CHARACTERISTICS, DIAGNOSTIC AND SYMPTOM PROFILE OF PATIENTS RECEIVING TEGASEROD IN ROUTINE CLINICAL PRACTICE IN CANADA

Main Article Content

Bradette M
Wawer AR
Balshaw R
Kelly S
Barbeau M
Sambrook R

Keywords

Irritable bowel syndrome, symptoms, diagnosis

Abstract

Objective


This study was designed to assess the diagnostic and symptom profile of patients receiving tegaserod in routine clinical practice, and to identify their demographic characteristics, as well as the association between these characteristics and diagnosis.


Methods


This prospective, observational study collected data from physicians on the symptoms and/or diagnosis, age range and gender for patients to whom they prescribed tegaserod. Details of the physician characteristics included whether they were a family physician or a specialist, and the region of Canada in which their practice was located.


 Results


A total of 500 patients were enrolled at 85 sites in Canada. The majority (85%) of the patients were enrolled by family physicians, and the remainder by community-based specialists. The patients were predominantly female (87%) and the highest percentages were in the 35-44 (23%) and 45-54 (25%) age groups. Nearly all patients (96%) were prescribed tegaserod on the basis of both symptoms and diagnosis. The most frequently reported symptoms were abdominal pain and/or discomfort (87%), bloating (80%) and constipation (75%). Most patients (57%) presented with all three of these symptoms. Constipation-predominant Irritable Bowel Syndrome (IBS-C) was the most common diagnosis (55%), followed by IBS alternating between constipation and diarrhea (IBS-A) (23%). Based on this, 67% of patients were given tegaserod strictly according to the label, although it was appropriately prescribed to 87%.


 Conclusions


In Canada, tegaserod is prescribed to patients with symptoms of abdominal pain and/or discomfort, bloating and constipation. Most of them will also have a diagnosis of either IBS-C or IBS. It is generally being prescribed appropriately

Abstract 121 | PDF Downloads 81

References

1. Drossman DA, et al. AGA technical review on irritable bowel syndrome. Gastroenterology 2002;123(6):2108 -31.
2. Camilleri M, Heading RC, Thompson WG. Clinical perspectives, mechanisms, diagnosisand management of irritable bowel syndrome. Aliment Pharmacol Ther 2002;16(8):1407-30.
3. Longstreth GF, Wolde-Tsadik G. Irritable bowel-type symptoms in HMO examinees. Prevalence, demographics, and clinical correlates. Dig Dis Sci 1993;38(9):1581- 9.
4. Thompson WG. The treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2002; 16(8):1395-406.
5. Thompson WG, et al. Functional gastrointestinal disorders in Canada: first population-based survey using Rome II criteria with suggestions for improving the questionnaire. Dig Dis Sci 2002;47(1):225-35.
6. Stewart WF, et al. Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features. Am J Gastroenterol 1999;94(12):3530-40.
7. Jones R, Lydeard S. Irritable bowel syndrome in the general population. BMJ 1992; 304(6819): 87-90.
8. Wilson S, et al. Prevalence of irritable bowel syndrome: a community survey. Br J Gen Pract 2004; 54(504):495- 502.
9. Hahn BA, et al. Patient- perceived severity of irritable bowel syndrome in relation to symptoms, health resource utilization and quality of life. Aliment Pharmacol Ther 1997; 11(3):553-9.
10. Drossman DA, Thompson WG. The irritable bowel syndrome: review and a graduated multicomponent treatment approach. Ann Intern Med 1992;116(12 Pt 1):1009-16.
11. Evans BW, et al. Tegaserod for the treatment of irritable bowel syndrome. Cochrane Database Syst Rev 2004;(1):CD003960.
12. Tack J, et al. A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. Gut 2005;54(12): 1707-13.
13. Zelnorm (tegaserod maleate) Product Monograph. Novartis Pharmaceuticals Canada Inc. February 27, 2002.
14. Drossman DA, et al. A prospective assessment of bowel habit in irritable bowel syndrome in women: defining an alternator. Gastroenterology
2005;128(3):580-9.
15. Guilera M, Balboa A, Mearin F. Bowel habit subtypes and temporal patterns in irritable bowel syndrome: systematic review. Am J Gastroenterol 2005;100(5):1174-84.
16. Mearin F, et al. Irritable bowel syndrome subtypes according to bowel habit: revisiting the alternating subtype. Eur J Gastroenterol Hepatol
2003;15(2):165-72.
17. Mearin F, et al. Clinical patterns over time in irritable bowel syndrome: symptom instability and severity variability. Am J Gastroenterol,
2004;99(1):113 -21.
18. Evidence -based position statement on the management of irritable bowel syndrome in North America. Am J Gastroenterol 2002;97(11 Suppl): p. S1-5.
19. Talley NJ, et al. Overlapping upper and lower gastrointestinal symptoms in irritable bowel syndrome patients with constipation or diarrhea. Am J Gastroenterol 2003;98(11):2454- 9.
20. Agreus L, et al. Irritable bowel syndrome and dyspepsia in the gener al population: overlap and lack of stability over time. Gastroenterology 1995;109(3):671 -80.
21. Novick J, et al. A randomized, double-blind,placebo -controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2002;16(11):1877 -88.
22. Muller -Lissner SA, et al. Tegaserod, a 5- HT(4) receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Aliment Pharmacol Ther 2001;15(10):1655-66.
23. Kellow J, et al. An Asia- Pacific, double blind, placebo controlled, randomised study to evaluate the efficacy, safety, and tolerability of tegaserod in patients with irritable bowel syndrome. Gut 2003;52(5):671 -6.