ORIGINAL ARTICLE Long-Term Tegaserod Treatment for Dysmotility-like Functional Dyspepsia: Results of Two Identical 1-year Cohort Studies William D. Chey • Colin W. Howden • Jan Tack • Gregory Ligozio • David L. Earnest Received: 19 June 2009 / Accepted: 28 October 2009 / Published online: 3 December 2009 Ó Springer Science+Business Media, LLC 2009 Abstract Background Functional dyspepsia (FD) is a chronic dis- order that adversely affects health-related quality of life (HRQoL). Published information on its long-term man- agement 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, ran- domized, 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. Keywords Tegaserod Á Dyspepsia Á Dysmotility Á Long-term Á Safety Á Quality of life Introduction Functional dyspepsia (FD) is a common chronic disorder characterized by multiple upper gastrointestinal (GI) symptoms in the absence of structural disease [1, 2]. The Rome II consensus document proposed two main sub- groups of FD based on the patient’s predominant symptom: dysmotility-like FD (discomfort centered in the upper abdomen associated with early satiety, postprandial full- ness, bloating or nausea) and ulcer-like FD (pain centered in the upper abdomen) [3]. These criteria were recom- mended at the time this study was initiated. The more recent Rome III criteria have updated the classification of FD so there are two new diagnostic categories based on meal-induced versus meal-unrelated symptoms rather than a predominant symptom; these are postprandial distress syndrome (PDS); and epigastric pain syndrome (EPS) [2]. Of note, the Rome III criteria for FD have yet to be vali- dated in clinical trials. However, in the majority of cases, patients with dysmotility-like FD would now be classified W. D. Chey (&) Division of Gastroenterology, University of Michigan Health System, 3912 Taubman Center, SPC 0362, Ann Arbor, MI 48109-0362, USA e-mail: wchey@med.umich.edu C. W. Howden Division of Gastroenterology, Northwestern University Feinberg School of Medicine, 676 N. St. Clair Street, Suite 1400, Chicago, IL 60611, USA J. Tack University Hospitals Leuven, Leuven, Belgium G. Ligozio Á D. L. Earnest Novartis Pharmaceuticals Inc, East Hanover, NJ 07936, USA 123 Dig Dis Sci (2010) 55:684–697 DOI 10.1007/s10620-009-1049-0