STATIN-INDUCED LIVER INJURY: DATA FROM URUGUAYAN PROSPECTIVE HEPATOTOXICITY REGISTRY.

Introduction and Objectives

Statins, widely used for cardiovascular prevention, have been linked to idiosyncratic drug-induced liver injury (DILI). To characterize their clinical features, cases attributed to statins reported to the Uruguayan Hepatotoxicity Registry (UHR) were analyzed.

Materials and Methods

We conducted a descriptive observational study of DILI cases attributed to statins and reported to the UHR between November 2015 and April 2025. Variables assessed included age, sex, type of statin, latency, biochemical pattern, hypersensitivity features, jaundice, severity, and clinical outcomes.

Results

Among 197 DILI cases reported to the UHR, 14 (7.1%) were attributed to statins, predominantly atorvastatin (12 cases). Atorvastatin dose ranged from 10 to 80 mg, and rosuvastatin (the remaining 2 cases) dose was 20 mg. The mean age was 65.1 years. Latency varied widely (mean: 156 days), with the shortest latency (21 days) in the two patients treated with 80 mg of atorvastatin. Liver enzyme normalization occurred in nine patients (mean: 60 days), eight recovered within 180 days, and one at 202 days. One patient had persistent abnormalities at 231 days, while four cases had incomplete follow-up (<180 days). Eosinophilia was the only hypersensitivity feature identified; no cases showed autoimmune-like hepatitis. Detailed characteristics are presented in the attached table.

Conclusions

Statin-related DILI represented a small proportion of UHR cases, despite high population exposure and their classification as high-potential hepatotoxins (category A). This may suggest underreporting or underdiagnosis. Nonetheless, clinical presentation was generally mild, and outcomes were favorable following drug discontinuation, although follow-up was incomplete in several cases.