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      <abstractText>BACKGROUND: Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn's disease. However, there is no precise recommendation for budesonide dosing due to lack of comparative data. A once-daily (OD) 9 mg dose may improve adherence and thereby efficacy. METHODS: An eight-week, double-blind, double-dummy randomised trial compared budesonide 9 mg OD versus 3mg three-times daily (TID) in patients with mild-to-moderately active ileocolonic Crohn's disease. Primary endpoint was clinical remission defined as CDAI &lt;150 at week 8 (last observation carried forward). RESULTS: The final intent-to-treat population comprised 471 patients (238 [9 mg OD], 233 [3 mg TID]). The confirmatory population for the primary endpoint analysis was the interim per protocol population (n=377; 188 [9 mg OD], 189 [3mg TID]), in which the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus 3 mg TID. Clinical remission was achieved in 71.3% versus 75.1%, a difference of -3.9% (95% CI [-14.6%; 6.4%]; p=0.020 for non-inferiority). The mean (SD) time to remission was 21.9 (13.8) days versus 21.4 (14.6) days with budesonide 9 mg OD versus 3 mg TID, respectively. In a subpopulation of 122 patients with baseline SES-CD ulcer score >/=1, complete mucosal healing occurred in 32.8% (21/64) on 9 mg OD and 41.4% (24/58) on 3mg TID; deep remission (mucosal healing and clinical remission) was observed in 26.6% (17/64) and 32.8% (19/58) of patients, respectively. Treatment-emergent suspected adverse drug reactions were reported in 4.6% of 9 mg OD and 4.7% of 3 mg TID patients. CONCLUSIONS: Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately active Crohn's disease.</abstractText>
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&lt;span class=&quot;author-affil&quot;&gt;&lt;span title=&quot;Debreceni Egyetem&quot;&gt;DE&lt;/span&gt;/&lt;span title=&quot;Klinikai Központ&quot;&gt;KK&lt;/span&gt;/&lt;span title=&quot;Belgyógyászati Klinika&quot;&gt;BelgyKL&lt;/span&gt;/B épület&lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Tuculanu D &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Bunganic I &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Pokrotnieks J &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Kupcinskas L &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Dilger K &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Greinwald R &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Mueller R &lt;/span&gt; &lt;/div&gt; &lt;div class=&quot;autype autype-11&quot;&gt; Kollaborációs közreműködő: &lt;span class=&quot;author-name&quot; mtid=&quot;1405456&quot;&gt;&lt;a href=&quot;/gui2/?type=authors&amp;mode=browse&amp;sel=1405456&quot; target=&quot;_blank&quot;&gt;Tulassay Z (&lt;span class=&quot;authorship-author-name&quot;&gt;Tulassay Zsolt&lt;/span&gt; &lt;span class=&quot;authorAux-mtmt&quot;&gt; belgyógyászat, gastroenterologia&lt;/span&gt;) &lt;/a&gt; &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; mtid=&quot;10001301&quot;&gt;&lt;a href=&quot;/gui2/?type=authors&amp;mode=browse&amp;sel=10001301&quot; target=&quot;_blank&quot;&gt;Herszényi L (&lt;span class=&quot;authorship-author-name&quot;&gt;Herszényi László&lt;/span&gt; &lt;span class=&quot;authorAux-mtmt&quot;&gt; Belgyógyászat, gasztroenterológia, klinikai onk...&lt;/span&gt;) &lt;/a&gt; &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; mtid=&quot;10015656&quot;&gt;&lt;a href=&quot;/gui2/?type=authors&amp;mode=browse&amp;sel=10015656&quot; target=&quot;_blank&quot;&gt;Juhász M (&lt;span class=&quot;authorship-author-name&quot;&gt;Juhász Márk&lt;/span&gt; &lt;span class=&quot;authorAux-mtmt&quot;&gt; belgyógyászat, gastroenterológia,molekuláris él...