title: Long-term tegaserod treatment for dysmotility-like functional dyspepsia: results of two identical 1-year cohort studies.
abstract: BACKGROUND
  Functional dyspepsia (FD) is a chronic disorder that adversely affects health-related quality of life (HRQoL). Published information on its long-term management is minimal and treatment options are limited.
  
  
  OBJECTIVE
  The aim of this study was to evaluate safety, efficacy and HRQoL with tegaserod 6 mg twice daily over 1 year in women with FD who completed one of two 6-week, randomized, placebo-controlled, double-blind studies.
  
  
  METHODS
  About 780 patients received tegaserod 6 mg twice daily in two identical 1-year extension studies. Scheduled assessments included adverse events, the Short-Form Nepean Dyspepsia Index (SF-NDI), Work Productivity and Activity Impairment-Dyspepsia (WPAI-Dyspepsia) questionnaire, and patient perceptions of treatment efficacy.
  
  
  RESULTS
  Mean tegaserod treatment duration in the two studies was 236 and 222 days. Most adverse events occurred in the first 6 months, were similar to previous reports (commonly diarrhea), and were transient and well tolerated. SF-NDI, WPAI-Dyspepsia scores and perceived symptom relief improved from baseline over the 1-year evaluation.
  
  
  CONCLUSIONS
  The long-term safety profile of tegaserod in women with FD was consistent with that of short-term treatment and accompanied by improvements in HRQoL, work productivity and symptom relief. These long-term results add to the clinical experience with FD and support the potential value of a 5-HT(4) agonist in the management of FD.
authors: Division of Gastroenterology, University of Michigan Health System, 3912 Taubman Center, SPC 0362, Ann Arbor, MI 48109-0362, USA. wchey@med.umich.edu
authors: William D
authors: WD
authors: Chey
authors: Colin W
authors: CW
authors: Howden
authors: Jan
authors: J
authors: Tack
authors: Gregory
authors: G
authors: Ligozio
authors: David L
authors: DL
authors: Earnest
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D005765:Gastrointestinal Agents; D007211:Indoles; C105050:tegaserod