Mesalazine (Mesasal/Claversal) 1.5 g b.d. vs. placebo in the maintenance of remission of patients with Crohn's disease
Autor: | Robert J Bailey, K. A. Wilson‐Lynch, M. Vatn, D. Rachmilewitz, J. P. Wright, M. Adler, Abr Thomson |
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Rok vydání: | 2007 |
Předmět: |
Adult
Male Canada medicine.medical_specialty Placebo law.invention South Africa chemistry.chemical_compound Crohn Disease Double-Blind Method Randomized controlled trial Mesalazine law Internal medicine medicine Humans Pharmacology (medical) Ileitis Mesalamine Adverse effect Aged Crohn's disease Hepatology business.industry Anti-Inflammatory Agents Non-Steroidal Therapeutic effect Gastroenterology Middle Aged Colitis medicine.disease digestive system diseases Surgery Europe Clinical trial Aminosalicylic Acids chemistry Female business |
Zdroj: | Alimentary Pharmacology & Therapeutics. 9:673-683 |
ISSN: | 1365-2036 0269-2813 |
Popis: | SUMMARY Investigators: This multicentre study was conducted by 29 principal investigators in 11 countries. Aims: To compare the safety and efficacy of oral mesalazine (Mesasal/Claversal, 5-ASA) 1.5 g b.d. in comparison with placebo in the maintenance of remission in 286 patients with Crohn's disease. Materials and Methods: Patients had to score less than 150 in their Crohn's Disease Activity Index (CDAI), and had to have had one period of clinical activity (CDAI > 150) within 18 months of the study start. Patients were randomized to receive 5-ASA 1.5 g b.d. daily or matching placebo for 12 months. Study visits were scheduled for months 1, 3, 6, 9 and 12, or when symptoms suggested a relapse of the disease. Relapse was defined as a CDAI score greater than 150, with at least a 60-point increase from the baseline index score. None of the patients used glucocorticoids or immunosuppressants during the trial. Results: In the first group, 207 patients with Crohn's colitis or ileocolitis were randomized: there were 101 females and 106 males, in age range 18–71 years. A total of 106 patients (51 in the 5-ASA group and 55 in the placebo group) were withdrawn from the study due to adverse events, insufficient therapeutic effect, or for other reasons. This left 101 patients (51 in the 5-ASA group and 50 in the placebo group) who completed the 12-month trial. In the second group, 79 patients with Crohn's ileitis were randomized to treatment. There were 53 females and 26 males, age range 18–66 years. A. total of 41 patients (19 in the 5-ASA group and 22 in the placebo group) were withdrawn from the study. This left 38 patients (17 in the 5-ASA group and 21 in the placebo group) who completed the 12-month trial. the primary efficacy variable was the CDAI. A protocol-eligible analysis and an intent-to-treat analysis were performed. No statistical differences were noted Between the two analyses. In patients with Crohn's colitis or ileocolitis, or in those with ileitis, no statistically significant differences were noted with: espect to the relapse rates between the 5-ASA and the, placebo treatment groups. Adverse events in the gastrointestinal system were the most frequently, eported in both treatment groups. Many of the events such as diarrhoea or abdominal pain are symptoms of crohn's disease. The majority of the events reported were mild or moderate in severity. In neither study was he prevalence of adverse events or the proportion of drop-outs different between patients in the treatment or in the placebo groups. The site of the Crohn's disease had no effect on the frequency of adverse events. conclusion: The relapse rates of Crohn's disease were similar for up to 12 months in both the 5-ASA 1.5 g b.d. and the placebo treatment groups. |
Databáze: | OpenAIRE |
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