&lt;/span&gt;) &lt;/a&gt; &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; mtid=&quot;10015669&quot;&gt;&lt;a href=&quot;/gui2/?type=authors&amp;mode=browse&amp;sel=10015669&quot; target=&quot;_blank&quot;&gt;Miheller P (&lt;span class=&quot;authorship-author-name&quot;&gt;Miheller Pál&lt;/span&gt; &lt;span class=&quot;authorAux-mtmt&quot;&gt; belgyógyászat, gasztroenterologia, molekuláris ...&lt;/span&gt;) &lt;/a&gt; &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; mtid=&quot;10023605&quot;&gt;&lt;a href=&quot;/gui2/?type=authors&amp;mode=browse&amp;sel=10023605&quot; target=&quot;_blank&quot;&gt;Mihály E (&lt;span class=&quot;authorship-author-name&quot;&gt;Mihály Emese&lt;/span&gt; &lt;span class=&quot;authorAux-mtmt&quot;&gt; belgyógyászat, gastroenterologia, klinikai farm...&lt;/span&gt;) &lt;/a&gt; &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; mtid=&quot;10039339&quot;&gt;&lt;a href=&quot;/gui2/?type=authors&amp;mode=browse&amp;sel=10039339&quot; target=&quot;_blank&quot;&gt;Palatka K (&lt;span class=&quot;authorship-author-name&quot;&gt;Palatka Károly&lt;/span&gt; &lt;span class=&quot;authorAux-mtmt&quot;&gt; gastroenterológia&lt;/span&gt;) &lt;/a&gt; &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Kacska S &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Demeter P &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Penyige J &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Sike R &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; mtid=&quot;10048687&quot;&gt;&lt;a href=&quot;/gui2/?type=authors&amp;mode=browse&amp;sel=10048687&quot; target=&quot;_blank&quot;&gt;Mester G (&lt;span class=&quot;authorship-author-name&quot;&gt;Mester Gábor&lt;/span&gt; &lt;span class=&quot;authorAux-mtmt&quot;&gt; Belgyógyászat-Gasztroenterológia&lt;/span&gt;) &lt;/a&gt; &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Balogh M &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; mtid=&quot;10003584&quot;&gt;&lt;a href=&quot;/gui2/?type=authors&amp;mode=browse&amp;sel=10003584&quot; target=&quot;_blank&quot;&gt;Rácz I (&lt;span class=&quot;authorship-author-name&quot;&gt;Rácz István&lt;/span&gt; &lt;span class=&quot;authorAux-mtmt&quot;&gt; Gasztroenterológia&lt;/span&gt;) &lt;/a&gt; &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Szabó A &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Karasz T &lt;/span&gt; ;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;span class=&quot;author-name&quot; &gt;Csöndes M &lt;/span&gt; &lt;/div&gt; &lt;div class=&quot;autype autype-29&quot;&gt; Kollaborációs szervezet: &lt;span class=&quot;author-affil&quot;&gt;International Budenofalk Study Group&lt;/span&gt; &lt;/div&gt; &lt;/div&gt; &lt;div class=&quot;title&quot;&gt;&lt;a href=&quot;/gui2/?mode=browse&amp;params=publication;2808988&quot; target=&quot;_blank&quot;&gt;Once versus three times daily dosing of oral budesonide for active Crohn&apos;s disease: a double-blind, double-dummy, randomised trial&lt;/a&gt;&lt;/div&gt; &lt;div&gt; &lt;span class=&quot;journal-title&quot;&gt;JOURNAL OF CROHNS &amp; COLITIS&lt;/span&gt; &lt;span class=&quot;journal-issn&quot;&gt;(&lt;a target=&quot;_blank&quot; href=&quot;https://portal.issn.org/resource/ISSN/1873-9946&quot;&gt;1873-9946&lt;/a&gt; &lt;a target=&quot;_blank&quot; href=&quot;https://portal.issn.org/resource/ISSN/1876-4479&quot;&gt;1876-4479&lt;/a&gt;)&lt;/span&gt;: &lt;span class=&quot;journal-volume&quot;&gt;8&lt;/span&gt; &lt;span