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

Table 2 Incidence of abdominal or pelvic surgeries among tegaserod initiators and comparators (as-matched analysis)

Variable	Events	Person years	I.R.¹	95% C.I.		Hazard ratio²	95% C.I.		Hazard ratio³	95% C.I.
				Low	High		Low	High		Low	High
Exposure
Tegaserod Initiators	94	1,101	0.09	0.07	0.10	0.70	0.54	0.91	0.71	0.55	0.93
Comparators	134	1,100	0.12	0.10	0.14	1.00			1.00
Gender
Female	207	1,963	0.11	0.09	0.12	1.00			1.00
Male	21	237	0.09	0.05	0.14	0.83	0.53	1.31	0.74	0.47	1.18
Age
0 – 29	25	295	0.08	0.06	0.12	0.65	0.45	0.96	0.63	0.41	0.94
30 – 49	146	1118	0.13	0.11	0.15	1.00			1.00
50 +	57	788	0.07	0.06	0.09	0.55	0.26	0.94	0.65	0.30	1.02
Abdominal Surgery Risk Factors
Cholelithiasis	19	43	0.45	0.27	0.69				5.06	2.85	8.96
Inguinal Hernia	3	7	0.43	0.09	1.27				3.82	1.17	12.49
Diagnostic Procedures, Abdomen/Pelvis	3	5	0.61	0.13	1.79				4.34	1.32	14.22
Radiologic Small Bowel Exam	21	59	0.35	0.22	0.54				2.35	1.43	3.86
Urinary Tract Diagnostic Procedures	15	71	0.21	0.12	0.35				2.11	1.14	3.90
Gallbladder Radiography	19	50	0.38	0.23	0.60				2.82	1.69	4.69

¹ Incidence rate (IR), events per person year.
² Adjusted for age, gender, region, calendar year and quarter of cohort entry.
³ Adjusted for. age, gender, region, antidepressants, appendicitis, gallbladder surgeries, cholelithiasis, colonoscopy, irritable bowel syndrome, gastritis/duodenitis, hepatitis, disorders of liver, inguinal hernia, male genital surgery, MRI abdomen, diagnostic procedures, abdomen/pelvis, small bowel radiology, rectum/anus diagnostic procedures, urinary tract diagnostic procedures, urinary tract surgeries, gallbladder radiography, abdominal radiology, calendar year and quarter of cohort entry.

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