Perfil clínico de los pacientes tratados con evolocumab en unidades de lípidos/medicina interna en España. Estudio observacional (RETOSS-IMU)
- Masana, Lluís
- López Miranda, José
- Civeira, Fernando
- Reinares, Leonardo
- Guijarro, Carlos
- Plana, Núria
- Cuenca, Rafael 1
- Sánchez, Demetrio 2
- Hernández, José Luis 3
- Andrés, Raimundo 4
- Blanco, Agustín 5
- Villamayor, Santiago 6
- 1 Servicio de Medicina Interna, Hospital Alto Guadalquivir, Andújar, Jaén, España
- 2 Servicio de Medicina Interna, Hospital Nuestra Señora de Sonsoles, Ávila, España
- 3 Unidad de Lípidos y Riesgo Vascular, Servicio de Medicina Interna, Hospital Universitario Marqués de Valdecilla-IDIVAL, Universidad de Cantabria, Santander, España
- 4 Servicio de Medicina Interna, Hospital Universitario Fundación Jiménez Díaz, Madrid, España
- 5 Servicio de Medicina Interna, Hospital Universitario 12 de Octubre, Madrid, España
- 6 Departamento Médico, Amgen S.A., Barcelona, España
ISSN: 0214-9168, 1578-1879
Ano de publicación: 2020
Volume: 32
Número: 5
Páxinas: 183-192
Tipo: Artigo
Outras publicacións en: Clínica e investigación en arteriosclerosis
Resumo
Objective To describe the clinical characteristics, the reasons for initiating therapy, and the effects of treatment in the initial phase of evolocumab availability in lipid/internal medicine units in Spain. Methods Retrospective, observational study, based on the medical records of consecutive patients initiating treatment with evolocumab (from February 2016 to July 2017) in 20 internal medicine units in Spain. A review was made of the demographic and clinical characteristics of the patients, the lipid lowering treatment, and the evolution of the lipid profiles between 12 weeks pre-initiation and 12 ± 4 weeks post-initiation of evolocumab. Results A total of 136 patients were analysed, of whom 64.0% were men, and the mean age (standard deviation, SD) was 56.6 (11.5) years. The large majority (75%) had familial hypercholesterolaemia (4 homozygous), and 51.0% of them had suffered at least one cardiovascular event. Atherosclerotic cardiovascular disease (ASCVD) was present in 61% of all patients. At initiation of evolocumab, 61.0% of the patients were taking high-intensity statins, and 60.3% were receiving ezetimibe. The mean (and SD) of LDL-C levels at initiation of evolocumab was 169.1 (56.6) mg/dL. The LDL-C was greater than 160 mg/dL in 46.4% of patients, and ≥ 190 mg/dL in 26.5%. During the observation period, evolocumab produced significant reductions in LDL-C of 55.7% (P < .0001), achieving mean values of 74.3 mg/dL. At week 12, more than half (53.8%) of patients achieved LDL-C levels < 70 mg/dL, and 26.9% < 50 mg/dL. Conclusions In the lipid/internal medicine units, evolocumab was mainly prescribed in patients with familial hypercholesterolaemia, with or without ASCVD. The initial use of evolocumab was in accordance with the guidelines of the Spanish Society of Arteriosclerosis (SEA) of 2016, with LDL-C levels being well above the recommended thresholds for treatment initiation. Evolocumab treatment in clinical practice reduced LDL-C levels by about 55%, a similar reduction to that reported in clinical trials. Most patients achieved LDL-C goals.