Oral Beclomethasone Dipropionate in Pediatric Active Ulcerative Colitis: A Comparison Trial With Mesalazine

Romano, Claudio; Famiani, Annalisa; Comito, D.; Rossi, Paolo; Raffa, V.; Fries, Walter

doi:10.1097/mpg.0b013e3181bb3457

Cited by 35 publications

(23 citation statements)

References 37 publications

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“…Ten studies conducted from 2001 to 2015 included data on efficacy of BDP, orally administered as tablets, in patients with active UC [24–33]. Of them, eight evaluated patients with left sided (i.e., limited to below the splenic flexure) or total colitis [24,26,28–33], one evaluated patients with left sided colitis [25], while another evaluated patients without restriction for colitis extension [28]. The sample size was precalculated only in five studies [24,30–33].…”

Section: Resultsmentioning

confidence: 99%

“…Four studies were conducted in double blind [24,30,32–33], two in single blind [25,31], and four in open fashion [26–29]. Randomization of patients was made in seven studies [24–25,28,30–33]. One study compared the efficacy of oral BDP and 5-ASA enema [25].…”

Section: Resultsmentioning

confidence: 99%

“…Moreover, it is of note that the search for differences in AEs, including reduced cortisol concentration, in the Van Assche’s study [24] was influenced by the analytical method used for cortisolemia [48], conducing to a lower number of AEs observed in the PD arm. However, a large burden of data in adults affected by UC from non-controlled ‘real life’ studies [25–27,29] or in a controlled study on children [28] confirmed a good efficacy and safety profile of oral BDP administrated at different dosages (from 5 to 15 mg/day) for at least 4 weeks.…”

Section: Discussionmentioning

confidence: 99%

“…Oral BDP for UC has been approved in a number of European and non-European countries [1], but only a few randomized controlled trials (RCTs) have been produced to evaluate the efficacy and safety of oral BDP in UC patients [24–25,28,30–33]. Given that few data have been published in the field, we conducted a meta-analysis to estimate the efficacy and safety of oral prolonged release of BDP 5 mg/day vs. all oral active controls in adult patients with extensive or left-sided mild to moderate UC.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

et al. 2016

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Background and AimWe performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA.MethodsLiterature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis.ResultsFive randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23–2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03–1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00–2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76–2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24–1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44–1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD.ConclusionsOral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

et al. 2016

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“…Several studies have shown its effectiveness in UC, including one small pediatric trial in which remission occurred more often than with 5-ASA [62]. Nonetheless, this drug should not be used as maintenance therapy since some systemic effect may still occur.…”

Section: Experimental and Supplementary Interventionsmentioning

confidence: 99%

Relapsing and Refractory Ulcerative Colitis in Children

Turner

2014

Dig Dis

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Approximately half of the children with ulcerative colitis (UC) have refractory, relapsing or steroid-dependent disease. UC in children is more extensive than in adults, presents more often with severe attacks and carries a more aggressive disease course. Therefore, although a step-up approach is usually recommended in UC, aggressive therapy will often be indicated in children since steroid dependency should never be tolerated. It is vital to ensure that in every resistant case, the symptoms are truly related to the inflammatory disease activity and not to other conditions such as poor adherence to treatment, infections, adverse reactions to drugs, irritable bowel syndrome, lactose intolerance, celiac disease and bacterial overgrowth. The clinician should be ready to escalate therapy in a timely manner but only after ensuring optimization of current treatments. Optimization may include, among others, appropriate dosage, utilization of assays that determine thiopurine, calcineurin inhibitors and anti-tumor necrosis factor levels, introduction of combination therapy when indicated (enemas and immunomodulators) and a long enough time for treatment to become effective. Colectomy is always a valid option and should be discussed before major treatment escalations. Experimental therapies can be considered when all else fails and the family prefers to avoid colectomy. The management of refractory and relapsing disease is particularly challenging in children, and this review summarizes the available evidence to guide treatment decisions in this setup.

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Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis

Feagan¹,

MacDonald²

2012

Cochrane Database of Systematic Reviews

115

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Oral Beclomethasone Dipropionate in Pediatric Active Ulcerative Colitis: A Comparison Trial With Mesalazine

Abstract: Oral BDP was well tolerated and acts significantly faster and more effectively than 5-ASA in inducing clinical remission and endoscopic improvement in pediatric mild-to-moderate UC.

Cited by 35 publications

References 37 publications

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

Relapsing and Refractory Ulcerative Colitis in Children

Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis

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