Table 6. Safety assessment because of adverse events and abnormal laboratory values during the study.
Bezafibrate treatment (n= 60) | Pemafibrate treatment (n= 60) | |
---|---|---|
Total AEs | 22 (37) | 26 (43) |
Treatment-related AEs | 3 (5) | 1 (2) |
Discontinuation due to AEs | 0 (0) | 0 (0) |
SAEs | 5 (8) | 6 (10) |
Treatment-related SAEs | 2 (3) | 0 (0) |
Discontinuation due to SAEs | 0 (0) | 0 (0) |
AEs of clinical interest | ||
CK levels of >5×ULN | 1 (2) | 0 (0) |
AST and/or ALT levels of >3×ULN | 0 (0) | 0 (0) |
Increase in the creatinine levels of ≥ 0.5 mg/dL and/or 25% | 14 (23) ‡ | 3 (5) |
Symptoms related to rhabdomyolysis/myopathy | 0 (0) | 0 (0) |
Symptoms related to gallbladder disease | 1 (2) | 0 (0) |
Symptoms related to hepatic disease | 0 (0) | 0 (0) |
Symptoms related to pancreatic disease | 0 (0) | 0 (0) |
Symptoms related to gastrointestinal disease | 0 (0) | 0 (0) |
Data are presented as n (%). ‡p<0.005 vs. pemafibrate treatment. AEs, adverse events; SAEs, serious adverse events; CK, creatine kinase; ULN, upper limit of normal; AST, aspartate aminotransferase; ALT, alanine aminotransferase.