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Clinical symptoms varied in patients with statin-induced liver injuries

Liver injuries in patients who received statins for hyperlipidemia were rare, with patients displaying wide clinical presentations and latencies to onset, according to data from a new study.

Researchers, including Naga Chalasani, MD, chief of the division of gastroenterology and hepatology, Indiana University School of Medicine, conducted a cohort study of 22 patients with liver injury due to statins. All patients (median age, 60 years; 15 women) were enrolled in the US Drug Induced Liver Injury Network between September 2004 and November 2012.

Naga Chalasani

Eight patients had drug-induced liver injury attributed to atorvastatin; five from simvastatin; four due to rosuvastatin; two due to fluvastatin; two to pravastatin; and one to lovastatin. Median daily doses were 20 mg, and all were within recommended ranges.

Researchers said latency to liver damage (median, 155 days) was between 1 and 6 months in six patients, 3 to 6 months in six patients, 6 to 12 months in five patients, and more than 1 year among five patients. Median peak levels of alanine aminotransferase (892 U/L), alkaline phosphatase (358 U/L) and total bilirubin (6.1 mg/dL) were observed.

Twelve patients had hepatocellular carcinoma and were younger (mean age, 57 years) compared with nine cholestatic patients (mean age, 65 years). Of these patients, six had an autoimmune phenotype, and one died during follow-up. Researchers said all statins were implicated, and there were no differences attributed to BMI, latency, disease severity or sex. Four patients developed chronic liver injury, including three with an autoimmune phenotype.

“The current case series suggests that clinically apparent liver injury from the statins is likely a class effect and can arise many months and sometimes years after initiation,” researchers wrote. “Based on these data, prospective monitoring for drug-induced liver injury from statins is not warranted, but patients who develop a liver injury with an autoimmune phenotype should be closely monitored and evaluated for immunosuppressive therapy if liver tests fail to improve.”

Disclosure: See the study for a full list of relevant financial disclosures.