Long-term tegaserod treatment for dysmotility-like functional dyspepsia: results
of two identical 1-year cohort studies.
Author(s): Chey WD, Howden CW, Tack J, Ligozio G, Earnest DL.
Affiliation(s): Division of Gastroenterology, University of Michigan Health System, 3912 Taubman
Center, SPC 0362, Ann Arbor, MI 48109-0362, USA. wchey@med.umich.edu
Publication date & source: 2010, Dig Dis Sci. , 55(3):684-97
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.
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