Effect of Once- or Twice-Daily MMX Mesalamine (SPD476) for the Induction of Remission of Mild to Moderately Active Ulcerative Colitis

Lichtenstein, Gary R.; Kamm, Michael A.; Prabhakar, B.; Губергріц, Н. Б.; Lyne, A. G.; Butler, Todd; Lees, Kirstin; Joseph, Richard J.; Sandborn, William J.

doi:10.1016/j.cgh.2006.10.025

Cited by 245 publications

(271 citation statements)

References 27 publications

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“…No diff erences were seen, however, in complete remission rates between the two dosages ( 134,135 ). Similarly, there were no signifi cant diff erences in clinical responses or remissions in patients with mild or moderate disease when treated with multimatrix-mesalamine with 2.4 g daily compared to 4.8 g daily ( 83,132 ). Th e combination of oral mesalamine and topical mesalamine was more successful than oral mesalamine alone in achieving clinical remission at 8 (but not 4) weeks ( 136 ).…”

Section: Recommendations For Maintenance Of Remission In Distal Diseasementioning

confidence: 83%

“…Th e " newer " aminosalicylates -balsalazide ( 82,88,89 ), olsalazine ( 90 -93 ), Eudragit-S-coated, pH-dependent mesalamine ( 54,87 ), ethylcellulose-coated mesalamine ( 131 ), and multimatrix-release mesalamine ( 83,132 ) -are all superior to placebo and equivalent to sulfasalazine in acute therapy ( 80 ). As with sulfasalazine, therapeutic benefi t requires a threshold dose, with daily doses less than 2 g being ineff ective ( 54,80,87,133 ).…”

Section: Recommendations For Maintenance Of Remission In Distal Diseasementioning

confidence: 99%

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Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,112

977

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Guidelines for clinical practice are aimed to indicate preferred approaches to medical problems as established by scientifi cally valid research. Double-blind placebo controlled studies are preferable, but compassionate-use reports and expert review articles are used in a thorough review of the literature conducted through Medline with the National Library of Medicine. When only data that will not withstand objective scrutiny are available, a recommendation is identifi ed as a consensus of experts. Guidelines are applicable to all physicians who address the subject regardless of specialty training or interests and are aimed to indicate the preferable but not necessarily the only acceptable approach to a specifi c problem. Guidelines are intended to be fl exible and must be distinguished from standards of care, which are infl exible and rarely violated. Given the wide range of specifi cs in any healthcare problem, the physician must always choose the course best suited to the individual patient and the variables in existence at the moment of decision. Guidelines are developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee and approved by the board of trustees. Each has been intensely reviewed and revised by the Committee, other experts in the fi eld, physicians who will use them, and specialists in the science of decision analysis. The recommendations of each guideline are therefore considered valid at the time of composition based on the data available. New developments in medical research and practice pertinent to each guideline will be reviewed at a time established and indicated at publication to assure continued validity. The recommendations made are based on the level of evidence found. Grade A recommendations imply that there is consistent level 1 evidence (randomized controlled trials), grade B indicates that the evidence would be level 2 or 3, which are cohort studies or case -control studies. Grade C recommendations are based on level 4 studies, meaning case series or poor-quality cohort studies, and grade D recommendations are based on level 5 evidence, meaning expert opinion.

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Section: Recommendations For Maintenance Of Remission In Distal Diseasementioning

confidence: 83%

Section: Recommendations For Maintenance Of Remission In Distal Diseasementioning

confidence: 99%

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,112

977

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“…In a large randomized, double-blind, placebo-controlled trial, Lichtenstein et al [35] investigated the efficacy of MMX mesalazine 1.2 g twice daily and 4.8 g once-daily compared with a placebo for 8 wk, for the induction of remission in patients with mild-to moderate UC. Both MMX mesalazine groups achieved statistically significant clinical and endoscopic remission compared with the placebo (34.1% and 29.2% vs 12.9%, 2.4 g/d and 4.8 g/d vs placebo, P < 0.001 and P = 0.009, respectively).…”

