TITLE

A CLINICAL INVESTIGATION OF THE EFFECTS OF TEGASEROD TREATMENT REGIMEN ON THE SYMPTOMS OF IBS-C IN TEGASEROD RESPONSIVE PATIENTS

AUTHOR(S)
Bardhan, K.D.; Forbes, A.; Marsden, C.L.
PUB. DATE
April 2003
SOURCE
Gut;Apr2003 Supplement 1, Vol. 52, pA14
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Background and Aims: Tegaserod is effective in relieving the symptoms of lBS with constipation (lBS-C), including abdominal discomfort or pain and bloating. However, the post-withdrawal characteristics and optimal long term treatment strategy still remain to be defined. The aim of this study was to investigate the effects of withdrawing tegaserod, as compared to maintaining patients on continuous treatment. Methods: A randomised, open label parallel group multi-centre trial. 519 patients (≥18 years) diagnosed with IBS-C (4.57 females, 62 males) were treated with tegaserod (6mg twice daily) for 4 weeks. Responders were randomised (1:1) to either continue on tegaserod at the same dose, or to withdraw from treatment for 8 weeks. The absence or recurrence of IBS-C symptoms was measured at 4 weekly intervals, as derived from the patient's weekly Overall Relief Assessment (ORA). Results: 274/410 (68%) patients who completed the initial 4 weeks of treatment were responders (experienced relief of symptoms for ≥2 weeks). The remaining patients had little or no benefit (n = 131, 32.3%), or were not assessed (n = 5). At the end of the 8 week comparator phase, 90/104 (87%) of those maintained on tegaserod continued in symptomatic remission, judged by ORA scores at the end of week 12, compared with only 61/105 (58%) in whom therapy was withdrawn (p < 0.0001). Adverse events (AEs) were mild or moderate severity. The most frequent AEs in the treatment-continuation arm were diarrhoea (8/130, 6%), reflecting the promotile effect of the drug, and headache (15/130, 12%). In the treatment withdrawal arm no patients reported diarrhoea and 6% (9/141) reported headaches. Conclusions: Based on weekly ORA scores, when patients who are responsive to tegaserod were maintained on treatment for 12 weeks, the recurrence of IBS-C symptoms was significantly reduced. Tegaserod treatment was well tolerated.
ACCESSION #
9747353

 

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