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

Table 3 Incidence of gallbladder surgery among tegaserod initiators and comparators (as-matched analysis)

Variable	Events	Person years	I.R.¹	95% Confidence interval		Hazard ratio²	95% Confidence interval		Hazard ratio³	95% Confidence interval
				Low	High		Low	High		Low	High
Exposure
Tegaserod Initiators	36	1,115	0.03	0.02	0.04	0.98	0.62	1.55	0.99	0.62	1.58
Comparators	37	1,125	0.03	0.02	0.05	1.00			1.00
Gender
Female	67	1,999	0.03	0.03	0.04	1.00			1.00
Male	6	242	0.02	0.01	0.05	0.76	0.33	1.75	0.50	0.20	1.24
Age
0 – 29	9	299	0.03	0.01	0.06	0.77	0.56	1.21	0.77	0.56	1.22
30 – 49	45	1144	0.04	0.03	0.05	1.00			1.00
50 +	19	797	0.02	0.01	0.04	0.61	0.55	0.81	0.61	0.52	0.83
Gallbladder Surgery Risk Factors
Other Diseases of Appendix	1	2	0.49	0.01	2.71				13.60	1.77	401.41
Gallbladder or Bile Duct Surgeries	3	30	0.10	0.02	0.29				0.07	0.02	0.31
Acute Cholecystitis (575.0)	4	8	0.47	0.13	1.21				5.34	1.42	20.06
Cholelithiasis (574)	14	44	0.32	0.18	0.54				8.59	4.09	18.01
Constipation (564.0)	17	814	0.02	0.01	0.03				0.58	0.33	1.00
Abdominal Ultrasound	33	283	0.12	0.08	0.02				2.84	1.62	4.98
Radiographic Visualization, Gallbladder	13	51	0.25	0.13	0.43				3.31	1.63	6.71

¹ Incidence rate (IR) per person year.
² Adjusted for age, gender, region, and calendar year and quarter of cohort entry.
³ Adjusted for age, gender, region, and calendar year and quarter of cohort entry, number of abdominal pain physician visits, appendicitis, gallbladder surgery, cholecystitis, cholelithiasis, constipation, disorders of stomach and duodenum, liver surgery, peptic ulcer disease, sucralfate, abdominal ultrasound, and radiographic visualization of the gallbladder.

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