News
PACMAN-AMI: new data on lesion-level effects of lipid lowering
A new pre-specified, post-hoc analysis of results from the PACMAN-AMI study has shown that lesion-level effects of intensive lipid lowering with alirocumab and statin are substantially greater than those previously seen at vessel level.1 The new findings, presented by Dr Flavio Giuseppe Biccire (Inselspital, University…
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AT-TARGET-IT shows reduced CV risk with early PCSK9i in ACS
Early, intensive lipid-lowering therapy including PCSK9 inhibition in patients with acute coronary syndrome (ACS) is associated with reduced risk of major adverse cardiovascular events (MACE), according to results from the AT-TARGET-IT registry using a ‘strike early, strike strong strategy’. In 771 patients with ACS who…
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Real world ischaemic event reduction with PCSK9i mAbs
Initiation of PCSK9i mAbs in patients with atherosclerotic cardiovascular disease (ASCVD) but without prior ischaemic events is associated with significantly and substantially lower risk for major ischaemic events, concluded Professor Deepak Bhatt (Icahn School of Medicine at Mount Sinai, New York, USA) from results of…
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Inclisiran role in plaque stabilisation
High intensity lipid lowering therapy, including inclisiran, has been shown to stabilise atherosclerotic plaques. In a study of 36 patients with stable coronary artery disease (CAD, 20-50% stenosis), atherosclerotic plaque lipid composition was evaluated before and after intensive lipid lowering therapy, using near-infrared spectroscopy (NIRS)….
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Discontinuing PCSK9i leads to increased MACE
Patients who discontinue PCSK9i are at increased risk of major adverse cardiovascular events (MACE), suggests a study of 203 patients who received PCSK9i in Japan between July 2016 and December 2023. At one year, median LDL-C was 43 mg/dL, and 158 patients (77%) reached LDL-C…
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V-MONO trial of inclisiran monotherapy meets primary endpoints
The Phase 3 V-MONO study of inclisiran monotherapy in patients at low or moderate risk of atherosclerotic cardiovascular disease (ASCVD) has met its primary endpoints. Top-line data show that inclisiran treatment resulted in a clinically meaningful and statistically significant reduction in LDL-C compared to placebo…
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Remembering Akira Endo and the beginning of the ‘statin era’
Dr Jonathan Tobert, University of Oxford, UK, recalls the landmark statin research by Dr Akira Endo that has saved countless lives. Akira Endo died on June 5 at the age of 90. He worked as a microbiologist in Japan and is universally recognised as the…
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CLEAR Outcomes confirms bempedoic acid benefits for recurrent CV events
Bempedoic acid reduces recurrent as well as first major adverse cardiovascular events (MACE), according to data from a prespecified analysis of the CLEAR Outcomes trial published in JAMA Cardiology.1 In the study of 13,970 participants, 9764 of whom had prior atherosclerotic cardiovascular disease (ASCVD) and…
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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
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
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
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
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 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
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
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?
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
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
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?
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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