Efficacy and safety of PCSK9 monoclonal antibodies in older patients: A real-world registry

Abstract

Background and aims: Proprotein convertase subtilisin/kexin type 9 monoclonal antibodies (PCSK9 mAbs) have a favourable efficacy and safety profile. Advancing age may pose challenges such as increasing drug toxicity, polypharmacy, and comorbidities. This study aims to assess whether the efficacy and safety of PCSK9 mAbs are comparable between patients ≥70 years versus patients <70 years.

Methods: In a prospective registry of all consecutive patients who started PCSK9 mAbs as part of routine care in a university medical center-based lipid clinic, data was collected on LDL cholesterol levels, side effects, and discontinuation. Data on efficacy and safety (reported side effects and discontinuation) were stratified for patients ≥70 and < 70 years.

Results: Of the 474 patients (median age 59 [51-66] years, 51 % men) who started a PCSK9 mAb, 70 patients were ≥70 years (15 %). After 6 months, relative and absolute LDL cholesterol reduction was similar across age groups (relative decrease: 58 % [48-70] vs 59 % [44-71], p = 0.99; mean (SD) absolute decrease 2.4 (0.8) vs 2.4 (1.2) mmol/L, p = 0.90). A comparable proportion of patients ≥70 years compared to those <70 years achieved European and Dutch guideline-recommended goals (36 % vs 46 %, p = 0.18, and 54 % vs 62 %, p = 0.26, respectively). Efficacy outcomes were similar after 12 and 24 months follow-up. Reported side effects and discontinuation of PCSK9 mAbs were comparable across age groups.

Conclusions: Efficacy and safety of PCSK9 mAbs are comparable for patients ≥70 years and patients <70 years in a real-world study.

Keywords: Age; Cardiovascular disease; Efficacy; Lipid-lowering therapy; Monoclonal antibodies; PCSK9 inhibitors; Safety.