Tegaserod is safe, well tolerated and effective in the treatment of patients with non-diarrhoea irritable bowel syndrome

Détails

ID Serval
serval:BIB_8180582F7383
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Tegaserod is safe, well tolerated and effective in the treatment of patients with non-diarrhoea irritable bowel syndrome
Périodique
European Journal of Gastroenterology and Hepatology
Auteur(s)
Fried  M., Beglinger  C., Bobalj  N. G., Minor  N., Coello  N., Michetti  P.
ISSN
0954-691X (Print)
Statut éditorial
Publié
Date de publication
04/2005
Volume
17
Numéro
4
Pages
421-7
Notes
Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't --- Old month value: Apr
Résumé
OBJECTIVE: To evaluate the safety/tolerability and efficacy of tegaserod, a 5-HT4 receptor partial agonist, in the treatment of patients with non-diarrhoea irritable bowel syndrome (non-D-IBS) in Switzerland. METHODS: This was an 8-week, open-label, prospective, multicentre study. Patients (> or =18 years old) met the Rome II diagnostic criteria for IBS, excluding those with diarrhoea for > or =14 days in the previous 3 months. Details of IBS symptoms experienced in the preceding week were recorded at visit 1 (day 1). Eligible patients received 6 mg tegaserod twice daily for 8 weeks. Adverse events (AEs) and serious AEs were recorded, along with detailed assessment of diarrhoeal episodes. Efficacy assessments included the overall number and percentage of responders after 8 weeks' treatment. RESULTS: A total of 850 patients (72% women; mean age, 51.4 years) were enrolled, and 843 received at least one dose of tegaserod. AEs were reported in 38% of patients, of which 13% were drug-related. Diarrhoea occurred early during treatment (13% in the first week, 7% thereafter), was mild to moderate in severity, was transient and was resolved with continued treatment. In total, 208 patients left the study early, primarily due to AEs. Diarrhoea accounted for 68 of these discontinuations. Nine serious AEs were reported but these were not related to tegaserod treatment. Sixty-six percent of patients responded to tegaserod on the Subject's Global Assessment of relief after 8 weeks. Benefits were also seen across individual IBS symptoms. CONCLUSION: Tegaserod (6 mg twice daily) appears to be safe, well-tolerated and effective in the treatment of non-D-IBS over 8 weeks.
Mots-clé
Adolescent Adult Aged Aged, 80 and over Diarrhea/chemically induced Female Humans Indoles/adverse effects/*therapeutic use Irritable Bowel Syndrome/*drug therapy/psychology Male Middle Aged Patient Satisfaction Prospective Studies Sample Size Serotonin Agonists/adverse effects/*therapeutic use
Pubmed
Web of science
Création de la notice
25/01/2008 17:02
Dernière modification de la notice
03/03/2018 18:48
Données d'usage