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Robert S Rosenson - One of the best experts on this subject based on the ideXlab platform.
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evolocumab use in hiv infected patients with Dyslipidemia primary results of the randomized double blind beijerinck study
Journal of the American College of Cardiology, 2020Co-Authors: Franck Boccara, Marcoli Cyrille, Antonio J G Lopez, Princy Kumar, Bruno Caramelli, Sarah Bray, Alexandra Calmy, Robert S RosensonAbstract:Abstract Background People living with HIV (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and 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 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 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% CI: 61.6%, 52.3%) from baseline to week 24 versus placebo. An LDL-C level of 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.
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Evolocumab in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-Blind BEIJERINCK Study
'Elsevier BV', 2020Co-Authors: Franck Boccara, Marcoli Cyrille, Bruno Caramelli, Sarah Bray, Alexandra Calmy, Robert S Rosenson, P.n. Kumar, J.a.g. Lopez, D. Baker, M. BlochAbstract: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\u2013drug 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\u2013high-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. (Safety, Tolerability & Efficacy on LDL-C of Evolocumab in Subjects With HIV & Hyperlipidemia/Mixed Dyslipidemia; NCT02833844
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low levels of high density lipoprotein cholesterol hypoalphalipoproteinemia an approach to management
JAMA Internal Medicine, 1993Co-Authors: Robert S RosensonAbstract:Clinical management of Dyslipidemias has focused primarily on the low-density lipoprotein cholesterol (LDL-C) fraction; however, lipid disorders accompanied by low levels of high-density lipoprotein cholesterol (HDL-C) (hypoalphalipoproteinemia) are common, particularly among subjects with the diagnosis of coronary artery disease prior to age 55 years. The therapeutic objectives for high-risk subjects with Dyslipidemias is directed initially toward reduction of the LDL-C fraction; thereafter, aggressive efforts aimed at raising the HDL-C fraction may be warranted. Strategies for raising the HDL-C fraction start with hygienic measures that include aerobic exercise, weight loss, smoking cessation, withdrawal of agents secondarily lowering HDL-C, and estrogen replacement. Pharmacotherapy selected according to the Dyslipidemia that accompanies the HDL-C disorder is indicated for subjects who manifest premature coronary artery disease or who have a familial history of coronary artery disease and hypoalphalipoproteinemia. (Arch Intern Med. 1993;153:1528-1538)
Alexia Letierce - One of the best experts on this subject based on the ideXlab platform.
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alirocumab vs usual lipid lowering care as add on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia the odyssey dm Dyslipidemia randomized trial
Diabetes Obesity and Metabolism, 2018Co-Authors: Kausik K Ray, Lawrence A Leiter, Dirk Mullerwieland, Bertrand Cariou, Helen M Colhoun, Robert R Henry, Francisco J Tinahones, Maja Bujasbobanovic, Catherine Domenger, Alexia LetierceAbstract:Aims Individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia represent a high-risk and difficult-to-treat population. ODYSSEY DM-Dyslipidemia (NCT02642159) compared alirocumab, a proprotein convertase subtilisin-kexin type 9 inhibitor, with usual care (UC) in individuals with T2DM and mixed dyslipidaemia not optimally managed by maximally-tolerated statins. Materials and Methods UC options (no additional lipid-lowering therapy; fenofibrate; ezetimibe; omega-3 fatty acid; nicotinic acid) were selected prior to stratified randomization to open-label alirocumab 75 mg every 2 weeks (Q2W; with increase to 150 mg Q2W at Week [W]12 if W8 non-high-density lipoprotein cholesterol [non-HDL-C] was ≥2.59 mmol/L [100 mg/dL]) or UC for 24 weeks. Primary efficacy endpoint was percentage change in non-HDL-C from baseline to W24. Results The randomized population comprised 413 individuals (409 intention-to-treat; 412 safety). At W24, mean non-HDL-C reductions were superior with alirocumab (-32.5% difference vs UC; 97.5% confidence interval: -38.1 to -27.0; P<.0001). Overall, 63.6% of alirocumab-treated individuals were maintained on 75 mg Q2W. Alirocumab also reduced low-density lipoprotein cholesterol (-43.0%), apolipoprotein B (-32.3%), total cholesterol (-24.6%), and LDL particle number (-37.8%) at W24 vs UC (all P<.0001). Consistent with the overall trial comparison, alirocumab reduced non-HDL-C to a greater degree within each UC stratum at W24. Incidence of treatment-emergent adverse events was 68.4% (alirocumab) and 66.4% (UC). No clinically meaningful effect on glycated hemoglobin, or change in number of glucose-lowering agents, was seen. Conclusions In individuals with T2DM and mixed dyslipidaemia on maximally tolerated statin, alirocumab showed superiority in non-HDL-C reduction vs UC and was generally well tolerated.
