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ODYSSEY OUTCOMES in press finally!

ODYSSEY OUTCOMES in press finally!

Final results of ODYSSEY OUTCOMES, presented at this year’s American College of Cardiology Annual Scientific Sessions, were published today. Together with the results of FOURIER (1) there is now definitive evidence for the outcomes benefits of PCSK9 inhibition in very high-risk patients, in this case,…

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NEW Complementary slide resources…

NEW Complementary slide resources…

PCSK9 Forum is globally-recognised as an independent, non-profit resource of expert knowledge of PCSK9 science and its translation to therapeutic innovation. The mission of PCSK9 Forum is to increase awareness and understanding of this exciting new development among healthcare professionals. For more information about the PCSK9…

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Alirocumab safe in patients with diabetes mellitus

Alirocumab safe in patients with diabetes mellitus

Safety analysis from 14 ODYSSEY trials involving more than 5000 patients shows a similar safety profile for alirocumab irrespective of diabetes status. This pooled analysis from the ODYSSEY development programme included 14 trials (8-104-weeks duration) with 5234 patients, 1554 (29.7%) with diabetes.  Adverse event data…

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PROFICIO analysis shows consistent LDL lowering with evolocumab

PROFICIO analysis shows consistent LDL lowering with evolocumab

Treatment with the PCSK9 inhibitor evolocumab produced a consistent LDL cholesterol lowering response, irrespective of age, gender, ethnicity, glucose tolerance status or global cardiovascular risk, according to the latest report from the PROFICIO clinical trial programme. PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following…

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International Atherosclerosis Society and FH Foundation join forces to improve FH management

International Atherosclerosis Society and FH Foundation join forces to improve FH management

The International Atherosclerosis Society (IAS) and the FH Foundation, a patient-centered nonprofit organization dedicated to research, advocacy, and education of familial hypercholesterolemia (FH, inherited high cholesterol), have announced a partnership to improve awareness of FH. Despite the fact that FH is the most common genetic…

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Two more analyses show efficacy of alirocumab in diabetes

Two more analyses show efficacy of alirocumab in diabetes

Two recent analyses add to the body of evidence supporting the efficacy and tolerability of the PCSK9 inhibitor alirocumab in patients with type 2 diabetes mellitus (T2DM), including those with mixed dyslipidaemia. The first report (1) was a pooled analysis of 5 placebo-controlled Phase 3…

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OSLER: sustained benefit with evolocumab in statin intolerant patients

OSLER: sustained benefit with evolocumab in statin intolerant patients

Statin intolerance, predominantly due to muscle symptoms, is a major issue affecting treatment adherence. This analysis of the open-label extension OSLER 1 and 2 studies adds to evidence from the GAUSS studies that evolocumab, added to standard of care, is a safe and effective option…

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Study shows no effect of circulating PCSK9 on beta-cell function

Study shows no effect of circulating PCSK9 on beta-cell function

Uncertainties persist about the effect of PCSK9 deficiency on glucose homeostasis. Mendelian randomization studies have indicated a potential risk for new-onset diabetes mellitus, although data from clinical trials suggest rates are similar to those observed with statin (with or without ezetimibe).1-4 This experimental study aimed…

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New Simon Broome register data: Mortality benefit of statins in men with familial hypercholesterolaemia but women lag behind

New Simon Broome register data: Mortality benefit of statins in men with familial hypercholesterolaemia but women lag behind

Updated data from this UK register of familial hypercholesterolaemia (FH, inherited high cholesterol) show that statin treatment has reduced coronary heart disease (CHD) mortality. However, patients with FH, especially women, still remain at high risk of CHD death. These findings highlight unmet clinical needs in the…

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SPIRE trials yield information on familial hypercholesterolaemia patients

SPIRE trials yield information on familial hypercholesterolaemia patients

Patients with familial hypercholesterolaemia (FH, inherited high cholesterol) gained similar clinical outcomes benefit from PCSK9 inhibition as other high risk groups, according to this analysis of more than 1,500 patients with FH enrolled in the SPIRE outcome trials with bococizumab. Untreated patients with FH are…

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PCSK9 inhibitors in chronic kidney disease – what do we know?

PCSK9 inhibitors in chronic kidney disease – what do we know?

