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- W3037855256 abstract "Presentar el primer registro que analiza el perfil clínico de los pacientes tratados en España con evolocumab y la efectividad sobre el perfil lipídico y su seguridad en el «mundo real». Estudio multicéntrico, retrospectivo, observacional, de los pacientes que empezaron tratamiento con evolocumab entre febrero de 2016 y mayo de 2017 en la práctica clínica en unidades de cardiología en España. Se incluyó a 186 pacientes de 31 unidades de cardiología (edad media 60,3 ± 9,8 años; 35,5% con hipercolesterolemia familiar y 94,1% con evento cardiovascular previo). Perfil lipídico basal: colesterol total 219,4 ± 52,2 mg/dL, colesterol-LDL 144,0 ± 49,0 mg/dL, colesterol-HDL 47,7 ± 13,0 mg/dL y triglicéridos 151,0 ± 76,2 mg/dL. En el momento del inicio de evolocumab, el 53,8% estaba tomando estatinas (el 50% presentaba intolerancia a las estatinas, total o parcial) y el 51,1% ezetimiba. En todos los casos se empleó la dosis de evolocumab de 140 mg y, principalmente, cada 2 semanas (97,3%). El cumplimiento terapéutico fue elevado (92,3%). En 6 pacientes (3,2%) se interrumpió el tratamiento, pero solo en uno (0,5%), por posible efecto adverso. Evolocumab redujo significativamente el colesterol total (30,9% a las 2 semanas y 39,3% a las 12 semanas; p < 0,001), colesterol-LDL (44,4 y 57,6%, respectivamente; p < 0,001) y triglicéridos (14,8 y 5,2%; p < 0,001), sin modificar significativamente el colesterol-HDL (6,7 y 2,0%; p = 0,14). En la práctica clínica, evolocumab se asocia con reducciones del colesterol-LDL cercanas al 60% tras 12 semanas de tratamiento, con una tasa de retiradas por efectos adversos muy baja y con un elevado cumplimiento terapéutico. Estos resultados son consistentes con los obtenidos en los ensayos clínicos aleatorizados. To present the first registry used to analyse the clinical profile of patients treated with evolocumab in Spain, including the effectiveness on the lipid profile and safety in the «real world» setting. Multicentre, retrospective, and observational study of patients starting treatment with evolocumab from February 2016 to May 2017 in clinical practice in Spanish cardiology units. A total of 186 patients (mean age 60.3 ± 9.8 years were included, 35.5% with familial hypercholesterolaemia, and 94.1% with a previous cardiovascular event) from 31 cardiology units. Baseline lipid profile: Total cholesterol 219.4 ± 52.2 mg/dL, LDL-cholesterol 144.0 ± 49.0 mg/dL, HDL-cholesterol 47.7 ± 13.0 mg/dL, and triglycerides 151.0 ± 76.2 mg/dL. At the time of initiating evolocumab, 53.8% of patients were taking statins (50% had partial or total intolerance to statins), and 51.1% ezetimibe. In all cases, the dose of evolocumab used was 140 mg, mainly every 2 weeks (97.3%). Evolocumab compliance was high (92.3%). Treatment with evolocumab was interrupted in 6 patients (3.2%), with only 1 (0.5%) due to a probable side effect. Evolocumab significantly reduced total cholesterol (30.9% at week 2, and 39.3% at week 12; P<.001), LDL cholesterol (44.4% and 57.6%, respectively; P<.001), and triglycerides (14.8% and 5.2%, respectively; P<001), with no significant changes in HDL-cholesterol (6.7% and 2.0%; P=.14). In clinical practice, evolocumab is associated with reductions in LDL cholesterol, with nearly 60% after 12 weeks of treatment, and with low rates of interruptions due to side effects and high medication compliance. These results are consistent with those reported in randomised clinical trials." @default.
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- W3037855256 date "2020-11-01" @default.
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- W3037855256 title "Primer registro nacional sobre la efectividad y seguridad de evolocumab en la práctica clínica en pacientes atendidos en cardiología en España. Estudio RETOSS-CARDIO" @default.
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- W3037855256 doi "https://doi.org/10.1016/j.arteri.2020.05.002" @default.
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