetano

AU - Prada, Alberto

AU - Ferrau, Oscar

AU - Turiano, Santi

AU - Loriga, Pietro

AU - Muscas, Alessandro

AU - Murgia, Raimondo

AU - Colombo, Enrico

AU - Canevelli, Eugenio

AU - Menardo, Giorgio

AU - Dagnino, Franco

AU - Monica, Fabio

AU - Giordano, Massimo

AU - Torelli, Iliana

AU - Cuoco, Davide Lo

AU - Villa, Erica

AU - Rigo, Giampiero

AU - Bertani, Angela

AU - Cremonini, Claudia

AU - Minoli, Giorgio

AU - Meucci, Gianmichele

AU - Cattoni, Massimo

PY - 2005/4

Y1 - 2005/4

N2 - Goals: Therapy for active ulcerative colitis (UC) usually involves rectal formulations of corticosteroids (CS), which are characterized by the risk of systemic steroid-related adverse effects. Background: To compare the efficacy and safety of the topically acting CS beclomethasone dipropionate (BDP) versus mesalamine (5-ASA) in the treatment of active UC. Study: Patients with mild to moderate distal active UC were randomized to a 6-week treatment with BDP 3 mg enema o.d. or 5-ASA 1 g enema daily in a single-blind, multicenter, parallel-group, controlled study. The primary efficacy variable was the decrease in Disease Activity Index (DAI) score. Safety variables were adrenal function, monitoring of adverse events, vital signs, and laboratory parameters. Results: A total of 217 patients were enrolled and treated with BDP (n = 111) or 5-ASA (n = 106). A significant decrease in the DAI score (P <0.05) was observed in both treatment groups, with a clinical remission rate of 36.7% in the BDP group and of 29.2% in the 5-ASA group. Both treatments were well tolerated. No changes from baseline in morning cortisol levels were observed in the BDP group. Conclusions: BDP administered as a rectal enema over a 6-week treatment period was efficacious and safe in patients with active UC, without interference with pituitary adrenal axis.

AB - Goals: Therapy for active ulcerative colitis (UC) usually involves rectal formulations of corticosteroids (CS), which are characterized by the risk of systemic steroid-related adverse effects. Background: To compare the efficacy and safety of the topically acting CS beclomethasone dipropionate (BDP) versus mesalamine (5-ASA) in the treatment of active UC. Study: Patients with mild to moderate distal active UC were randomized to a 6-week treatment with BDP 3 mg enema o.d. or 5-ASA 1 g enema daily in a single-blind, multicenter, parallel-group, controlled study. The primary efficacy variable was the decrease in Disease Activity Index (DAI) score. Safety variables were adrenal function, monitoring of adverse events, vital signs, and laboratory parameters. Results: A total of 217 patients were enrolled and treated with BDP (n = 111) or 5-ASA (n = 106). A significant decrease in the DAI score (P <0.05) was observed in both treatment groups, with a clinical remission rate of 36.7% in the BDP group and of 29.2% in the 5-ASA group. Both treatments were well tolerated. No changes from baseline in morning cortisol levels were observed in the BDP group. Conclusions: BDP administered as a rectal enema over a 6-week treatment period was efficacious and safe in patients with active UC, without interference with pituitary adrenal axis.

KW - Beclomethasone

KW - Mesalamine

KW - Topical therapy

KW - Ulcerative colitis

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