Efficacy of Beclomethasone Dipropionate in Lowering Fecal Calprotectin Levels in Patients with Ulcerative Colitis in Clinical Remission and at Risk of Relapse: The Becalcu Randomized, Controlled Trial
Por:
Ginard D, Barreiro-de Acosta M, Nos P, Moraleja I, Muñoz Nuñez F, Aldeguer X, Echarri A, Villoria A, Riestra S, Boscá Watts MM, González-Lama Y, Royo V, Ferreiro-Iglesias R, Iborra M, Elorza A, Fernandez-Pordomingo A, Sans M
Publicada:
1 dic 2024
Ahead of Print:
1 ago 2024
Resumen:
Introduction: Identifying novel treatment strategies for patients with ulcerative colitis (UC) and at risk of relapse is critical. The objective of this study was to assess the efficacy of beclomethasone dipropionate (BDP) in lowering fecal calprotectin (FC) levels in UC patients in clinical remission and at risk of relapse. Methods: This multicenter study comprised a double-blind, randomized, placebo-controlled phase (part I) and an open-label, non-randomized phase (part II). Eligible participants with UC in clinical remission treated with 5-aminosalicylic acid and with FC levels >= 250 mu g/g were randomized to receive 5 mg/day of BDP or placebo for 4 weeks (part I). At week 5, patients with FC >= 100 mu g/g were treated with 5 mg/day of BDP for 4 weeks (part II), and FC levels were tested at week 9. Results: Forty-three patients were randomized: 22 received BDP (group A) and 21 placebo (group B). At week 4, 13 patients (59.1%) in group A and 3 (17.6%) in group B had FC levels <100 mu g/g (p value = 0.010). In the double-blind phase of the study, no patient relapsed in group A and 4 in group B (p value = 0.049). Both treatment groups showed a favorable safety profile, with the most common adverse events being gastrointestinal disorders. Conclusion: In this multicenter, randomized clinical trial including patients with UC in clinical remission but with elevated FC, BDP was efficacious in reducing FC and well-tolerated.
Filiaciones:
Ginard D:
Gastroenterology Unit, Hospital Universitario Son Espases, Instituto de Investigación Sanitaria Illes Balears, Palma de Mallorca, Spain
Barreiro-de Acosta M:
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
Nos P:
Hospital Universitario y Politécnico La Fe, Valencia, Spain
Moraleja I:
Hospital Galdakao-Usansolo, Galdakao, Spain
Muñoz Nuñez F:
Hospital Universitario De Salamanca, Salamanca, Spain
Aldeguer X:
Hospital Universitario Doctor Josep Trueta de Girona, Girona, Spain
Echarri A:
Complejo Hospitalario Universitario de Ferrol, Ferrol, Spain
Villoria A:
Corporación sanitaria Parc Taulí, Sabadell, Spain
Riestra S:
Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain
Boscá Watts MM:
Hospital Clínico Universitario de Valencia, Valencia, Spain
González-Lama Y:
Hospital Universitario Puerta de Hierro, Madrid, Spain
Royo V:
Gastroenterology Unit, Hospital Universitario Son Espases, Instituto de Investigación Sanitaria Illes Balears, Palma de Mallorca, Spain
Ferreiro-Iglesias R:
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
Iborra M:
Hospital Universitario y Politécnico La Fe, Valencia, Spain
Elorza A:
Hospital Galdakao-Usansolo, Galdakao, Spain
Fernandez-Pordomingo A:
Hospital Universitario De Salamanca, Salamanca, Spain
Sans M:
Gastroenterology Unit, ISADMU, Centro Médico Teknon Barcelona, Barcelona, Spain
Green Submitted, hybrid
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