Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine : a single-blind randomized controlled trial
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.
| Media Type: |
Article |
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| Year of Publication: |
2005 |
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| Contained In: |
Journal of clinical gastroenterology - Vol. 39, No. 4 (2005), p. 291-7 |
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| Language: |
English |
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| Notes: |
Date Completed 18.07.2005 Date Revised 17.08.2019 published: Print Citation Status MEDLINE Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine |
|---|
| PMID: |
15758622 |
|---|
| PPN (Catalogue-ID): |
NLM154134112 |
|---|
| LEADER | 05095naa a2201105 c 4500 | ||
|---|---|---|---|
| 001 | NLM154134112 | ||
| 003 | DE-601 | ||
| 005 | 20200216034134.0 | ||
| 008 | 180204s2005 000 0 eng d | ||
| 028 | 5 | 2 | |a pubmed20n0514.xml |
| 035 | |a (DE-599)NLM15758622 | ||
| 040 | |b ger |c GBVCP | ||
| 041 | 0 | |a eng | |
| 100 | 1 | |a Gionchetti, Paolo | |
| 245 | 1 | 0 | |a Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine |b a single-blind randomized controlled trial |
| 500 | |a Date Completed 18.07.2005 | ||
| 500 | |a Date Revised 17.08.2019 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 500 | |a Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 611 | 2 | 7 | |a Clinical Trial |2 gnd |
| 611 | 2 | 7 | |a Comparative Study |2 gnd |
| 611 | 2 | 7 | |a Journal Article |2 gnd |
| 611 | 2 | 7 | |a Multicenter Study |2 gnd |
| 611 | 2 | 7 | |a Randomized Controlled Trial |2 gnd |
| 611 | 2 | 7 | |a Research Support, Non-U.S. Gov't |2 gnd |
| 653 | 2 | |a Administration, Topical |6 D000287 | |
| 653 | 2 | |a Adolescent |6 D000293 | |
| 653 | 2 | |a Adult |6 D000328 | |
| 653 | 2 | |a Aged |6 D000368 | |
| 653 | 2 | |a Anti-Inflammatory Agents, Non-Steroidal |6 D000894 |a *administration & dosage |6 Q000008 | |
| 653 | 2 | |a Beclomethasone |6 D001507 |a *administration & dosage |6 Q000008 | |
| 653 | 2 | |a Biomarkers |6 D015415 |a blood |6 Q000097 | |
| 653 | 2 | |a Blood Sedimentation |6 D001799 | |
| 653 | 2 | |a Colitis, Ulcerative |6 D003093 |a blood |6 Q000097 |a *drug therapy |6 Q000188 |a pathology |6 Q000473 | |
| 653 | 2 | |a Colonoscopy |6 D003113 | |
| 653 | 2 | |a Erythrocyte Count |6 D004906 | |
| 653 | 2 | |a Female |6 D005260 | |
| 653 | 2 | |a Follow-Up Studies |6 D005500 | |
| 653 | 2 | |a Glucocorticoids |6 D005938 |a *administration & dosage |6 Q000008 | |
| 653 | 2 | |a Humans |6 D006801 | |
| 653 | 2 | |a Intestinal Mucosa |6 D007413 |a pathology |6 Q000473 | |
| 653 | 2 | |a Leukocyte Count |6 D007958 | |
| 653 | 2 | |a Male |6 D008297 | |
| 653 | 2 | |a Mesalamine |6 D019804 |a *administration & dosage |6 Q000008 | |
| 653 | 2 | |a Middle Aged |6 D008875 | |
| 653 | 2 | |a Remission Induction |6 D012074 | |
| 653 | 2 | |a Retrospective Studies |6 D012189 | |
| 653 | 2 | |a Safety |6 D012449 | |
| 653 | 2 | |a Severity of Illness Index |6 D012720 | |
| 653 | 2 | |a Single-Blind Method |6 D016037 | |
| 653 | 2 | |a Treatment Outcome |6 D016896 | |
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| 689 | 0 | |5 DE-601 | |
| 689 | 2 | 0 | |a Anti-Inflammatory Agents, Non-Steroidal |
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| 700 | 1 | |a D'Arienzo, Agesilao | |
| 700 | 1 | |a Rizzello, Fernando | |
| 700 | 1 | |a Manguso, Francesco | |
| 700 | 1 | |a Maieron, Roberto | |
| 700 | 1 | |a Lecis, Pier Enrico | |
| 700 | 1 | |a Valpiani, Daniela | |
| 700 | 1 | |a Iaquinto, Gaetano | |
| 700 | 1 | |a Annese, Vito | |
| 700 | 1 | |a Balzano, Antonio | |
| 700 | 1 | |a Varoli, Guido | |
| 700 | 1 | |a Campieri, Massimo | |
| 700 | 0 | |a Italian BDP Study Group | |
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