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Alirocumab in diabetes patients with mixed dyslipidaemia

Alirocumab in diabetes patients with mixed dyslipidaemia

Alirocumab shows benefit in patients with type 2 diabetes mellitus (T2DM) and mixed dyslipidaemia, according to this analysis of the ODYSSEY DM-DYSLIPIDEMIA trial. Individuals with T2DM are at increased risk for atherosclerotic cardiovascular disease (ASCVD), in part due to the mixed dyslipidaemia, characterized by elevated…

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BEIJERINCK: Evolocumab in people living with HIV

BEIJERINCK: Evolocumab in people living with HIV

First trial of PCSK9 monoclonal antibody therapy in people living with HIV and at moderate/high cardiovascular risk, with elevated LDL cholesterol levels has closed enrolment, with 464 patients. Due to advances in antiretroviral treatment, HIV is now regarded as a chronic disease. Consequently, attention has…

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DE LAVAL: Evolocumab reduces need for lipoprotein apheresis

DE LAVAL: Evolocumab reduces need for lipoprotein apheresis

Treatment with evolocumab may replace lipoprotein apheresis in patients with high LDL cholesterol levels, refractory to conventional treatment, according to the findings from the DE LAVAL study. Lipoprotein apheresis, which removes LDL cholesterol from the circulation, is indicated in patients with refractory heterozygous familial hypercholesterolemia…

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New FOURIER analysis underlines consistent efficacy of evolocumab

New FOURIER analysis underlines consistent efficacy of evolocumab

A key question posed by all clinicians is whether age or sex impacts the efficacy of a cholesterol-lowering therapy. This is highly pertinent given the ‘greying’ of populations, and the associated increase in risk for cardiovascular events.  A new analysis from the FOURIER study which…

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Inclisiran dose adjustment not necessary in renal impairment

Inclisiran dose adjustment not necessary in renal impairment

Renal impairment does not influence the pharmacodynamics/pharmacokinetics of inclisiran, according to a new analysis. Impaired renal function alters drug pharmacokinetics, potentially changing drug efficacy and increasing the likelihood of unwanted effects, including renal toxicity. This is a key consideration for individuals taking long-term medications, such…

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New EAS Consensus Panel statement: an Opus for LDL-driven mechanisms in atherosclerosis

New EAS Consensus Panel statement: an Opus for LDL-driven mechanisms in atherosclerosis

A new statement from the European Atherosclerosis Society (EAS) consensus panel is set to become THE reference for the role of LDL in driving atherosclerosis. Published in The European Heart Journal, this is an essential follow-up to a previous statement1 which appraised clinical evidence supporting…

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TAUSSIG reports evolocumab treatment up to 5 years in homozygous or severe FH

TAUSSIG reports evolocumab treatment up to 5 years in homozygous or severe FH

TAUSSIG: Evolocumab provides sustained benefit in severe heterozygous or homozygous FH Evolocumab treatment for up to 5 years was effective and well tolerated in patients with homozygous or severe heterozygous familial hypercholesterolaemia (FH, inherited high cholesterol) in this latest follow-up from the TAUSSIG study. Over…

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ODYSSEY OUTCOMES: Lipoprotein(a) analysis

ODYSSEY OUTCOMES: Lipoprotein(a) analysis

Following much discussion among the clinical community, the lipoprotein(a) analysis from the ODYSSEY OUTCOMES study has been published. This analysis shows that lipoprotein(a) lowering by alirocumab is an independent contributor to the reduction in cardiovascular events observed in this trial, beyond that attributed to LDL…

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Targeting PCSK9 and ANGPTL3 with statin regresses atherosclerosis

Targeting PCSK9 and ANGPTL3 with statin regresses atherosclerosis

In a mouse model of hyperlipidaemia, the combination of the PCSK9 inhibitor alirocumab, a monoclonal antibody to ANGPTL3 (angiopoietin-like 3 protein) evinacumab, and atorvastatin not only reduced LDL cholesterol by 73% but also regressed atherosclerosis. Read the article:  Pouwer MG, et al. Alirocumab, evinacumab, and…

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ODYSSEY: alirocumab improves outcomes in older patients post-ACS

ODYSSEY: alirocumab improves outcomes in older patients post-ACS

A pre-specified analysis from the ODYSSEY OUTCOMES study shows that, in patients with recent acute coronary syndrome (ACS), alirocumab improves outcomes irrespective of age. Increasing absolute benefit but not harm with advancing age suggests that LDL-C lowering is an important preventive intervention for older patients…

