Article ; Online: PCSK9 inhibitors revisited: Effectiveness and safety of PCSK9 inhibitors in a real-life Spanish cohort.
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie
2021 Volume 146, Page(s) 112519
Abstract: Introduction: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have emerged as a therapeutic option for patients with hypercholesterolemia who do not attain low-density lipoprotein cholesterol (LDL-C) goals and/or are intolerant to ... ...
| Abstract | Introduction: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have emerged as a therapeutic option for patients with hypercholesterolemia who do not attain low-density lipoprotein cholesterol (LDL-C) goals and/or are intolerant to other lipid-lowering drugs. Our aim was to analyze the effectiveness and safety of PCSK9i in routine clinical practice and factors related to poor outcomes. Materials and methods: We conducted an ambispective study in 115 patients who recieved alirocumab or evolocumab, in a tertiary level hospital. From February 2017 to April 2020, patients were recruited and followed up for a median of 20.4 months. The main outcomes were relative reduction in LDL-C, percentage of patients achieving the therapeutic goals established by 2016 ESC/EAS guidelines, incidence of major cardiovascular events (MACEs) and drug-related adverse events (ADRs). Results: The median LDL-C achieved was 57.0 mg/dL (relative reduction of 59.9% from baseline, p< 0.001). After adjusting for confounders, smaller LDL-C reductions were related to female sex, absence of concomitant lipid-lowering therapy and treatment with alirocumab. Overall, 84.6% of the patients achieved the therapeutic goals. During follow-up, 7 MACEs were detected. ADRs, generally considered mild, affected 38.1% of the participants (mainly mialgias and arthralgias) and triggered discontinuations in 8.7% of cases. Conclusions: PCSK9i are effective and safe, although certain factors may influence their effectiveness. Interestingly, our results suggest that alirocumab and evolocumab may not be therapeutic equivalents, as initially suggested. |
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| MeSH term(s) | Age Factors ; Aged ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Anticholesteremic Agents/administration & dosage ; Anticholesteremic Agents/adverse effects ; Anticholesteremic Agents/therapeutic use ; Cardiovascular Diseases/epidemiology ; Comorbidity ; Dose-Response Relationship, Drug ; Female ; Humans ; Hypercholesterolemia/drug therapy ; Life Style ; Lipids/blood ; Male ; Middle Aged ; PCSK9 Inhibitors/administration & dosage ; PCSK9 Inhibitors/adverse effects ; PCSK9 Inhibitors/therapeutic use ; Sex Factors ; Spain |
| Chemical Substances | Antibodies, Monoclonal, Humanized ; Anticholesteremic Agents ; Lipids ; PCSK9 Inhibitors ; evolocumab (LKC0U3A8NJ) ; alirocumab (PP0SHH6V16) |
| Language | English |
| Publishing date | 2021-12-28 |
| Publishing country | France |
| Document type | Journal Article |
| ZDB-ID | 392415-4 |
| ISSN | 1950-6007 ; 0753-3322 ; 0300-0893 |
| ISSN (online) | 1950-6007 |
| ISSN | 0753-3322 ; 0300-0893 |
| DOI | 10.1016/j.biopha.2021.112519 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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