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

BMC Gastroenterology

Alexander M Walker⁷  Elena Rivero³  Braden Kuo⁵  Anthony Lembo⁶  David L Earnest²  Sherry Quinn¹  John D Seeger⁴ 

[1]OptumInsight, Waltham, MA, USA

[2]Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

[3]Novartis Farmaceutica, Barcelona, Spain

[4]1620 Tremont St, Suite 3300, Boston, MA, 02120, USA

[5]Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA, USA

[6]Beth Israel Medical Center, Boston, MA, USA

[7]World Health Information Science Consultants (WHISCON), Newton, MA, USA

关键词: Cohort study;    Tegaserod;    Abdominal surgery;   

Others  :  858279
DOI  :  10.1186/1471-230X-12-171

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

【 摘 要 】

Background

Pre-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.

Methods

This 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.

Results

Among 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.

Conclusions

In 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】

   
2012 Seeger et al.; licensee BioMed Central Ltd.

【 图 表 】

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