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PCSK9i access remains challenging in USA

PCSK9i access remains challenging in USA

Persistent barriers to guidelines-recommended use of PCSK9 inhibitors have been identified in a retrospective cohort study of adults prescribed a PCSK9 inhibitor between July 2015 and December 2021 in the USA. US health care claims data from more than 700,000 people receiving a first prescription…

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FOURIER-OLE shows greater MACE reduction in multivessel disease

FOURIER-OLE shows greater MACE reduction in multivessel disease

Evolocumab reduced major adverse cardiovascular events (MACE) in patients with and without multivessel disease (MVD), with greater and earlier benefits seen in those with MVD. These are the recently published findings from the FOURIER-Open Label Extension (OLE) trial of evolocumab in 5,887 patients with coronary…

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Phase 3 alirocumab results in paediatric HeFH published

Phase 3 alirocumab results in paediatric HeFH published

Results of a Phase 3 trial of alirocumab in children aged eight to 17 years with inadequately controlled heterozygous familial hypercholesterolaemia (HeFH) have been published in JAMA Pediatrics. The data, presented at ESC Congress 2023, showed that among 153 patients randomised to receive alirocumab every…

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Phase 3 programme for MK-0616 gets underway

Phase 3 programme for MK-0616 gets underway

The first participants are enrolling in two registrational Phase 3 studies (CORALreef Lipids and CORALreef HeFH) to evaluate the effects of the oral PCSK9 inhibitor, MK-0616, on LDL cholesterol (LDL-C) reduction in adults with hypercholesterolaemia. A Phase 3 cardiovascular outcomes study, CORALreef Outcomes, is expected…

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PACMAN-AMI sub study provides further insights on PCSK9i plaque effects

PACMAN-AMI sub study provides further insights on PCSK9i plaque effects

Treating patients with non-obstructive lesions after acute myocardial infarction (AMI) with alirocumab leads to significant regression of angiographic diameter stenosis (DS%) but does not affect quantitative flow rate (QFR), according to results of a prespecified substudy of PACMAN-AMI (NCT03067844).1 This has led the trial investigators…

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EAS answers questions on Lp(a) consensus statement

EAS answers questions on Lp(a) consensus statement

In a follow up to its 2022 consensus statement on lipoprotein(a) [Lp(a)],1 the European Atherosclerosis Society (EAS) has published the answers to 30 of the most frequently asked questions about how the recommendations affect everyday clinical practice and management of atherosclerotic cardiovascular disease (ASCVD).2  They…

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EAS updates HoFH guidance

EAS updates HoFH guidance

The European Atherosclerosis Society has updated its 2014 Consensus Statement on the diagnosis and treatment of homozygous familial hypercholesterolaemia (HoFH), including new insights into the genetic complexity of the disease, and a recommendation to prioritise phenotypic features over genotype.1 The guidance makes combination LDL-C-lowering therapy…

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AT-TARGET-IT: Real world data show high adherence to PCSK9 inhibitors

AT-TARGET-IT: Real world data show high adherence to PCSK9 inhibitors

Real world data from the AT-TARGET-IT multicentre, observational registry in Italy have shown substantial reductions in LDL-cholesterol (LDL-C) and high levels of LDL-C target achievement with PCSK9 inhibitors (PCSK9i), leading to very high adherence and therapy persistence.1 Recently reported results from 798 patients enrolled in…

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Genetic variants in PCSK9 gene not linked to heart failure

Genetic variants in PCSK9 gene not linked to heart failure

New data which do not show any association between PCSK9 loss-of-function variants and changes in cardiac structure or function, or heart failure (HF), are providing reassuring evidence in relation to PCSK9 inhibition.1 The results, reported in JAMA Cardiology, come from a nested case-control study of…

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Do men respond better to PCSK9 inhibition than women?

Do men respond better to PCSK9 inhibition than women?

