News
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
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
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
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
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 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
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
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)
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
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
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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More insights from ODYSSEY Outcomes
Does alirocumab have preventive effects on MI beyond LDL cholesterol lowering? Myocardial infarction (MI) indicates irreversible myocardial injury resulting in necrosis of a significant portion of myocardium (generally >1 cm). According to the Third Universal Definition of MI Task Force,1 MI can be categorised into…
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VESALIUS-CV: New outcomes study with evolocumab
Amgen has announced a new cardiovascular outcomes study in patients at high risk of cardiovascular events who are already receiving lipid lowering treatment but have not had a previous myocardial infarction (MI) or stroke. VESALIUS-CV is a multinational, double-blind, randomised, placebo-controlled, parallel-group clinical outcomes study…
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New US FDA approval for alirocumab
Based on data from ODYSSEY OUTCOMES (1), the Food and Drugs Administration has now approved alirocumab to prevent heart attack, stroke and unstable angina requiring hospitalization. ODYSSEY OUTCOMES, the longest cardiovascular outcomes trial of any PCSK9 inhibitor to date, assessed the effect of alirocumab on…
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Familial hypercholesterolaemia in China – registry urgently needed
The size of the population in China implies a major burden of familial hypercholesterolaemia (FH, inherited high cholesterol). Yet, like the majority of countries world-wide, FH is underdiagnosed and undertreated. China may pose specific issues that contribute to this. Cholesterol levels have been lower in…
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OSLER 5-year data in Japanese: evolocumab continues to impress
Treatment with evolocumab, in addition to standard of care including statin therapy, was well tolerated and led to sustained reduction in LDL cholesterol in Japanese subjects enrolled in the long-term OSLER studies (Open-Label Study of Long-Term Evaluation Against LDL-C). The OSLER studies were designed to…
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Who is receiving PCSK9 inhibitors in the real world?
PCSK9 inhibitors have been endorsed for use in patients at high and very risk of cardiovascular events (1,2). In the real-world, however, which type of patients are more commonly prescribed a PCSK9 inhibitor? Findings based on data from three Danish registries indicate that the majority…
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Cost remains the issue for use of PCSK9 inhibitors
PCSK9 inhibitors are highly efficacious LDL cholesterol lowering treatments that have been endorsed by guidelines and experts for use in very high-risk patients (1-3). The key groups identified by these groups have been patients with clinical atherosclerotic cardiovascular disease (ASCVD), familial hypercholesterolaemia (FH, inherited high…
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VIDEO: BANTING study in type 2 diabetes: evolocumab improves lipid goals and postprandial lipids
Results from the BANTING study add to the evidence-base that PCSK9 inhibition is efficacious in improving lipid goal attainment in individuals with type 2 diabetes mellitus (T2DM) with hypercholesterolaemia or mixed dyslipidaemia. There were also favourable changes in postprandial lipids. Dyslipidaemia is one of the…
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Alirocumab: EU Regulatory update
The European Union (EU) has now approved alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) monoclonal antibody, to reduce the risk of cardiovascular events in patients with established cardiovascular disease.1 The approval is based on data from the ODYSSEY OUTCOMES trial, which not only showed…
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