The Zelnorm epidemiologic study (ZEST): a cohort study evaluating incidence of abdominal and pelvic surgery related to tegaserod treatment

BMC Gastroenterology

Research Article

Anthony Lembo¹  John D Seeger²  Alexander M Walker³  Braden Kuo⁴  Elena Rivero⁵  David L Earnest⁶  Sherry Quinn⁷ 

[1] Beth Israel Medical Center, Boston, MA, USA;Brigham & Women’s Hospital and Harvard Medical School, Boston, MA, USA;Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA;OptumInsight, Waltham, MA, USA;World Health Information Science Consultants (WHISCON), Newton, MA, USA;1620 Tremont St, Suite 3300, 02120, Boston, MA, USA;Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA;World Health Information Science Consultants (WHISCON), Newton, MA, USA;Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA, USA;Novartis Farmaceutica, Barcelona, Spain;Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA;OptumInsight, Waltham, MA, USA;

关键词: Abdominal surgery;    Tegaserod;    Cohort study;   

DOI  :  10.1186/1471-230X-12-171

 received in 2012-05-09, accepted in 2012-11-22,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundPre-marketing clinical studies of tegaserod suggested an increased risk of abdominal surgery, particularly cholecystectomy. We sought to quantify the association between tegaserod use and the occurrence of abdominal or pelvic surgery, including cholecystectomy.MethodsThis cohort study was conducted within an insured population. Tegaserod initiators and similar persons who did not initiate tegaserod were followed for up to six months for the occurrence of abdominal or pelvic surgery. Surgical procedures were identified from health insurance claims validated by review of medical records. The incidence of confirmed outcomes was compared using both as-matched and as-treated analyses.ResultsAmong 2,762 tegaserod initiators, there were 94 abdominal or pelvic surgeries (36 gallbladder): among 2,762 comparators there were 134 abdominal or pelvic surgeries (37 gallbladder) (hazard ratio HR] = 0.70, 95% confidence interval [C.I.] = 0.54-0.91 overall, HR = 0.98, 95% C.I. = 0.62-1.55 for gallbladder). Current tegaserod exposure compared to nonexposure was associated with a rate ratio [RR] of 0.68 (95% C.I. = 0.48-0.95) overall, while the RR was 0.99 (95% C.I. = 0.56-1.77) for gallbladder surgery.ConclusionsIn this study, tegaserod use was not found to increase the risk of abdominal or pelvic surgery nor the specific subset of gallbladder surgery.

【 授权许可】

CC BY   
© Seeger et al.; licensee BioMed Central Ltd. 2012