Bezzio Cristina, Festa Stefano, Zerboni Giulia, Papi Claudio, Manes Gianpiero, Saibeni Simone
a Gastroenterology Unit , Rho Hospital, ASST Rhodense , Garbagnate Milanese , Italy.
b IBD Unit , San Filippo Neri Hospital , Rome , Italy.
Expert Opin Drug Saf. 2018 Apr;17(4):437-444. doi: 10.1080/14740338.2018.1442432. Epub 2018 Feb 23.
Budesonide belongs to low-bioavailability steroids class. A novel oral formulation of budesonide, which uses the Multi-Matrix System (MMX) for delivering drugs to the colon, is now available as a possible treatment of ulcerative colitis patients intolerant or not-responding to first-line therapy with 5-ASA. Areas covered: in this review we present information about the development and the use of budesonide MMX and we provide data about its mechanism of action as well as, pharmacodynamics and pharmacokynetics. Moreover, we present the available literature data about the efficacy and, mainly, the safety of budesonide-MMX. Expert opinion: budesonide-MMX is a new therapeutic option in mild-to-moderate UC patients. Its good safety profile in clinical trials undoubtedly represents a strength for a possible wide use in clinical practice, mainly if it will be confirmed by post-marketing data. Other indications, such as treatment of colonic Crohn's disease, could theoretically be considered, if sustained by reliable scientific data.
布地奈德属于生物利用度低的类固醇类药物。一种新型的布地奈德口服制剂，它采用多矩阵系统（MMX）将药物递送至结肠，目前可作为治疗对5-氨基水杨酸一线治疗不耐受或无反应的溃疡性结肠炎患者的一种可能选择。涵盖领域：在本综述中，我们介绍了布地奈德MMX的研发和使用信息，并提供了其作用机制、药效学和药代动力学的数据。此外，我们还展示了有关布地奈德-MMX疗效，主要是安全性的现有文献数据。专家观点：布地奈德-MMX是轻至中度溃疡性结肠炎患者的一种新的治疗选择。其在临床试验中的良好安全性无疑是其可能在临床实践中广泛应用的一个优势，主要是如果上市后数据能够证实这一点的话。如果有可靠的科学数据支持，理论上可以考虑其他适应症，如结肠克罗恩病的治疗。