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alirocumab vs usual lipid lowering care as add on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia the odyssey dm Dyslipidemia randomized trial
Diabetes Obesity and Metabolism, 2018Co-Authors: Lawrence A Leiter, Dirk Mullerwieland, Bertrand Cariou, Helen M Colhoun, Robert R Henry, Francisco J Tinahones, Maja Bujasbobanovic, Catherine Domenger, Alexia Letierce, Rita SamuelAbstract:Aims Individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia represent a high-risk and difficult-to-treat population. ODYSSEY DM-Dyslipidemia (NCT02642159) compared alirocumab, a proprotein convertase subtilisin-kexin type 9 inhibitor, with usual care (UC) in individuals with T2DM and mixed dyslipidaemia not optimally managed by maximally-tolerated statins. Materials and Methods UC options (no additional lipid-lowering therapy; fenofibrate; ezetimibe; omega-3 fatty acid; nicotinic acid) were selected prior to stratified randomization to open-label alirocumab 75 mg every 2 weeks (Q2W; with increase to 150 mg Q2W at Week [W]12 if W8 non-high-density lipoprotein cholesterol [non-HDL-C] was ≥2.59 mmol/L [100 mg/dL]) or UC for 24 weeks. Primary efficacy endpoint was percentage change in non-HDL-C from baseline to W24. Results The randomized population comprised 413 individuals (409 intention-to-treat; 412 safety). At W24, mean non-HDL-C reductions were superior with alirocumab (-32.5% difference vs UC; 97.5% confidence interval: -38.1 to -27.0; P<.0001). Overall, 63.6% of alirocumab-treated individuals were maintained on 75 mg Q2W. Alirocumab also reduced low-density lipoprotein cholesterol (-43.0%), apolipoprotein B (-32.3%), total cholesterol (-24.6%), and LDL particle number (-37.8%) at W24 vs UC (all P<.0001). Consistent with the overall trial comparison, alirocumab reduced non-HDL-C to a greater degree within each UC stratum at W24. Incidence of treatment-emergent adverse events was 68.4% (alirocumab) and 66.4% (UC). No clinically meaningful effect on glycated hemoglobin, or change in number of glucose-lowering agents, was seen. Conclusions In individuals with T2DM and mixed dyslipidaemia on maximally tolerated statin, alirocumab showed superiority in non-HDL-C reduction vs UC and was generally well tolerated.
Ruiz, Álvaro J. - One of the best experts on this subject based on the ideXlab platform.
