Navigation überspringen
Universitätsbibliothek Heidelberg
Status: Bibliographieeintrag

Verfügbarkeit
Standort: ---
Exemplare: ---
heiBIB
 Online-Ressource
Verfasst von:Dignaß, Axel Uwe [VerfasserIn]   i
 Stremmel, Wolfgang [VerfasserIn]   i
 Horyński, Marek [VerfasserIn]   i
 Poyda, Oleksandr [VerfasserIn]   i
 Armerding, Peter [VerfasserIn]   i
 Fellermann, Klaus [VerfasserIn]   i
 Langhorst, Jost [VerfasserIn]   i
 Kuehbacher, Tanja [VerfasserIn]   i
 Uebel, Peter [VerfasserIn]   i
 Stein, Jürgen [VerfasserIn]   i
 Novacek, Gottfried [VerfasserIn]   i
 Avalueva, Elena [VerfasserIn]   i
 Olijnyk, Oleksandr Ljeontijovyč [VerfasserIn]   i
 Hasselblatt, Peter [VerfasserIn]   i
 Dorofeyev, Andrey [VerfasserIn]   i
 Heinemann, Heidrun [VerfasserIn]   i
 Mueller, Ralph [VerfasserIn]   i
 Greinwald, Roland [VerfasserIn]   i
 Reinisch, Walter [VerfasserIn]   i
Titel:Modified-release phosphatidylcholine (LT-02) for ulcerative colitis
Titelzusatz:two double-blind, randomized, placebo-controlled trials
Verf.angabe:Axel Dignass, Wolfgang Stremmel, Marek Horyński, Oleksandr Poyda, Peter Armerding, Klaus Fellermann, Jost Langhorst, Tanja Kuehbacher, Peter Uebel, Juergen Stein, Gottfried Novacek, Elena Avalueva, Oleksandr Oliinyk, Peter Hasselblatt, Andrey Dorofeyev, Heidrun Heinemann, Ralph Mueller, Roland Greinwald and Walter Reinisch
E-Jahr:2024
Jahr:April 2024
Umfang:11 S.
Fussnoten:Gesehen am 02.12.2024
Titel Quelle:Enthalten in: Clinical gastroenterology and hepatology
Ort Quelle:New York, NY : Elsevier Science, 2003
Jahr Quelle:2024
Band/Heft Quelle:22(2024), 4, Seite 810-820
ISSN Quelle:1542-7714
Abstract:Background & Aims - The aim of this study was to evaluate the efficacy of LT-02, a novel modified-release phosphatidylcholine (PC) formulation, for induction and maintenance of remission in patients with mild to moderate ulcerative colitis (UC) and inadequate response to mesalamine. - Methods - LT-02 was evaluated in a multicenter double-blind, randomized, placebo-controlled study comprising a 12-week induction trial (PCG-2), followed by a 48-week maintenance trial (PCG-4). In PCG-2, patients were randomized 1:1:1 to treatment with 0.8 g LT-02 4 times daily (QID), 1.6 g LT-02 twice daily (BID), or placebo, respectively. All patients continued to take a standard dose of oral mesalamine (≥2.4 g/day). The primary end point in PCG-2 was deep remission. Patients achieving remission at week 12 were randomly assigned 2:1:1 to 1.6 g LT-02 BID, placebo, or 500 mg mesalamine (3 times daily), respectively, in PCG-4; the primary end point was remission at 48 weeks. - Results - PCG-2 was terminated early for futility after a prespecified interim analysis; 466 patients (of 762 planned) were randomized. There was no statistically significant difference in deep remission at week 12 (placebo, 13.5%; LT-02 BID, 14.2%; LT-02 QID, 9.7%). In PCG-4, 150 patients (of approximately 400 planned) were randomized. There was no statistically significant difference in remission rates at week 48 (LT-02 BID, 49.3%; mesalamine, 50.0%; placebo, 43.2%). LT-02 was safe. - Conclusions - Despite prior evidence of beneficial effects of PC in phase 2 trials, our induction study with LT-02 in patients with mild to moderate UC was terminated prematurely for futility. Signals of efficacy in maintenance therapy require confirmation in an adequately powered maintenance trial. LT-02 was safe and well-tolerated. ClinicalTrials.gov: NCT02280629, NCT02142725.
DOI:doi:10.1016/j.cgh.2023.09.031
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

Volltext: https://doi.org/10.1016/j.cgh.2023.09.031
 Volltext: https://www.sciencedirect.com/science/article/pii/S1542356523007711
 DOI: https://doi.org/10.1016/j.cgh.2023.09.031
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:Mesalamine
 Mucus
 Phosphatidylcholine
 Ulcerative Colitis
K10plus-PPN:1910625361
Verknüpfungen:→ Zeitschrift

Permanenter Link auf diesen Titel (bookmarkfähig):  https://katalog.ub.uni-heidelberg.de/titel/69279483   QR-Code
zum Seitenanfang