Effectiveness and safety of PCSK9 inhibitors in real-world clinical practice. An observational multicentre study. The IRIS-PCSK9I study

Atherosclerosis Plus

Purificación Sánchez López¹  Belén Sánchez Rodríguez²  Beatriz Hidalgo Martín³  Alba María Castillo Fernández³  María Magdalena Carrillo Bailén³  María Josefa Álvarez Soria³  Eduardo Agüera Morales⁴  Roberto Valverde Moyano⁴  Antonio Arjona-Padillo⁵  Javier Fernández Pérez⁵  Manuel Payán Ortiz⁵  Laura Amaya-Pascasio⁵  Rodrigo Milán Pinilla⁵  Luis Andrade Zumárraga⁵  Marina Blanco-Ruiz⁵  María Victoria Mejías Olmedo⁵  Patricia Martínez-Sánchez⁵  Cristina Del Toro Pérez⁵  Reyes de Torres Chacón⁶  Pablo González Bustos⁷  Irene Pérez Ortega⁷  Ricardo Roa Chamorro⁷ 

[1] Department of Internal Medicine, Torrecárdenas University Hospital, Almería, Spain;Department of Pharmacy. Torrecárdenas, University Hospital, Almería, Spain;Stroke Unit and Department of Neurology, Jaén University Hospital, Jaén, Spain;Stroke Unit and Department of Neurology, Reina Sofia University Hospital, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Spain;Stroke Unit and Department of Neurology, Torrecárdenas University Hospital, Almería, Spain;Stroke Unit and Department of Neurology, Virgen Macarena University Hospital, Seville, Spain;Stroke Unit and Department of Neurology, Virgen de las Nieves University Hospital, Granada, Spain;

关键词: Evolocumab;    Alirocumab;    PCSK9i;    Hypercholesterolemia familiar;    Cardiovascular disease;    Statins intolerance;   

DOI  :  

来源: DOAJ

【 摘 要 】

Background and aims: The benefits of the PCSK9 inhibitors, alirocumab and evolocumab, in lowering LDL-cholesterol and preventing major adverse cardiac events (MACE) have been demonstrated in pivotal clinical trials. However, few studies of routine clinical practice have been conducted to analyse and compare the efficacy and safety of the two drugs. Methods: Retrospective observational study of patients treated with a PCSK9 inhibitor in five hospitals in Andalusia (southern Spain). Baseline demographic and clinical data, LDL-cholesterol levels and the occurrence of MACEs during the follow-up period were recorded. Results: A total of 141 patients were included in the study: 90 were treated with alirocumab and 51 with evolocumab. The patients’ mean age (IQR) was 58 (11) years and 58 (41%) were women. The most frequent concomitant medications were statins, 94 (66.7%), followed by antiplatelet therapy (66%) and ezetimibe (65.2%). The median (IQR) follow-up period was 18 (18) months, with 18 (24) for alirocumab and 11 (18) for evolocumab. At the six-month follow-up visit, LDL-cholesterol values had decreased to pre-treatment levels and remained significantly decreased (p < 0.05) over time, for both drugs, and a greater reduction was achieved in patients with established cardiovascular disease and concomitant treatment with statins. With respect to adverse effects, there were nine MACEs (6.4%), of which seven were with alirocumab (7.8%) and two with evolocumab (3.9%) (p NS). Other adverse effects (9.2%) included local erythema (3.5%), muscle cramps (2.1%), respiratory symptoms (2.1%) and asthaenia (1.4%). Conclusions: The efficacy and safety of alirocumab and evolocumab in routine clinical practice are consistent with the findings of the pivotal clinical trials.

【 授权许可】

Unknown