Abstract | BACKGROUND: 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:
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Authors | David 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 |
Journal | Digestive diseases and sciences
(Dig Dis Sci)
Vol. 60
Issue 11
Pg. 3408-17
(Nov 2015)
ISSN: 1573-2568 [Electronic] United States |
PMID | 26386854
(Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents
- Dosage Forms
- Glucocorticoids
- Budesonide
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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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