Pharmacokinetics of budesonide controlled ileal release capsules in children and adults with active Crohn's disease

Lundin, P.; Edsbäcker, Staffan; Bergstrand, Martin; Ejderhamn, Jan; Linander, H.; Högberg, Lotta; Persson, Tore; Escher, Johanna C.; Lindquist, B

doi:10.1046/j.1365-2036.2003.01386.x

Cited by 48 publications

(23 citation statements)

References 24 publications

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“…Recently, I have had some success with use of a unique oral steroidEntocort (budesonide). [49][50][51] This agent is used as an anti-inflammatory in children with Crohn's disease. Entocort is absorbed predominantly in the distal ileum and is 90% metabolized at first pass through the liver, hence minimizing systemic side effects, making this a very attractive agent for use.…”

Section: Suggested Treatment Strategies For Ple After Fontan Operationmentioning

confidence: 99%

Protein-Losing Enteropathy after Fontan Operation

Rychik¹

2007

Congenital Heart Disease

171

194

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A B S T R A C TProtein-losing enteropathy (PLE) is a poorly understood and enigmatic disease process affecting patients with single ventricle after Fontan operation. In those afflicted, PLE after Fontan operation results in significant morbidity and mortality. The pathophysiology of the disease is unknown; however, a proposed mechanism incorporates a combination of phenomena including: (1) altered hemodynamics, specifically low cardiac output; (2) increased mesenteric vascular resistance; (3) systemic inflammation; and (4) altered enterocyte basal membrane glycosaminoglycan make-up. A paradigm for the clinical management of PLE after Fontan operation is proposed.

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Section: Suggested Treatment Strategies For Ple After Fontan Operationmentioning

confidence: 99%

Protein-Losing Enteropathy after Fontan Operation

Rychik¹

2007

Congenital Heart Disease

171

194

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“…No differences in the drug's availability were noted in a pharmacokinetic analysis of children with mild and acute Crohn's disease (Lundin et al 2003). The systemic availability of Budesonide was determined at 9-12% in patients with Crohn's disease (Lundin et al 2003) and in healthy subjects (Edsbacker and Andersson 2004).…”

Section: Discussionmentioning

confidence: 91%

“…Similar doses were used by Tumulty and colleagues (3 mg/m 2 , which is equivalent to 1 mg/10.7 kg) and Stroup and co-workers (2 mg per dog with body weight less than 18 kg and 3 mg per dog with body weight greater than or equal to 18 kg; Tumulty et al 2004;Stroup et al 2006). In humans, the pharmacokinetics and systemic availability of Budesonide are similar in children with body weight below 20 kg and in adults who are administered the drug at a daily dose of 9 mg (Lundin et al 2003). This dose is believed to be the lowest effective one for the maintenance of remission in patients with Crohn's disease (Greenberg et al 1994).…”

Section: Discussionmentioning

confidence: 94%

The effect of orally administered Budesonide on the hypothalamic-pituitary-adrenal axis in dogs with inflammatory bowel disease

Rychlik¹,

Nowicki²,

Kołodziejska-Sawerska³

et al. 2017

Vet. Med. - Czech

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ABSTRACT:The aim of this study was to evaluate the effect of Budesonide on the hypothalamic-pituitary-adrenal (HPA) axis in dogs with inflammatory bowel disease. The effect of orally administered Budesonide (Entocort) on the HPA axis was analysed in 21 dogs with inflammatory bowel disease. Biochemical analyses were carried out to evaluate the activity levels of alanine aminotransferase, asparagine aminotransferase, alkaline phosphatase, cortisol and endogenous adrenocorticotropic hormone. Urine samples were collected from each patient before the study and after 30 days of the experiment to determine the composition and the physical and chemical properties of urine sediments. Considerably lower serum concentrations of cortisol and endogenous adrenocorticotropic hormone were observed after 30 days of treatment. A significant increase in alkaline phosphatase levels was noted on Day 30. In the studied dogs, the drop in HPA axis activity was correlated with side effects associated with the administered glucocorticosteroid (polyuria, polydipsia). In conclusion, we have shown that oral administration of Budesonide to dogs diagnosed with inflammatory bowel disease significantly suppressed the activity of the HPA axis.Keywords: glucocorticosteroids; IBD treatment; eACTH concentration; side effects; HPA axis List of abbreviations ACTH = adrenocorticotropic hormone, ALKP = alkaline phosphatase, ALT = alanine aminotransferase, AST = asparagine aminotransferase, CD = Crohn's disease, CIBDAI = canine inflammatory bowel disease activity index, CORT = cortisol, eACTH = endogenous adrenocorticotropic hormone, GC = glucocorticosteroids, HPA = hypothalamic-pituitary-adrenal axis, HUC = histiocytic ulcerative colitis, IBD = inflammatory bowel disease, SG = urinary specific gravity, UC = ulcerative colitis

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“…Food had little influence over systemic availability, with following peak plasma concentrations of budesonide administered in controlled ileal release capsules being achieved at the same dose regardless of prandial status in patients with CD [14]. The systemic exposure, systemic availability and cortisol suppression after oral administration of budesonide in children with active CD were similar to those in adults [15].…”

Section: Pharmacology Of Budesonidementioning

confidence: 90%

Budesonide: Teaching an Old Dog New Tricks for Inflammatory Bowel Disease Treatment

Angelucci

Malesci

Danese

2008

CMC

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Crohn's disease and ulcerative colitis are chronic relapsing inflammatory bowel diseases with extremely great variability in presentation and clinical course. For many decades, corticosteroids and aminosalicylates have been the mainstay of the treatment for both Crohn's disease and ulcerative colitis, for the induction and maintenance of remission, respectively. The main limiting factors for the repeated use of corticosteroids or the use as a maintenance treatment are the very high prevalence of systemic side effects, together with the possibility of developing dependency on and/or resistance to the drug, which are reported in more than one third of patients with inflammatory bowel disease. In the last decade, a number of corticosteroids with enhanced topical activity and low systemic activity have been developed. Among them, budesonide and beclomethasone dipropionate are the most used for the treatment of the inflammatory bowel diseases. Indeed, budesonide is the drug of choice for the treatment of ileo(-cecal) active Crohn's disease with mild-to-moderate activity, due to controlled ileal release. Budesonide foam and/or enemas are also efficacious in the treatment of left-sided/distal ulcerative colitis. Gastro-resistant, extended release tablets characterized by a multimatrix structure (i.e. MMX-budesonide), have also been developed to allow uniform release along the length of the colon. This paper reviews the mechanism-of-action, safety and efficacy of budesonide in the treatment of inflammatory bowel disease.

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Pharmacokinetics of budesonide controlled ileal release capsules in children and adults with active Crohn's disease

Cited by 48 publications

References 24 publications

Protein-Losing Enteropathy after Fontan Operation

Protein-Losing Enteropathy after Fontan Operation

The effect of orally administered Budesonide on the hypothalamic-pituitary-adrenal axis in dogs with inflammatory bowel disease

Budesonide: Teaching an Old Dog New Tricks for Inflammatory Bowel Disease Treatment

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