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Budesonide Foam Has a Favorable Safety Profile for Inducing Remission in Mild-to-Moderate Ulcerative Proctitis or Proctosigmoiditis.

AbstractBACKGROUND:
Budesonide foam, a rectally administered, second-generation corticosteroid with extensive hepatic first-pass metabolism, is efficacious for the treatment of mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis.
AIM:
The aim of this study was to comprehensively assess the safety and pharmacokinetic profile of budesonide foam.
METHODS:
Data from five phase III studies were pooled to further evaluate safety, including an open-label study (once-daily treatment for 8 weeks), an active-comparator study (once-daily treatment for 4 weeks), and two placebo-controlled studies and an open-label extension study (twice-daily treatment for 2 weeks, then once daily for 4 weeks). Data from the placebo-controlled studies and two phase I studies (i.e., patients with mild-to-moderate ulcerative colitis and healthy volunteers) were pooled to evaluate the pharmacokinetics of budesonide foam.
RESULTS:
A similar percentage of patients reported adverse events in the budesonide foam and placebo groups, with the majority of adverse events being mild or moderate in intensity (93.3 vs 96.0%, respectively). Adverse events occurred in 41.4 and 36.3% of patients receiving budesonide foam and placebo, respectively. Mean morning cortisol concentrations remained within the normal range for up to 8 weeks of treatment; there were no clinically relevant effects of budesonide foam on the hypothalamic-pituitary-adrenal axis. Population pharmacokinetic analysis demonstrated low systemic exposure after budesonide foam administration.
CONCLUSIONS:
This integrated analysis demonstrated that budesonide foam for the induction of remission of distal ulcerative colitis is safe overall, with no clinically relevant effects on the hypothalamic-pituitary-adrenal axis.
AuthorsDavid T Rubin, William J Sandborn, Brian Bosworth, Salam Zakko, Glenn L Gordon, Mark E Sale, Robert L Rolleri, Pamela L Golden, Andrew C Barrett, Enoch Bortey, William P Forbes
JournalDigestive diseases and sciences (Dig Dis Sci) Vol. 60 Issue 11 Pg. 3408-17 (Nov 2015) ISSN: 1573-2568 [Electronic] United States
PMID26386854 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Inflammatory Agents
  • Dosage Forms
  • Glucocorticoids
  • Budesonide
Topics
  • Administration, Rectal
  • Adult
  • Anti-Inflammatory Agents (administration & dosage, adverse effects, pharmacokinetics)
  • Budesonide (administration & dosage, adverse effects, pharmacokinetics)
  • Clinical Trials as Topic
  • Dosage Forms
  • Drug Monitoring
  • Female
  • Glucocorticoids (administration & dosage, adverse effects, pharmacokinetics)
  • Humans
  • Male
  • Middle Aged
  • Proctocolitis (diagnosis, drug therapy)
  • Remission Induction
  • Severity of Illness Index
  • Treatment Outcome

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