. 2017 Nov 18;6(11):e006901. doi: 10.1161/JAHA.117.006901

Table 3.

Safety Outcomes by Sex (Intention to Treat Population)

End Points	Sex	Placebo/Simvastatin	Ezetimibe/Simvastatin	P Value^a	P _int ^b
Permanently stopped study drug because of adverse events	Women	274 (14.6)	272 (14.3)	0.85	0.45
Permanently stopped study drug because of adverse events	Men	739 (12.4)	778 (13.1)	0.27	0.45
ALT, AST, or both ≥3× ULN	Women	57 (2.6)	56 (2.5)	0.92	0.50
ALT, AST, or both ≥3× ULN	Men	151 (2.2)	168 (2.5)	0.31	0.50
Gallbladder‐related AEs	Women	95 (4.3)	86 (3.9)	0.45	0.91
Gallbladder‐related AEs	Men	226 (3.3)	196 (2.9)	0.17	0.91
Rhabdomyolysis	Women	10 (0.5)	5 (0.2)	0.21	0.33
Rhabdomyolysis	Men	8 (0.1)	8 (0.1)	>0.99	0.33
Rhabdomyolysis or myopathy	Women	15 (0.7)	10 (0.4)	0.32	0.21
Rhabdomyolysis or myopathy	Men	13 (0.2)	17 (0.2)	0.47	0.21
Rhabdomyolysis, myopathy, or myalgia with CK elevation ≥5× ULN	Women	24 (1.1)	13 (0.6)	0.07	0.054
	Men	34 (0.5)	40 (0.6)	0.49	0.054
Cancer	Women	145 (8.3)	144 (8.2)	0.97	0.83
Cancer	Men	587 (10.8)	604 (10.8)	0.53	0.83

Ezetimibe did not increase the risk of adverse myotoxic events or cancer regardless of sex. Data shown are number (percentage), except for cancer, which is shown as 7‐year Kaplan‐Meier rates. AE indicates adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CK, creatine kinase; P _int, P value for interaction; and ULN, upper limit of normal.

P value comparing treatment within the same sex group.

P _int comparing treatment effects between women and men.