Cognitive Function in a Randomized Trial of Evolocumab
Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR, EBBINGHAUS Investigators
The New England journal of medicine · 371 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute for Health and Care Research
- Universidad u hospital
- University of California, Davis
- Gobierno
- National Institute for Health Research (NIHR)
- Subvenciones
- National Institute for Health and Care Research (NF-SI-0513-10059)
Según 3 financiadores declarados.
Publicación
- Publicado
- 2017-08-16 · N Engl J Med · vol. 377 · número 7 · págs. 633–643
- Editorial
- Massachusetts Medical Society
- Citado
- 492 citas · más que el 100% de estudios similares · 57.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 29 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Dementia and Cognitive Impairment Research · Cholesterol and Lipid Metabolism
- Palabras clave
- evolocumab, PCSK9 inhibitors, cognitive function, executive function, spatial working memory, working memory, episodic memory, psychomotor speed, LDL cholesterol, statin therapy, non-inferiority, cognitive safety, hypercholesterolemia, Alzheimer's disease risk, dementia risk, cognitive decline
- MeSH
- humans, antibodies, monoclonal, anticholesteremic agents, hydroxymethylglutaryl-coa reductase inhibitors, drug therapy, combination, prospective studies, double-blind method, cognition, memory, psychological tests, adult, aged, aged, 80 and over, middle aged, female, male, atherosclerosis, cholesterol, ldl, self-assessment, antibodies, monoclonal, humanized, proprotein convertase 9, pcsk9 inhibitors
16 autores
- Robert Patrick Giugliano🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- François Mach🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Kenton H. Zavitz🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Cambridge Cognition (United Kingdom); Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Christopher E. Kurtz🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; Amgen (United States); University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Kyungah Im🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Estella Kanevsky🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Jingjing Schneider🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; Amgen (United States); University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Huei Wang🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; Amgen (United States); University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- ANTHONY C. KEECH🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; National Health and Medical Research Council; Imperial College London
- Terje Rolf Pedersen🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Marc Steven Sabatine🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Peter S. Sever🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Jennifer G. Robinson🇺🇸🇳🇴🇦🇺🇨🇭🇬🇧University of Iowa; Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Narimon Honarpour🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; Amgen (United States); University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Scott M. Wasserman🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; Amgen (United States); University of Oslo; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
- Brian R. Ott🇳🇴🇺🇸🇦🇺🇨🇭🇬🇧Oslo University Hospital; Brigham and Women's Hospital; The University of Sydney; University of Oslo; Brown University; Rhode Island Hospital; University Hospital of Geneva; Thrombolysis in Myocardial Infarction Study Group; Imperial College London
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background Findings from clinical trials of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have led to concern that these drugs or the low levels of low-density lipoprotein (LDL) cholesterol that result from their use are associated with cognitive deficits. Methods In a subgroup of patients from a randomized, placebo-controlled trial of evolocumab added to statin therapy, we prospectively assessed cognitive function using the Cambridge Neuropsychological Test Automated Battery. The primary end point was the score on the spatial working memory strategy index of executive function (scores range from 4 to 28, with lower scores indicating a more efficient use of strategy and planning). Secondary end points were the scores for working memory (scores range from 0 to 279, with lower scores indicating fewer errors), episodic memory (scores range from 0 to 70, with lower scores indicating fewer errors), and psychomotor speed (scores range from 100 to 5100 msec, with faster times representing better performance). Assessments of cognitive function were performed at baseline, week 24, yearly, and at the end of the trial. The primary analysis was a noninferiority comparison of the mean change from baseline in the score on the spatial working memory strategy index of executive function between the patients who received evolocumab and those who received placebo; the noninferiority margin was set at 20% of the standard deviation of the score in the placebo group. Results A total of 1204 patients were followed for a median of 19 months; the mean (±SD) change from baseline over time in the raw score for the spatial working memory strategy index of executive function (primary end point) was -0.21±2.62 in the evolocumab group and -0.29±2.81 in the placebo group (P<0.001 for noninferiority; P=0.85 for superiority). There were no significant between-group differences in the secondary end points of scores for working memory (change in raw score, -0.52 in the evolocumab group and -0.93 in the placebo group), episodic memory (change in raw score, -1.53 and -1.53, respectively), or psychomotor speed (change in raw score, 5.2 msec and 0.9 msec, respectively). In an exploratory analysis, there were no associations between LDL cholesterol levels and cognitive changes. Conclusions In a randomized trial involving patients who received either evolocumab or placebo in addition to statin therapy, no significant between-group difference in cognitive function was observed over a median of 19 months. (Funded by Amgen; EBBINGHAUS ClinicalTrials.gov number, NCT02207634 .).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.