Table 4.
Myopathy and raised alanine aminotransferase and creatine kinase concentrations
| 80 mg simvastatin daily (n=6031) | 20 mg simvastatin daily (n=6033) | ||
|---|---|---|---|
| Alanine aminotransferase | |||
| >2 to ≤4 times ULN | 197 (3·3%) | 119 (2·0%) | |
| >4 times ULN | 51 (0·8%) | 40 (0·7%) | |
| >4 times ULN on repeat visits | 14 (0·2%) | 10 (0·2%) | |
| Creatine kinase | |||
| >5 to ≤10 times ULN | 77 (1·3%) | 31 (0·5%) | |
| >10 to ≤40 times ULN * | 45 (0·7%) | 12 (0·2%) | |
| >40 times ULN * | 23 (0·4%) | 0 | |
| Myopathy | |||
| Incipient | 82 (1·4%) | 12 (0·2%) | |
| Definite† | 53 (0·9%) | 2 (0·0%) | |
| No rhabdomyolysis | 46 (0·8%) | 2 (0·0%) | |
| Rhabdomyolysis | 7 (0·1%) | 0 | |
Data are number of patients (%). ULN=upper limit of normal for laboratory.
*
20 (vs 11) patients with creatine kinase more than ten times ULN were asymptomatic (and so not classified as myopathy).
†
Five (vs one) of the patients with definite myopathy did not have a recorded measurement of creatine kinase more than ten times ULN, but presented with clinical myopathy.