News
Evinacumab, ANGPTL3 inhibitor, awarded breakthrough status by FDA
This monoclonal antibody to angiopoietin-like protein 3 (ANGPTL3), an inhibitor of lipoprotein lipase and endothelial lipase, is targeted to homozygous familial hypercholesterolaemia (FH, inherited high cholesterol), the most severe form of FH. The award of breakthrough status by the Food and Drugs Administration reflects the…
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Dr Brian Ference sets the record straight on questions about benefit in FOURIER
In discussions at ACC.2017, some have suggested that the results of FOURIER were less than anticipated from the meta-analysis of statin trials by the Cholesterol Treatment Trialists’ Collaboration (CTTC) (1). PCSK9 Forum Editor Dr Brian Ference (Division of Cardiovascular Medicine, Wayne State University School of…
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Events are the driver in PCSK9 cardiovascular outcomes trials
A recurrent question at ACC.2017 was why FOURIER had a short duration of follow-up, given the average duration of the statin trials was typically in the region of 4-5 years. This debate has been fanned by colourful but misinformed reports in the investment media (1).’…
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SPIRE trials: Bococizumab was insufficiently humanized for long-term use
The development of bococizumab, the third of the PCSK9 monoclonal antibodies, was discontinued by Pfizer in early November (1). Insights from a late breaker trial presentation provide some answers why this might be the case. SPIRE programme: lipid lowering trials The SPIRE program included 6…
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SPIRE-2: Cardiovascular benefit in very high risk patients
Evidence from the two cardiovascular outcomes studies with bococizumab, notably SPIRE-2, added to the buzz around FOURIER. According to PCSK9 Forum Editor Professor Philip Barter (University of New South Wales, Sydney, Australia): ‘Despite follow-up being short due to termination of the development of bococizumab, SPIRE-2…
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A landmark day for PCSK9 inhibition
What a landmark day for lipid lowering. All eyes were focused on FOURIER at the first of the late-breaking clinical trial sessions at ACC.2017. And the results didn’t disappoint. In patients with stable cardiovascular disease on maximally tolerated statin therapy, evolocumab treatment lowered LDL cholesterol…
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Countdown to FOURIER: What are the implications for patients?
Countdown to FOURIER: What are the implications for patients? PCSK9 Forum Editor Professor Anthony Wierzbicki gives his view.
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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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