Financiado en parte por Amgen, AMGEN
LDL-cholesterol lowering with evolocumab, and outcomes according to age and sex in patients in the FOURIER Trial
Sever P, Gouni-Berthold I, Keech A, Giugliano R, Pedersen TR, Im K, Wang H, Knusel B, Sabatine MS, O'Donoghue ML
European journal of preventive cardiology · 74 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Amgen
- Empresa
- AMGEN
- Sin clasificar
- FOURIER
Según 3 financiadores declarados.
Publicación
- Publicado
- 2020-02-05 · Eur J Prev Cardiol · vol. 28 · número 8 · págs. 805–812
- Editorial
- Oxford University Press
- Citado
- 106 citas · más que el 99% de estudios similares · 12.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 14 trabajos
- Acceso
- De pago
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Acute Myocardial Infarction Research · Atherosclerosis and Cardiovascular Diseases
- Palabras clave
- evolocumab, PCSK9 inhibitors, LDL cholesterol lowering, FOURIER trial, atherosclerotic cardiovascular disease, statin therapy, cardiovascular outcomes, cardiovascular mortality, myocardial infarction, stroke, elderly patients, drug safety, hypercholesterolemia
- MeSH
- humans, angina, unstable, antibodies, monoclonal, anticholesteremic agents, treatment outcome, double-blind method, aged, child, preschool, female, male, cholesterol, ldl, antibodies, monoclonal, humanized, proprotein convertase 9
10 autores
- Peter S. Sever🇬🇧 · autor de correspondenciaImperial College London
- Ioanna Gouni‐Berthold🇩🇪University of Cologne
- ANTHONY C. KEECH🇦🇺The University of Sydney; National Health and Medical Research Council
- Robert Patrick Giugliano🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Terje Rolf Pedersen🇳🇴Oslo University Hospital
- KyungAh Im🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Huei Wang🇺🇸Amgen (United States)
- Beat Knüsel🇺🇸Amgen (United States)
- Marc Steven Sabatine🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Michelle L. O’Donoghue🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aims
Some trials have reported diminished efficacy for statins in the elderly, and in women compared with men. We examined the efficacy and safety of evolocumab by patient age and sex in the FOURIER trial, the first major cardiovascular outcome trial of a PCSK9 inhibitor.
Methods and results
FOURIER was a randomised, double blind trial, comparing evolocumab with placebo in 27,564 patients with atherosclerotic cardiovascular disease receiving statin therapy (median follow-up 2.2 years). The primary endpoint was cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina or coronary revascularisation. Cox proportional hazards models were used to assess the efficacy of evolocumab versus placebo stratified by quartiles of patient age and by sex. There were small variations in the cardiovascular event rate across the age range (for the primary endpoint, Kaplan-Meier at 3 years 15.6%, >69 years, vs. 15.1%, ≤56 years, P = 0.45); however, the relative efficacy of evolocumab was consistent regardless of patient age (for the primary endpoint (Q1 hazard ratio, 95% confidence interval) 0.83, 0.72-0.96, Q2 0.88, 0.76-1.01, Q3 0.82, 0.71-0.95, Q4 0.86, 0.74-1.00; Pinteraction = 0.91), and the key secondary endpoint (cardiovascular death, myocardial infarction, stroke) (Q1 0.74 (0.61-0.89), Q2 0.83 (0.69-1.00), Q3 0.78 (0.65-0.94), Q4 0.82 (0.69-0.98)); Pinteraction = 0.81). Women had a lower primary endpoint rate than men (Kaplan-Meier at 3 years 12.5 vs. 15.3%, respectively, P < 0.001). Relative risk reductions in the primary endpoint and key secondary endpoint were similar in women (0.81 (0.69-0.95) and 0.74 (0.61-0.90), respectively) compared with men (0.86 (0.80-0.94) and 0.81 (0.73-0.90), respectively), Pinteraction = 0.48 and 0.44, respectively. Adverse events were more common in women and with increasing age but, with the exception of injection site reactions, there were no important significant differences reported by those assigned evolocumab versus placebo.
Conclusions
The efficacy and safety of evolocumab are similar throughout a broad range of ages and in both men and women.
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