The safety profile of budesonide capsules (Entocort (R))

The initial studies in acute Crohn's disease showed that budesonide capsule s (Entocort(R)) were better tolerated than prednisolone and that the system ic glucocorticosteroid effects, including the cosmetically important facial changes, were significantly less frequent at similar clinical efficacy. In the long-term studies and in the prolongation of remission studies, there was a low, dose-dependent incidence of systemic effects while the time to r emission was significantly prolonged. In the study comparing the efficacy a nd safety of 5-aminosalicylic acid (5-ASA, Pentasa(R)) over 16 weeks, the s erious adverse events and the discontinuations due to adverse events were l ess frequent in the budesonide capsule group. The postmarketing reports sho w a low frequency of such adverse events and the profile is that of a gluco corticosteroid. In summary, budesonide capsules seem to be well tolerated i n treatment of Crohn's disease affecting the ileum and/or ascending colon a nd to have a good balance between the effect and the side effect profile, b oth in comparison with prednisolone and 5-ASA. (C) 2000 Prous Science. All rights reserved.