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      Tegaserod in the treatment of irritable bowel syndrome (IBS) with constipation as the prime symptom

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          Abstract

          Irritable bowel syndrome with constipation (IBS-C) as the predominant bowel symptom is a prevalent disorder, characterized by recurring abdominal pain/discomfort, bloating, and constipation, and imposes a significant socio-economic burden. Traditional treatments generally address just one of the multiple IBS symptoms. The efficacy and safety profile of tegaserod, a serotonin 5-HT 4 receptor agonist, has been demonstrated in several randomized, placebo-controlled, and open-label trials. This review discusses the major clinical trials of tegaserod, which have involved 8948 IBS patients. Overall, data reveal that tegaserod is an effective treatment for IBS-C, providing statistically significant relief of overall and multiple individual IBS-C symptoms (abdominal pain/discomfort, bloating, and constipation) in both placebo-controlled and “real-life” open-label settings. Repeat treatments with tegaserod were also shown to be effective, which is noteworthy given the chronic and episodic nature of IBS. Moreover, tegaserod was associated with improvements in patients’ quality of life and work productivity. Data also indicate that tegaserod is well tolerated over the short-term (4 weeks), long-term (12 months), and repeated treatments. Diarrhea is the only adverse event consistently associated with tegaserod and was generally mild and transient. Overall, tegaserod has been demonstrated to offer effective and well-tolerated treatment of IBS-C, providing patients with meaningful symptom relief.

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          Most cited references 78

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          The impact of irritable bowel syndrome on health-related quality of life.

          Few data are available to evaluate health-related quality of life (HRQOL) of people with irritable bowel syndrome (IBS). We evaluated and compared the impact of IBS on HRQOL using previously reported HRQOL data for the U.S. general population and for people with selected chronic diseases. Using the SF-36 Health Survey, we compared the HRQOL of IBS patients (n = 877) with previously reported SF-36 data for the general U.S. population and for patients with gastroesophageal reflux disease (GERD), diabetes mellitus, depression, and dialysis-dependent end-stage renal disease (ESRD). On all 8 SF-36 scales, IBS patients had significantly worse HRQOL than the U.S. general population (P < 0. 001). Compared with GERD patients, IBS patients scored significantly lower on all SF-36 scales (P < 0.001) except physical functioning. Similarly, IBS patients had significantly worse HRQOL on selected SF-36 scales than patients with diabetes mellitus and ESRD. IBS patients had significantly better mental health SF-36 scale scores than patients with depression (P < 0.001). IBS patients experience significant impairment in HRQOL. Decrements in HRQOL are most pronounced in energy/fatigue, role limitations caused by physical health problems, bodily pain, and general health perceptions. These data offer further insight into the impact of IBS on patient functional status and well-being.
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            The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40,000 subjects.

            To determine the prevalence, symptom pattern and impact of the irritable bowel syndrome, across eight European countries, using a standardized methodology. A community survey of 41 984 individuals was performed using quota sampling and random digit telephone dialing to identify those with diagnosed irritable bowel syndrome or those meeting diagnostic criteria, followed by in-depth interviews. The overall prevalence was 11.5% (6.2-12%); 9.6% had current symptoms, 4.8% had been formally diagnosed and a further 2.9%, 4.2% and 6.5% met the Rome II, Rome I or Manning criteria, respectively. Bowel habit classification varied by criteria: 63% had an 'alternating' bowel habit by Rome II vs. 21% by self-report. On average, 69% reported symptoms lasting for 1 h, twice daily, for 7 days a month. Irritable bowel syndrome sufferers reported more peptic ulcer (13% vs. 6%), reflux (21% vs. 7%) and appendectomy (17% vs. 11%), but not hysterectomy, cholecystectomy or bladder procedures. Ninety per cent had consulted in primary care and 17% in hospital; 69% had used medication. Irritable bowel syndrome substantially interfered with lifestyle and caused absenteeism. Irritable bowel syndrome is common with major effects on lifestyle and health care. The majority of cases are undiagnosed and the prevalence varies strikingly between countries. Diagnostic criteria are associated with varying prevalences and bowel habit sub-types. This limits their utility in clinical practice and the transferability of research findings using them.
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              Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact.

              The impact of irritable bowel syndrome, a gastrointestinal motility disorder, is underestimated and poorly quantified, as clinicians may see only a minority of sufferers. To determine the prevalence, symptom patterns and impact of irritable bowel syndrome in the US. This two-phase community survey used quota sampling and random-digit telephone dialing (screening interview) to identify individuals with medically diagnosed irritable bowel syndrome or individuals not formally diagnosed, but fulfilling irritable bowel syndrome diagnostic criteria (Manning, Rome I or II). Information on irritable bowel syndrome symptoms, general health status, lifestyle and impact of symptoms on individuals' lives was collected using in-depth follow-up interviews. Data were also collected for healthy controls identified in the screening interviews. The total prevalence of irritable bowel syndrome in 5009 screening interviews was 14.1% (medically diagnosed: 3.3%; undiagnosed, but meeting irritable bowel syndrome criteria: 10.8%). Abdominal pain/discomfort was the most common symptom prompting consultation. Most sufferers (74% medically diagnosed; 63% undiagnosed) reported alternating constipation and diarrhoea. Previously diagnosed gastrointestinal disorders occurred more often in sufferers than non-sufferers. Irritable bowel syndrome sufferers had more days off work (6.4 vs. 3.0) and days in bed, and reduced activities to a greater extent than non-sufferers. Most (76.6%) irritable bowel syndrome sufferers in the US are undiagnosed. Irritable bowel syndrome has a substantial impact on sufferers' well-being and health, with considerable socioeconomic consequences.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                March 2007
                March 2007
                : 3
                : 1
                : 107-118
                Affiliations
                [1 ]Department of Internal Medicine, Israelitisches Krankenhaus Hamburg, Germany
                [2 ]Clinical Development, Novartis Pharma GmbH Nuremberg, Germany
                Author notes
                Correspondence: Peter Layer Professor of Medicine, Medical Director, Israelitic Hospital, Academic Hospital, Hamburg University, Orchideenstieg 14, D 22297 Hamburg, Germany Tel: +49 40 5112 5211 Fax: +49 40 5112 5227 Email: layer@ 123456ik-h.de
                Article
                1936292
                18360619
                © 2007 Dove Medical Press Limited. All rights reserved
                Categories
                Review

                Medicine

                tegaserod, efficacy, ibs, zelnorm, serotonin, safety

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