Long-term Tegaserod Treatment for Dysmotility-Like Functional Dyspepsia: Results of Two Identical 1-year Cohort Studies

Dig Dis Sci. 2010 Mar;55(3):684-97. doi: 10.1007/s10620-009-1049-0. Epub 2009 Dec 3.

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.

Aim: 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Double-Blind Method
  • Dyspepsia / drug therapy*
  • Female
  • Gastrointestinal Agents / administration & dosage
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Indoles / administration & dosage
  • Indoles / adverse effects
  • Indoles / therapeutic use*
  • Quality of Life
  • Surveys and Questionnaires

Substances

  • Gastrointestinal Agents
  • Indoles
  • tegaserod