News
Heart UK statement on homozygous familial hypercholesterolaemia places PCSK9 inhibitors as second‑line treatment
Although homozygous familial hypercholesterolaemia (FH, inherited high cholesterol) is rare, the severity of the condition underlines the need for an aggressive approach to management. This statement from Heart UK has weighed up the evidence for all three treatment modalities – pharmacotherapy, lipoprotein apheresis and liver…
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Bococizumab exits the PCSK9 stage: A response from PCSK9 Forum Editors
Pfizer announced on Tuesday, 1st November that it was discontinuing development of bococizumab, its PCSK9 inhibitor. According to the press release, the Company stated that: ‘The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering…
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SAFEHEART: Consider more than coronary complications in FH
The Spanish Familial Hypercholesterolaemia Cohort Study (SAFEHEART) has highlighted the prevalence and different distribution of atherosclerotic cardiovascular disease (ASCVD) in individuals with familial hypercholesterolaemia (FH, inherited high cholesterol). In particular, coronary artery disease and peripheral artery disease were more prevalent among those with FH than…
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No effect of PCSK9 inhibitors on new-onset diabetes
Treatment with alirocumab for up to 18 months did not affect the incidence of new-onset diabetes, according to this pooled analysis of Phase III trials from the ODYSSEY programme. These findings are in line with reports with evolocumab which showed no effect on glycaemic measures…
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PCSK9 inhibitors: Who and when to treat?
Professor Tony Wierzbicki (Guy’s & St Thomas’ Hospitals, London, UK) discusses considerations for the use of PCSK9 inhibitors from a policy maker perspective (NICE, National Institute for Health and Care Excellence in the UK). He raises issues about the data for each high risk patient…
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Premium quality or just over-priced? How affordable are the PCSK9 monoclonal antibodies?
Anthony Wierzbicki, Guy’s & St Thomas’ Hospitals, London discusses recent economic analyses from the US and UK. Cardiovascular disease (CVD) remains one of the commonest causes of morbidity and mortality in the world. The epidemiology of CVD is changing as rates of smoking decrease but…
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PCSK9 inhibitors: How do we weigh up the benefit versus cost of treatment?
PCSK9 Forum Editor, Professor Henry Ginsberg (Columbia University, New York, USA) offers a pragmatic perspective about cost-effectiveness analyses for the use of PCSK9 monoclonal antibody therapy in high risk patients.
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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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