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      Actualidad de los Inhibidores de la PCSK9 Translated title: Current state of PCSK9 inhibitors

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          Abstract

          RESUMEN Hasta hace poco los fármacos hipolipemiantes que habían demostrado, de manera consistente y reproducible, capacidad para prevenir la aparición de las enfermedades cardiovasculares, sobre todo de la cardiopatía isquémica, tanto en prevención primaria como secundaria, eran las estatinas1. En España, hay comercializadas siete y todas tienen estudios de reducción de eventos clínicos frente a placebo y, en algunos casos de prevención secundaria, de tratamiento intensivo frente al convencional2, menos la pitavastatina que solo cuenta con un estudio que compara dosis altas con dosis bajas de la misma estatina3,4. Tras los fracasos en la prevención cardiovascular del ácido nicotínico5,6, actualmente no comercializado en España, la limitada utilidad de los fibratos7,8 y de los ácidos grasos omega 39, solo nos quedan como tratamiento para asociar a las estatinas las resinas de intercambio iónico, habitualmente mal toleradas10, y ezetimiba, fármaco que solo tiene estudios de reducción de eventos en asociación con estatinas en pacientes con insuficiencia renal11 y con síndrome coronario agudo12.

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          Most cited references29

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          Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients

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            Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial.

            In phase 2 studies, evolocumab, a fully human monoclonal antibody to PCSK9, reduced LDL-C levels in patients receiving statin therapy. To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate- vs high-intensity statin. Phase 3, 12-week, randomized, double-blind, placebo- and ezetimibe-controlled study conducted between January and December of 2013 in patients with primary hypercholesterolemia and mixed dyslipidemia at 198 sites in 17 countries. Patients (n = 2067) were randomized to 1 of 24 treatment groups in 2 steps. Patients were initially randomized to a daily, moderate-intensity (atorvastatin [10 mg], simvastatin [40 mg], or rosuvastatin [5 mg]) or high-intensity (atorvastatin [80 mg], rosuvastatin [40 mg]) statin. After a 4-week lipid-stabilization period, patients (n = 1899) were randomized to compare evolocumab (140 mg every 2 weeks or 420 mg monthly) with placebo (every 2 weeks or monthly) or ezetimibe (10 mg or placebo daily; atorvastatin patients only) when added to statin therapies. Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) level at the mean of weeks 10 and 12 and at week 12. Evolocumab reduced LDL-C levels by 66% (95% CI, 58% to 73%) to 75% (95% CI, 65% to 84%) (every 2 weeks) and by 63% (95% CI, 54% to 71%) to 75% (95% CI, 67% to 83%) (monthly) vs placebo at the mean of weeks 10 and 12 in the moderate- and high-intensity statin-treated groups; the LDL-C reductions at week 12 were comparable. For moderate-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline mean of 115 to 124 mg/dL to an on-treatment mean of 39 to 49 mg/dL; monthly evolocumab reduced LDL-C from a baseline mean of 123 to 126 mg/dL to an on-treatment mean of 43 to 48 mg/dL. For high-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 35 to 38 mg/dL; monthly evolocumab reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 33 to 35 mg/dL. Adverse events were reported in 36%, 40%, and 39% of evolocumab-, ezetimibe-, and placebo-treated patients, respectively. The most common adverse events in evolocumab-treated patients were back pain, arthralgia, headache, muscle spasms, and pain in extremity (all <2%). In this 12-week trial conducted among patients with primary hypercholesterolemia and mixed dyslipidemia, evolocumab added to moderate- or high-intensity statin therapy resulted in additional LDL-C lowering. Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering. clinicaltrials.gov Identifier: NCT01763866.
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              Drug treatment of lipid disorders.

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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Journal
                albacete
                Revista Clínica de Medicina de Familia
                Rev Clin Med Fam
                Sociedad Castellano-Manchega de Medicina de Familia y Comunitaria (Albacete, Castilla La Mancha, Spain )
                1699-695X
                2386-8201
                2019
                : 12
                : 3
                : 125-131
                Affiliations
                [1] orgnameSociedad Española de Medicina de Familia y Comunitaria (semFYC) orgdiv1Grupo de Trabajo de Dislipemias
                Article
                S1699-695X2019000300125
                25f53f64-cf67-4cef-989f-b40ce54ad26c

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                : 15 May 2019
                : 22 May 2019
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 48, Pages: 7
                Product

                SciELO Spain

                Categories
                Artículos Especiales

                Fármacos Hipocolesteromiantes,Proproteína Convertasas,Anticholesteremic Agents,Hypercholesterolemia,Proprotein Convertases,Hipercolesterolemia

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