
doi: 10.1111/bcp.15494
pmid: 35973681
AimsTo identify and characterize ocular adverse events (oAEs) that are significantly associated with proprotein convertase subtilisin‐like/kexin type 9 (PCSK9) inhibitors using the US Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsWe conducted a disproportionality analysis of PCSK9 inhibitors in the FAERS (01/2004–12/2021). The association between PCSK9 inhibitors and oAEs was evaluated using the information component (IC) and the reporting odds ratio (ROR), and the difference in oAEs between evolocumab and alirocumab was compared using the ROR. Different sensitivity analyses were conducted to evaluate the robustness of results.ResultsA total of 103 531 reports involving at least 1 PCSK9 inhibitor were found in the FAERS. PCSK9 inhibitors were associated with higher reporting of increased lacrimation (IC 0.27 [95% confidence interval {CI} 0.02–0.45]; ROR 1.21 [95% CI 1.04–1.40]), seasonal allergy (IC 0.39 [95% CI 0.04–0.64]; ROR 1.32 [95% CI 1.07–1.62]) and eye operation (IC 0.66 [95% CI 0.04–1.10]; ROR 1.60 [95% CI 1.11–2.30]) compared with the full database, and there was no difference between evolocumab and alirocumab. Sensitivity analyses showed that the disproportionate signals of increased lacrimation disappeared after excluding cases with other lipid‐lowering agents in the combined drugs. Except for eye operations, most of these adverse events occurred within 30 days of the first dose, and all 3 oAEs were mostly reported in women and individuals >65 years.ConclusionThis pharmacovigilance study identified a possible signal of ocular disorders associated with PCSK9 inhibitors and encourages paying attention to at‐risk populations in PCSK9 inhibitors medication.
Pharmacovigilance, Eye Diseases, PCSK9 Inhibitors, Humans, Adverse Drug Reaction Reporting Systems, Female, Proprotein Convertase 9, Hypolipidemic Agents
Pharmacovigilance, Eye Diseases, PCSK9 Inhibitors, Humans, Adverse Drug Reaction Reporting Systems, Female, Proprotein Convertase 9, Hypolipidemic Agents
| selected citations These citations are derived from selected sources. This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | 12 | |
| popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network. | Top 10% | |
| influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | Average | |
| impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network. | Top 10% |
