An Asia-Pacific, double blind, placebo controlled, randomised study to evaluate the efficacy, safety, and tolerability of tegaserod in patients with irritable bowel syndrome
- J Kellow1,
- O Y Lee2,
- F Y Chang3,
- S Thongsawat4,
- M Z Mazlam5,
- H Yuen6,
- K A Gwee7,
- Y T Bak8,
- J Jones9,
- A Wagner9
- 1Royal North Shore Hospital, Sydney, Australia
- 2Hanyang University Medical Centre, Seoul, Korea
- 3Veterans General Hospital, Taipei, Taiwan
- 4Chiang Mai University Hospital, Chiang Mai, Thailand
- 5Ampang Puteri Specialist Hospital, Kuala Lumpur, Malaysia
- 6Princess Margaret Hospital, Kowloon, Hong Kong
- 7National University Hospital, Singapore
- 8Korea University Medical Centre, Seoul, Korea
- 9Novartis Pharma AG, Basel, Switzerland
- Correspondence to:
Dr A Wagner, Novartis Pharma AG, Lichstrasse 35, CH-4056, Basel, Switzerland;
- Accepted 15 October 2002
Background: Tegaserod has been shown to be an effective therapy for the multiple symptoms of irritable bowel syndrome (IBS) in Western populations. However, little information is available regarding the use of tegaserod in the Asia-Pacific population.
Aims: To evaluate the efficacy, safety, and tolerability of tegaserod versus placebo in patients with IBS from the Asia-Pacific region.
Patients: A total of 520 patients from the Asia-Pacific region with IBS, excluding those with diarrhoea predominant IBS.
Methods: Patients were randomised to receive either tegaserod 6 mg twice daily (n=259) or placebo (n=261) for a 12 week treatment period. The primary efficacy variable (over weeks 1–4) was the response to the question: “Over the past week do you consider that you have had satisfactory relief from your IBS symptoms?” Secondary efficacy variables assessed overall satisfactory relief over 12 weeks and individual symptoms of IBS.
Results: The mean proportion of patients with overall satisfactory relief was greater in the tegaserod group than in the placebo group over weeks 1–4 (56% v 35%, respectively; p<0.0001) and weeks 1–12 (62% v 44%, respectively; p<0.0001). A clinically relevant effect was observed as early as week 1 and was maintained throughout the treatment period. Reductions in the number of days with at least moderate abdominal pain/discomfort, bloating, no bowel movements, and hard/lumpy stools were greater in the tegaserod group compared with the placebo group. Headache was the most commonly reported adverse event (12.0% tegaserod v 11.1% placebo). Diarrhoea led to discontinuation in 2.3% of tegaserod patients. Serious adverse events were infrequent (1.5% tegaserod v 3.4% placebo).
Conclusions: Tegaserod 6 mg twice daily is an effective, safe, and well tolerated treatment for patients in the Asia-Pacific region suffering from IBS and whose main bowel symptom is not diarrhoea.
- AE, adverse event
- IBS, irritable bowel syndrome
- 5-HT4, 5-hydroxytryptamine (type 4) receptor
- ITT, intention to treat
- NNT, number needed to treat
- SAE, serious adverse event