A double‐blind, placebo‐controlled, randomized study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome

References

• Saito YA, Schoenfeld P, Locke GR. The epidemiology of irritable bowel syndrome in North America: a systematic review. Am J Gastroenterol 2002;97:1910–5.
   Google Scholar
• Icks A, Haastert B, Enck P, Rathmann W, Giani G. Prevalence of functional bowel disorders and related health care seeking: a population-based study. Z Gastroenterol 2002;40:177–83.
   Google Scholar
• Agreus L. The epidemiology of functional gastrointestinal disorders. Eur J Surg 1998;Suppl 583:60–6.
   Google Scholar
• Jones R, Lydeard S. Irritable bowel syndrome in the general population. Br Med J 1992;304:87–90.
   PubMed Web of Science ®Google Scholar
• Thompson WG, Longstreth GF, Drossman DA, et al. Functional bowel disorders and functional abdominal pain. Gut 1999; 45 Suppl 2:II43–7.
   Google Scholar
• Drossman DA, Whitehead WE, Camilleri M. Irritable bowel syndrome: a technical review for practice guideline development. Gastroenterology 1997;112:2120–37.
   Google Scholar
• Grider JR, Foxx-Orenstein AE, Jin J-G. 5-hydroxytryptamine4 receptor agonists initiate the peristaltic reflex in human, rat and guinea pig intestine. Gastroenterology 1998;115:370–80.
   PubMed Web of Science ®Google Scholar
• Schikowski A, Thewissen M, Mathias C, Ross HG, Enck P. Serotonin type-4 receptors modulate the sensitivity of intramural mechanoreceptive afferents in the cat rectum. Neurogastro- enterol Motil 2002;14: 221–7.
   Google Scholar
• Coelho A-M, Rovira P, Fioramonti J, Bueno L. Antinociceptive properties of HTF 919 (tegaserod), a 5-HT4 receptor partial agonist, on colorectal distension in rats. Gastroenterology 2000; 118:A835.
   Google Scholar
• Wei JY, Wang YH, Mayer E. The 5-HT4 receptor partial agonist, tegaserod inhibits the colorectal distension-induced response of rat inferior splanchic afferents in vitro. Gastroenterology 2002; 122:A-317-A–31.
   Google Scholar
• Buchheit KH, Gamse R, Giger R, Hoyer D, Klein F, Kloppner E, Pfannkuche HJ, Mattes H. The serotonin 5-HT4 receptor. 1. Design of a new class of agonists and receptor map of the agonist recognition site. J Med Chem 1995;38:2326–30.
   Google Scholar
• Buchheit KH, Gamse R, Giger R, Hoyer D, Klein F, Kloppner E, Pfannkuche HJ, Mattes H. The serotonin 5-HT4 receptor. 2. Structure-activity studies of the indole carbazimidamide class of agonists. J Med Chem 1995;38:2331–8.
   Google Scholar
• Pfannkuche HJ, Buhl T, Garnse R, Hoyer D, Mattes H, Buchheit KH. The properties of a new prokinetically active drug SDZ HTF 919. Neurogastroenterol Motil 1995;7:280.
   Google Scholar
• Nguyen A, Camilleri M, Kost LJ, Metzger A, Sarr MG, Hanson RB, et al. SDZ HTF 919 stimulates canine colonic motility and transit in vivo. J Pharmacol Exp Ther 1997;280:1270–6.
   PubMed Web of Science ®Google Scholar
• Fioramonti J, Million M, Bueno L. Investigations on a 5-HT4 agonist (SDZ HTF 919) and its main metabolite in conscious dogs: effects on gastrointestinal motility and impaired gastric emptying. Gastroenterology 1998;114:A752.
   Google Scholar
• Stoner M, Arcuni J, Lee J, Kellum JM. A selective 5-HT4 receptor agonist induces c-AMP mediated CP efflux from rat colonocytes. Gastroenterology 1999;116:A648.
