Effectiveness, Safety, and Adherence to Treatment of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Real Practice

Garcı́a-Barros, Mónica; Díaz-Trastoy, Olaia; Romero-Ventosa, Elena Yaiza; García-Beloso, Nerea; González-Freire, Lara; Lorenzo-Lorenzo, Karina; Mantiñán-Gil, Beatriz; Palmeiro-Carballeira, Regina; Bravo-Amaro, Marisol; López-Gil-Otero, María del Mar; Martínez-Reglero, Cristina; Crespo-Diz, Carlos; Fernández-Catalina, Pablo; Corrales, Guadalupe Piñeiro

doi:10.1016/j.clinthera.2021.02.002

Cited by 9 publications

(9 citation statements)

References 17 publications

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“…Recently, a Spanish group has published a multicentre, real-life study including 154 patients with hypercholesterolaemia treated with PCSK9i and a follow-up period between 3 and 24 months [ 36 ]. Compared to our study, the treatment with Evolocumab was more frequent (58% vs 36%), and there was a higher percentage of patients with FH (29.9% vs. 13,5%).…”

Section: Discussionmentioning

confidence: 99%

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

Blanco-Ruiz

Amaya-Pascasio

Chacon

et al. 2021

Atherosclerosis Plus

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Section: Discussionmentioning

confidence: 99%

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

Blanco-Ruiz

Amaya-Pascasio

Chacon

et al. 2021

Atherosclerosis Plus

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“…Another observational, retrospective, descriptive, and multicenter study conducted for 24 months on 90 patients with hypercholesterolemia, receiving 140 mg evolocumab every two weeks, found that the frequency of cardiovascular adverse reactions was low. In particular, it detected a light significant increase in injection site reactions in the youngest age in men with respect to women [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

Adverse Reactions to Evolocumab: Analysis of Real-World Data from EudraVigilance

Calapai,

Mannucci,

Currò

et al. 2024

Pharmaceuticals

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Background: Evolocumab is a humanized immunoglobulin G2 monoclonal antibody, directed against Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), prescribed in hypercholesterolemic patients. The safety profile of this drug is currently defined by the data of pre-authorization clinical trials. The purpose of this study is to update knowledge of the safety of evolocumab through an analysis of post-marketing real-world data on suspected adverse reactions (SARs), reported by the EudraVigilance database system. Methods: The public version of the EudraVigilance database has been used, and only serious SARs signals were included. Results: Musculoskeletal system disorders, flu-like symptoms, injection-site reactions, skin reactions, and metabolism and nutrition disorders are observed in the post-marketing surveillance, as well as being found in the pre-authorization studies. Not previously signaled in the pre-marketing studies, diarrhea was reported. Furthermore, signals related to cardiac adverse reactions, more frequently at the expense of adults in comparison to elders, were found. Conclusions: The post-marketing safety profile of evolocumab emerging from an analysis of the EudraVigilance data system indicates it is sufficiently safe but suggests the necessity for caution when it is prescribed to hyperlipidemic patients affected by heart diseases.

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“…In the context of actual clinical practice, recent studies reported that therapeutic adherence and effectiveness of PCSK9 inhibitors were maintained in the long-term and adverse reactions are sparse and mild [21,22]. Even though one of the most frequently reported adverse reactions in trials was injection site reactions, the subcutaneous administration of PCSK9 inhibitors was well accepted by patients [22]. In addition, multiple studies evaluating PCSK9 inhibitors treatment acceptance suggested a high level of drug acceptance and tolerability [23][24][25].…”

Section: Discussionmentioning

confidence: 99%

Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period

Boccara

Caramelli

Calmy³

et al. 2022

Aids

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Objectives:People with HIV (PWH) are at an increased risk of atherosclerotic cardiovascular disease. Suboptimal responses to statin therapy in PWH may result from antiretroviral therapies (ARTs). This open-label extension study aimed to evaluate the long-term safety and efficacy of evolocumab up to 52 weeks in PWH.Design:This final analysis of a multinational, placebo-controlled, double-blind, randomized phase 3 trial evaluated the effect of monthly subcutaneous evolocumab 420 mg on low-density lipoprotein cholesterol (LDL-C) during the open-label period (OLP) following 24 weeks of double-blind period in PWH with hypercholesterolemia/mixed dyslipidemia. All participants enrolled had elevated LDL-C or nonhigh-density lipoprotein cholesterol (non-HDL-C) and were on stable maximally tolerated statin and stable ART.Methods:Efficacy was assessed by percentage change from baseline in LDL–C, triglycerides, and atherogenic lipoproteins. Treatment-emergent adverse events (TEAEs) were examined.Results:Of the 467 participants randomized in the double-blind period, 451 (96.6%) received at least one dose of evolocumab during the OLP (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). By the end of the 52-week OLP, the overall mean (SD) percentage change in LDL-C from baseline was −57.8% (22.8%). Evolocumab also reduced triglycerides, atherogenic lipid parameters (non-HDL-C, apolipoprotein B, total cholesterol, very-low-density lipoprotein cholesterol, and lipoprotein[a]), and increased HDL-C. TEAEs were similar between placebo and evolocumab during the OLP.Conclusion:Long-term administration of evolocumab lowered LDL-C and non-HDL-C, allowing more PWH to achieve recommended lipid goals with no serious adverse events.Trail Registration:NCT02833844Video abstract:http://links.lww.com/QAD/C441

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Effectiveness, Safety, and Adherence to Treatment of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Real Practice

Cited by 9 publications

References 17 publications

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

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

Adverse Reactions to Evolocumab: Analysis of Real-World Data from EudraVigilance

Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period

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