Table 2. Summary of reported statin-induced cholestatic hepatitis cases.
| Case report | Age/Sex | Statin | Symptoms | Labs (peak) | Timeframe | Liver biopsy | Rechallenge | Reference ranges |
|---|---|---|---|---|---|---|---|---|
| Jimenez 199929 | 20, F | Atorvastatin 10 mg (3 weeks) then 20 mg (5.5 weeks) | Fatigue, anorexia, jaundice | Bili: 7.0; AST/ALT: 869/783; ALP: 669 | 8.5 weeks | No | No | Not provided |
| Hartleb 199930 | 57, M | Pravastatin 20 mg | Jaundice | Bili: 13.6; AST/ALT: 297/421; ALP: 482 | 7 weeks | Yes | No | Not provided |
| Ridruejo 200231 | 69, M | Atorvastatin 10 mg | asthenia, nausea, pruritus and dark urine | Bili: 2.6; AST/ALT: 669/727; ALP: 3,767 | 6 months* | No | No | Bili reference range not provided; AST/ALT <40/35 UI/L, ALP <270 UI/L |
| Perger 200332 | 83, M | Atorvastatin 20 mg | Fatigue, anorexia, jaundice | Bili: 24.85; AST/ALT: 1,312/1,401; ALP: 393 | 2 weeks | Yes | No | Bili <17 µmol/L, AST/ALT <40/40 UI/L, ALP <115 UI/L |
| De Castro 200633 | 72, M | Atorvastatin, 40 mg | Jaundice, dark urine | Bili: 7.4; AST/ALT: 679; ALP 1,259 | 1 week | Yes | Yes, recurrence | Not provided |
| Vergura 200734 | 77, M | Atorvastatin, 20 mg | Asymptomatic, incidental | Bili: N/A; AST/ALT: 564/738; ALP: 519 | 1 month | Yes | No | Bili reference range not provided, AST/ALT <45/50 UI/L, ALP <129 UI/L |
| Kleiner 201135 | 82, M | Simvastatin (N/A) | Jaundice | Bili: 5.2; AST/ALT: 1,919/1,737; ALP: 260 | 4 months | Yes | No | Not provided |
| Krezner 201336 | 79, F | Atorvastatin (N/A) | Pruritis, Jaundice, Scleral icterus | Bili: 2.5; AST/ALT: 124/307; ALP: 953 | 1 month | No | Yes, recurrence | Not provided |
| Alanazi 202137 | 69, M | Fluvastatin 40 mg | Fatigue, abdominal pain, vomiting, pruritis, weakness | Bili: 318; AST/ALT: 202/108; ALP: 1,200 | 7 weeks | No | Not mentioned | Bili less than 21 µmol/L, AST/ALT >45/45 UI/L, ALP <100 UI/L |
| Xu 202038 | 47, M | Atorvastatin 10 mg | Not described | Bili: “normal”; AST/ALT: “normal”/51; ALP: 178 | 2 months | No | Not mentioned | ALT <41 UI/L, ALP <129 UI/L |
| Kuniyoshi 201939 | 44, F | Atorvastatin 5 mg | Fatigue | Bili:.7; AST/ALT: 66/84; ALP: 1,557 | 10 months | Yes | Not mentioned | Not provided |
*Patient paused therapy for 1 week because of partial colonic resection with re-initiation 1 week prior to symptom onset. ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; Bili, bilirubin.