class=&quot;journal-issue&quot;&gt;9&lt;/span&gt; &lt;span class=&quot;page&quot;&gt; pp 970-980 &lt;/span&gt; &lt;span class=&quot;year&quot;&gt;(2014)&lt;/span&gt; &lt;/div&gt; &lt;div class=&quot;pub-footer&quot;&gt;  &lt;span class=&quot;language&quot; xmlns=&quot;http://www.w3.org/1999/html&quot;&gt;Nyelv: Angol | &lt;/span&gt; &lt;span class=&quot;identifiers&quot;&gt; &lt;span class=&quot;id identifier oa_none&quot; title=&quot;none&quot;&gt; &lt;a style=&quot;color:blue&quot; title=&quot;10.1016/j.crohns.2014.01.021&quot; target=&quot;_blank&quot; href=&quot;https://doi.org/10.1016/j.crohns.2014.01.021&quot;&gt; DOI &lt;/a&gt; &lt;/span&gt; &lt;span class=&quot;id identifier oa_none&quot; title=&quot;none&quot;&gt; &lt;a style=&quot;color:blue&quot; title=&quot;000342264900008&quot; target=&quot;_blank&quot; href=&quot;https://www.webofscience.com/wos/woscc/full-record/000342264900008&quot;&gt; WoS &lt;/a&gt; &lt;/span&gt; &lt;span class=&quot;id identifier oa_none&quot; title=&quot;none&quot;&gt; &lt;a style=&quot;color:blue&quot; title=&quot;84906792062&quot; target=&quot;_blank&quot; href=&quot;http://www.scopus.com/record/display.url?origin=inward&amp;eid=2-s2.0-84906792062&quot;&gt; Scopus &lt;/a&gt; &lt;/span&gt; &lt;span class=&quot;id identifier oa_none&quot; title=&quot;none&quot;&gt; &lt;a style=&quot;color:blue&quot; title=&quot;24534142&quot; target=&quot;_blank&quot; href=&quot;http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&amp;db=PubMed&amp;list_uids=24534142&amp;dopt=Abstract&quot;&gt; PubMed &lt;/a&gt; &lt;/span&gt; &lt;/span&gt; &lt;OnlyViewableByAuthor&gt;&lt;div class=&quot;ratings&quot;&gt; &lt;div class=&quot;journal-subject&quot;&gt;Folyóirat szakterülete: Scopus - Medicine (miscellaneous)&amp;nbsp;&amp;nbsp;&amp;nbsp;SJR indikátor:&amp;nbsp;D1&lt;/div&gt; &lt;div class=&quot;journal-subject&quot;&gt;Folyóirat szakterülete: Scopus - Gastroenterology&amp;nbsp;&amp;nbsp;&amp;nbsp;SJR indikátor:&amp;nbsp;Q1&lt;/div&gt; &lt;/div&gt;&lt;/OnlyViewableByAuthor&gt; &lt;div class=&quot;publication-citation&quot; style=&quot;margin-left: 0.5cm;&quot;&gt; &lt;span title=&quot;Nyilvános idézőközlemények összesen, említések nélkül&quot; class=&quot;citingPub-count&quot;&gt;Nyilvános idéző összesen: 38&lt;/span&gt; | Független: 37 | Függő: 1 | Nem jelölt: 0 | WoS jelölt: 30 | Scopus jelölt:&amp;nbsp;36 | WoS/Scopus jelölt:&amp;nbsp;38 | DOI jelölt:&amp;nbsp;37 &lt;/div&gt;   &lt;div class=&quot;publication-citation&quot;&gt; &lt;a target=&quot;_blank&quot; href=&quot;/api/publication?cond=citations.related;eq;2808988&amp;sort=publishedYear,desc&amp;sort=title&quot;&gt; Idézett közlemények száma: 1 &lt;/a&gt; &lt;/div&gt; &lt;div class=&quot;mtid&quot;&gt;&lt;span class=&quot;long-pub-mtid&quot;&gt;Közlemény: 2808988&lt;/span&gt; | &lt;span class=&quot;status-data status-ADMIN_APPROVED&quot;&gt; Admin láttamozott &lt;/span&gt; &lt;span class=&quot;oldId&quot;&gt;Régi azonosító: 2808988&lt;/span&gt; | Forrás Idéző | &lt;span class=&quot;type-subtype&quot;&gt;Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) &lt;/span&gt; | &lt;span class=&quot;pub-category&quot;&gt;Tudományos&lt;/span&gt; | &lt;span class=&quot;publication-sourceOfData&quot;&gt;MEDLINE&lt;/span&gt; &lt;/div&gt; &lt;div class=&quot;lastModified&quot;&gt;Utolsó módosítás: 2023.05.25. 21:36 Pécsi Éva (MTMT Közp 2,3, admin) &lt;/div&gt; &lt;div class=&quot;lockedBy&quot;&gt;Központi kezelésű 2023.04.19. 14:08 Pécsi Éva (MTMT Közp 2,3, admin) &lt;/div&gt; &lt;/div&gt;&lt;/div&gt;</template2>
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