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Once-daily, high-concentration MMX mesalamine in active ulcerative colitis.

Abstract：

BACKGROUND & AIMS:SPD476 (LIALDA in the US; MEZAVANT in the EU; otherwise known as MMX mesalamine; Shire Pharmaceuticals Inc., Wayne, PA, under license from Giuliani SpA, Milan, Italy) is a novel, once-daily, high-strength (1.2 g/tablet) formulation of mesalamine, utilizing MMX Multi Matrix System (MMX) technology designed to deliver the active drug throughout the colon. We performed a double-blind, multicenter study, comparing MMX mesalamine vs placebo for the treatment of active ulcerative colitis. A delayed-release oral mesalamine (ASACOL; Procter & Gamble, Cincinnati, OH) reference arm was included. METHODS:Three hundred forty-three patients with active, mild-to-moderate ulcerative colitis received MMX mesalamine 2.4 g/day or 4.8 g/day given once daily, ASACOL 2.4 g/day given in 3 divided doses, or placebo for 8 weeks. The primary end point was the proportion of patients in clinical and endoscopic remission (modified ulcerative colitis disease activity index of < or =1 with rectal bleeding and stool frequency scores of 0, no mucosal friability, and a > or =1-point reduction in sigmoidoscopy score from baseline). RESULTS:A significantly greater proportion of patients receiving MMX mesalamine 2.4 g/day given once daily (40.5%; P = .01) and 4.8 g/day given once daily (41.2%; P = .007) achieved clinical and endoscopic remission at week 8, vs placebo (22.1%). The clinical and endoscopic remission rate for ASACOL (32.6%; P = .124) was not significantly superior to placebo. All active treatments were well-tolerated. CONCLUSIONS:Once-daily MMX mesalamine was efficacious and well-tolerated for the induction of clinical and endoscopic remission. MMX mesalamine offers effective and convenient mesalamine therapy, potentially improving treatment compliance.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Kamm MA,Sandborn WJ,Gassull M,Schreiber S,Jackowski L,Butler T,Lyne A,Stephenson D,Palmen M,Joseph RE

doi

10.1053/j.gastro.2006.10.011

subject

Has Abstract

pub_date

2007-01-01 00:00:00

pages

66-75; quiz 432-3

issue

1

eissn

0016-5085

issn

1528-0012

pii

S0016-5085(06)02234-7

journal_volume

132

pub_type

杂志文章,多中心研究,随机对照试验

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