Delayed-Release Oral Mesalamine 4.8 g/day (800 mg tablets) Compared with 2.4 g/day (400 mg tablets) for the Treatment of Mildly to Moderately Active Ulcerative Colitis: The ASCEND I Trial

Hanauer, Stephen B.; Sandborn, William J.; Dallaire, Christian; Archambault, A; Yacyshyn, Bruce; Yeh, Chyon; Smith-Hall, Nancy

doi:10.1155/2007/862917

Cited by 149 publications

(112 citation statements)

References 10 publications

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“…Two dose-ranging studies of Eudragit-S-coated pH-dependent release mesalamine show a dose -response relationship, comparing 2.4 g daily with 4.8 g daily, with a greater clinical response to the higher dose seen in patients with moderate but not mild disease. 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 ).…”

Section: Recommendations For Maintenance Of Remission In Distal Diseasementioning

confidence: 83%

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

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,140

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%

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

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,140

977

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“…This would explain why the mean dose of MSZ was significantly higher in patients who had had at least one flare-up in the previous year compared to patients who were in remission at the time of data collection. Results obtained in ASCEND I/II trials indicated that 4.8 g/day MSZ provides statistically significant higher rates of mucosal healing and sigmoidoscopic improvement within a 6-week period when compared with a 2.4 g/day dosing regimen in patients with moderately active UC (20)(21)(22). Takeshima et al conducted a multicenter retrospective study to investigate the efficacy of continuous maintenance treatment with 4.0 g/day of MSZ (23).…”

Section: Discussionmentioning

confidence: 99%

What is the real-life maintenance mesalazine dose in ulcerative colitis?

et al. 2016

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Objective: To describe how mesalazine (MSZ) is used in our practice in ulcerative colitis (UC), at what dose, and the success rate (regarding adherence to therapy).Methods: Observational, transversal study, including all patients with UC and with MSZ maintenance therapy seen from September 2014 to February 2015 at two IBD units in Spain. Treatment adherence was measured by the Morisky-Green scale.Results: We included 203 patients (mean MSZ dose: 2.6 ± 1.0 g/d; median of treatment: 19.5 months [IQR: 8-48]). Doses < 2 g/d were used in 15.3% of cases, 2-2.9 g/d doses in 35.0%, 3-3.9 doses in 29.5%, and ≥ 4 g/d doses in the remaining 20.2%. A single daily dose was preferred in 51.2% of cases, two doses in 33.0% and three doses in 15.8%. A different MSZ brand had been previously used in 36.6% of patients. In 134 cases (66%), the maintenance dose had been increased during a flare-up, and in 49 (36.6% of cases) this higher dose had been kept for maintenance (dose ≥ 4 g/d in 36 patients). During the MSZ therapy, 14 patients (6.9%) suffered mild side effects (21.4% altered liver function tests). Therapy adherence was good in 81.8% of cases.Conclusions: Half of our UC patients take high MSZ doses (≥ 3 g/d) as maintenance therapy, with acceptable safety and good adherence. Half of all patients take a single daily dose, and one third needed a different commercial brand during therapy. Opting for a higher MSZ maintenance dose is a possible strategy for a satisfactory maintenance therapy.

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“…The ASCEND trials were a series of dose-finding trials for 5-ASA in UC. The ASCEND I trial studied patients with mild-moderate UC treated for 6 weeks with either 4.8 or 2.4 g/day of an oral delayed release Eudragit S formulation of 5-ASA (Asacol Õ ) administered as divided doses TID [Hanauer et al 2007]. There was no significant difference between the 4.8 and 2.4 g/day doses of 5-ASA in achieving overall clinical improvement (i.e.…”

Section: Maintenance Of Remission In Ulcerative Colitismentioning

confidence: 99%

Optimizing clinical use of mesalazine (5-aminosalicylic acid) in inflammatory bowel disease

Panaccione

Ghosh

et al. 2011

Therap Adv Gastroenterol

107

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Delayed-Release Oral Mesalamine 4.8 g/day (800 mg tablets) Compared with 2.4 g/day (400 mg tablets) for the Treatment of Mildly to Moderately Active Ulcerative Colitis: The ASCEND I Trial

Abstract: Delayed-release oral mesalamine is an effective and well-tolerated initial therapy in patients with mildly to moderately active UC, and a 4.8 g/day dose may enhance treatment success rates in patients with moderate disease compared with mesalamine 2.4 g/day.

Cited by 149 publications

References 10 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

What is the real-life maintenance mesalazine dose in ulcerative colitis?

Optimizing clinical use of mesalazine (5-aminosalicylic acid) in inflammatory bowel disease

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