Table 4.
Reasons for randomised patients stopping study simvastatin/placebo tablets
| Reason(s) given |
Simvastatin-allocated (n = 10269) |
Placebo-allocated (n = 10267) |
|||
| Patient wishes | 2186 | (21.3%) | 2113 | (20.6%) | |
| Unable or unwilling to attend clinic | 757 | (7.4%) | 745 | (7.3%) | |
| Non-study statin started | 364 | (3.5%) | 1401 | (13.6%) | |
| Other contraindicated drug started | 11 | (0.1%) | 50 | (0.5%) | |
| Poor compliance | 88 | (0.9%) | 120 | (1.2%) | |
| Raised liver or muscle enzymes** | 57 | (0.6%) | 46 | (0.4%) | |
| Raised liver enzymes | 46 | (0.4%) | 36 | (0.4%) | |
| Raised muscle enzymes | 11 | (0.1%) | 2 | (0.0%) | |
| Muscle pain or weakness | 60 | (0.6%) | 62 | (0.6%) | |
| Medical advice | 158 | (1.5%) | 206 | (2.0%) | |
| Medical diagnosis/treatment/investigation | 143 | (1.4%) | 160 | (1.6%) | |
| Non-specific adverse events | 110 | (1.1%) | 126 | (1.2%) | |
| Other adverse events | 229 | (2.2%) | 225 | (2.2%) | |
| Gastrointestinal | 114 | (1.1%) | 104 | (1.0%) | |
| Psychological/psychiatric | 49 | (0.5%) | 54 | (0.5%) | |
| Rash or skin | 22 | (0.2%) | 22 | (0.2%) | |
| Neurological | 10 | (0.1%) | 14 | (0.1%) | |
| Other | 44 | (0.4%) | 43 | (0.4%) | |
| Other or family reasons | 149 | (1.5%) | 141 | (1.4%) | |
| Any of the above* | 3440 | (33.5%) | 4424 | (43.1%) | P = 0.0000 |
* Patient may stop study treatment for more than one reason
** Includes 6 vs 2 myopathy cases (the remaining myopathy patients had no further visits) and 2 vs 1 hepatitis cases