   Web of Science ®Google Scholar
• Coffin B, Farmachidi J-P, Ruegg P, Bastie A, Bouhassira D. Tegaserod, a 5-HT4 receptor partial agonist decreases sensitivity to rectal distension in healthy subjects. Aliment Pharmacol Ther 2003;17: 577–85.
   Google Scholar
• Degen L, Matzinger D, Merz M, Appel-Dingemanse S, Osborne S, Luchinger S, et al. Tegaserod, a 5-HT4 receptor partial agonist, accelerates gastric emptying and gastrointestinal transit in healthy male subjects. Aliment Pharmacol Ther 2001;11: 1745–51.
   Google Scholar
• Baker DE. Tegaserod for the treatment of constipation- predominant irritable bowel syndrome. Rev Gastroenterol Disord 2001;1:187–98.
   PubMedGoogle Scholar
• Morganroth J, Ruegg PC, Dunger-BaldaufC, Appel-Dingemanse S, Bliesath H, Lefkowitz M. Tegaserod, a 5-hydroxytrptamine type 4 receptor partial agonist, is devoid of electrocardiographic effects. Am J Gastroenterol 2002;97: 2321–7.
   Google Scholar
• Bran S, Murray WA, Hirsch IB, Palmer JP. Long QT syndrome during high-dose cisapride. Arch Int Med 1995;155:765–8.
   PubMedGoogle Scholar
• Corsetti M, Tack J. Tegaserod: a new 5-HT4 agonist in the treatment of irritable bowel syndrome. Expert Opin Pharmaco- ther 2002;3:1211–8.
   PubMedGoogle Scholar
• Novick J, Milner P, Krause R, Glebas K, Bliesath H, Ligozio G, et al. A randomized, double-blind, placebo-controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2002;16: 1877–88.
   PubMed Web of Science ®Google Scholar
• Tougas G, Snape Jr WJ, Otten MH, Earnest DL, Langaker KE, Pruitt RE, et al. Long-term safety of tegaserod in patients with constipation-predominant irritable bowel syndrome. Aliment Pharmacol Ther 2002;16:1701–8.
   PubMed Web of Science ®Google Scholar
• Müller-Lissner SA, Fumagalli I, Bardhan KD, Pace F, Pecher E, Nault B, et al. Tegaserod, a 5-HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Aliment Pharmacol Ther 2001;15: 1655–66.
   Google Scholar
• Kellow J, Lee OY, Chang FY, Thongsawat S, Mazlam MZ, Yuen H, et al. An Asia-Pacific, double-blind, placebo-controlled, randomised study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome. Gut 2003; 52:671–6.
   PubMed Web of Science ®Google Scholar
• The Rome II Modular Questionnaire. In: Drossman DA, Corazziari E, Talley NJ, Thompson WG, Whitehead W, editors. Rome II—The Functional Gastrointestinal Disorders; Diagnosis, Pathophysiology and Treatment: A Multinational Consensus. McLean VA: Degnon Associates 2000; 360.
   Google Scholar
• Committee for Proprietary Medicinal Products (CPMP). The European Agency for the Evaluation of Medicinal Products. Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome. London, UK; 2003.
   Google Scholar
• Chatellier G, Zapletal E, Lemaitre D, Menard J, Degoulet P. The number needed to treat a clinically useful nomogram in its proper context. Br Med J 1966;312:426–9.
   Google Scholar
• Harding JP, Hamm LR, Ehsanullah RSB, Heath AT, Sorrells SC, Haw J, Dukes GE, Wolfe SG, Mangel AW, Northcutt AR. Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome. Aliment Pharmacol Ther 1997; 11: 1073–6.
   PubMed Web of Science ®Google Scholar
• Spiller RC. Problems and challenges in the design of irritable bowel syndrome clinical trials: experience from published trials. Am J Med 1999;107:91S–97S.
   Google Scholar