Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis. A multicenter study
| Autor: | Walter H. Jacobs, David Cort, Bernard J. Powers, Sessions Jt, Cerda Jj, Simon K. Lo, Ronald Pruitt, Sninsky Ca, Fergus Shanahan, Targan |
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| Rok vydání: | 1991 |
| Předmět: |
Adult
Male medicine.medical_specialty Statistics as Topic Administration Oral Placebo Inflammatory bowel disease Gastroenterology Severity of Illness Index law.invention chemistry.chemical_compound Mesalazine Randomized controlled trial Double-Blind Method Sulfasalazine law Internal medicine Internal Medicine Medicine Humans Colitis Mesalamine Aged Chi-Square Distribution Dose-Response Relationship Drug business.industry General Medicine Middle Aged medicine.disease Ulcerative colitis Aminosalicylic Acids chemistry Private practice Colitis Ulcerative Female Tablets Enteric-Coated business medicine.drug |
| Zdroj: | Annals of internal medicine. 115(5) |
| ISSN: | 0003-4819 |
| Popis: | Objective To evaluate the efficacy and safety of a pH-sensitive, polymer-coated oral preparation of mesalamine in patients with mildly to moderately active ulcerative colitis. Design A multicenter, double-blind, placebo-controlled randomized trial. Setting Five university-based medical centers, one inflammatory bowel disease center, and three private practice sites. Patients A total of 158 patients with newly or previously diagnosed active ulcerative colitis. Intervention A pH-sensitive, polymer-coated oral preparation of mesalamine (5-aminosalicylic acid) was used at 1.6 and 2.4 g/d for 6 weeks. Measurements Efficacy was measured by scores for stool frequency, rectal bleeding, patient's functional assessment, sigmoidoscopic findings, and physician's global assessment. Stringent criteria for disease activity were established prospectively. Results The analysis of protocol-compliant patients showed a significant improvement at 3 weeks in patients taking 2.4 g/d of mesalamine compared with patients taking placebo (32% versus 9%; P = 0.003). At 6 weeks, both the 1.6 g/d (43%) and 2.4 g/d (49%) doses were significantly superior to placebo (23%) (P = 0.03 and P = 0.003, respectively). In addition, more patients worsened in the placebo group compared with the 2.4 g/d group (50% versus 19%; P = 0.003); however, there was no statistically significant difference in worsening between the 1.6 g/d mesalamine group and the placebo group. The oral mesalamine tablet was well tolerated, and no clinically significant changes were observed in hematologic, hepatic, or renal laboratory profiles. Conclusion Colon-targeted oral mesalamine at 2.4 g/d is effective therapy for mildly to moderately active ulcerative colitis. It is well tolerated and should provide a viable therapeutic alternative to sulfasalazine. |
| Databáze: | OpenAIRE |
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