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Efecto de las resinas secuestradoras de ácidos biliares en los desenlaces cardiovasculares y en los niveles séricos de lípidos
Sociedad Colombiana de Cardiología y Cirugía Cardiovascular. Published by Elsevier España S.L., 2016Co-Authors: Muñoz, Oscar M., Correa, Néstor F., Higuera Angélica, García, Ángel A., Ruiz, Álvaro J.Abstract:ResumenAntecedentesLas guías internacionales recientes proponen el uso de estatinas como piedra angular del manejo de la dislipidemia en adultos. Sin embargo, no se ha definido con claridad el tratamiento de los pacientes con intolerancia o efectos adversos asociados con estas. Las resinas secuestradoras de ácidos biliares son una alternativa interesante, pese a que la evidencia que avala su uso no ha sido evaluada cuidadosamente.MétodosSe realizó una búsqueda de la literatura en MEDLINE, Embase y en la Biblioteca Cochrane hasta junio de 2013, acerca de artículos publicados en inglés y español, identificando experimentos clínicos aleatorizados y estudios de cohortes que evaluaran el impacto de las resinas secuestradoras de ácidos biliares en mortalidad, eventos cardiovasculares, niveles de lípidos séricos y efectos adversos. Se presenta la información de forma descriptiva.ResultadosSe identificaron cuatro experimentos clínicos aleatorizados y un estudio de cohortes, que incluían 6.833 pacientes. Solo uno de los estudios evaluó el impacto en la mortalidad cardiovascular, evidenciando que no hay diferencia estadísticamente significativa en comparación con placebo (RR de 0,76; IC 95% 0,5:1,15), aunque se observó una reducción del 16% en la incidencia de infarto agudo de miocardio (RR 0,84; IC 95% 0,67:1,00). Tres estudios evaluaron cambios en las fracciones lipídicas, los cuales mostraron disminución moderada en los niveles de colesterol LDL, sin percibir diferencias clínicamente significativas en los niveles de colesterol HDL y triglicéridos.ConclusiónLa evidencia que respalda el uso de resinas secuestradoras de ácidos biliares es limitada y no avala su empleo como terapia de primera línea en pacientes con dislipidemia; no obstante, son una alternativa en pacientes con efectos adversos o intolerancia al manejo con estatinas.AbstractBackgroundRecent international guidelines have proposed statins as the corner stone of Dyslipidemia management in adults. However it is not clear if they are best option for patients with statin related intolerance or what their adverse effects are. The bile acid sequestrants are an interesting alternative, however its evidence has not been carefully evaluated.MethodsA search was conducted on MEDLINE, Embase and Cochrane library databases for articles published up to June 2013, limited to Spanish and English language. Randomized clinical trials (RCT) and cohort studies evaluating the impact of bile acid sequestrants on mortality, cardiovascular outcomes, seric lipids and adverse effects were selected. Information was presented in a descriptive way.ResultsFour RCT and one cohort study with aggregate data on 6833 people were included. Just one study evaluated cardiovascular mortality showing no statistically significant difference when compared with placebo, (RR 0.76; 95% CI 0.5:1.15), however there was a 16% reduction on acute myocardial infarction incidence. (RR 0.84; 95% IC 0.67: 1.00). Three studies evaluated seric lipids changes showing a moderate reduction in LDL levels without clinical significant differences on HDL and triglyceride levels.ConclusionsThe evidence supporting bile acid sequestrants use is lacking and not conclusive to recommend its use as first-line therapy in dyslipidemic patients; however, these are an alternative option for patients with statin-related intolerance or adverse effects
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Effect of bile acid sequestrants on cardiovascular outcomes and seric lipids: A systematic review
'Elsevier BV', 2015Co-Authors: Pontificia Universidad Javeriana. Facultad De Medicina. Departamento De Medicina Interna. Gru, Muñoz, Oscar M., Correa, Néstor F., Higuera Angélica, García, Ángel A., Ruiz, Álvaro J.Abstract:Antecedentes Las guías internacionales recientes proponen el uso de estatinas como piedra angular del manejo de la dislipidemia en adultos. Sin embargo, no se ha definido con claridad el tratamiento de los pacientes con intolerancia o efectos adversos asociados con estas. Las resinas secuestradoras de ácidos biliares son una alternativa interesante, pese a que la evidencia que avala su uso no ha sido evaluada cuidadosamente. Métodos Se realizó una búsqueda de la literatura en MEDLINE, Embase y en la Biblioteca Cochrane hasta junio de 2013, acerca de artículos publicados en inglés y español, identificando experimentos clínicos aleatorizados y estudios de cohortes que evaluaran el impacto de las resinas secuestradoras de ácidos biliares en mortalidad, eventos cardiovasculares, niveles de lípidos séricos y efectos