Table 2.
Parameter | Exposure-adjusted incidence per 100 person-years (n) | |||
---|---|---|---|---|
ASCVD/HeFH on statins pool | Statin intolerant pool | |||
Bempedoic acid (n = 2009) |
Placebo (n = 999) |
Bempedoic acid (n = 415) |
Placebo (n = 198) |
|
ALT and/or AST > 3 × ULNa | 0.6 (13) | 0.3 (3) | 2.8 (5) | 0 |
ALT and/or AST > 5 × ULNa | 0.2 (4) | 0.2 (2) | 1.1 (2) | 0 |
Blood creatinine levels increased | 0.9 (16) | 0.4 (4) | 1.8 (3) | 0 |
Blood urea levels increased | 0.2 (3) | 0.1 (1) | 0 | 0 |
Blood uric acid levels increased | 1.8 (33) | 0.4 (4) | 10.7 (18) | 2.4 (2) |
Creatine kinase >5 × ULNa | 0.3 (7) | 0.2 (2) | 0.6 (1) | 0 |
ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal
aPatients with repeated and confirmed elevations in aminotransferase or creatine kinase levels