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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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PEARL: Statin intolerance a key reason for real-world alirocumab prescription

PEARL: Statin intolerance a key reason for real-world alirocumab prescription

In the PEARL study of real-world use of alirocumab in Germany, nearly three-quarters of patients were prescribed this PCSK9 inhibitor due to statin intolerance. PEARL was an open, prospective, multicentre study including 619 patients for whom alirocumab 75 or 150 mg every 2 weeks was…

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PCSK9 inhibitors work – but access is the problem

PCSK9 inhibitors work – but access is the problem

PCSK9 inhibitors work – but access is the problem Rejection of PCSK9 inhibitor treatment by payers significantly increases the risk of cardiovascular events in very high-risk patients in real-world practice, based on a US report. PCSK9 Forum Editor Professor Chris Packard, University of Glasgow, UK,…

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ScreenPro FH project: international cooperation on screening and treatment

ScreenPro FH project: international cooperation on screening and treatment

An international collaboration (the ScreenPro FH Project) has improved screening for familial hypercholesterolaemia across seven countries in central, eastern and southern Europe (CESE). However, although there has been a significant increase in the numbers of patients in national registries and treatment centres, these patients are…

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ODYSSEY insights: race and ethnicity, very high-risk patients

ODYSSEY insights: race and ethnicity, very high-risk patients

Similar alirocumab efficacy and safety across different races and ethnicities Alirocumab significantly reduced LDL cholesterol (LDL-C) and lipoprotein(a) [Lp(a)] levels compared with controls, regardless of race and ethnicity, together with overall safety comparable to control across the majority of racial and ethnic groups analysed. This…

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More insights from ODYSSEY, PCSK9 inhibition, LDL-C and Lp(a)

More insights from ODYSSEY, PCSK9 inhibition, LDL-C and Lp(a)

Alirocumab in patients without prior MI or stroke Alirocumab showed similar efficacy and tolerability in patients with or without a prior myocardial infarction (MI) or ischaemic stroke, according to this latest report. This analysis included patient-level data from 9 phase 3 ODYSSEY trials involving 4,880…

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FOURIER: Evolocumab reduced the burden of total cardiovascular events

FOURIER: Evolocumab reduced the burden of total cardiovascular events

Treatment with evolocumab versus placebo prevented more than double the number of total events compared with first events in this analysis of the FOURIER study. These findings align with data from ODYSSEY OUTCOMES1 and support continued benefit from aggressive LDL cholesterol lowering therapy to prevent…

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News from FOURIER: Evolocumab in chronic kidney disease

News from FOURIER: Evolocumab in chronic kidney disease

A new analysis from the FOURIER study demonstrates clinical benefit with evolocumab in chronic kidney disease (CKD), with the greatest absolute benefit in patients with more advanced disease. CKD is a global health burden with a high socioeconomic cost. European guidelines consider CKD patients to…

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