Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double‐blind placebo‐controlled study

Rizzello, Fernando; Gionchetti, Paolo; D’Arienzo, A.; Manguso, Francesco; Matteo, G. Di; Annese, Vito; Valpiani, D.; Casetti, T.; Adamo, Salvatore; Prada, Alberto; Castiglione, G. N.; Varoli, Guido; Campieri, Massimo

doi:10.1046/j.1365-2036.2002.01298.x

Cited by 121 publications

(91 citation statements)

References 19 publications

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“…Patients with the DAI score <3 are considered in clinical remission, 3-6 in mild, 7-10 in moderate and >10 in severe activity of the disease. 24 Exclusion criteria were:…”

Section: Patientsmentioning

confidence: 99%

Granulocyte and monocyte adsorptive apheresis in the treatment of active distal ulcerative colitis: a prospective, pilot study

Yamamoto¹,

Umegae²,

Kitagawa³

et al. 2004

Aliment Pharmacol Ther

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SUMMARYAim: To assess safety and clinical efficacy of granulocyte and monocyte adsorptive apheresis for distal ulcerative colitis. Methods: Granulocyte and monocyte adsorptive apheresis therapy (five aphereses for 5 consecutive weeks) was performed for 30 consecutive patients with active distal ulcerative colitis. Patient compliance, adverse effects and clinical symptoms were regularly assessed. Results: Adverse effects were noted during nine (6%) apheresis sessions in eight patients; slight headache five, transient abdominal pain with tenesmus two, fever (38°C) one and mild liver dysfunction one. None of these adverse effects was serious and all patients could complete five aphereses. Clinical symptoms (stool frequency and consistency, rectal bleeding, tenesmus and mucus in stools) significantly improved after the third apheresis. Clinical remission (normal stool frequency and no rectal bleeding) was achieved in 21 patients (70%) after five aphereses. The median Disease Activity Index score significantly decreased; from 6 [interquartile range (IQR): 4-7] to 2 (IQR: 1-3) (P < 0.0001). Conclusion: In the treatment of active distal ulcerative colitis, granulocyte and monocyte adsorptive apheresis is safe and well-tolerated. Granulocyte and monocyte adsorptive apheresis had a beneficial effect on clinical remission and symptoms. However, randomized-controlled trials would be necessary to assess a definite efficacy of granulocyte and monocyte adsorptive apheresis.

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“…Patients with the DAI score <3 are considered in clinical remission, 3-6 in mild, 7-10 in moderate and >10 in severe activity of the disease. 24 Exclusion criteria were:…”

Section: Patientsmentioning

confidence: 99%

Granulocyte and monocyte adsorptive apheresis in the treatment of active distal ulcerative colitis: a prospective, pilot study

Yamamoto¹,

Umegae²,

Kitagawa³

et al. 2004

Aliment Pharmacol Ther

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“…In previous studies, the role of rectal formulation of BDP in treatment of UC has been evaluated in comparison with 5-ASA or prednisolone sodium phosphate enemas showing similar efficacy for mild or moderate distal disease. [8][9][10][11][12][13][14][15][16][17][18] A standard dose of BDP 5 mg od (1 tablet day) has been established in the study conducted by Rizzello et al 9 In this study, administration of 5 mg or 10 mg daily showed therapeutic equivalence in patients affected by mild to moderate extensive or left-sided UC, whilst morning plasma cortisol level decreased in the 10 mg group without changes in vital signs. Oral BDP at a standard dose has been studied in treatment of active extensive or left-sided UC, either in combination with 5-ASA or alone resulting effective and safe, without signs of pituitaryadrenal function impairment.…”

Section: Discussionmentioning

confidence: 86%

Oral high dose Beclomethasone dipropionate for treatment of active ulcerative colitis

