Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Drug Safety
Published in: Drug Safety 7/2007

01-07-2007 | Original Research Article

An Observational Study of Cholecystectomy in Patients Receiving Tegaserod

Authors: Dr Allen Brinker, Stephanie D. Schech, Margaret Burgess, Mark Avigan

Published in: Drug Safety | Issue 7/2007

Login to get access

Abstract

Background: Registrational studies of patients treated with tegaserod for irritable bowel syndrome (IBS) suggest an increased risk for cholecystectomy versus treatment with placebo.
Objective: To study cholecystectomy rates in association with tegaserod within a large administrative medical claims database.
Methods: Patients were drawn from a large population within the US with commercial medical insurance. The primary analysis consisted of a comparison of the observed incidence rate for cholecystectomy claims among a large cohort of new-to-therapy tegaserod users with an incidence rate published for tegaserodnaive patients classified with IBS within the same insured population.
Results: An inception cohort of 7475 individuals with up to 103 weeks of claims history following initiation of therapy with tegaserod was identified. After a follow-up of 3 months (and thus similar to the longest registrational trials), the observed cholecystectomy incidence rate was 340 per 10 000 person-years (95% CI 258, 442). The rate of cholecystectomy was highest in the earliest months of observation following initiation of tegaserod. The observed cholecystecomy incidence rate is 2.9 times higher than an IBS-specific rate of 119 per 10 000 person-years as published for patients so classified within the same insured population.
Conclusion: Based on a large, inception cohort, we report a strong temporal association between the initiation of tegaserod therapy and an increased rate for cholecystectomy. The effect size at 3 months was similar to the relative risk for cholecystectomy reported in registrational studies comparing tegaserod with placebo. As misclassification of initial diagnosis for patients presenting with biliary colic-like symptoms may occur, precise measurements of tegaserodrelated relative risk for cholecystectomy from observational studies are problematic and will require prospective studies.
Footnotes
1
1The study was conducted and the article written prior to the voluntary withdrawal of tegaserod (Zelnorm®) from US and Canadian markets in March 2007 because of concerns regarding its cardiovascular safety profile.
 
2
2The use of trade names is for product identification purposes only and does not imply endorsement.
 
Literature
1.
Zelnorm. In: Kelly GL, Murray L, Chesanow N, et al., editors. Physicians’ desk reference. Montvale (NJ): Medical Economics Company, 2005: 2398–401
2.
3.
Graham DJ, Waller PC, Kurz X. A view from regulatory agencies. In: Strom BL, editor. Pharmacoepidemiology. 3rd ed. New York: John Wiley & Sons, Ltd., 2000: 109–24CrossRef
4.
Cole JA, Yeaw JM, Cutone JA, et al. The incidence of abdominal and pelvic surgery among patients with irritable bowel syndrome. Dig Dis Sci 2005; 50(12): 2268–75PubMedCrossRef
5.
Urbach DR, Stukel TA. Rate of elective cholecystectomy and the incidence of severe gallstone disease. CMAJ 2005; 172(8): 1015–9PubMed
6.
Shea JA, Berlin JA, Bachwich DR, et al. Indications for and outcomes of cholecystectomy: a comparison of the pre and postlaparoscopic eras. Ann Surg 1998; 227(3): 343–50PubMedCrossRef
7.
Talley NJ, Weaver AL, Zinsmeister AR, et al. Onset and disappearance of gastrointestinal symptoms and functional gastrointestinal disorders. Am J Epidemiol 1992; 136(2): 165–77PubMed
8.
Agreus L, Svardsudd K, Nyren O, et al. Irritable bowel syndrome and dyspepsia in the general population: overlap and lack of stability over time. Gastroenterology 1995; 109(3): 671–80PubMedCrossRef
9.
10.
Bennett EJ, Tennant CC, Piesse C, et al. Level of chronic life stress predicts clinical outcome in irritable bowel syndrome. Gut 1998; 43(2): 256–61PubMedCrossRef
11.
Owens DM, Nelson DK, Talley NJ. The irritable bowel syndrome: long-term prognosis and the physician-patient interaction. Ann Intern Med 1995; 122(2): 107–12PubMed
12.
Brinker A, Avigan M. Epidemiology of ischaemic colitis [letter]. Aliment Pharmacol Ther 2004; 20(6): 697–8PubMedCrossRef
13.
Sands BE, Duh MS, Cali C, et al. Algorithms to identify colonic ischemia, complications of constipation and irritable bowel syndrome in medical claims data: development and validation. Pharmacoepidemiol Drug Saf 2005; 15(1): 47–56CrossRef
14.
Camilleri M, Mayer EA, Drossman DA, et al. Improvement in pain and bowel function in female irritable bowel patients with alosetron, a 5-HT3 receptor antagonist. Aliment Pharmacol Ther 1999; 13(9): 1149–59PubMedCrossRef
15.
Muller-Lissner SA, Fumagalli I, Bardhan KD, 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): 1655–66PubMedCrossRef
16.
Brinker A, Senior J, Beitz J. Misdiagnosis of ischemic colitis as irritable bowel syndrome [abstract]. Clin Pharmacol Ther 2003; 73(2): P33CrossRef
Metadata
Title
An Observational Study of Cholecystectomy in Patients Receiving Tegaserod
Authors
Dr Allen Brinker
Stephanie D. Schech
Margaret Burgess
Mark Avigan
Publication date
01-07-2007
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 7/2007
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.2165/00002018-200730070-00003

Other articles of this Issue 7/2007

Drug Safety 7/2007 Go to the issue

Conference Paper

Prescription-Event Monitoring

Conference Paper

Signal Detection

Conference Paper

Thoughts on Signal Detection in Pharmacovigilance

Correspondence

Use of Contemporary Antidepressants during Breastfeeding

Conference Paper

Use of Triage Strategies in the WHO Signal-Detection Process

Original Research Article

Safety and Usage of Atypical Antipsychotic Medicines in Children