In randomized clinical trials (RCTs) proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors showed a favorable safety profile, however, “real-world” data on adverse events (AEs) is scarce. Three datasets, a hospital registry (n = 164), and two Pharmacovigilance databases, Lareb (n = 149) and VigiLyze (n = 15,554), reporting AEs attributed to PCSK9 inhibitors (alirocumab or evolocumab) prescribed in clinical practice were analyzed. In the hospital registry, 41.5% of the patients reported any AE, most often injection-site reactions (33.8%) and influenza-like illness (27.9%). Twelve patients (7%) discontinued PCSK9 inhibitor treatment. Most common AE reported in the Lareb and VigiLyze database was myalgia (12.8% and 8.3%, respectively). No clinically relevant differences in gender or between drugs were observed. No specific subgroup of patients could be identified at risk of developing AEs. During follow-up, AEs resolved in most patients (71.1%). In a real-world setting, PCSK9 inhibitors are well tolerated with an overall safety profile comparable to RCTs.

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Journal Clinical Pharmacology and Therapeutics
Gürgöze, M.T. (Muhammed T.), Muller-Hansma, A.H.G. (Annemarie H.G.), Schreuder, M.M. (Michelle M.), Galema-Boers, J.M.H, Boersma, H, & Roeters van Lennep, J.E. (2018). Adverse Events Associated With PCSK9 Inhibitors: A Real-World Experience. Clinical Pharmacology and Therapeutics. doi:10.1002/cpt.1193