Raimondo

Mangiavillano

et al. 2012

Gastroenterol Insights

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Oral corticosteroids (CS) have been widely used for treatment of ulcerative colitis (UC) at the price of systemic side effects. Role of topically active oral beclomethasone dipropionate (BDP) in clinical practice is still unclear. The aim of this paper is to investigate efficacy and tolerability of a high dose BDP regimen in mild to moderately active UC. Twenty-five patients (9 males, aged 25-40 years) with mild to moderately active UC, unresponsive to oral and topical 5-ASA (4.8 gr daily) and BDP (5 mg daily), were enrolled. All patients continued 5-ASA plus high dose oral BDP (15 mg od for 4 weeks and than tapered). Clinical, endoscopic, histological and laboratory parameters were monitored. Mean disease activity index (DAI) score at study entry was 8.82±4. Response to treatment was observed in all patients after 2 weeks. Remission was observed in all patients within 4-6 weeks from entering the study (mean DAI score: 2.34±0.5) and maintained throughout 6-month follow-up. No major adverse events were documented. Quality of life global evaluation score improved. This study provides the first evidence of efficacy and safety of high dose oral BDP-scheme in UC demonstrating excellent tolerability and favourable acceptability profile. This new BDPscheme might be a valid alternative to conventional oral CS when standard dose BDP is not effective. Future studies are needed to explore further clinical indications.

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“…The Campieri et al and Rizzello et al studies found no difference between the 2 medications with similar remission rates; 41,54 however, Rizzello et al found that at 4 weeks, patients treated with beclomethasone achieved clinical remission in 58.9% versus 34.4% of patients treated with the 5 ASA agent. 53 The mean age for these 3 studies was 40.3 years. Based on mean age plus SD, there were no elderly patients in the Rizzello 2001 study, and less than 16% in the other two studies.…”

Section: Efficacy Of Immunosuppressant Agentsmentioning

confidence: 98%

“…[39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58] All 20 studies reported a mean age. The composite mean age was 38.5 years, with a mean range of 30.5 to 46.4 years.…”

Section: Immunosuppressant Age Summationmentioning

confidence: 99%

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Baggenstos

Hanson²,

Shaukat

2013

Clinical Medicine Insights: Geriatrics

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Ulcerative colitis (UC) is increasingly recognized as a disease affecting the elderly. Approximately 10%-30% of the UC population is over the age of 60 years. Additionally, younger patients with UC are aging and thus comprise a second group of elderly IBD patients. To date, there have been no clinical trials that have evaluated treatment efficacy of UC in the elderly population. The aim of our study was to conduct a systematic review of all randomized controlled trials (RCTs) addressing treatment outcome in UC; we also sought to identify the elderly population, defined as age 60 years or older, represented in these studies, to see if pooled data would lead to meaningful conclusions regarding treatment efficacy and safety profile in the elderly. A search of the MEDLINE database via PubMed and the EMBASE database via Scopus was performed to identify all RCTs evaluating medical therapy for UC in humans, published within the English language through September 2012. Studies were grouped into three categories: biological agent (BA) therapy; immunosuppressant (IS) therapy; and 5-aminosalicylic acid (5-ASA) therapy. To estimate the number of elderly patients in each study, mean age plus 1 and 2 standard deviations (SD) was calculated to find the closest approximation to age 60. Of 876 studies, 112 RCTs were included in the final analysis-20 studies for BA, 20 for IS, and 72 for 5-ASA agents. While nearly all studies reported either a mean or median age, only 38% additionally reported the SD and age range. The mean composite age was 39.2 years for the BA studies, 38.5 years for the IS studies, and 42.8 years for the 5-ASA studies, consistent with a young middle-aged patient. We estimated that no more than 16% of patients per study would have qualified as elderly, and in most cases a much smaller percentage (,8%). Additionally, there were no BA or IS RCTs that reported results by age subgroup analysis. Four studies in the 5-ASA group report age-specific analyses and showed no difference in treatment efficacy by age. None of the 112 RCTs reported age sub-analyses of safety, tolerability, adverse events, or withdrawal rates. There is insufficient evidence to evaluate efficacy of treatment and adverse events from treatment for UC in the elderly. With the rising number of elderly patients with UC, there is a need for more clinical trials that specifically address UC treatment in this unique population.

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Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double‐blind placebo‐controlled study

Cited by 121 publications

References 19 publications

Granulocyte and monocyte adsorptive apheresis in the treatment of active distal ulcerative colitis: a prospective, pilot study

Granulocyte and monocyte adsorptive apheresis in the treatment of active distal ulcerative colitis: a prospective, pilot study

Oral high dose Beclomethasone dipropionate for treatment of active ulcerative colitis

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

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