Introduction: 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. 相似文献
Early inhaled corticosteroid treatment improves symptom control and pulmonary function in children with asthma; however, long-term
safety data are limited in infants and young children. This study assessed the long-term safety of budesonide inhalation suspension
(BIS) in young children with persistent asthma. To continue to provide BIS to children who needed it—prior to US Food and
Drug Administration approval—children 8 years of age or younger with mild, moderate, or severe persistent asthma who previously
completed a 52-week open-label study of BIS were enrolled in an additional multicenter, open-label study that was to be concluded
upon BIS approval. Patients already receiving BIS continued their current regimens. Patients younger than 4 years and those
4 years of age or older not receiving BIS at baseline started with total daily doses of 0.5 and 1.0 mg, respectively. BIS
doses were adjusted throughout the study based on individual response. Adverse events and changes in laboratory parameters,
vital signs, and physical examination findings were assessed. Of 198 enrolled patients, 152 (76.8%), 68 (34.3%), and 31 (15.7%)
completed 1, 2, and 3 years of BIS treatment (mean daily dose 0.62±0.32 mg), respectively. One hundred sixty-six (83.8%) patients
experienced an adverse event, of which 8.6% were considered by the investigator to be drug related. Adverse events were those
typically occurring in a pediatric asthma population, with respiratory infection (49.0%) and sinusitis (25.3%) occurring at
the greatest incidence. Only 2 patients withdrew due to adverse events. Mean changes in laboratory test results and physical
examination findings were not clinically important throughout the study. Long-term BIS treatment is well tolerated in young
children with persistent asthma, with a safety profile similar to that of short-term administration. 相似文献