Financiado en parte por Amgen, Eli Lilly and Company
Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab
Koren MJ, Lundqvist P, Bolognese M, Neutel JM, Monsalvo ML, Yang J, Kim JB, Scott R, Wasserman SM, Bays H, MENDEL-2 Investigators
Journal of the American College of Cardiology · 325 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Amgen
- Empresa
- Eli Lilly and Company
Según 2 financiadores declarados.
Publicación
- Publicado
- 2014-03-29 · J Am Coll Cardiol · vol. 63 · número 23 · págs. 2531–2540
- Editorial
- Elsevier BV
- Citado
- 412 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
- 16 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Lipid metabolism and disorders · Cholesterol and Lipid Metabolism
- Palabras clave
- evolocumab, PCSK9 inhibitors, hypercholesterolemia, LDL cholesterol lowering, ezetimibe, monoclonal antibodies, lipid-lowering therapy, treatment-emergent adverse events
- MeSH
- humans, hypercholesterolemia, serine endopeptidases, proprotein convertases, antibodies, monoclonal, treatment outcome, administration, oral, injections, subcutaneous, drug administration schedule, retrospective studies, follow-up studies, double-blind method, apoptosis, dose-response relationship, drug, adolescent, adult, aged, aged, 80 and over, middle aged, female, male, cholesterol, ldl, young adult, antibodies, monoclonal, humanized, proprotein convertase 9
10 autores
- Michael J. Koren🇺🇸 · autor de correspondenciaJacksonville Center for Clinical Research
- Pernille Lundqvist🇩🇰Center for Clinical & Basic Research
- Michael A. Bolognese🇺🇸National Institutes of Health
- Joel M. Neutel🇺🇸Orange County Research Center
- Maria Laura Monsalvo🇺🇸Amgen (United States)
- Jingyuan Yang🇺🇸Amgen (United States)
- Jae B. Kim🇺🇸Amgen (United States)
- Robert C. Scott🇺🇸Amgen (United States)
- Scott M. Wasserman🇺🇸Amgen (United States)
- Harold Edward Bays🇺🇸Louisville Metabolic and Atherosclerosis Research Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objectives
The aim of this study was to compare biweekly and monthly evolocumab with placebo and oral ezetimibe in patients with hypercholesterolemia in a phase III trial.
Background
Evolocumab, a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced LDL-C in phase II trials.
Methods
Patients 18 to 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥100 and <190 mg/dl and Framingham risk scores ≤10% were randomized (1:1:1:1:2:2) to oral placebo and subcutaneous (SC) placebo biweekly; oral placebo and SC placebo monthly; ezetimibe and SC placebo biweekly; ezetimibe and SC placebo monthly; oral placebo and evolocumab 140 mg biweekly; or oral placebo and evolocumab 420 mg monthly.
Results
A total of 614 patients were randomized and administered doses. Evolocumab treatment reduced LDL-C from baseline, on average, by 55% to 57% more than placebo and 38% to 40% more than ezetimibe (p < 0.001 for all comparisons). Evolocumab treatment also favorably altered other lipoprotein levels. Treatment-emergent adverse events (AEs), muscle-related AEs, and laboratory abnormalities were comparable across treatment groups.
Conclusions
In the largest monotherapy trial using a PCSK9 inhibitor to date, evolocumab yielded significant LDL-C reductions compared with placebo or ezetimibe and was well tolerated in patients with hypercholesterolemia. (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 [MENDEL-2]; NCT01763827).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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