Review Article
[Retracted] A Systematic Review and Meta-Analysis of Therapeutic Efficacy and Safety of Alirocumab and Evolocumab on Familial Hypercholesterolemia
Table 2
Prespecified safety end points. No statistical differences between the PCSK9-mAbs and control groups.
| Pre-specified Safety endpoints | PCSK9-mAbs | Control | | value | No. of patients/objects | Rate (%) | No. of patients/objects | Rate (%) |
| Any adverse events | 209/342 | 0.6111111 | 119/203 | 0.5862069 | 0.33 | 0.314 | Serious adverse events | 13/256 | 0.0507813 | 4/126 | 0.031746 | 0.72 | 0.287 | Nervous system disorders | 13/162 | 0.0802469 | 3/87 | 0.0344828 | 1.972 | 0.127 | Injection site reactions | 26/398 | 0.0653266 | 8/203 | 0.0394089 | 1.692 | 0.131 | Leading to treatment discontinuation | 10/257 | 0.0446429 | 4/128 | 0.03125 | 0.143 | 0.477 | Nasopharyngitis | 31/310 | 0.1 | 10/153 | 0.0653595 | 1.523 | 0.144 | Back pain | 7/151 | 0.0463576 | 2/75 | 0.0266667 | 0.508 | 0.377 | Headache | 13/277 | 0.0469314 | 7/137· | 0.0510949 | 0.035 | 0.513 | ALT, AST, or both | 8/216 | 0.037037 | 2/107 | 0.0186916 | 0.803 | 0.3 | Positively adjudicated cardiovascular events | 14/239 | 0.0585774 | 7/125 | 0.056 | 0.01 | 0.563 | Creatinine | 10/248 | 0.0403226 | 2/128 | 0.0169492 | 1.667 | 0.164 |
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