Table 5.
Liver- and muscle-related events (per cent per year) during follow-up
| ERN/LRPT | Placebo | P* | |
|---|---|---|---|
| Number randomized | 12 838 | 12 835 | |
| Person years follow-up | 46 239 | 46 359 | |
| Abnormal alanine transaminase | |||
| Results collected at routine visits | |||
| >3 ≤5× ULN | 111 (0.24) | 47 (0.10) | |
| >5 ≤10× ULN | 23 (0.05) | 15 (0.03) | |
| >10× ULN | 6 (0.01) | 5 (0.01) | |
| Any >3× ULN | 140 (0.30) | 67 (0.14) | <0.0001 |
| Any >3× ULN without muscle damagea | 124 (0.27) | 65 (0.14) | <0.0001 |
| >3× ULN + bilirubin ≥2× ULN | 3 (<0.01) | 5 (0.01) | 0.72 |
| All resultsb | |||
| >3 ≤5× ULN | 190 (0.41) | 76 (0.16) | |
| >5 ≤10× ULN | 81 (0.18) | 35 (0.08) | |
| >10× ULN | 44 (0.10) | 22 (0.05) | |
| Any >3× ULN | 315 (0.68) | 133 (0.29) | <0.0001 |
| Any >3× ULN without muscle damagea | 234 (0.51) | 119 (0.26) | <0.0001 |
| Consecutive >3× ULN | 88 (0.19) | 34 (0.07) | <0.0001 |
| Consecutive >3× ULN without muscle damagea | 48 (0.10) | 30 (0.06) | 0.04 |
| >3× ULN + bilirubin ≥2× ULN | 14 (0.03) | 18 (0.04) | 0.48 |
| Myopathy | |||
| Definite myopathy | |||
| Rhabdomyolysis | 7 (0.02) | 5 (0.01) | |
| Any definite myopathy | 75 (0.16) | 17 (0.04) | <0.0001 |
| Incipient myopathyc | |||
| Symptomatic | 23 (0.05) | 12 (0.03) | |
| Asymptomatic | 59 (0.13) | 10 (0.02) | |
| Any incipient myopathy | 81 (0.18) | 21 (0.05) | <0.0001 |
| Any myopathyd | 155 (0.34) | 38 (0.08) | <0.0001 |
aMuscle damage defined as simultaneous creatine kinase >5× baseline and >3× ULN (within 7 days) of the ALT abnormality or diagnosis of myopathy (within 28 days).
bIncludes results collected at routine and recall visits as well as external reports.
cIncipient myopathy with no definite myopathy within 28 days.
dOf these individuals 180/193 were taking randomized treatment and 191/193 were taking study or non-study LDL-lowering treatment at the time of their first myopathy event.
*P-values are calculated from z tests comparing the proportion of patients who had the event in the ERN/LRPT group with the proportion of patients who had the event in the placebo group.