Cargando…

Population Pharmacokinetic/Pharmacodynamic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using an Indirect Response Model to Predict Low-Density Lipoprotein Cholesterol Lowering: Support for a Biologics License Application Submission: Part II

BACKGROUND: Alirocumab, a human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly lowers low-density lipoprotein cholesterol levels. OBJECTIVE: This analysis aimed to develop and qualify a population pharmacokinetic/pharmacodynamic model for alirocumab...

Descripción completa

Detalles Bibliográficos
Autores principales:	Nicolas, Xavier, Djebli, Nassim, Rauch, Clémence, Brunet, Aurélie, Hurbin, Fabrice, Martinez, Jean-Marie, Fabre, David
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2018
Materias:	Original Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6325983/ https://www.ncbi.nlm.nih.gov/pubmed/29725997 http://dx.doi.org/10.1007/s40262-018-0670-5

Ejemplares similares

Population Pharmacokinetic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using a Michaelis–Menten Approximation of a Target-Mediated Drug Disposition Model—Support for a Biologics License Application Submission: Part I
por: Martinez, Jean-Marie, et al.
Publicado: (2018)

Target-Mediated Drug Disposition Population Pharmacokinetics Model of Alirocumab in Healthy Volunteers and Patients: Pooled Analysis of Randomized Phase I/II/III Studies
por: Djebli, Nassim, et al.
Publicado: (2017)

Combined Semi-mechanistic Target-Mediated Drug Disposition and Pharmacokinetic–Pharmacodynamic Models of Alirocumab, PCSK9, and Low-Density Lipoprotein Cholesterol in a Pooled Analysis of Randomized Phase I/II/III Studies
por: Nolain, Patrick, et al.
Publicado: (2022)

Effects of PCSK9 Inhibition With Alirocumab on Lipoprotein Metabolism in Healthy Humans
por: Reyes-Soffer, Gissette, et al.
Publicado: (2017)

PCSK9 Modulates the Secretion But Not the Cellular Uptake of Lipoprotein(a) Ex Vivo: An Effect Blunted by Alirocumab
por: Villard, Elise F., et al.
Publicado: (2016)

A Randomized Study of the Relative Pharmacokinetics, Pharmacodynamics, and Safety of Alirocumab, a Fully Human Monoclonal Antibody to PCSK9, After Single Subcutaneous Administration at Three Different Injection Sites in Healthy Subjects
por: Lunven, Catherine, et al.
Publicado: (2014)

Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial
por: Moriarty, Patrick M., et al.
Publicado: (2016)

Relation of Lipoprotein(a) Levels to Incident Type 2 Diabetes and Modification by Alirocumab Treatment
por: Schwartz, Gregory G., et al.
Publicado: (2021)

Relationship Between Low‐Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid‐Lowering Strategies
por: Rey, Jacques, et al.
Publicado: (2016)

A Quantitative Systems Pharmacology Platform to Investigate the Impact of Alirocumab and Cholesterol-Lowering Therapies on Lipid Profiles and Plaque Characteristics
por: Ming, Jeffrey E, et al.
Publicado: (2017)

The Effect of Acetaminophen on Oxidative Modification of Low-Density Lipoproteins in Hypercholesterolemic Rabbits
por: Özsoy, Meral Baş, et al.
Publicado: (2007)

Effect of PCSK9 Inhibition by Alirocumab on Lipoprotein Particle Concentrations Determined by Nuclear Magnetic Resonance Spectroscopy
por: Koren, Michael J., et al.
Publicado: (2015)

Effect of alirocumab on individuals with type 2 diabetes, high triglycerides, and low high-density lipoprotein cholesterol
por: Colhoun, Helen M., et al.
Publicado: (2020)

Lipoprotein(a) lowering by alirocumab reduces the total burden of cardiovascular events independent of low-density lipoprotein cholesterol lowering: ODYSSEY OUTCOMES trial
por: Szarek, Michael, et al.
Publicado: (2020)

Intensified lipid-lowering treatment with alirocumab in patients with coronary heart disease
por: Steffens, Daniel, et al.
Publicado: (2021)

Triglyceride concentrations and non-high-density lipoprotein cholesterol goal attainment in the ODYSSEY phase 3 trials with alirocumab
por: Vallejo-Vaz, Antonio J, et al.
Publicado: (2020)

