Continuous infusion versus bolus administration of steroids in severe attacks of ulcerative colitis

A randomized, double-blind trial

Fabrizio Bossa, Serafina Fiorella, Nazario Caruso, Laura Accadia, Grazia Napolitano, Maria Rosa Valvano, Angelo Andriulli, Vito Annese

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: In patients with severe attacks of ulcerative colitis (UC), IV steroids represent the first-line treatment, leading to clinical improvement in approximately 50-60% of patients. AIM: The aim of this study was to prospectively compare the efficacy and safety of different modalities of steroid administration, and to evaluate predictors of failure to therapy. MATERIALS AND METHODS: In a single-center, double-blind trial, consecutive patients with a severe attack of UC received 1 mg/kg/day of 6-methyl-prednisolone administered randomly by either a bolus injection (group A) or continuous infusion (group B). RESULTS: Sixty-six patients were enrolled (35 men, mean age 38 ± 15, range 18-75 yr), 15 of them at their first attack of UC; in the remaining cases, the mean duration of disease was 4.5 ± 5 yr. At inclusion, forty patients (60%) had pancolitis and the remainder had left-sided colitis. Overall, thirty-three patients (50%) underwent clinical remission after 7 days of treatment: 16 of 32 in group A and 17 of 34 in group B. Thirty-one patients eventually underwent total colectomy (12 in group A and 9 in group B), which was carried out by the first month in 10 patients (5 in each group). Twenty-eight patients (15 in group A and 13 in group B) experienced steroid-related adverse reactions. All differences between groups were not statistically significant. Previous use of steroids (OR 13.6, CI 2-86) and active smoking (OR 11.6, CI 1.4-107) were independent predictors of nonresponse. CONCLUSIONS: In severe attacks of UC, methyl-prednisolone given as a continuous infusion was no better than bolus administration in terms of efficacy and safety.

Original languageEnglish
Pages (from-to)601-608
Number of pages8
JournalAmerican Journal of Gastroenterology
Volume102
Issue number3
DOIs
Publication statusPublished - Mar 2007

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Ulcerative Colitis
Steroids
Prednisolone
Safety
Colectomy
Colitis
Therapeutics
Smoking
Injections

ASJC Scopus subject areas

  • Gastroenterology

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Continuous infusion versus bolus administration of steroids in severe attacks of ulcerative colitis : A randomized, double-blind trial. / Bossa, Fabrizio; Fiorella, Serafina; Caruso, Nazario; Accadia, Laura; Napolitano, Grazia; Valvano, Maria Rosa; Andriulli, Angelo; Annese, Vito.

In: American Journal of Gastroenterology, Vol. 102, No. 3, 03.2007, p. 601-608.

Research output: Contribution to journalArticle

Bossa, Fabrizio ; Fiorella, Serafina ; Caruso, Nazario ; Accadia, Laura ; Napolitano, Grazia ; Valvano, Maria Rosa ; Andriulli, Angelo ; Annese, Vito. / Continuous infusion versus bolus administration of steroids in severe attacks of ulcerative colitis : A randomized, double-blind trial. In: American Journal of Gastroenterology. 2007 ; Vol. 102, No. 3. pp. 601-608.
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abstract = "BACKGROUND: In patients with severe attacks of ulcerative colitis (UC), IV steroids represent the first-line treatment, leading to clinical improvement in approximately 50-60{\%} of patients. AIM: The aim of this study was to prospectively compare the efficacy and safety of different modalities of steroid administration, and to evaluate predictors of failure to therapy. MATERIALS AND METHODS: In a single-center, double-blind trial, consecutive patients with a severe attack of UC received 1 mg/kg/day of 6-methyl-prednisolone administered randomly by either a bolus injection (group A) or continuous infusion (group B). RESULTS: Sixty-six patients were enrolled (35 men, mean age 38 ± 15, range 18-75 yr), 15 of them at their first attack of UC; in the remaining cases, the mean duration of disease was 4.5 ± 5 yr. At inclusion, forty patients (60{\%}) had pancolitis and the remainder had left-sided colitis. Overall, thirty-three patients (50{\%}) underwent clinical remission after 7 days of treatment: 16 of 32 in group A and 17 of 34 in group B. Thirty-one patients eventually underwent total colectomy (12 in group A and 9 in group B), which was carried out by the first month in 10 patients (5 in each group). Twenty-eight patients (15 in group A and 13 in group B) experienced steroid-related adverse reactions. All differences between groups were not statistically significant. Previous use of steroids (OR 13.6, CI 2-86) and active smoking (OR 11.6, CI 1.4-107) were independent predictors of nonresponse. CONCLUSIONS: In severe attacks of UC, methyl-prednisolone given as a continuous infusion was no better than bolus administration in terms of efficacy and safety.",
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T2 - A randomized, double-blind trial

