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. 2023 May 2;30(6):698–699. doi: 10.5551/jat.ER63659

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.