Table 1.

Summary of Four Major Studies Evaluating Hepatotoxicity of Statins

Study Characteristics	Sweden10	Iceland9	REH8	DILIN (USA)7
Type of study and data source	Population; Swedish Adverse Drug Reactions Advisory Committee	Prospective and population based	Prospective	Prospective
Total DILI cases, n	73	96	446	899
Statin cases, n	73	3	47	22
Median age, years (statin cases)	64	55	62	60
Male sex, %	55	44	49	32
Pattern of DILI	59% HC	42% HC	51% HC	55% HC
	30% cholestatic	32% cholestatic	49% chol/mixed	45%
	11% mixed	26% mixed
Jaundice, %	34	50	53	68
Latency, days	90	NA	57	155
Notable adverse clinical outcomes	Acute liver failure (2 simvastatin, 1 atorvastatin) resulting in 2 deaths and 1 orthotopic liver transplantation	NA	40% hospitalized	18% hospitalized
			19% chronicity	4 evidence of hepatic failure
			2 deaths (but not due to statin DILI)	1 death
				4 chronicity