News
Countdown to FOURIER: Are very low levels of LDL cholesterol safe?
A view from PCSK9 Forum Editor Dr Peter Lansberg (Academic Medical Center, Amsterdam, the Netherlands) Comment relates to: Giugliano RP, Wiviott SD, Blazing MA et al. Long-term Safety and Efficacy of Achieving Very Low Levels of Low-Density Lipoprotein Cholesterol A Prespecified Analysis of the IMPROVE-IT…
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IMPROVE-IT: Further reassurance on very low LDL cholesterol
In a pre-specified analysis of IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial), patients with LDL cholesterol < 30mg/dL or <0.78 mmol/l after 1 month on treatment had a similar safety profile and fewer cardiovascular events over 6 years than those at higher levels….
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Cumulative 4-year OSLER data look good, sustained LDL lowering
In this report from OSLER (Open-Label Study of Long-term Evaluation Against LDL-C), covering the longest exposure to PCSK9 inhibitors to date, there was no decrease in the LDL cholesterol lowering response to evolocumab treatment over time, and no signal for any increase in adverse events….
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Looking to FOURIER: What do the trials tell us about LDL lowering and cardiovascular events?
Presentation of full results from the FOURIER cardiovascular outcomes trial with the PCSK9 monoclonal antibody evolocumab is imminent. Here, PCSK9 Forum Editor Professor Anthony Wierzbicki (Guy’s and St Thomas’ NHS Foundation Trust, London UK) looks back over more than 25 years of trials of LDL…
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TAUSSIG: What does it mean for the homozygous FH patient?
Data from TAUSSIG (Trial Assessing Long-Term Use of PCSK9 Inhibition in Subjects with Genetic LDL Disorders), the largest and longest study of lipid lowering therapy in patients with homozygous FH, indicate a complementary role for evolocumab with lipoprotein apheresis. PCSK9 Forum Editor Dr Peter Lansberg…
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Does PCSK9 inhibition have a role in HIV dyslipidaemia?
With HIV (human immunodeficiency virus) patients in developed countries living longer, appropriate management of cardiovascular risk factors, notably dyslipidaemia, becomes more of an issue. But is this also the same in developing regions? As a consequence of developments in HIV management, HIV patients in developed…
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Are very low LDL-C levels on a PCSK9 inhibitor safe?
One of the key concerns of clinicians is whether the very low LDL cholesterol levels attained on a PCSK9 inhibitor are safe. Such concerns have been sparked by a recent meta-analysis which suggested a signal for adverse neurocognitive effects (1). These concerns were investigated in…
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Is baseline PCSK9 a determinant of LDL cholesterol lowering with a PCSK9 inhibitor?
Is baseline PCSK9 a determinant of LDL cholesterol lowering with a PCSK9 inhibitor? This report addresses this question by investigating the association between plasma PCSK9 and the LDL cholesterol reduction attained with the PCSK9 inhibitor evolocumab. The authors evaluated pooled data from 3,016 patients (40%…
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FOURIER doesn’t disappoint: Amgen announces positive topline results
Amgen has confirmed that the much-awaited FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial showed that treatment with the PCSK9 inhibitor evolocumab significantly reduced the risk of cardiovascular events in patients with clinical atherosclerotic cardiovascular disease on optimized statin…
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First data on familial hypercholesterolaemia in China
Most of the information relating to familial hypercholesterolaemia (FH, inherited high cholesterol) is from Caucasian populations. In Northern Europe, about 1 in 200-250 individuals have FH; results from the US are similar (1,2). However, there are many ‘black holes’ where there is no information on…
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Looking back at 2016: What made the news?
PCSK9 Forum Editor Professor John Chapman reviews the ups and downs of LDL lowering news in 2016. The Highlights GLAGOV (Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound) (1) would have to feature very much in the forefront of…
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PCSK9 inhibitor evolocumab approved in Hong Kong
Evolocumab has now been approved by the Hong Kong Department of Health for use as an adjunct to diet and statin therapy for the treatment of adults with familial hypercholesterolaemia (FH, inherited high cholesterol) – both heterozygous and homozygous FH – or adults with clinical…
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PCSK9 inhibitors: cardiovascular benefit vs. diabetes risk
Two published Mendelian randomization studies have provided insights into potential long-term effects of PCSK9 inhibition. The studies follow hot on the heels of the GLAGOV study, which showed that treatment with evolocumab on top of statin induced atherosclerosis regression compared with statin alone (1). According…
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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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