Accumulating evidence from real-world studies suggests that men may get a greater reduction in LDL-cholesterol (LDL-C) with a PCSK9 inhibitor than women.1,2 However, questions have been raised about whether women are less aggressively treated than men.2 Results of a meta-analysis of six real-world studies with…

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New clues to PCSK9-LDL receptor degradation mechanism

New clues to PCSK9-LDL receptor degradation mechanism

Fresh insights into the molecular mechanism for the degradation of the PCSK9-LDL receptor (LDLR) complex are provided in a new study published in Molecular Metabolism (1). Researchers led by Professor Nabil Seidah (Université de Montréal, Canada) had previously suggested that the M2 subdomain of the C-terminal Cys/His-rich-domain…

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CLEAR OUTCOMES: Topline data show bempedoic acid reduces cardiovascular events

CLEAR OUTCOMES: Topline data show bempedoic acid reduces cardiovascular events

In a press release (1), Esperion announced that the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial has met the primary endpoint, with a statistically significant and clinically meaningful reduction in the primary endpoint. This was a 4-part composite of major…

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Lipoprotein(a) and atrial fibrillation – Is there a link?

Lipoprotein(a) and atrial fibrillation – Is there a link?

PCSK9 Forum Co-editors Professors John Chapman and Henry Ginsberg discuss recent data. Atrial fibrillation (AF) is the most common arrhythmia, affecting about 0.5% (circa one in 200) of the worldwide population (1). Moreover, as populations age, prevalence has increased dramatically (2). Due to the associated risk…

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ORION-3: 4-year data with inclisiran

ORION-3: 4-year data with inclisiran

News from the American Heart Association Scientific Sessions 2022 Results from ORION-3, the 4-year open-label extension of the ORION-1 trial (1), showed sustained reduction in LDL cholesterol levels with a favourable safety profile. ORION-1 (ClinicalTrials.gov, NCT02597127) randomized 501 subjects with atherosclerotic cardiovascular disease (ASCVD) or…

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OCEAN(a)-DOSE: Olpasiran shows substantial lipoprotein(a) reduction

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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How much reduction of Lp(a) is needed to translate into major clinical benefit? Setting the scene: Focus on PCSK9 inhibitors

How much reduction of Lp(a) is needed to translate into major clinical benefit? Setting the scene: Focus on PCSK9 inhibitors

Reports from the 17th Virtual Closed Scientific Expert Meeting of the Editorial Board  Pia Kamstrup 

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EPIC-STEMI: Early alirocumab shows benefit in STEMI patients

EPIC-STEMI: Early alirocumab shows benefit in STEMI patients

EPIC-STEMI (Effects of Acute, Rapid Lowering of Low-Density Lipoprotein Cholesterol with Alirocumab in Patients with ST Segment Elevation Myocardial Infarction Undergoing Primary PCI) showed that starting a PCSK9 inhibitor in the acute setting of STEMI (ST-segment elevation myocardial infarction) provided additional benefit in lowering LDL…

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PCSK9 inhibitors: effects beyond LDL cholesterol lowering

PCSK9 inhibitors: effects beyond LDL cholesterol lowering

Real-world data from the LIPID-REAL registry show that treatment with a PCSK9 inhibitor was associated with reduction in remnant cholesterol, with greater benefit among patients with higher levels (1). PCSK9 inhibitors are highly efficacious in lowering LDL cholesterol by over 50%, irrespective of baseline lipid…

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FOURIER-OLE: Long-term evolocumab treatment further reduced cardiovascular events

FOURIER-OLE: Long-term evolocumab treatment further reduced cardiovascular events

Long-term treatment with evolocumab (on top of intense statin therapy) further reduced cardiovascular events in patients with stable atherosclerotic cardiovascular disease (ASCVD) who previously completed the landmark FOURIER study. Evolocumab treatment was also well tolerated. The results from this open-label extension study (FOURIER-OLE) were published…

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Reducing residual risk: Are cholesterol crystals the next target?

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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