adversos. Se presenta la información de forma descriptiva. Resultados Se identificaron cuatro experimentos clínicos aleatorizados y un estudio de cohortes, que incluían 6.833 pacientes. Solo uno de los estudios evaluó el impacto en la mortalidad cardiovascular, evidenciando que no hay diferencia estadísticamente significativa en comparación con placebo (RR de 0,76; IC 95% 0,5:1,15), aunque se observó una reducción del 16% en la incidencia de infarto agudo de miocardio (RR 0,84; IC 95% 0,67:1,00). Tres estudios evaluaron cambios en las fracciones lipídicas, los cuales mostraron disminución moderada en los niveles de colesterol LDL, sin percibir diferencias clínicamente significativas en los niveles de colesterol HDL y triglicéridos. Conclusión La evidencia que respalda el uso de resinas secuestradoras de ácidos biliares es limitada y no avala su empleo como terapia de primera línea en pacientes con dislipidemia; no obstante, son una alternativa en pacientes con efectos adversos o intolerancia al manejo con estatinas.Q4Artículo original35-41Background Recent international guidelines have proposed statins as the corner stone of Dyslipidemia management in adults. However it is not clear if they are best option for patients with statin related intolerance or what their adverse effects are. The bile acid sequestrants are an interesting alternative, however its evidence has not been carefully evaluated. Methods A search was conducted on MEDLINE, Embase and Cochrane library databases for articles published up to June 2013, limited to Spanish and English language. Randomized clinical trials (RCT) and cohort studies evaluating the impact of bile acid sequestrants on mortality, cardiovascular outcomes, seric lipids and adverse effects were selected. Information was presented in a descriptive way. Results Four RCT and one cohort study with aggregate data on 6833 people were included. Just one study evaluated cardiovascular mortality showing no statistically significant difference when compared with placebo, (RR 0.76; 95% CI 0.5:1.15), however there was a 16% reduction on acute myocardial infarction incidence. (RR 0.84; 95% IC 0.67: 1.00). Three studies evaluated seric lipids changes showing a moderate reduction in LDL levels without clinical significant differences on HDL and triglyceride levels. Conclusions The evidence supporting bile acid sequestrants use is lacking and not conclusive to recommend its use as first-line therapy in dyslipidemic patients; however, these are an alternative option for patients with statin-related intolerance or adverse effects
Lawrence A Leiter - One of the best experts on this subject based on the ideXlab platform.
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alirocumab vs usual lipid lowering care as add on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia the odyssey dm Dyslipidemia randomized trial
Diabetes Obesity and Metabolism, 2018Co-Authors: Kausik K Ray, Lawrence A Leiter, Dirk Mullerwieland, Bertrand Cariou, Helen M Colhoun, Robert R Henry, Francisco J Tinahones, Maja Bujasbobanovic, Catherine Domenger, Alexia LetierceAbstract:Aims Individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia represent a high-risk and difficult-to-treat population. ODYSSEY DM-Dyslipidemia (NCT02642159) compared alirocumab, a proprotein convertase subtilisin-kexin type 9 inhibitor, with usual care (UC) in individuals with T2DM and mixed dyslipidaemia not optimally managed by maximally-tolerated statins. Materials and Methods UC options (no additional lipid-lowering therapy; fenofibrate; ezetimibe; omega-3 fatty acid; nicotinic acid) were selected prior to stratified randomization to open-label alirocumab 75 mg every 2 weeks (Q2W; with increase to 150 mg Q2W at Week [W]12 if W8 non-high-density lipoprotein cholesterol [non-HDL-C] was ≥2.59 mmol/L [100 mg/dL]) or UC for 24 weeks. Primary efficacy endpoint was percentage change in non-HDL-C from baseline to W24. Results The randomized population comprised 413 individuals (409 intention-to-treat; 412 safety). At W24, mean non-HDL-C reductions were superior with alirocumab (-32.5% difference vs UC; 97.5% confidence interval: -38.1 to -27.0; P<.0001). Overall, 63.6% of alirocumab-treated individuals were maintained on 75 mg Q2W. Alirocumab also reduced low-density lipoprotein cholesterol (-43.0%), apolipoprotein B (-32.3%), total cholesterol (-24.6%), and LDL particle number (-37.8%) at W24 vs UC (all P<.0001). Consistent with the overall trial comparison, alirocumab reduced non-HDL-C to a greater degree within each UC stratum at W24. Incidence of treatment-emergent adverse events was 68.4% (alirocumab) and 66.4% (UC). No clinically meaningful effect on glycated hemoglobin, or change in number of glucose-lowering agents, was seen. Conclusions In individuals with T2DM and mixed dyslipidaemia on maximally tolerated statin, alirocumab showed superiority in non-HDL-C reduction vs UC and was generally well tolerated.
