News
ESC Poster news: Long-term data with evolocumab in heterozygous FH
30th August 2016, Rome, Italy Evolocumab was effective and well tolerated in patients with heterozygous familial hypercholesterolaemia (FH, inherited high cholesterol) treated for up to 48 weeks (1). Previously, the RUTHEFORD studies in heterozygous FH showed that evolocumab given for 12 weeks was effective in…
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ESC Poster news: Consistent benefit with evolocumab in high and very high risk patients
30th August 2016, Rome, Italy In a pooled analysis of more than 2500 patients, the LDL cholesterol lowering efficacy of evolocumab was consistent in both very high risk and high risk patients (1). The 2016 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines categorise…
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ESC Poster news: More reassurance on alirocumab safety at very low LDL cholesterol
30th August 2016, Rome, Italy In an updated safety analysis for alirocumab treatment for up to 104 weeks, there was no evidence of any safety issues affecting neurological or neurocognitive function with alirocumab (1). Data were pooled from 14 Phase II and III trials, comprising…
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ESC Poster news: Alirocumab effective in patients with multiple manifestations of cardiovascular disease
30th August 2016, Rome, Italy Alirocumab, was effective and well tolerated in patients with multiple manifestations of cardiovascular disease receiving statins with or without other lipid lowering therapy, according to a post hoc analysis of the ODYSSEY trials (1). The investigators evaluated data from patients…
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PCSK9 inhibition reduces the need for lipoprotein apheresis in severe heterozygous familial hypercholesterolaemia patients
ESC Congress, Rome, 29 August 2016 Results from this Monday Hotline of the ODYSSEY ESCAPE study show that treatment with the PCSK9 monoclonal antibody alirocumab reduces the frequency of lipoprotein apheresis in patients with heterozygous familial hypercholesterolaemia (FH, inherited high cholesterol) requiring this therapy. At…
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ODYSSEY ESCAPE: a view from PCSK9 Forum
PCSK9 Forum News Editor, Dr Peter Lansberg (Amsterdam Medical Center, the Netherlands) discusses ODYSSEY ESCAPE and the implications for the management of heterozygous familial hypercholesterlaemia patients with severely elevated LDL cholesterol levels despite maximal LDL lowering therapy.
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Screening for Lipid Disorders in Children and Adolescents: A view from PCSK9 Forum Editors
Gerald F Watts, University of Western Australia, Perth, Australia Heterozygous familial hypercholesterolaemia (FH, inherited high cholesterol) starts as an asymptomatic disorder characterized by markedly elevated LDL cholesterol levels and untreated leads to accelerated atherosclerosis and cardiovascular disease. Typically, individuals may be only diagnosed in the…
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ODYSSEY JAPAN shows benefit of alirocumab
Alirocumab reduced LDL cholesterol by more than 60% and was well tolerated over 52 weeks in this study in Japanese patients at high cardiovascular risk on statin therapy. This Phase III study included 216 high risk patients, 19% each with heterozygous familial hypercholesterolaemia (FH, inherited…
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PCSK9 levels in diabetic kidney disease
PCSK9 levels did not appear to be influenced by the extent of renal dysfunction or albuminuria in this cross-sectional study in patients with diabetic kidney disease. Diabetic kidney disease is one of the key drivers of escalating morbidity and mortality due to chronic kidney disease…
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ORION I steams ahead
ORION I steams ahead This Phase II trial with the first-in-class RNA interference (RNAi) PCSK9 inhibitor (ALN-PCSsc) has now completed patient recruitment. Interim results (both efficacy and safety) from this dose ranging study are expected late in 2016. The trial is being run at 54…
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SPIRE trials: Bococizumab met primary endpoint in 4 trials
Following on the tails of the first two licensed PCSK9 monoclonal antibodies, there are encouraging early results from Phase III trials with the third PCSK9 monoclonal antibody bococizumab. Topline results from studies in patients with heterozygous familial hypercholesterolemia (SPIRE-FH), high cardiovascular risk (SPIRE-HR), or elevated…
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PCSK9 inhibitors for aortic valve stenosis?
Aortic valve stenosis is common in the older population (>65 years), and is associated with substantial morbidity and mortality. Among those with symptoms, 5- and 10-year mortality is 50% and 90%, respectively (1). Lipids, notably lipoprotein(a) [Lp(a)] and LDL cholesterol have both been implicated in…
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Plasma PCSK9 levels higher in PAD
Atherosclerotic peripheral artery disease (PAD) affects more than 200 million people worldwide (1), and is associated with substantial morbidity. More than 50% of people with PAD have concomitant coronary heart disease, cerebrovascular disease, or both (2). Management of more severe disease is costly; in the…
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ICD10 codes for familial hypercholesterolaemia: An important first step
After more than 3 years in discussion, International Classification of Diseases (ICD) 10TH Edition codes for familial hypercholesterolaemia (FH, inherited high cholesterol) have now been approved. Two codes will come into force on 1st October this year: E78.01: Familial hypercholesterolemia AND Z83.42: Family history of…
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Updated Canadian Consensus on statin intolerance
The availability of non-statin treatments that are effective in lowering LDL cholesterol and (may) also reduce cardiovascular events (ezetimibe, still be tested with the PCSK9 inhibitors) has been a key driver for new consensus on statin intolerance. Use of these nonstatin therapies offers the possibility…
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Phase II studies
ALN-PCSsc ORION programme This programme with the first-in-class RNA interference (RNAi) PCSK9 inhibitor ALN-PCSsc was launched with the ORION-1 study. Trial ORION-1: Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) ClinicalTrials.gov Identifier: NCT02597127 Aim To evaluate the efficacy, safety,…
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PCSK9 inhibitors in the clinic: New analyses provide clarification on long-term treatment issues
Reports from EAS Congress provide important insights into the long-term use of PCSK9 inhibitors. Statins are the first-line therapy for LDL cholesterol lowering given indisputable evidence that this treatment reduces cardiovascular events in both men and women (1,2). The PCSK9 inhibitors undoubtedly have proven efficacy,…
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News: International Atherosclerosis Society consensus statement on severe familial hypercholesterolaemia
In this new statement, the International Atherosclerosis Society (IAS) has placed phenotype at the heart of management strategies for familial hypercholesterolaemia (FH, inherited high cholesterol). Commenting, lead author Dr. Raul Santos (University of São Paulo Medical School Hospital and Preventive Medicine Centre and Cardiology Program,…
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EAS Congress Innsbruck: Mixed results with novel agents in homozygous FH
The Clinical Late breaker session reported on three agents with potential for the management of homozygous familial hypercholesterolaemia (FH, inherited high cholesterol). One of these – evinacumab (REGN1500), a human monoclonal antibody to angiopoietin-like protein 3 (ANGPTL3) – showed interesting results in a small proof-of-concept study…
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Is lipoprotein(a) a cause of clinical familial hypercholesterolaemia?
Familial hypercholesterolaemia (FH, inherited high cholesterol) is a common autosomal dominant condition which is characterized by raised LDL cholesterol, family history of dyslipidaemia, and early onset of coronary heart disease. Beyond mutations in the LDLR, APOB and PCSK9 genes, a new study from the University…
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