Insights from a real-world experience with inclisiran at a large United States lipid clinic.

Abstract

Background: Inclisiran is a Food and Drug Administration-approved small interfering RNA targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) that lowers low-density lipoprotein cholesterol (LDL-C) by ∼50% in clinical trials. Real-world studies with inclisiran are limited.

Objective: Examine patient characteristics and the real-world safety and efficacy of inclisiran.

Methods: From 3/2022 to 11/2023, 60 patients at University of California San Diego Health met inclusion criteria of at least one follow-up LDL-C measurement ≥30 days after initiating inclisiran. Patients were examined for baseline characteristics and follow-up lipid levels measured as part of routine medical care.

Results: Patients were a mean (± SD) age of 71 ± 9.2 years, 31 (52%) were women, and 54 (90%) were White individuals. A total of 52 (87%) had a history of atherosclerotic cardiovascular disease. Mean ± SD LDL-C decreased 38% from 107 ± 47 mg/dL at baseline to 66 ± 41 mg/dL at first follow-up (P < .001). Excluding patients who switched from a PCSK9 inhibitor monoclonal antibody (PCSK9i mAb) within 1 month prior to starting inclisiran treatment (n = 12), a 45% decrease in LDL-C was observed (114 ± 45 mg/dL to 62 ± 41 mg/dL, P < .001). Excluding patients who switched from a PCSK9i mAb (n = 12) and patients on no background lipid-lowering therapy at time of inclisiran initiation (n = 9), LDL-C decreased 47% (102 ± 42 mg/dL to 54 ± 40 mg/dL, P < .001). Three patients (5%) reported mild side-effects that resolved by their second injection.

Conclusion: Inclisiran in real-world practice was well-tolerated and patients on background lipid-lowering therapy who were not switching from a PCSK9i mAb to inclisiran observed LDL-C reductions of approximately 50%, consistent with clinical trials.