Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study
Rattachement africain : jp. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: Efficacy of maintenance therapy in ulcerative colitis (UC) in the remission stage has been reported to depend on release profile or dosing regimen of oral 5-aminosalicylic acid (5-ASA) products used. Aim of this study is to investigate real life results in using oral 5-ASA products for maintaining mild to moderate UC patients in Japan. METHODS: Adult UC outpatients treated with oral 5-ASA products were enrolled from 379 sites in Japan between July 2012 and July 2013, and followed for 52 weeks. Remission maintenance rate was evaluated by products and dosages. Factors affecting recurrence were also examined. RESULTS: A total of 5695 UC patients were registered. Among the 4677 patients in whom remission maintenance was observed, remission maintenance rate at week 52 was 80.2%. As for disease duration and dosage, Pentasa® 4000 mg/day in 2 divided doses was administered to 480 (21.0%) patients in remission and 341 (46.6%) patients in active stage, and Asacol® 3600 mg/day in 3 divided doses was administered to 696 (46.4%) patients in remission and 473 (67.3%) patients in active stage. The remission maintenance rate at week 52 by dosage and frequency did not significantly differ between Pentasa® Tablets at 4000 mg/day in 2 divided doses (76.5%) and Asacol® Tablets at 3600 mg/day in 3 divided doses (76.1%, P = 0.7868). Factors affecting the risk of relapse in UC were identified. Significantly persistent remission maintenance was noted in patients in whom duration of remission maintenance until enrollment was 12 to <24 months or ≥24 months relative to the reference category of <3 months (12 to <24 months: HR 0.600 [0.486-0.740], p < 0.0001]; ≥24 months: HR 0.352 [0.289-0.431], p < 0.0001). CONCLUSIONS: Efficacy of real life results in using oral 5-ASA products for maintaining mild to moderate UC patients was favorable. Maintaining remission for 12 months or longer after induction therapy was shown to reduce recurrence risk thereafter. TRIAL REGISTRATION: UMIN 000008563 (the date of registration: July 30, 2012), ClinicalTrials.gov NCT01654783 (the date of registration: July 30, 2012).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study
- Date Crossref
- 04/04/2017
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Tokyo Medical and Dental University Department of Gastroenterology pays non établi dans la noticeUniversité ou école supérieure
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Matsuyama Red Cross Hospital Division of Gastroenterology pays non établi dans la noticeÉtablissement de santé
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Hamamatsu Medical Center pays non établi dans la noticeÉtablissement de santé
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Yokkaichi Social Insurance Hospital pays non établi dans la noticeÉtablissement de santé
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Hyogo Medical University pays non établi dans la noticeUniversité ou école supérieure
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Kitasato Institute Hospital pays non établi dans la noticeÉtablissement de santé
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Kitasato University Kitasato Institute Hospital pays non établi dans la noticeUniversité ou école supérieure
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Hamamatsu South Hospital Center for Gastroenterology and Inflammatory Bowel Disease Research pays non établi dans la noticeÉtablissement de santé
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Yokkaichi Hazu Medical Center Inflammatory Bowel Disease Center pays non établi dans la noticeÉtablissement de santé
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Hyogo College of Medicine Department of Inflammatory Bowel Disease pays non établi dans la noticeUniversité ou école supérieure
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Clinical Development Center Medical Affairs pays non établi dans la noticeÉtablissement de santé
Department of Gastroenterology — Tokyo Medical and Dental University, Division of Gastroenterology — Matsuyama Red Cross Hospital et Hamamatsu Medical Center, avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.