Abstract
Treatment with mesalamine to maintain endoscopic remission (mucosal healing) of ulcerative colitis (UC) has been shown to reduce the risk of relapse and is the recommended first-line maintenance therapy. To improve treatment adherence, a mesalamine formulation that can be administered once-daily, MMX(®) mesalamine (Lialda; Shire Pharmaceuticals LLC, Wayne, PA), was developed. This study was conducted to determine the efficacy and safety of once-daily MMX mesalamine compared with twice-daily delayed-release mesalamine (Asacol; Warner Chilcott, Dublin, Ireland) for maintaining endoscopic remission in patients with UC. A multicenter, randomized, double-blind, 6-month, active-control trial was conducted to assess the non-inferiority of once-daily MMX mesalamine 2.4 g/day compared with twice-daily delayed-release mesalamine at a total daily dose of 1.6 g/day in patients with UC in endoscopic remission. The primary end point was maintenance of endoscopic remission at month 6 in the per-protocol (PP) population. Overall, 826 patients were randomized and dosed. The primary objective (non-inferiority) was met. At month 6, 83.7 and 77.8% of patients receiving MMX mesalamine in the PP and intent-to-treat (ITT) populations, respectively, h...Continue Reading
References
Jun 1, 1988·Gastroenterology·S A RileyL A Turnberg
Jun 1, 1988·Gut·A IrelandD P Jewell
Dec 1, 1988·Gastroenterology·C J MulderH van der Heide
Dec 24, 1987·The New England Journal of Medicine·K W SchroederD M Ilstrup
Jun 1, 1987·Gastroenterology·L R SutherlandL Borgen
Dec 1, 1973·Gut·A S Dissanayake, S C Truelove
Feb 1, 1995·Digestive Diseases and Sciences·P MinerS Arora
Oct 1, 1993·Digestive Diseases and Sciences·J P WrightK Jaskiewicz
Jan 15, 1996·Annals of Internal Medicine
Dec 1, 1995·Journal of Clinical Gastroenterology·S ArdizzoneG Bianchi Porro
Nov 1, 1995·European Journal of Gastroenterology & Hepatology·P FockensP A van Hees
Jan 9, 1999·Alimentary Pharmacology & Therapeutics·J R GreenM D Taylor
Nov 16, 2001·Gut·W KruisU Ewald
Jul 19, 2002·Gastroenterology Clinics of North America·Edward V Loftus, William J Sandborn
Sep 3, 2003·Alimentary Pharmacology & Therapeutics·J Eaden
Jul 5, 2005·Gut·T P van StaaH G M Leufkens
Apr 28, 2006·Statistics in Medicine·UNKNOWN Committee for Medicinal Products for Human UseUNKNOWN Committee for Release for Consultation
Sep 21, 2006·Alimentary Pharmacology & Therapeutics·G D'HaensR Joseph
Nov 23, 2006·Inflammatory Bowel Diseases·Edward V Loftus
Jan 20, 2007·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Gary R LichtensteinWilliam J Sandborn
Jan 24, 2007·Gastroenterology·Michael A KammRaymond E Joseph
Jan 30, 2007·Gastroenterology·Geert D'HaensLloyd R Sutherland
Mar 21, 2007·Gut·Paul RutgeertsGert Van Assche
Aug 8, 2007·Gastroenterology·Kathrine Frey FrøslieUNKNOWN IBSEN Group
Feb 15, 2008·Gut·M A KammR Joseph
Jul 29, 2009·Inflammatory Bowel Diseases·Gary R Lichtenstein, Paul Rutgeerts
Aug 15, 2009·Alimentary Pharmacology & Therapeutics·C PranteraS Bellinvia
Jan 13, 2010·Gastroenterology·William J SandbornSunanda Kane
Jan 14, 2010·The American Journal of Gastroenterology·Asher KornbluthUNKNOWN Practice Parameters Committee of the American College of Gastroenterology
Feb 16, 2010·Digestive Diseases and Sciences·David T RubinJoseph Hopper
Oct 13, 2010·Alimentary Pharmacology & Therapeutics·G R LichtensteinW P Forbes
Dec 9, 2010·Alimentary Pharmacology & Therapeutics·W KruisUNKNOWN International Salofalk OD Study Group
Mar 1, 2008·Journal of Crohn's & Colitis·S P L TravisUNKNOWN European Crohn's and Colitis Organisation (ECCO)
Citations
May 29, 2014·Drug Design, Development and Therapy·David PierceSandra K Willsie
Mar 13, 2014·European Journal of Clinical Pharmacology·Leo RussoSusan Rosen
Feb 26, 2016·Journal of Crohn's & Colitis·David T RubinUNKNOWN Ulcerative Colitis Remission Study Group
Sep 14, 2012·Expert Opinion on Pharmacotherapy·Sara N Horst, Sunanda Kane
May 18, 2017·Journal of Crohn's & Colitis·Marcus HarbordUNKNOWN European Crohn’s and Colitis Organisation
[ECCO]
Mar 22, 2018·Scandinavian Journal of Gastroenterology·Radan KeilJindra Lochmannová
Nov 6, 2015·Inflammatory Bowel Diseases·Nilesh ChandeBrian G Feagan
May 4, 2018·Alimentary Pharmacology & Therapeutics·P SehgalN Narula
Nov 7, 2015·Digestive Diseases and Sciences·Gary R Lichtenstein
Jul 4, 2017·Intestinal research·Haruhiko OgataToshifumi Hibi
Oct 5, 2018·Expert Review of Gastroenterology & Hepatology·Belinda Jackson, Peter De Cruz
Apr 5, 2019·Medicine·Xin ZhengXimo Wang
May 4, 2013·Expert Review of Gastroenterology & Hepatology·Makoto NaganumaToshifumi Hibi
Apr 12, 2014·Paediatric Drugs·Brian P Regan, Athos Bousvaros
May 10, 2016·The Cochrane Database of Systematic Reviews·Yongjun WangJohn K MacDonald
Mar 18, 2020·Journal of Crohn's & Colitis·Stefan SchreiberKaren Barrett
Mar 22, 2014·Expert Review of Gastroenterology & Hepatology·Anthony O'Connor, Alan C Moss
May 9, 2015·Advances in Therapy·Adeyinka Abinusawa, Srini Tenjarla
Aug 29, 2020·The Cochrane Database of Systematic Reviews·Alistair MurrayJohn K MacDonald
Feb 26, 2016·Advances in Therapy·Jing Sun, Yaozong Yuan
May 24, 2016·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland·Wei LiXue-Liang Jiang
Jan 13, 2021·Journal of Crohn's & Colitis·Brigida BarberioAlexander C Ford
Sep 25, 2012·Gastroenterology·Geert D'HaensUNKNOWN International Organization for Inflammatory Bowel Diseases (IOIBD) and the Clinical Trial Committee Clincom of the European