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alirocumab vs usual lipid lowering care as add on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia the odyssey dm Dyslipidemia randomized trial
Diabetes Obesity and Metabolism, 2018Co-Authors: Lawrence A Leiter, Dirk Mullerwieland, Bertrand Cariou, Helen M Colhoun, Robert R Henry, Francisco J Tinahones, Maja Bujasbobanovic, Catherine Domenger, Alexia Letierce, Rita SamuelAbstract:Aims Individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia represent a high-risk and difficult-to-treat population. ODYSSEY DM-Dyslipidemia (NCT02642159) compared alirocumab, a proprotein convertase subtilisin-kexin type 9 inhibitor, with usual care (UC) in individuals with T2DM and mixed dyslipidaemia not optimally managed by maximally-tolerated statins. Materials and Methods UC options (no additional lipid-lowering therapy; fenofibrate; ezetimibe; omega-3 fatty acid; nicotinic acid) were selected prior to stratified randomization to open-label alirocumab 75 mg every 2 weeks (Q2W; with increase to 150 mg Q2W at Week [W]12 if W8 non-high-density lipoprotein cholesterol [non-HDL-C] was ≥2.59 mmol/L [100 mg/dL]) or UC for 24 weeks. Primary efficacy endpoint was percentage change in non-HDL-C from baseline to W24. Results The randomized population comprised 413 individuals (409 intention-to-treat; 412 safety). At W24, mean non-HDL-C reductions were superior with alirocumab (-32.5% difference vs UC; 97.5% confidence interval: -38.1 to -27.0; P<.0001). Overall, 63.6% of alirocumab-treated individuals were maintained on 75 mg Q2W. Alirocumab also reduced low-density lipoprotein cholesterol (-43.0%), apolipoprotein B (-32.3%), total cholesterol (-24.6%), and LDL particle number (-37.8%) at W24 vs UC (all P<.0001). Consistent with the overall trial comparison, alirocumab reduced non-HDL-C to a greater degree within each UC stratum at W24. Incidence of treatment-emergent adverse events was 68.4% (alirocumab) and 66.4% (UC). No clinically meaningful effect on glycated hemoglobin, or change in number of glucose-lowering agents, was seen. Conclusions In individuals with T2DM and mixed dyslipidaemia on maximally tolerated statin, alirocumab showed superiority in non-HDL-C reduction vs UC and was generally well tolerated.
Franck Boccara - One of the best experts on this subject based on the ideXlab platform.
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evolocumab use in hiv infected patients with Dyslipidemia primary results of the randomized double blind beijerinck study
Journal of the American College of Cardiology, 2020Co-Authors: Franck Boccara, Marcoli Cyrille, Antonio J G Lopez, Princy Kumar, Bruno Caramelli, Sarah Bray, Alexandra Calmy, Robert S RosensonAbstract:Abstract Background People living with HIV (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and 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 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 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% CI: 61.6%, 52.3%) from baseline to week 24 versus placebo. An LDL-C level of 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.
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Evolocumab in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-Blind BEIJERINCK Study
'Elsevier BV', 2020Co-Authors: Franck Boccara, Marcoli Cyrille, Bruno Caramelli, Sarah Bray, Alexandra Calmy, Robert S Rosenson, P.n. Kumar, J.a.g. Lopez, D. Baker, M. BlochAbstract: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\u2013drug 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\u2013high-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. (Safety, Tolerability & Efficacy on LDL-C of Evolocumab in Subjects With HIV & Hyperlipidemia/Mixed Dyslipidemia; NCT02833844