TY - JOUR
T1 - Evolocumab in HIV-Infected Patients With Dyslipidemia
T2 - Primary Results of the Randomized, Double-Blind BEIJERINCK Study
AU - BEIJERINCK Investigators
AU - Boccara, Franck
AU - Kumar, Princy N.
AU - Caramelli, Bruno
AU - Calmy, Alexandra
AU - López, J. Antonio G.
AU - Bray, Sarah
AU - Cyrille, Marcoli
AU - Rosenson, Robert S.
AU - Baker, David
AU - Bloch, Mark
AU - Finlayson, Robert
AU - Hoy, Jennifer
AU - Koh, Kenneth
AU - Roth, Norman
AU - De Wit, Stephane
AU - Florence, Eric
AU - Vandekerckhove, Linos
AU - Ramalho Madruga, Jose Valdez
AU - Wagner Cardoso, Sandra
AU - Bondy, Greg
AU - Gill, Michael
AU - Tsoukas, George
AU - Trottier, Sylvie
AU - Smieja, Marek
AU - Katlama, Christine
AU - Bonnet, Fabrice
AU - Raffi, Francois
AU - Cotte, Laurent
AU - Molina, Jean Michel
AU - Reynes, Jacques
AU - Papadopoulos, Antonios
AU - Metallidis, Simeon
AU - Paparizos, Vassilios
AU - Papastamopoulos, Vasileios
AU - Mussini, Cristina
AU - Galli, Massimo
AU - Antinori, Andrea
AU - Di Biagio, Antonio
AU - Viale, Pierluigi
AU - Horban, Andrzej
AU - Marques, Nuno
AU - Coutinho, Daniel
AU - Oliveira, Joaquim
AU - Freitas, Paula
AU - Preotescu, Liliana Lucia
AU - Marincu, Iosif
AU - Silaghi, Rodica
AU - Rugina, Sorin
AU - Mwelase, Noluthando
AU - Grossberg, Robert
N1 - Publisher Copyright:
© 2020 The Authors
PY - 2020/5/26
Y1 - 2020/5/26
N2 - Background: People living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and are prone to statin-related adverse events from drug–drug interactions with certain antiretroviral regimens. Objectives: This study sought to evaluate the efficacy and safety of evolocumab in dyslipidemic PLHIV. Methods: BEIJERINCK (EvolocumaB Effect on LDL-C Lowering in SubJEcts with Human Immunodeficiency VirRus and INcreased Cardiovascular RisK) is a randomized, double-blind, multinational trial comparing monthly subcutaneous evolocumab 420 mg with placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia taking maximally-tolerated statin therapy. The primary endpoint was the percent change (baseline to week 24) in low-density lipoprotein cholesterol (LDL-C); secondary endpoints included achievement of LDL-C <70 mg/dl and percent change in other plasma lipid and lipoprotein levels. Treatment-emergent adverse events were also examined. Results: A total of 464 patients were analyzed (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). ASCVD was documented in 35.6% of patients, and statin intolerance/contraindications to statin use were present in 20.7% of patients. Evolocumab reduced LDL-C by 56.9% (95% confidence interval: 61.6% to 52.3%) from baseline to week 24 versus placebo. An LDL-C level of <70 mg/dl was achieved in 73.3% of patients in the evolocumab group versus 7.9% in the placebo group. Evolocumab also significantly reduced other atherogenic lipid levels, including non–high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) (all p < 0.0001). Evolocumab was well tolerated, and treatment-emergent adverse events patient incidence was similar among evolocumab and placebo groups. Conclusions: Evolocumab was safe and significantly reduced lipid levels in dyslipidemic PLHIV on maximally-tolerated statin therapy. Evolocumab is an effective therapy for lowering atherogenic lipoproteins in PLHIV with high cardiovascular risk.
AB - Background: People living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and are prone to statin-related adverse events from drug–drug interactions with certain antiretroviral regimens. Objectives: This study sought to evaluate the efficacy and safety of evolocumab in dyslipidemic PLHIV. Methods: BEIJERINCK (EvolocumaB Effect on LDL-C Lowering in SubJEcts with Human Immunodeficiency VirRus and INcreased Cardiovascular RisK) is a randomized, double-blind, multinational trial comparing monthly subcutaneous evolocumab 420 mg with placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia taking maximally-tolerated statin therapy. The primary endpoint was the percent change (baseline to week 24) in low-density lipoprotein cholesterol (LDL-C); secondary endpoints included achievement of LDL-C <70 mg/dl and percent change in other plasma lipid and lipoprotein levels. Treatment-emergent adverse events were also examined. Results: A total of 464 patients were analyzed (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). ASCVD was documented in 35.6% of patients, and statin intolerance/contraindications to statin use were present in 20.7% of patients. Evolocumab reduced LDL-C by 56.9% (95% confidence interval: 61.6% to 52.3%) from baseline to week 24 versus placebo. An LDL-C level of <70 mg/dl was achieved in 73.3% of patients in the evolocumab group versus 7.9% in the placebo group. Evolocumab also significantly reduced other atherogenic lipid levels, including non–high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) (all p < 0.0001). Evolocumab was well tolerated, and treatment-emergent adverse events patient incidence was similar among evolocumab and placebo groups. Conclusions: Evolocumab was safe and significantly reduced lipid levels in dyslipidemic PLHIV on maximally-tolerated statin therapy. Evolocumab is an effective therapy for lowering atherogenic lipoproteins in PLHIV with high cardiovascular risk.
KW - cardiovascular disease
KW - hypercholesterolemia
KW - low-density lipoprotein cholesterol (LDL-C)
KW - people living with HIV (PLHIV)
KW - proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor
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U2 - 10.1016/j.jacc.2020.03.025
DO - 10.1016/j.jacc.2020.03.025
M3 - Article
C2 - 32234462
AN - SCOPUS:85084505222
SN - 0735-1097
VL - 75
SP - 2570
EP - 2584
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 20
ER -