Lipoprotein(a) Cellular Uptake Ex Vivo and Hepatic Capture In Vivo Is Insensitive to PCSK9 Inhibition With Alirocumab
por: Chemello, Kévin, et al.
Publicado: (2020)

Effect of Alirocumab on Stroke in ODYSSEY OUTCOMES
por: Jukema, J. Wouter, et al.
Publicado: (2019)

Splice correction therapies for familial hypercholesterolemic patients with low-density lipoprotein receptor mutations
por: McIntosh, Craig S., et al.
Publicado: (2021)

Study of GABA in Healthy Volunteers: Pharmacokinetics and Pharmacodynamics
por: Li, Junfeng, et al.
Publicado: (2015)

Submission
Publicado: (1890)

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study
por: Li, Haiyan, et al.
Publicado: (2020)

RE: Praluent (Alirocumab)-Induced Renal Injury
por: Rosenson, Robert S., et al.
Publicado: (2017)

Mortality Benefit of Alirocumab: A Bayesian Perspective
por: Labos, Christopher, et al.
Publicado: (2019)

Effect of alirocumab on lipids and lipoproteins in individuals with metabolic syndrome without diabetes: Pooled data from 10 phase 3 trials
por: Henry, Robert R., et al.
Publicado: (2018)

Ocular Drug Distribution After Topical Administration: Population Pharmacokinetic Model in Rabbits
por: Djebli, Nassim, et al.
Publicado: (2016)

Effect of alirocumab on specific lipoprotein non-high-density lipoprotein cholesterol and subfractions as measured by the vertical auto profile method: analysis of 3 randomized trials versus placebo
por: Toth, Peter P., et al.
Publicado: (2016)

The Pharmacokinetics and Pharmacodynamics of Prasugrel and Clopidogrel in Healthy Japanese Volunteers
por: Umemura, Kazuo, et al.
Publicado: (2016)

Characterization of the pharmacokinetics of entrectinib and its active M5 metabolite in healthy volunteers and patients with solid tumors
por: Meneses-Lorente, Georgina, et al.
Publicado: (2021)

Exploring the Efficacy of Alirocumab and Evolocumab in Reducing Low-Density Lipoprotein (LDL) Cholesterol Levels in Patients With Familial Hypercholesterolemia: A Systematic Review
por: Luthra, Gaurav, et al.
Publicado: (2022)

Imbalance in superoxide dismutase/thioredoxin reductase activities in hypercholesterolemic subjects: relationship with low density lipoprotein oxidation
por: Augusti, Paula Rossini, et al.
Publicado: (2012)

Anti-Atherogenic Properties of Allium ursinum Liophylisate: Impact on Lipoprotein Homeostasis and Cardiac Biomarkers in Hypercholesterolemic Rabbits
por: Bombicz, Mariann, et al.
Publicado: (2016)

Aortic valve calcium score in hypercholesterolemic patients with and without low-density lipoprotein receptor gene mutation
por: Gałąska, Rafal, et al.
Publicado: (2018)

Alirocumab and Lipid Levels, Inflammatory Biomarkers, Metabolomics, and Safety in Patients Receiving Maintenance Dialysis: The ALIrocumab in DIALysis Study (A Phase 3 Trial to Evaluate the Efficacy and Safety of Biweekly Alirocumab in Patients on a Stable Dialysis Regimen)
por: East, Cara, et al.
Publicado: (2022)

Eligibility for alirocumab or evolocumab treatment in 1090 hypercholesterolemic patients referred to a regional cholesterol treatment center with LDL cholesterol ≥70 mg/dL despite maximal-tolerated LDL-cholesterol-lowering therapy
por: Jetty, Vybhav, et al.
Publicado: (2017)

Effect of alirocumab on cataracts in patients with acute coronary syndromes
por: Suc, Gaspard, et al.
Publicado: (2023)

MPWR submission
por: G. Casse, et al.
Publicado: (2016)

Effects of renal function on pharmacokinetics and pharmacodynamics of lesinurad in adult volunteers
por: Gillen, Michael, et al.
Publicado: (2016)

Population Pharmacokinetics and Pharmacodynamics of Benralizumab in Healthy Volunteers and Patients With Asthma
por: Wang, B, et al.
Publicado: (2017)

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral Venglustat in Healthy Volunteers
por: Peterschmitt, M. Judith, et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_bpgqbssd72a5uuifnkjlm4o2e6