Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristics

People living with human immunodeficiency virus (PLHIV) are at higher risk of atherosclerotic cardiovascular disease (ASCVD) due to traditional and HIV- or antiretroviral treatment (ART)-related risk factors. The use of high-intensity statin therapy is often limited by comorbidities and drug–drug in...

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Bibliographic Details
Published in:	The American heart journal 2020-02, Vol.220, p.203-212
Main Authors:	Boccara, Franck, Kumar, Princy, Caramelli, Bruno, Calmy, Alexandra, López, J. Antonio G., Bray, Sarah, Cyrille, Marcoli, Rosenson, Robert S.
Format:	Article
Language:	eng
Subjects:	Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Anticholesteremic Agents - administration & dosage Anticholesteremic Agents - adverse effects Antiretroviral agents Antiretroviral therapy Arteriosclerosis Atherosclerosis Cardiology and cardiovascular system Cardiovascular disease Cardiovascular diseases Cholesterol Cholesterol, LDL - blood Chronic illnesses Clinical trials Control methods Design Double-Blind Method Drug Administration Schedule Drug development Drug dosages Dyslipidemia Dyslipidemias - blood Dyslipidemias - complications Dyslipidemias - drug therapy Fasting Female Health risks Heart attacks Hepatitis HIV HIV Infections - blood HIV Infections - complications HIV Infections - drug therapy HIV Infections - virology HIV Long-Term Survivors Human health and pathology Human immunodeficiency virus Humans Hypercholesterolemia Hypercholesterolemia - blood Hypercholesterolemia - complications Hypercholesterolemia - drug therapy Hypertension Inflammation Intolerance Life Sciences Lipids Lipoproteins Low density lipoprotein Male Medical research Metabolic disorders Middle Aged Monoclonal antibodies Patients Pharmaceutical sciences Pharmacology Proprotein Convertase 9 - antagonists & inhibitors Reference Values Risk analysis Risk factors Safety Statins Stroke Therapy Triglycerides Viral Load Viruses
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Summary:	People living with human immunodeficiency virus (PLHIV) are at higher risk of atherosclerotic cardiovascular disease (ASCVD) due to traditional and HIV- or antiretroviral treatment (ART)-related risk factors. The use of high-intensity statin therapy is often limited by comorbidities and drug–drug interactions with ART. Herein, we present the design and baseline characteristics of the BEIJERINCK study, which will assess the safety and efficacy of evolocumab in PLHIV and hypercholesterolemia/mixed dyslipidemia. Randomized, double-blind, placebo-controlled, multinational trial that investigates monthly subcutaneous evolocumab 420 mg versus placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia who are treated with maximally-tolerated statin therapy. The primary outcome is the baseline to week 24 percent change in low density lipoprotein cholesterol (LDL-C). Secondary outcomes include achievement of LDL-C
ISSN:	0002-8703 1097-6744