PCSK9 inhibitors linked to ocular disorders

Use of proprotein convertase subtilisin-like/kexin type 9 (PCSK9) inhibitors appears to increase the risk of ocular disorders, as shown in a study.

A disproportionality analysis of PCSK9 inhibitors was performed using the US Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to December 2021.

The authors examined the association between PCSK9 inhibitors and ocular adverse events (AEs) using the information component (IC) and the reporting odds ratio (ROR), as well as the difference in ocular AEs between evolocumab and alirocumab using the ROR. The robustness of results was assessed using different sensitivity analyses.

The FAERS yielded a total of 103,531 reports involving PCSK9 inhibitors, which were found to correlate with greater reporting of increased lacrimation (IC, 0.27, 95 percent confidence interval [CI], 0.02‒0.45; ROR, 1.21, 95 percent CI, 1.04‒1.40), seasonal allergy (IC, 0.39, 95 percent CI, 0.04‒0.64; ROR, 1.32, 95 percent CI, 1.07‒1.62), and eye operation (IC, 0.66, 95 percent CI, 0.04‒1.10; ROR, 1.60, 95 percent CI, 1.11‒2.30) relative to the full database.

No difference was observed between evolocumab and alirocumab.

On sensitivity analysis, disproportionate signals of increased lacrimation ceased to exist when cases with other lipid-lowering agents in the combined drugs were excluded. Most of the AEs, except for eye operations, occurred within 30 days of the first dose. Notably, all three ocular AEs occurred most often in women and older individuals (>65 years of age).

“This 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,” the authors said.