Lipid‐lowering therapy with PCSK9‐inhibitors in the real‐world setting: Two‐year experience of a regional lipid clinic

Summary Aim PCSK9 inhibitors (PCSK9i) effectively lower cholesterol levels in randomized trials with reduction in cardiovascular outcomes and favorable safety profile. However, the access to PCSK9i is limited due to high cost and data regarding the use of PCSK9i in real‐world practice is limited. Methods Data on all patients submitted for approval of PCSK9i at a regional lipid clinic, outside of clinical trials. Patients' profile, approval rates, low‐density lipoprotein cholesterol (LDL‐C) reduction rates, and adverse events were evaluated. Results Recommendation for PCSK9i was given to 133 patients; 16 did not receive insurance approval and additional 16 were approved but did not initiate therapy. Of the 101 treated patients (47% females; mean age 61 ± 11 years), 52 had probable/definite familial hypercholesterolemia (FH) (peak LDL‐C level 305 ± 87 mg/dL vs non‐FH 204 ± 39 mg/dL) and 62% had an established cardiovascular disease. Statin intolerance was reported by 77%. Follow‐up lipid panel was available in 66/101 patients: mean LDL‐C reduction was 59% ± 19. Subjects with heterozygous FH had similar LDL‐C decrease than those with non‐FH (59% ± 22 vs 60% ± 14, P = .792). LDL‐C