No evidence of neurocognitive adverse events associated with alirocumab treatment in 3340 patients from 14 randomized Phase 2 and 3 controlled trials: A meta-analysis of individual patient data
European Heart Journal | Dec 04, 2017
Harvey PD, et al. - The study entailed the evaluation of the incidence of neurocognitive treatment-emergent adverse events (TEAEs) from 14 Phase 2 and 3 trials of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab. With low (≤1.2%) neurocognitive TEAE incidences, no significant differences were reported between alirocumab vs controls up to 104 weeks. On the basis of the examination of completed Phase 2 and 3 trials, no link was evident between neurocognitive TEAEs and LDL cholesterol (LDL-C) <25 mg/dL, although long-term impacts of very low LDL-C levels induced by PCSK9 inhibitors are currently unknown.
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