Table 4. Types of Adverse Events (Liver-related and Rhabdomyolysis/Myopathy-related).
| Placebo | Pemafibrate |
Fenofibrate |
||||
|---|---|---|---|---|---|---|
| 0.1 mg/day | 0.2 mg/day | 0.4 mg/day | 100 mg/day | 200 mg/day | ||
| (N = 43) | (N = 45) | (N = 128) | (N = 85) | (N = 85) | (N = 140) | |
| Liver-related AEs | 4 (9.3) | 2 (4.4) | 3 (2.3) | 7 (8.2) | 13 (15.3) | 34 (24.3) |
| Hepatobiliary disorders | 0 | 0 | 0 | 0 | 1 (1.2) | 3 (2.1) |
| Hepatic function abnormal | 0 | 0 | 0 | 0 | 1 (1.2) | 3 (2.1) |
| Laboratory test abnormalities | 4 (9.3) | 2 (4.4) | 3 (2.3) | 7 (8.2) | 12 (14.1) | 31 (22.1) |
| Abnormal liver function tests | 1 (2.3) | 2 (4.4) | 2 (1.6) | 4 (4.7) | 11 (12.9) | 22 (15.7) |
| AST increased | 0 | 0 | 0 | 1 (1.2) | 0 | 0 |
| ALT increased | 1 (2.3) | 0 | 1 (0.8) | 1 (1.2) | 0 | 2 (1.4) |
| γ-GT increased | 1 (2.3) | 0 | 0 | 0 | 1 (1.2) | 4 (2.9) |
| Blood bilirubin increased | 1 (2.3) | 0 | 0 | 0 | 0 | 2 (1.4) |
| Blood fibrinogen decreased | 0 | 0 | 0 | 1 (1.2) | 0 | 2 (1.4) |
| Rhabdomyolysis-/myopathy-related AEs | 3 (7.0) | 1 (2.2) | 2 (1.6) | 2 (2.4) | 3 (3.5) | 7 (5.0) |
| Laboratory test abnormalities | 3 (7.0) | 1 (2.2) | 2 (1.6) | 1 (1.2) | 2 (2.4) | 7 (5.0) |
| Serum CK increased | 3 (7.0) | 1 (2.2) | 1 (0.8) | 1 (1.2) | 2 (2.4) | 3 (2.1) |
| Serum Cr increased | 0 | 0 | 1 (0.8) | 0 | 0 | 4 (2.9) |
| Musculoskeletal and connective tissue disorders | 0 | 0 | 0 | 1 (1.2) | 1 (1.2) | 0 |
| Myalgia | 0 | 0 | 0 | 1 (1.2) | 1 (1.2) | 0 |
AST, aspartate aminotransferase; ALT, alanine aminotransferase; γ-GT, gamma glutamyl transpeptidase; CK, creatine kinase; Cr, creatinine; AE, adverse event