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Alirocumab: EU Regulatory update

Alirocumab: EU Regulatory update

The European Union (EU) has now approved alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) monoclonal antibody, to reduce the risk of cardiovascular events in patients with established cardiovascular disease.1 The approval is based on data from the ODYSSEY OUTCOMES trial, which not only showed…

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Diabetes does not affect the efficacy of inclisiran

Diabetes does not affect the efficacy of inclisiran

A new analysis from the ORION-1 trial shows that the efficacy and safety of inclisiran, a small interfering RNA (siRNA) therapeutic, is not influenced by diabetes status. Inclisiran differs from monoclonal antibody therapy by acting intracellularly in the liver to inhibit synthesis of PCSK9 protein…

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Statins versus PCSK9 inhibitors: new metabolomic analysis

Statins versus PCSK9 inhibitors: new metabolomic analysis

What explains the cardiovascular outcomes benefit with a statin or a PCSK9 inhibitor? Do effects on LDL cholesterol, as well as lipids beyond LDL cholesterol differ? A metabolite profiling study provides new insights. Treatment with statin monotherapy or as add-on to a PCSK9 inhibitor has…

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New meta-analysis of PCSK9 inhibitors: a mortality benefit or not?

New meta-analysis of PCSK9 inhibitors: a mortality benefit or not?

A new meta-analysis lends further support that PCSK9 inhibition reduces nonfatal major adverse cardiovascular events (MACE). However, the jury is still out regarding effects on mortality. Randomized controlled trials of at least 6 months duration were identified from searching CENTRAL, Embase, MedLine and the grey…

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Stratifying risk in familial hypercholesterolaemia: does coronary artery calcium have a role?

Stratifying risk in familial hypercholesterolaemia: does coronary artery calcium have a role?

PCSK9 Forum Editors Professor Gerald Watts (University of Western Australia, Perth, Australia) and Professor Derick Raal (University of the Witwatersrand, Johannesburg, South Africa) give their view. As a result of life-long exposure to high LDL cholesterol levels, individuals with familial hypercholesterolaemia (FH, inherited high cholesterol)…

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Coronary artery calcium in familial hypercholesterolaemia

Coronary artery calcium in familial hypercholesterolaemia

Coronary artery calcium (CAC) score may have a role in stratifying short-term risk in patients with familial hypercholesterolaemia (FH, inherited high cholesterol), according to a new study. The authors suggest that this noninvasive approach may have value in targeting treatment with a PCSK9 inhibitor to…

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Future dual PCSK9/GLP-1 therapy for diabetes patients?

Future dual PCSK9/GLP-1 therapy for diabetes patients?

Atherosclerotic cardiovascular disease is the leading cause of morbidity and mortality in patients with type 2 diabetes. Management is multifactorial, targeting major modifiable risk factors including glycaemia, dyslipidaemia, obesity and hypertension. Despite this, less than 10% of patients achieve combined target goals. To address this…

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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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