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Neue positive Daten zeigen Überlegenheit von PLENVU® (1-Liter-PEG-Vorbereitung) im Vergleich zu MOVIPREP® (2-Liter-PEG + Ascorbat)
  • USA - español
  • USA - Français

Norgine B.V. (PRNewsfoto/Norgine B.V.)

News provided by

Norgine B.V.

Feb 22, 2018, 10:30 ET

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AMSTERDAM, February 22, 2018 /PRNewswire/ --

  • PLENVU® ist das erste 1-Liter-PEG-basierte Darmvorbereitungspräparat, für das im Vergleich zu MOVIPREP ® (2-Liter-PEG + Ascorbat) eine höhere Reinigungswirkung nachgewiesen wurde  

Norgine B.V. gab heute auf der Konferenz der Belgian Society for Gastrointestinal Endoscopy (BSGIE) neue positive Daten zur Überlegenheit von PLENVU® (NER1006) bekannt. In dieser Post-hoc-Analyse der Phase-III-Studie MORA wurde die Reinigungswirkung von PLENVU® im Vergleich zu MOVIPREP® sowohl im Gesamtkolon aus auch im rechten Kolon verglichen. Die Beurteilung erfolgte anhand der mittleren Score-Werte auf der Boston Bowel Preparation Scale (BBPS).

     (Logo: http://mma.prnewswire.com/media/597589/Norgine_Logo.jpg )

Die Analyse enthielt Daten von 792 Patienten. Sowohl mit PLENVU® nachmittags/vormittags (PM/AM) als auch mit PLENVU® vormittags/vormittags (AM/AM) wurden im Vergleich zu MOVIPREP® PM/AM höhere BBPS-Gesamtscores erreicht (6,7 und 6,6 versus 6,3; P = 0,0001 bzw. P = 0,0058). Ähnlich verhielt es sich im rechten Kolon: sowohl mit PLENVU® PM/AM als auch mit PLENVU® AM/AM wurden im Vergleich zu MOVIPREP® PM/AM höhere BBPS-Gesamtscores erreicht (2,2 und 2,2 versus 2,0; P = 0,0003 bzw. P = 0,0134).

Prof. Raf Bisschops erklärte: "Diese neuen Daten sind sehr wichtig. Durch den Nachweis der höheren Reinigungswirkung im Kolon im Vergleich zum 2-Liter-Standard-Darmvorbereitungspräparat mit PEG und Ascorbat wurde deutlich, dass PLENVU® dabei helfen kann, qualitativ hochwertigere Koloskopien durchzuführen und die Detektion von Läsionen zu verbessern. PLENVU® ist eine neue, wirksame Option für Ärzte und Patienten. Letztere finden es möglicherweise leichter, ein Darmvorbereitungspräparat mit geringerem Flüssigkeitsvolumen zu sich zu nehmen."

Dr. Alastair Benbow, Chief Development & Medical Officer bei Norgine, meinte: "Wir glauben, dass PLENVU® allen Patienten, die sich einer Koloskopie unterziehen, als Standardoption zur Darmreinigung angeboten werden sollte. Patienten wünschen sich nicht nur ein Vorbereitungspräparat mit geringem Volumen, das leicht anzuwenden ist, sie möchten auch ein Darmreinigungspräparat, mit dem Adenome und Polypen (die zu kolorektalem Karzinom führen können) wirksam nachgewiesen werden."

Koloskopie ist ein wichtiges Screening-Verfahren zur Detektion von Läsionen. Kolorektale Karzinome sind mit jährlich 447.000 Neudiagnosen die zweithäufigste krebsassoziierte Todesursache in Europa.

PLENVU® ist heute in Australien, Belgien, Dänemark, Deutschland, Finnland, Frankreich, Großbritannien, Irland, Island, Italien, Kroatien, den Niederlanden, Norwegen, Österreich, Portugal, Rumänien und Ungarn für die Anwendung zugelassen (in den Niederlanden und Österreich unter dem Handelsnamen PLEINVUE™). PLENVU®  ist in Großbritannien und Belgien bereits über die Vertriebsstruktur von Norgine im Handel erhältlich.

Präsentation: Prof. Raf Bisschops am Donnerstag, 22. Februar 2018, 16:00-16:30 bei der Belgian Society for Gastrointestinal Endoscopy. Die Post-hoc-Datenanalysen wurden von Norgine finanziert.

Medien: Isabelle Jouin +44(0)1895-453643

Die vollständige Mitteilung finden Sie unter http://www.norgine.com/media

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