AU - Bossa, Fabrizio

AU - Fiorella, Serafina

AU - Caruso, Nazario

AU - Accadia, Laura

AU - Napolitano, Grazia

AU - Valvano, Maria Rosa

AU - Andriulli, Angelo

AU - Annese, Vito

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N2 - BACKGROUND: In patients with severe attacks of ulcerative colitis (UC), IV steroids represent the first-line treatment, leading to clinical improvement in approximately 50-60% of patients. AIM: The aim of this study was to prospectively compare the efficacy and safety of different modalities of steroid administration, and to evaluate predictors of failure to therapy. MATERIALS AND METHODS: In a single-center, double-blind trial, consecutive patients with a severe attack of UC received 1 mg/kg/day of 6-methyl-prednisolone administered randomly by either a bolus injection (group A) or continuous infusion (group B). RESULTS: Sixty-six patients were enrolled (35 men, mean age 38 ± 15, range 18-75 yr), 15 of them at their first attack of UC; in the remaining cases, the mean duration of disease was 4.5 ± 5 yr. At inclusion, forty patients (60%) had pancolitis and the remainder had left-sided colitis. Overall, thirty-three patients (50%) underwent clinical remission after 7 days of treatment: 16 of 32 in group A and 17 of 34 in group B. Thirty-one patients eventually underwent total colectomy (12 in group A and 9 in group B), which was carried out by the first month in 10 patients (5 in each group). Twenty-eight patients (15 in group A and 13 in group B) experienced steroid-related adverse reactions. All differences between groups were not statistically significant. Previous use of steroids (OR 13.6, CI 2-86) and active smoking (OR 11.6, CI 1.4-107) were independent predictors of nonresponse. CONCLUSIONS: In severe attacks of UC, methyl-prednisolone given as a continuous infusion was no better than bolus administration in terms of efficacy and safety.

AB - BACKGROUND: In patients with severe attacks of ulcerative colitis (UC), IV steroids represent the first-line treatment, leading to clinical improvement in approximately 50-60% of patients. AIM: The aim of this study was to prospectively compare the efficacy and safety of different modalities of steroid administration, and to evaluate predictors of failure to therapy. MATERIALS AND METHODS: In a single-center, double-blind trial, consecutive patients with a severe attack of UC received 1 mg/kg/day of 6-methyl-prednisolone administered randomly by either a bolus injection (group A) or continuous infusion (group B). RESULTS: Sixty-six patients were enrolled (35 men, mean age 38 ± 15, range 18-75 yr), 15 of them at their first attack of UC; in the remaining cases, the mean duration of disease was 4.5 ± 5 yr. At inclusion, forty patients (60%) had pancolitis and the remainder had left-sided colitis. Overall, thirty-three patients (50%) underwent clinical remission after 7 days of treatment: 16 of 32 in group A and 17 of 34 in group B. Thirty-one patients eventually underwent total colectomy (12 in group A and 9 in group B), which was carried out by the first month in 10 patients (5 in each group). Twenty-eight patients (15 in group A and 13 in group B) experienced steroid-related adverse reactions. All differences between groups were not statistically significant. Previous use of steroids (OR 13.6, CI 2-86) and active smoking (OR 11.6, CI 1.4-107) were independent predictors of nonresponse. CONCLUSIONS: In severe attacks of UC, methyl-prednisolone given as a continuous infusion was no better than bolus administration in terms of efficacy and safety.

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