Section: Mesalazinementioning

confidence: 99%

Recent advances in the management of distal ulcerative colitis

Koutroubakis¹

2010

WJGPT

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The most frequent localization of ulcerative colitis (UC) is the distal colon. In treating patients with active distal UC, efficacy and targeting of the drug to the distal colon are key priorities. Oral and rectal 5-aminosalicylic acid (5-ASA) preparations represent the first line therapy of mild-to-moderate distal UC for both induction and maintenance treatment. It has been reported that many UC patients are not adherent to therapy and that noncompliant patients had a 5-fold risk of experiencing a relapse. These findings led to the introduction of oncedaily oral regimens of 5-ASA as better therapeutic options in clinical practice due to improved adherence. New formulations of mesalazine, including the multimatrix delivery system, and mesalazine granules, which allow once-daily administration, have been developed. They have been demonstrated to be efficacious in inducing and maintaining remission in mild-to-moderate distal UC in large clinical trials. However, existing data for distal UC are rather insufficient to make a comparison between new and classical 5-ASA formulations. It seems that the new formulations are at least as effective as classical oral 5-ASA formulations. Other treatment options, in the case that 5-ASA therapy is not effective, include systemic corticosteroids, thiopurines (azathioprine or 6-mercaptopurine), cyclosporine, infliximab and surgery. The combination of a prompt diagnostic workup, a correct therapeutic approach and an appropriate follow-up schedule is important in the management of patients with distal UC. This approach can shorten the duration of symptoms, induce a prolonged remission, improve patient's quality of life, and optimize the use of health resources.

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“…Of the 434 MMX mesalazine recipients evaluated for safety in the four published controlled trials [13][14][15][16][17][18][19][20][21] , only two patients had serious adverse events that were considered treatment-related; both included pancreatitis caused by hypersensitivity to mesalazine. There was no evidence of a dose-response relationship with MMX mesalazine for any tolerability parameter in either trial.…”

Section: Maintenance Of Remissionmentioning

confidence: 99%

“…The FDA's approval of MMX mesalazine (SPD476, MezavantTM, LialdaTM) was based on the two randomized, double-blind, placebo-controlled Phase Ⅲ trials [15,16] . The first trial investigated the efficacy of MMX mesalazine 1.2 g twice daily and 4.8 g once-daily compared with the placebo for eight weeks, for the induction of remission in 280 patients with mild-tomoderate UC.…”

Section: Maintenance Of Remissionmentioning

confidence: 99%

Use of new once-daily 5-aminosalicylic acid preparations in the treatment of ulcerative colitis: Is there anything new under the sun?

Lakatos¹

2009

WJG

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5-aminosalicylate (5-ASA) agents remain the mainstay treatment in ulcerative colitis (UC). A number of oral 5-ASA agents are commercially available, including azobond pro-drugs, as well as delayed-and controlledrelease forms of mesalazine. However, poor adherence due to frequent daily dosing and a large number of tablets has been shown to be an important barrier to successful management of patients with UC. Recently, new, once-daily formulations of mesalazine, including the unique multi-matrix delivery system and mesalazine granules, were proven to be efficacious in inducing and maintaining remission in mild-to-moderate UC, with a good safety profile comparable to that of other oral mesalazine formulations. In addition, they offer the advantage of a low pill burden and might contribute to increased long-term compliance and treatment success in clinical practice. This editorial summarizes the available literature on the short-and medium-term efficacy and safety of the new once-daily mesalazine formulations.

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Effect of Once- or Twice-Daily MMX Mesalamine (SPD476) for the Induction of Remission of Mild to Moderately Active Ulcerative Colitis

Cited by 245 publications

References 27 publications

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Recent advances in the management of distal ulcerative colitis

Use of new once-daily 5-aminosalicylic acid preparations in the treatment of ulcerative colitis: Is there anything new under the sun?

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