Once-Daily Dosing of Delayed-Release Oral Mesalamine (400-mg Tablet) Is as Effective as Twice-Daily Dosing for Maintenance of Remission of Ulcerative Colitis

Sandborn, William J.; Korzenik, Joshua R.; Lashner, Bret A.; Leighton, Jonathan A.; Mahadevan, Uma; Marion, James F.; Safdi, Michael; Sninsky, Charles A.; Patel, Raman M.; Friedenberg, Keith; Dunnmon, Preston; Ramsey, David; Kane, Sunanda V.

doi:10.1053/j.gastro.2009.12.054

Cited by 121 publications

(95 citation statements)

References 33 publications

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“…110 In a dosing study by Sandborn et al, once daily dosing was found to be as effective as BID dosing and no difference in outcome seen in patients , 65 years or 65 years and older. 122 Finally, Fockens et al reported that Pentasa ® 3 g/d was more effective in maintaining remission than a dose of 1.5 g/d, but interestingly found that older age was associated with a lower relapse rate. If one were to extrapolate data from these 4 studies, it would appear that mesalamine at a dose of 2.4 g/d is most effective in an elderly patient and that once daily dosing is a reasonable frequency schedule.…”

Section: Discussionmentioning

confidence: 99%

“…70,106,110,122 Sandborn et al report that in patients with clinical remission of UC, once-daily dosing of Asacol ® at doses of 1.6-2.4 g/d, when compared to the same daily doses but given as BID, was as effective for the maintenance of clinical remission over a 12 month period, with remission rates of 85.4% in both groups. 122 Furthermore, treatment outcomes were consistent between age subgroups younger or older than 65 years. Paoluzi et al found that, compared to 1.2 g/d, Asacol ® 2.4 g/d maintained remission in 30% vs. 26% of patients after 12 months of treatment, with no difference in outcomes when stratified by age.…”

Section: Efficacy Of 5-asa Agentsmentioning

confidence: 99%

“…Nine studies (6 not reporting SD) reported age subgroups, generally with subdivision of age 65 or older, which was representative of 8% of the study population. 81,82,84,101,110,116,[122][123][124] One of these studies only reported on age . 40, with a mean age of 47.7.…”

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confidence: 99%

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Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Baggenstos

Hanson²,

Shaukat

2013

Clinical Medicine Insights: Geriatrics

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Ulcerative colitis (UC) is increasingly recognized as a disease affecting the elderly. Approximately 10%-30% of the UC population is over the age of 60 years. Additionally, younger patients with UC are aging and thus comprise a second group of elderly IBD patients. To date, there have been no clinical trials that have evaluated treatment efficacy of UC in the elderly population. The aim of our study was to conduct a systematic review of all randomized controlled trials (RCTs) addressing treatment outcome in UC; we also sought to identify the elderly population, defined as age 60 years or older, represented in these studies, to see if pooled data would lead to meaningful conclusions regarding treatment efficacy and safety profile in the elderly. A search of the MEDLINE database via PubMed and the EMBASE database via Scopus was performed to identify all RCTs evaluating medical therapy for UC in humans, published within the English language through September 2012. Studies were grouped into three categories: biological agent (BA) therapy; immunosuppressant (IS) therapy; and 5-aminosalicylic acid (5-ASA) therapy. To estimate the number of elderly patients in each study, mean age plus 1 and 2 standard deviations (SD) was calculated to find the closest approximation to age 60. Of 876 studies, 112 RCTs were included in the final analysis-20 studies for BA, 20 for IS, and 72 for 5-ASA agents. While nearly all studies reported either a mean or median age, only 38% additionally reported the SD and age range. The mean composite age was 39.2 years for the BA studies, 38.5 years for the IS studies, and 42.8 years for the 5-ASA studies, consistent with a young middle-aged patient. We estimated that no more than 16% of patients per study would have qualified as elderly, and in most cases a much smaller percentage (,8%). Additionally, there were no BA or IS RCTs that reported results by age subgroup analysis. Four studies in the 5-ASA group report age-specific analyses and showed no difference in treatment efficacy by age. None of the 112 RCTs reported age sub-analyses of safety, tolerability, adverse events, or withdrawal rates. There is insufficient evidence to evaluate efficacy of treatment and adverse events from treatment for UC in the elderly. With the rising number of elderly patients with UC, there is a need for more clinical trials that specifically address UC treatment in this unique population.

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Section: Discussionmentioning

confidence: 99%

Section: Efficacy Of 5-asa Agentsmentioning

confidence: 99%

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Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Baggenstos

Hanson²,

Shaukat

2013

Clinical Medicine Insights: Geriatrics

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“…Õ was equivalent in efficacy to twice daily dosing of this product for prevention of UC relapse over a 1 year observation period [Sandborn et al 2010]. By comparison, others showed that a 2.0 g once daily dosage of oral ethylcellulosecoated 5-ASA (Pentasa Õ ) was statistically superior to the 1.0 g twice daily format in maintenance of clinical remission in UC [Dignass et al 2009].…”

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

116

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“…However, the sachet presentation has the advantage of reducing the number of applications per day, limiting it to only one, and contributing significantly to increasing the adhesion (7) and acceptance of the treatment (6,18,24) , which is directly reflected in the improvement of patients' quality of life.…”

Section: Introductionmentioning

confidence: 99%

Decision Tree Construction and Cost-Effectiveness Analysis of Treatment of Ulcerative Colitis With Pentasa®mesalazine 2 G Sachet

Nishikawa

Paladini

Delfini

et al. 2013

Arq. Gastroenterol.

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-Context -Unspecified Ulcerative Rectocolitis is a chronic disease that affects between 0.5 and 24.5/10 5 inhabitants in the world. National and international clinical guidelines recommend the use of aminosalicylates (including mesalazine) as first-line therapy for induction of remission of unspecified ulcerative rectocolitis, and recommend the maintenance of these agents after remission is achieved. However, multiple daily doses required for the maintenance of disease remission compromise compliance with treatment, which is very low (between 45% and 65%). Use of mesalazina in granules (2 g sachet) once daily -Pentasa ® sachets 2 g -can enhance treatment adherence, reflecting in an improvement in patients' outcomes. Objective -To evaluate the evidence on the use of mesalazine for the maintenance of remission in patients with unspecified ulcerative rectocolitis and its effectiveness when taken once versus more than once a day. From an economic standpoint, to analyze the impact of the adoption of this dosage in Brazil's public health system, considering patients' adherence to treatment. Methods -A decision tree was developed based on the Clinical Protocol and Therapeutic Guidelines for Ulcerative Colitis, published by the Ministry of Health in the lobby SAS/MS n° 861 of November 4 th, 2002 and on the algorithms published by the Associação Brasileira de Colite Ulcerativa e Doença de Crohn, aiming to get the cost-effectiveness of mesalazine once daily in granules compared with mesalazine twice daily in tablets. ResultsThe use of mesalazine increases the chances of remission induction and maintenance when compared to placebo, and higher doses are associated with greater chance of success without increasing the risk of adverse events. Conclusion -The use of a single daily dose in the maintenance of remission is effective and related to higher patient compliance when compared to the multiple daily dose regimens, with lower costs.

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Once-Daily Dosing of Delayed-Release Oral Mesalamine (400-mg Tablet) Is as Effective as Twice-Daily Dosing for Maintenance of Remission of Ulcerative Colitis

Cited by 121 publications

References 33 publications

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

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

Decision Tree Construction and Cost-Effectiveness Analysis of Treatment of Ulcerative Colitis With Pentasa®mesalazine 2 G Sachet

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