Long-term safety and tolerability of once-daily mesalamine granules in the maintenance of remission of ulcerative colitis.

Abstract:

BACKGROUND:Ulcerative colitis (UC), a chronic, relapsing, and remitting inflammatory bowel disease, requires long-term treatment to maintain remission. In this study, the long-term safety and tolerability of mesalamine granules (MG) therapy was evaluated in the maintenance of UC remission. Previous prospective studies evaluating different oral mesalamine formulations have not exceeded a duration of 14 months. METHODS:A phase 3, multicenter, 24-month, open-label extension study evaluating MG 1.5 g once daily in patients who achieved previous remission from mild to moderate UC was performed. Eligible patients had successfully participated in 1 of 2 previous 6-month double-blind, placebo-controlled trials or were new patients in remission. Safety assessments included monitoring of adverse events (AEs) and clinical laboratory tests. Risk of UC recurrence was assessed by the occurrence of UC-related AEs. RESULTS:Of the 393 patients enrolled (280 from the double-blind studies; 113 new patients), 388 were included in the safety population. The most common AEs included nasopharyngitis (13.9%), headache (11.6%), and diarrhea (10.8%), and the incidence of these events was generally lower in the MG group versus historical placebo group from the double-blind studies. Pancreatic, renal, and hepatic AEs occurred in 23 patients (5.9%). The risk of UC-related AEs was low and was maintained for 24 months during the open-label study. CONCLUSIONS:Once-daily MG has a favorable safety profile for the maintenance of remission for up to 2 years in patients with UC.

journal_name

Inflamm Bowel Dis

authors

Lichtenstein GR,Barrett AC,Bortey E,Paterson C,Forbes WP

doi

10.1097/MIB.0000000000000076

subject

Has Abstract

pub_date

2014-08-01 00:00:00

pages

1399-406

issue

8

eissn

1078-0998

issn

1536-4844

journal_volume

20

pub_type

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