Table 5.
Absolute incidence rates of adverse events by eGFR (milliliters per minute per 1.73 m2) and treatment arm (n=18,015)
| Adverse Event | eGFR<45 (%), n=1018 | eGFR=45–59 (%), n=2743 | eGFR=60–89 (%), n=9572 | eGFR≥90 (%), n=4682 | ||||
|---|---|---|---|---|---|---|---|---|
| S Alone, n=532 | Ez/S, n=486 | S Alone, n=1359 | Ez/S, n=1384 | S Alone, n=4748 | Ez/S, n=4824 | S Alone, n=2372 | Ez/S, n=2310 | |
| Gallbladder-related adverse events | 24 (4.5) | 20 (4.1) | 57 (4.2) | 50 (3.6) | 160 (3.4) | 146 (3.0) | 78 (3.3) | 63 (2.7) |
| ALT, AST, or both ≥3×ULN | 27 (5.1) | 20 (4.1) | 38 (2.8) | 44 (3.2) | 87 (1.8) | 98 (2.0) | 54 (2.3) | 62 (2.7) |
| Myalgia | 12 (2.3) | 8 (1.6) | 14 (1.0) | 13 (0.9) | 56 (1.2) | 49 (1.0) | 20 (0.8) | 19 (0.8) |
| Myopathy | 3 (0.6) | 1 (0.2) | 3 (0.2) | 5 (0.4) | 3 (0.1) | 5 (0.1) | 1 (0.0) | 4 (0.2) |
| Rhabdomyolysis with or without kidney dysfunction | 4 (0.8) | 2 (0.4) | 3 (0.2) | 6 (0.4) | 7 (0.1) | 4 (0.1) | 3 (0.1) | 1 (0.0) |
| Myalgia with CK≥5×ULN | 4 (0.8) | 4 (0.8) | 3 (0.2) | 4 (0.3) | 17 (0.4) | 13 (0.3) | 7 (0.3) | 5 (0.2) |
| Myopathy, rhabdomyolysis, or myalgia with CK≥5×ULN | 11 (2.1) | 7 (1.4) | 9 (0.7) | 15 (1.1) | 26 (0.5) | 21 (0.4) | 11 (0.5) | 10 (0.4) |
Data are presented as n (%). S, simvastatin monotherapy; Ez/S, ezetimibe plus simvastatin; ULN, upper limit of normal; CK, creatinine kinase.