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      Maintaining remission in ulcerative colitis – role of once daily extended-release mesalamine

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          Abstract

          The aminosalicylates (5-ASA; also referred to as mesalamine-based agents) are considered as first-line in the maintenance of remission of mild to moderate ulcerative colitis (UC). Traditionally these agents have required a large pill burden and multiple daily dosing regimens which may account for the low adherence rates, especially in patients in remission. Extended-release mesalamine is the first once daily mesalamine product approved by the Food and Drug Administration for the maintenance of UC remission. This review will examine the pharmacokinetics, dosing, efficacy, and safety data of extended-release mesalamine, and discuss the potential role of improving medication compliance and decreasing costs in UC maintenance.

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          Most cited references 38

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          The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States.

          Previous US studies of inflammatory bowel disease (IBD) prevalence have sampled small, geographically restricted populations and may not be generalizable to the entire nation. This study sought to determine the prevalence of Crohn's disease (CD) and ulcerative colitis (UC) in a large national sample and to compare the prevalence across geographic regions and other sociodemographic characteristics. We analyzed the health insurance claims for 9 million Americans, pooled from 87 health plans in 33 states, and identified cases of CD and UC using diagnosis codes. Prevalence was determined by dividing the number of cases by the number of persons enrolled for 2 years. Logistic regression was used to compare prevalence estimates by geographic region, age, sex, and insurance type (Medicaid vs commercial). The prevalence of CD and UC in children younger than 20 years was 43 (95% confidence interval [CI], 40-45) and 28 (95% CI, 26-30) per 100,000, respectively. In adults, the prevalence of CD and UC was 201 (95% CI, 197-204) and 238 (95% CI, 234-241), respectively. The prevalence of both conditions was lower in the South, compared with the Northeast, Midwest, and West. IBD appears to be more common in commercially insured individuals, compared with those insured by Medicaid. This estimation of the prevalence of IBD in the US should help quantify the overall burden of disease and inform the planning of appropriate clinical services.
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            Effect of 5-aminosalicylate use on colorectal cancer and dysplasia risk: a systematic review and metaanalysis of observational studies.

            We performed a systematic review with metaanalysis of observational studies evaluating the association between 5-ASA use and colorectal cancer (CRC) or dysplasia among patients with ulcerative colitis. We conducted a search of Medline Embase Biosis, Web of Science, Cochrane Collaboration, manually reviewed the literature, and consulted with experts. Studies were included if they 1) evaluated and clearly defined exposure to 5-aminosalicylates in patients with ulcerative colitis, 2) reported CRC or dysplasia outcomes, 3) reported relative risks or odds ratio or provided data for their calculations. Quantitative analysis using a random-effects model is presented. Nine studies (3 cohort, 6 case-control) containing 334 cases of CRC, 140 cases of dysplasia, and a total of 1,932 subjects satisfied all inclusion criteria. Five studies reported CRC outcomes alone, two studies reported separate cancer and dysplasia outcomes, and two studies reported a combined outcome of CRC or dysplasia. All primary estimates are homogenous. Pooled analysis showed a protective association between use of 5-aminosalicylates and CRC (OR=0.51; 95% confidence interval (CI): 0.37-0.69) or a combined endpoint of CRC/dysplasia (OR 0.51; 95% CI: 0.38-0.69). 5-ASA use was not associated with a lower risk of dysplasia, although only two studies evaluated this outcome (OR=1.18; 95% CI: 0.41-3.43). Pooled results of observational studies support a protective association between 5-aminosalicylates and CRC or a combined endpoint of CRC/dysplasia in patients with ulcerative colitis. Additional studies analyzing the effect of 5-ASA on risk of dysplasia are needed.
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              Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis.

              There are scant data regarding outpatient adherence in quiescent ulcerative colitis aside from patients enrolled in controlled clinical trials. We conducted a prevalence study to determine the medication adherence rate of maintenance therapy and to identify possible risk factors for nonadherence. Outpatients with clinically quiescent ulcerative colitis for >6 months on maintenance mesalamine (Asacol, Procter and Gamble, Cincinnati, OH) were eligible. Patients were interviewed regarding disease history, and demographics were obtained from medical records. Refill information for at least 6 months was obtained from computerized pharmacy records. Adherence was defined as at least 80% consumption of supply dispensed. Using nonadherence as the outcome of interest, stratified analysis and regression modeling were used to identify significant associations. Data were complete for the 94 patients recruited. The overall adherence rate was found to be 40%. The median amount of medication dispensed per patient was 71% (8-130%) of the prescribed regimen. Nonadherent patients were more likely to be male (67% vs 52%, p < 0.05), single (68% vs 53%, p = 0.04), and to have disease limited to the left side of the colon versus pancolitis (83% vs 51%, p < 0.01). Sixty-eight percent of patients who took more than four prescription medications were found to be nonadherent versus only 40% of those patients taking fewer medications (p = 0.05). Age, occupation, a family history of inflammatory bowel disease, length of remission, quality-of-life score, or method of recruitment (telephone interview vs clinical visit) were not associated with nonadherence. Logistic regression identified that a history of more than four prescriptions (odds ratio [OR] 2.5 [1.4-5.7]) and male gender (OR 2.06 [1.17-4.88]) increased the risk of nonadherence. Two statistically significant variables, which were protective against nonadherence, were endoscopy within the past 24 months (OR 0.96 [0.93-0.99]) and being married (OR 0.46 [0.39-0.57]). Nonadherence is associated with multiple concomitant medications, male gender, and single status. These patient characteristics may be helpful in targeting those patients at higher risk for nonadherence.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2011
                27 February 2011
                : 5
                : 111-116
                Affiliations
                The Department of Medicine, Section of Gastroenterology, University of Chicago Medical Center, Chicago, IL, USA
                Author notes
                Correspondence: Russell D Cohen, The University of Chicago Medical Center, MC 4076, 5841 S. Maryland Avenue, Chicago, IL 60637, USA, Tel +1 773 702 0719, Fax +1 773 702 2182, Email rcohen@ 123456medicine.bsd.uchicago.edu
                Article
                dddt-5-111
                10.2147/DDDT.S5392
                3063115
                21448448
                © 2011 Oliveira and Cohen, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

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