Clinical–alimentary tractOnce-Daily, High-Concentration MMX Mesalamine in Active Ulcerative Colitis
Section snippets
Participants
Male and female patients aged ≥18 years who had newly diagnosed or relapsing (relapsed ≤6 weeks prior to baseline) active, mild-to-moderate UC (score of 4–10 on a modified UC-disease activity index [UC-DAI], with a sigmoidoscopy score ≥1 and a Physician’s Global Assessment [PGA] score ≤2) with compatible histology were eligible for enrollment in this study. The modified UC-DAI scoring system used in this study was based on that developed by Sutherland et al,19 in which patients found to have
Participant Flow
The study was conducted between December 4, 2003 and October 20, 2004 and 343 patients were randomized to treatment (Figure 1). Thirty-five patients underwent forced randomization; this affected treatment groups similarly (MMX mesalamine 2.4 g/day given QD, n = 10; MMX mesalamine 4.8 g/day given QD, n = 8; ASACOL, n = 8; placebo, n = 9). Two patients were randomized in error and excluded from the study. Both of these patients were found to have a positive stool culture. Neither patient received
Discussion
Our study was designed to evaluate the efficacy and tolerability of MMX mesalamine, a novel formulation of 5-ASA designed to deliver the active drug throughout the colon in a single daily dose, potentially improving patient compliance and thus overall treatment success.
The data from our study show that MMX mesalamine 2.4 g/day or 4.8 g/day given once per day was well tolerated and efficacious for the induction of clinical and endoscopic remission of active, mild-to-moderate UC. Both doses of
References (25)
- et al.
Mesalamine delivery systems: do they really make much difference?
Adv Drug Deliv Rev
(2005) - et al.
Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis
Gastroenterology
(1998) - et al.
Randomised comparison of olsalazine and mesalazine in prevention of relapses in ulcerative colitis
Lancet
(1992) - et al.
A randomized, double-blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative coltis
Am J Gastroenterol
(2002) - et al.
Balsalazide is superior to mesalamine in the time to improvement in signs and symptoms of acute mild-to-moderate ulcerative colitis
Am J Gastroenterol
(2002) - et al.
Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis
Am J Gastroenterol
(2001) - et al.
Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis
Am J Med
(2003) - et al.
Formulation and in vitro evaluation of prednisolone buccoadhesive tablets
Farmaco
(2005) - et al.
5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis
Gastroenterology
(1987) - et al.
A pilot feasibility study of once daily versus conventional dosing mesalamine for maintenance of ulcerative colitis
Clin Gastroenterol Hepatol
(2003)
The optimal dose of 5-aminosalicylic acid in active ulcerative colitis: a dose-finding study with newly developed mesalamine
Clin Gastroenterol Hepatol
Asacol (mesalazine) delayed-release tabletsProduct Monograph
Cited by (328)
Colon targeting in rats, dogs and IBD patients with species-independent film coatings
2024, International Journal of Pharmaceutics: XGADECCU 2022 Guideline for the treatment of Ulcerative Colitis. Adaptation and updating of the GETECCU 2020 Guideline
2023, Gastroenterologia y HepatologiaColonic drug delivery: Formulating the next generation of colon-targeted therapeutics
2023, Journal of Controlled ReleaseIs it time to include older adults in inflammatory bowel disease trials? A call for action
2022, The Lancet Healthy LongevityClinical translation of advanced colonic drug delivery technologies
2022, Advanced Drug Delivery ReviewsMesalamine in the Initial Therapy of Ulcerative Colitis
2020, Gastroenterology Clinics of North AmericaCitation Excerpt :These coatings release at a pH of greater than 7, beginning in the terminal ileum and colon.14,15 The hydrophilic component allows the tablet to swell to a viscous gel state, allowing for proposed slower diffusion throughout the small bowel and colon, while the lipophilic core repels water from entering the core of the tablet prolonging its half-life.14,15 This nature also allows for once-daily administration.14
Supported by Shire Pharmaceuticals Inc.
- 1
M.K. and W.J.S. have served as consultants for and have participated in continuing medical education events indirectly sponsored by Shire Pharmaceuticals Inc.