The first reported data for the use of PCSK9 inhibitors in patients with impaired renal function show that this treatment effectively lowers LDL cholesterol with no evidence to suggest deterioration in renal function. These findings justify new trials specifically in this patient group. As recognized…

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Greatest mortality benefit with highest LDL cholesterol above 100 mg/dl

Greatest mortality benefit with highest LDL cholesterol above 100 mg/dl

A systematic review and meta-analysis in over 260,000 patients reaffirms that patients with the highest LDL cholesterol levels at baseline derive the greatest reduction in cardiovascular and all-cause death. The association was not evident in patients with LDL cholesterol levels <2.6 mmol/L or 100 mg/dL….

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Hyporesponsiveness to PCSK9 inhibitors or lack of adherence?

Hyporesponsiveness to PCSK9 inhibitors or lack of adherence?

A pooled analysis of 10 phase 3 ODYSSEY studies with alirocumab suggests that lack of adherence with lipid lowering therapy may explain a poor response to PCSK9 inhibition. Clinical trials of statins and other lipid-lowering therapies often report large inter-individual variations in low-density lipoprotein (LDL)…

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How low should LDL cholesterol be lowered after stroke?

How low should LDL cholesterol be lowered after stroke?

LDL cholesterol should be lowered to 80 to 100 mg/dl to prevent recurrent stroke, according to data from the J-STARS Study (Japan Statin Treatment Against Recurrent Stroke). J-STARS (1) examined whether low-dose pravastatin reduced the recurrence of strokes and other vascular events in non-cardioembolic stroke…

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FOURIER analysis: consistent benefit with evolocumab across the range of inflammatory risk

FOURIER analysis: consistent benefit with evolocumab across the range of inflammatory risk

While much of the focus in cardiovascular disease prevention has been on LDL cholesterol as the major modifiable driver of cardiovascular risk, other mediators of risk have been debated. A new analysis from FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated…

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Alirocumab shows efficacy in homozygous FH phenotype

Alirocumab shows efficacy in homozygous FH phenotype

Treatment with alirocumab led to clinically meaningful LDL cholesterol lowering in patients with a clinical phenotype typically associated with homozygous familial hypercholesterolaemia (FH, inherited high cholesterol), including those who were double heterozygous, compound heterozygous, or homozygous for genes that are causative for FH. Homozygous familial…

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ODYSSEY DM-DYSLIPIDEMIA: Alirocumab show benefit in type 2 diabetes with mixed dyslipidaemia

ODYSSEY DM-DYSLIPIDEMIA: Alirocumab show benefit in type 2 diabetes with mixed dyslipidaemia

In the first dedicated study of a PCSK9 inhibitor in individuals with type 2 diabetes and mixed dyslipidaemia (elevated triglyceride-rich lipoproteins and low HDL cholesterol levels), alirocumab provided superior control of non-HDL cholesterol levels compared with usual care (including maximally-tolerated statins). Non-HDL cholesterol comprises the…

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Do PCSK9 inhibitors increase new-onset diabetes? Another meta-analysis

Do PCSK9 inhibitors increase new-onset diabetes? Another meta-analysis

A new meta-analysis involving more than 26,000 patients reports no increase in new-onset diabetes and no impact on glucose metabolism with PCSK9 inhibitor treatment. The authors performed a comprehensive medical literature to identify 18 randomized controlled studies with 26,123 patients without diabetes at study baseline….

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ODYSSEY OUTCOMES to report at ACC.2018

ODYSSEY OUTCOMES to report at ACC.2018

The second completed cardiovascular outcomes study with a PCSK9 inhibitor will be up first at the first latebreaker session at the American College of Cardiology Scientific Sessions this March. ODYSSEY OUTCOMES with alirocumab follows reporting of FOURIER with evolocumab and the terminated SPIRE studies with…

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Highest risk-highest benefit from PCSK9 inhibition

Highest risk-highest benefit from PCSK9 inhibition

Using a pragmatic approach, experts have recommended a ‘highest risk–highest benefit’ strategy for clinicians considering PCSK9 inhibitor treatment for their patients. This takes into account the clinical need, outcome benefit and cost of the PCSK9 inhibitors. Briefly, ‘highest risk’ refers to patients with the highest…

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