Ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in high cardiovascular risk patients with primary hypercholesterolemia: a randomized, double-blind, active-controlled, multicenter study

Table 3 Summary of safety data (All Patients as Treated population)

	EZ/Simva 10/40 mg N = 119 n (%)	Atorvastatin 40 mg N = 130 n (%)
≥ 1AE	11 (9.2)	18 (13.8)
Drug-related* AEs	2 (1.7)	3 (2.3)
Serious AEs	1 (0.8)	1 (0.8)
Discontinuations^†
due to an AE	0	2 (1.5)
due to a drug-related AEs	0	2 (1.5)
Gallbladder-related AEs	0	0
Gastrointestinal-related AEs	1 (0.8)	5 (3.8)
Hepatitis-related AEs	1 (0.8)	0
Allergic reaction or rash	0	2 (1.5)
ALT ≥ 3× ULN or AST ≥ 3× ULN	0	0
Creatinine kinase ≥ 10× ULN	0	0

*Determined by the investigator to be related to study drug
^†Study medication withdrawn
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; EZ, ezetimibe; simva, simvastatin; ULN, upper limit of normal

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