Budesonid-Schaum als neues Therapieprinzip bei der distalen Colitis ulcerosa im Vergleich mit Mesalazin-Klysmen. Eine offene, kontrollierte, randomisierte und prospektive multizentrische Pilotstudie

Abstract

Budesonide is a locally acting steroid with a high first-pass metabolism in the liver and low systemic effects. We performed the first pilot study comparing budesonide foam (1 mg/50 ml b.i.d.) with mesalazine enemas (4 g/60 ml o.d.). 33 patients from 3 centres were enrolled in this open randomized clinical trial. 16 patients got budesonide foam and 17 got mesalazine enemas. The drugs were administered for 4 weeks. Histological index (HI) and endoscopic index (EI) were assessed at day 1 and day 28, clinical activity index (CAI) at day 1, 14 and 28. For patients with left-sided colitis and proctosigmoiditis improvement was defined as decrease in CAI of > or = 2 points. For patients with proctitis improvement was defined as decrease in HI of > or = 1 point. The primary efficacy evaluation was performed with the intention to treat population (n = 32). Improvement was found in 67% of the patients in the budesonide group compared to 71% in the mesalazine group. There was no statistically significant difference between the groups. Adverse events were mild and rare in both groups. Both treatments had no significant influence on plasma cortisol. In this pilot study for distal ulcerative colitis budesonide foam is as safe and effective as mesalazine enema.

Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis

“…The results of the present multicentre study are in good agreement with the results of previous studies using budesonide foam 12–14 . In the study of Bar‐Meir et al , 14 budesonide foam was tested in a similar patient population as in the present study.…”

“…Two pilot trials 12, 13 have demonstrated that budesonide foam led to a statistically significant improvement of clinical symptoms in patients with active distal UC. A recent randomized, open, parallel‐group, active‐controlled, multicentre clinical trial including 251 patients has shown similar efficacy and safety of budesonide foam compared with hydrocortisone acetate foam in patients with active ulcerative proctosigmoiditis 14 …”

Systematic review with meta‐analysis: Medical therapies for treatment of ulcerative proctitis

“…Fifty manuscripts reporting on the results of 53 studies (4096 participants) met the inclusion criteria and were included in the review (Figure S1). 9,11,18–65 Several manuscripts report on the results of more than one study. Sandborn et al 9 report on the results of two phase III RCTs.…”

Budesonide: Teaching an Old Dog New Tricks for Inflammatory Bowel Disease Treatment

“…with mesalamine enemas (4 g/ 60 ml o.d.) in the treatment of 33 patients with active distal UC [58].…”