Efficacy and safety of PCSK9 inhibitors in real life.

Objective: To confirm the effectiveness and safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in daily clinical practice.

Methods: Retrospective observational study of patients from hospital registry of PCSK9 inhibitor treatment with a follow-up ≥ 6 months. The lipid-lowering effect and safety were evaluated.

Results: Of the 193 patients included in the study, 168 (87%) had cardiovascular disease, and 54 (28%) had familial hypercholesterolemia; 85 (44%) were intolerant to statins/ezetimibe. No differences between alirocumab and evolocumab groups regarding the rate of LDL-C reduction ≥ 50% (82.8% vs. 83.1%), achievement of the therapeutic target (60.9% vs. 65.5%), or complete remission (60.2% vs. 58.5%) were found. An erythema at the injection site in one patient treated with alirocumab and urticaria in one patient treated with evolocumab were recorded. According to the logistic regression analysis, complete remission of LDL-C in subjects treated with PCSK9 inhibitors was positively associated with increased age (OR: 1.045; 95%CI: 1.0-1.092; P=.049) and active smoking (OR: 4.562; 95%CI: 1.434-14.515; P=.010), and negatively associated with female gender (OR: 0.403; 95%CI: 0.171-0.949; P=.038), baseline LDL-C levels (OR: 0.969; 95%CI: 0.957-0.981; P<.001)and statin/ezetimibe intolerance (OR: 0.403; 95%CI: 0.176-0.925; P=.041).

Conclusion: This real-world practice study has confirmed that PCSK9 inhibitors are effective, safe and well tolerated, with lipid-lowering effects comparable to those described in randomized controlled trials, regardless of the monoclonal antibody used.