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GAUSS-4: Evolocumab superiority over ezetimibe confirmed

GAUSS-4: Evolocumab superiority over ezetimibe confirmed

Initial results from the GAUSS-4  trial (ClinicalTrials.gov NCT02634580) show that evolocumab was superior to ezetimibe in reducing LDL-C during the 12-week double-blind period in patients with statin intolerance, with efficacy and safety results maintained for 1 year. In patients with hyperlipidaemia, intolerance to statins presents…

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FOURIER: genetic risk score and evolocumab benefit

FOURIER: genetic risk score and evolocumab benefit

A new analysis of the FOURIER trial (in patients with clinically evident atherosclerotic cardiovascular disease) shows that those with high genetic risk, regardless of clinical risk, had a high cardiovascular event rate and derived the greatest relative and absolute benefit from evolocumab. Treatment with evolocumab…

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ODYSSEY: predicting alirocumab benefit with genetic risk score

ODYSSEY: predicting alirocumab benefit with genetic risk score

Post hoc analyses of the ODYSSEY OUTCOMES trial reveal that a high polygenic risk score (PRS) for coronary artery disease (CAD) is associated with elevated risk for recurrent major adverse cardiovascular events (MACE) after acute coronary syndrome (ACS), and larger absolute and relative risk reduction…

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TST trial results: lower LDL-C target benefits ASCVD patients

TST trial results: lower LDL-C target benefits ASCVD patients

The Treat Stroke to Target trial (ClinicalTrials.gov Identifier: NCT01252875) shows that aggressive LDL-C reduction with a goal of <70 mg/dl is superior to a more modest reduction (LDL-C 90-110 mg/dl) among patients with atherosclerotic cardiovascular disease (ASCVD) and evidence of ischaemic stroke or transient ischaemic…

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ODYSSEY: Alirocumab decreases stroke risk in ACS patients

ODYSSEY: Alirocumab decreases stroke risk in ACS patients

In patients with recent acute coronary syndrome (ACS) and dyslipidaemia despite intensive statin therapy, alirocumab decreased the risk of ischaemic stroke without increasing haemorrhagic stroke, irrespective of baseline LDL-C and history of cerebrovascular disease, over a median follow-up of 2.8 years. ODYSSEY OUTCOMES (NCT01663402) compared…

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ORION-1: Less frequent dosing potential with inclisiran

ORION-1: Less frequent dosing potential with inclisiran

A one-year follow up of the ORION-1 study (Clinical Trial NCT02597127: https://clinicaltrials.gov/ct2/show/NCT02597127) suggests that inclisiran may offer a novel approach to LDL-C reduction with the convenience of less frequent dosing. The study involved prespecified analysis of the randomised, double-blind, placebo-controlled multicentre phase 2 clinical trial. Participants,…

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OSLER-1: 5-year efficacy and safety data published

OSLER-1: 5-year efficacy and safety data published

Final data from the OSLER-11 (Open-Label Study of Long-term Evaluation against LDL-C) study have been published, highlighting the sustained LDL-C lowering efficacy, tolerance and safety of evolocumab in the longest duration study of a PCSK9 inhibitor reported to date. These data were first reported by…

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ODYSSEY: effect of BMI on alirocumab efficacy and safety

ODYSSEY: effect of BMI on alirocumab efficacy and safety

A pooled post-hoc analysis from ten phase 3 ODYSSEY trials shows that alirocumab gives consistent LDL-C reductions with similar safety findings across different BMI subgroups. The study was conducted as increased BMI contributes to cardiovascular risk and may influence the efficacy of therapeutic antibodies. Data…

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ORION: top line results revealed

ORION: top line results revealed

The Medicines Company has reported positive top line results for the ORION-9 and ORION-10 phase 3 clinical studies of inclisiran in heterozygous familial hypercholesterolaemia patients and atherosclerotic cardiovascular disease patients (ASCVD). Detailed efficacy, tolerability and safety data from both studies will be presented at the…

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Insights from REGARDS: PCSK9 loss-of-function variants and Lp(a) phenotypes

Insights from REGARDS: PCSK9 loss-of-function variants and Lp(a) phenotypes

In US black individuals, PCSK9 loss-of-function variants were associated with lower plasma levels of lipoprotein(a) [Lp(a)] and oxidized phospholipid (OxPL-apoB). While PCSK9 loss-of-function variants have been associated with lower LDL cholesterol levels and lower rates of myocardial infarction (MI) in black versus white individuals,1,2 it…

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