News
OCEAN(a)-DOSE: Olpasiran shows substantial lipoprotein(a) reduction
News from the American Heart Association Scientific Sessions 2022 In the OCEAN(a)-DOSE trial, treatment with olpasiran, a small interfering RNA (siRNA) agent targeting apolipoprotein(a), reduced lipoprotein(a) [Lp(a)] by up to 100%. The study was simultaneously published in the New England Journal of Medicine (1). In…
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Reducing residual risk: Are cholesterol crystals the next target?
Professor John Chapman Sorbonne University, Pitié-Salpetrière University Hospital, National Institute for Health and Medical Research (INSERM), Paris France Cardiovascular disease is the worldwide leading cause of mortality, responsible for about one-third of all deaths (1). Much of this burden is attributable to atherosclerotic cardiovascular disease…
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Trial with CRISPR PCSK9 treatment underway
The first trial of VERVE-101, a novel gene editing treatment that permanently turns off the PCSK9 gene in the liver to lower LDL cholesterol, is now underway in New Zealand (NCT05398029)(1). The trial is recruiting patients with heterozygous familial hypercholesterolaemia (FH) caused by an LDLR…
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Do PCSK9 inhibitors have a role in sepsis?
Sepsis poses a major global burden affecting over 50 million people and contributing to over 11 million deaths (2017 data) (1). Even among people who survive, many endure substantial reduction in physical, emotional and cognitive quality of life. Current management strategies focus on early aggressive…
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RACING trial: Do we need to rethink LDL-lowering strategies in Asian high-risk patients?
Guidelines recommend maximal tolerable statin therapy as the foundation of LDL cholesterol lowering in patients with atherosclerotic cardiovascular disease (ASCVD), ideally in combination with non-statin therapeutic options (1,2). While this strategy is undoubtedly effective, there may be concerns regarding possible side effects with high-intensity statin…
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More reassurance on the safety of PCSK9 inhibitors
The latest analysis of the Food and Drug Administration’s adverse event reporting system (FAERS) reinforced the safety of alirocumab and evolocumab. The FAERS is a database containing information on adverse event and medication error reports submitted to the Food and Drug Administration, which supports post-marketing…
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News from ACC.22 – New insights from ORION-10 and ORION-11: inclisiran effective in post-MI patients
Inclisiran was effective in lowering LDL cholesterol and generally well tolerated in patients with a prior myocardial infarction (MI), irrespective of the timing of MI, according to latest data from the ORION-10 and ORION-11 studies. Inclisiran is a small interfering ribonucleic acid (siRNA) therapeutic targeting…
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News from ACC.22 late breaking trials: Results from the APOLLO trial with new RNA therapeutic
Results from the APOLLO trial showed that single doses of SLN360, an investigational short interfering RNA (siRNA), resulted in dose-dependent lowering of plasma lipoprotein(a) [Lp(a)] concentration in adults with high Lp(a) and no pre-existing cardiovascular disease. The trial was simultaneously published in the Journal of…
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News from ACC.22 – Long-term data from HAUSER-OLE in paediatric familial hypercholesterolaemia
Results from the HAUSER Open-Label Extension Study (HAUSER-OLE) (1) show that treatment with evolocumab was well tolerated, safe, and led to substantial reduction in LDL cholesterol in children with heterozygous familial hypercholesterolaemia (FH). As previously reported on PCSK9 Forum, HAUSER-RCT evaluated the efficacy and safety…
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Consider familial hypercholesterolaemia in young heart attack survivors
Familial hypercholesterolaemia (FH) was more than 30-fold more prevalent among young people surviving an acute coronary syndrome (ACS) compared with the general population, according to this French report. These findings reinforce the need to investigate the possibility of FH in these individuals. Heterozygous FH is…
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Lessons from the HEYMANS registry: do we need to lower LDL thresholds for initiating a PCSK9 inhibitor?
Insights from the HEYMANS registry show that criteria for initiation of the PCSK9 inhibitor in real-world practice are far from optimal. The 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines for management of dyslipidaemia underline the need for combination therapy in high-risk individuals to…
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New trials: Inclisiran investigated in adolescents with familial hypercholesterolaemia
Trials of PCSK9-targeted therapies have predominantly focused on adults at increased cardiovascular risk due to elevated LDL cholesterol levels. In the setting of familial hypercholesterolaemia (FH), in which individuals have elevated LDL cholesterol levels from birth, it makes sense to prioritize initiation of treatment in…
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Update from FOURIER: Evolocumab provides benefit in patients with prior PCI
In this latest analysis from FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) (1), evolocumab treatment was associated with significant clinical benefit in patients with prior percutaneous coronary intervention (PCI), who are at high residual risk for multiple types of…
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First data from global homozygous FH registry
News from the Homozygous Familial Hypercholesterolaemia International Clinical Collaboration (HICC) registry, a unique global registry of homozygous familial hypercholesterolaemia (HoFH) patients, highlighted the poor management of this severe condition, especially among less affluent countries (1). FH is an inherited disorder characterised by elevated LDL cholesterol…
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ODYSSEY OUTCOMES analysis targets heart failure
A recent post hoc analysis from ODYSSEY OUTCOMES did not suggest benefit from treatment with alirocumab in heart failure patients (1). The role of statin treatment in patients with heart failure is much debated. Individual randomized controlled trials with statins have been inconclusive, although treatment…
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Long-term evolocumab in people living with HIV
Follow-up data from the BEIJERINCK study show that treatment with evolocumab for up to 1 year was effective in HIV individuals with dyslipidaemia (1). HIV is considered a risk-enhancing factor due to the concomitant presence of underlying infection (chronic inflammation, immune dysregulation, and metabolic abnormalities…
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Introducing another PCSK9 inhibitor – recaticimab
A recent report highlights therapeutic potential for recaticimab, a humanized monoclonal antibody targeting PCSK9, with LDL cholesterol reductions ranging from 50-60%, when added to statin therapy (1). Recaticimab (SHR-1209) is the latest PCSK9 monoclonal antibody which has shown efficacy in early clinical trials in healthy…
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Inclisiran available in the USA from early January 2022
Hot off the Press: Inclisiran available in the USA from early January 2022 In an ad hoc announcement (pursuant to Art. 53 LR), the US Food and Drugs Administration approved the use of inclisiran, the siRNA therapy for hypercholesterolaemia. Inclisiran is the first and only…
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More insights from ORION
News from AHA Scientific Sessions 2021 Baseline glycaemic status or body mass index (BMI) did not impact the efficacy of inclisiran, according to two post hoc analyses of the ORION trials. The first poster presentation reported findings from a post hoc analysis of the ORION-10…
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Long-term evinacumab in homozygous FH
News from AHA Scientific Sessions 2021 Evinacumab was the focus of two presentations in patients with homozygous familial hypercholesterolaemia (FH, inherited high cholesterol). Homozygous FH is a rare genetic lipid disorder, which is characterized by markedly elevated low-density lipoprotein (LDL) cholesterol levels from birth and…
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