The following article which appeared in J Atheroscler Thromb, 2023; 30: 443-454, contained the errors described below.
(on page 443)
Abstract
Incorrect
Results: The %Change in TG and Apo A-I levels was significantly greater with pemafibrate than with bezafibrate (−46.1% vs. −34.7%, p＜0.001; 9.2% vs. 5.7%, p=0.018, respectively). %Change in HDL-C levels was not significantly different between the two treatments. %Change in liver enzyme levels was markedly decreased with pemafibrate than with bezafibrate. Creatinine levels significantly increased in both treatments; however, its %Change was significantly lower with pemafibrate than with bezafibrate (5.72% vs. 15.5%, p＜0.001). The incidence of adverse events (AEs) or serious AEs did not differ between the two treatments; however, the number of patients with elevated creatinine levels (≥ 0.5 mg/dL and/or 25% from baseline) was significantly lower in the bezafibrate group than in the pemafibrate group (16/60 vs. 3/60, p =0.004).
Correct
Results: The %Change in TG and Apo A-I levels was significantly greater with pemafibrate than with bezafibrate (−46.1% vs. −34.7%, p＜0.001; 9.2% vs. 5.7%, p =0.018, respectively). %Change in HDL-C levels was not significantly different between the two treatments. %Change in liver enzyme levels was markedly decreased with pemafibrate than with bezafibrate. Creatinine levels significantly increased in both treatments; however, its %Change was significantly lower with pemafibrate than with bezafibrate (5.72% vs. 15.5%, p＜0.001). The incidence of adverse events (AEs) or serious AEs did not differ between the two treatments; however, the number of patients with elevated creatinine levels (≥ 0.5 mg/dL and/or 25% from baseline) was significantly higher in the bezafibrate group than in the pemafibrate group (14/60 vs. 3/60, p =0.004).
(on page 450)
Table 6
Incorrect
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 | 1 (2) | 1 (2) |
| Discontinuation due to AEs | 0 (0) | 0 (0) |
| SAEs | 5 (8) | 6 (10) |
| Treatment-related SAEs | 0 (0) | 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/day 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.
Correct
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.