Double-blind, double-dummy, randomised, placebo-controlled, multicentre trial of budesonide and mesalazine in collagenous colitis
| Author | Affiliation |
|---|---|
Miehlke, Stephan | |
| Date |
|---|
2012-10-20 |
Bibliogr.: p. A102
Introduction: Budesonide is effective for the treatment of collagenous colitis (CC), however previous trials have been small and variable in design. Mesalazine has never been tested in CC by placebo-controlled trials, therefore its true efficacy remains unknown. Aims & methods: aims: To evaluate the efficacy of budesonide and mesalazine for induction of remission in CC in a multi-national phase III study. Methods: Patients with active CC randomly received either budesonide capsules (9 mg budesonide OD) or mesalazine granules (3 g mesalazine OD) or placebo for 8 weeks in a double-blind double-dummy fashion. The primary endpoint was clinical remission (CR) at 8 weeks defined as _3 stools/d (one-sided, a=0.025). Secondary endpoints included CR at 8 weeks according to the Hjortswang-Criteria of disease activity1 and safety. An interim analysis was planned with 50% of total sample size. Results: Ninety-two patients were randomised (83% female, mean age 59 years, mean duration of symptoms 3.6 years, mean stool frequency 5.9/d). The proportion of patients in CR at week 8 was higher with budesonide than with placebo (intention-totreat 80.0% vs. 59.5%, p = 0.036, per protocol 84.6% vs. 60.6%, p = 0.023). According to the Hjortswang-Criteria CR was achieved in 80.0% with budesonide and 37.8% with placebo (2-sided: p<0.0001). With budesonide, the mean number of watery stools/ week dropped from 29.7 to 2.4, the mean number of solid stools/week increased from 0.3 to 6.7. Mesalazine was not better than placebo at interim analysis (CR rate at week 8: 44.0%) and therefore this treatment group was stopped prematurely for futility. The rate of adverse events did not differ between the three treatment groups. Conclusion: Budesonide is highly effective for induction of remission in collagenous colitis and improves both stool frequency and consistency. Mesalazine appears to be ineffective in collagenous colitis.