TITLE

Efficacy of Tegaserod in Chronic Constipation in Men

AUTHOR(S)
Fried, Michael; Johanson, John F.; Gwee, Kok Ann; Wagner, Amy; Pecher, Eckhard; Rueegg, Peter
PUB. DATE
February 2007
SOURCE
American Journal of Gastroenterology;Feb2007, Vol. 102 Issue 2, p362
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
OBJECTIVES: Chronic constipation/idiopathic constipation is highly prevalent in western countries and traditional treatments are suboptimal. This multicenter study evaluated the efficacy and safety of tegaserod, a selective 5-HT4 agonist and promotility agent, in men with chronic constipation. METHODS: After screening and baseline phases, men with chronic constipation were randomized to receive either tegaserod 6 mg twice daily or placebo in a double-blind manner for 12 wk. Patients recorded symptoms using a diary. Primary efficacy variable was the response rate for an increase in complete spontaneous bowel movements (CSBMs) during the first 4 wk of double-blind treatment. Other efficacy measures included patient assessment of symptoms and satisfaction with symptom relief. Safety and tolerability were also evaluated. RESULTS: In total, 322 patients were randomized to tegaserod (N = 158) or placebo (N = 164). Increases of at least one CSBM per wk during the first 4 wk of treatment observed for tegaserod compared with placebo (40.5% vs 29.3%, P= 0.03) were sustained throughout the 12-wk treatment period. Response rate for CSBM was also superior for tegaserod ( P= 0.04 vs placebo) over the treatment period. Benefits for tegaserod over placebo were also observed for some secondary efficacy variables, however, statistical significance was not achieved at all weeks. Frequency of adverse events was similar with tegaserod and placebo. CONCLUSIONS: Tegaserod 6 mg twice daily was effective and well tolerated in the treatment of chronic constipation in men. Tegaserod provided rapid relief of constipation within 1 wk and the effects were sustained for up to 12 wk.
ACCESSION #
23774278

 

Related Articles

  • Atomoxetine in the Management of Children with ADHD: Effects on Quality of Life and School Functioning. Brown, Ronald T.; Perwien, Amy; Faries, Douglas E.; Kratochvil, Christopher J.; Vaughan, Brigette S. // Clinical Pediatrics;Nov2006, Vol. 45 Issue 9, p819 

    The purpose of this study was to examine in a controlled trial the effects of atomoxetine on the management of attention deficit-hyperactivity disorder (ADHD) symptoms and functional impairments at school and at home. Participants were 153 children (age 8 to 12 years) diagnosed with...

  • Penicillin for acute sore throat in children: randomised, double blind trial. Zwart, Sjoerd; Rovers, Maroeska M.; de Melker, Ruut A.; Hoes, Arno W. // BMJ: British Medical Journal (International Edition);12/6/2003, Vol. 327 Issue 7427, p1324 

    Abstract Objective: To assess the effectiveness of penicillin for three days and treatment for seven days compared with placebo in resolving symptoms in children with sore throat. Design: Randomised, double blind, placebo controlled trial. Setting: 43 family practices in the Netherlands....

  • A Placebo-Controlled Trial of Itopride in Functional Dyspepsia. Holtmann, Gerald; Talley, Nicholas J.; Liebregts, Tobias; Adam, Birgit; Parow, Christopher // New England Journal of Medicine;2/23/2006, Vol. 354 Issue 8, p832 

    Background: The treatment of patients with functional dyspepsia remains unsatisfactory. We assessed the efficacy of itopride, a dopamine D2 antagonist with acetylcholinesterase effects, in patients with functional dyspepsia. Methods: Patients with functional dyspepsia were randomly assigned to...

  • Pexelizumab for Acute ST-Elevation Myocardial Infarction in Patients Undergoing Primary Percutaneous Coronary Intervention. Armstrong, Paul W.; Granger, Christopher B.; Abrams, Peter X.; Hamm, Christian; Holmes Jr., David; O'Neil, William W.; Todaro, Thomas G.; Vahanian, Alec; Van de Werf, Frans; Al-Khalidi, Hussein; Ardissino, Diego; Aylward, Phil; Betriu, Amadeo; Hochman, Judith; Huber, Kurt; James, Stefan; Lee, Kerry; Mahaffey, Kenneth W.; Moliterno, David; Montalescot, Gilles // JAMA: Journal of the American Medical Association;1/3/2007, Vol. 297 Issue 1, p43 

    This article focuses on a placebo-controlled phase 3 study of the effectiveness of the drug, pexelizumab, as an adjunct to percutaneous transliminal coronary intervention (PCI) in the treatment of patients with acute ST-elevation myocardial infarction. Patients received either placebo or...

  • Review: omalizumab reduces exacerbation and steroid use in chronic asthma. Rees, P. John // Archives of Disease in Childhood -- Education & Practice Edition;Aug2007, Vol. 92 Issue 4, p127 

    This article provides information on a study that examined whether omalizumab, a recombinant humanised monoclonal anti-IgE, is better than placebo for clinical outcomes. The data sources for this study are given. Adults and children with chronic asthma served as study subjects. According to...

  • Modelling and Simulation of the Positive and Negative Syndrome Scale (PANSS) Time Course and Dropout Hazard in Placebo Arms of Schizophrenia Clinical Trials. Reddy, Venkatesh Pilla; Kozielska, Magdalena; Johnson, Martin; Suleiman, Ahmed Abbas; Vermeulen, An; Liu, Jing; de Greef, Rik; Groothuis, Geny M. M.; Danhof, Meindert; Proost, Johannes H. // Clinical Pharmacokinetics;2012, Vol. 51 Issue 4, p261 

    Background and Objectives: The likelihood of detecting a therapeutic signal of an effective drug for schizophrenia is impeded by a high placebo effect and by high dropout of patients. Several unsuccessful trials of schizophrenia, at least partly due to highly variable placebo effects, have...

  • Opioids for Chronic Back Pain: Short-Term Effectiveness, Long-Term Uncertain. BARRY, HENRY C. // American Family Physician;8/15/2014, Vol. 90 Issue 4, p259B 

    The article discusses research which investigated the therapeutic effectiveness of opioids for chronic low back pain, conducted by L. E. Chaparro and colleagues, published in a 2014 issue of "The Spine Journal." Topics explored include a comparison between placebo and opioid use in relieving...

  • Placebo effects: clinical aspects and neurobiology.  // Brain: A Journal of Neurology;Nov2008, Vol. 131 Issue 11, p2812 

    Placebo effects are beneficial health outcomes not related to the relatively direct biological effects of an intervention and can be elicited by an agent that, by itself, is inert. Understanding these placebo effects will help to improve clinical trial design, especially for interventions such...

  • Placebo Effect in Clinical Trial Design for Irritable Bowel Syndrome. Shah, Eric; Pimentel, Mark // Journal of Neurogastroenterology & Motility;Apr2014, Vol. 20 Issue 2, p163 

    Ongoing efforts to improve clinical trial design in irritable bowel syndrome have been hindered by high placebo response rates and ineffective outcome measures. We assessed established strategies to minimize placebo effect as well as the various approaches to placebo effect which can affect...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics