Table 4.
Safety Outcomes by Sex (Receiving Treatment)
| End Points | Sex | Placebo/Simvastatin | Ezetimibe/Simvastatin | P Valuea | P int b |
|---|---|---|---|---|---|
| ALT, AST, or both ≥3× ULN | Women | 50 (2.3) | 52 (2.4) | 0.92 | 0.82 |
| Men | 143 (2.1) | 153 (2.3) | 0.56 | ||
| Gallbladder‐related AEs | Women | 72 (3.4) | 63 (2.9) | 0.38 | 0.93 |
| Men | 180 (2.7) | 151 (2.3) | 0.13 | ||
| Rhabdomyolysis | Women | 10 (0.5) | 4 (0.2) | 0.12 | 0.22 |
| Men | 8 (0.1) | 8 (0.1) | >0.99 | ||
| Myopathy | Women | 4 (0.2) | 5 (0.2) | NA | 0.76 |
| Men | 5 (0.1) | 8 (0.1) | 0.42 | ||
| Rhabdomyolysis, myopathy, or myalgia with CK elevation ≥5× ULN | Women | 21 (1.0) | 12 (0.6) | 0.12 | 0.16 |
| Men | 34 (0.5) | 35 (0.5) | 0.90 | ||
| Cancer | Women | 102 (4.8) | 111 (5.1) | 0.62 | 0.41 |
| Men | 453 (6.7) | 454 (6.8) | 0.92 |
Data shown are number (percentage). Treatment effects were all comparable between men and women. AE indicates adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CK, creatine kinase; NA, not applicable; P int, P value for interaction; and ULN, upper limit of normal.
a
P value comparing treatment within the same sex group.
b
P int comparing treatment effects between women and men.