Table 4.
Effects of allocation to simvastatin plus ezetimibe on muscle and hepatobiliary system
| Simvastatin plus ezetimibe (n=4650) | Placebo (n=4620) | p value | ||
|---|---|---|---|---|
| Muscle pain | ||||
| Any report | 992 (21·3%) | 960 (20·8%) | 0·53 | |
| Study treatment stopped | 49 (1·1%) | 28 (0·6%) | 0·02 | |
| Increased creatine kinase* | ||||
| >5 to ≤10 times ULN | 50 (1·1%) | 47 (1·0%) | 0·86 | |
| >10 to ≤40 times ULN | 17 (0·4%) | 16 (0·3%) | 1·00 | |
| >40 times ULN | 4 (0·1%) | 5 (0·1%) | 0·99 | |
| Persistently increased transaminases† | 30 (0·6%) | 26 (0·6%) | 0·71 | |
| Hepatitis | ||||
| Infective | 12 (0·3%) | 12 (0·3%) | 1·00 | |
| Non-infective | 6 (0·1%) | 4 (0·1%) | 0·76 | |
| No cause identified | 3 (0·1%) | 3 (0·1%) | 1·00 | |
| Any hepatitis | 21 (0·5%) | 18 (0·4%) | 0·76 | |
| Gallstones | ||||
| Complicated | 85 (1·8%) | 76 (1·6%) | 0·55 | |
| Uncomplicated | 21 (0·5%) | 30 (0·6%) | 0·25 | |
| Pancreatitis (without gallstones) | 12 (0·3%) | 27 (0·6%) | 0·02 | |
ULN=upper limit of normal.
*
Myopathy, defined as creatine kinase greater than ten times the ULN with muscle symptoms, occurred in nine (0·19%) versus five (0·11%) patients, of whom eight (0·17%) versus three (0·06%) were taking allocated treatment (and not taking any non-study statin) at the time of the event (both p=NS); for rhabdomyolysis, defined as myopathy with creatine kinase greater than 40 times the ULN (and hence included in counts of myopathies), the corresponding numbers were four (0·09%) versus one (0·02%) and four (0·09%) versus none, again both p=NS.
†
Consecutive increases of alanine or aspartate transaminase greater than three times the ULN.