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Alirocumab

ODYSSEY CHOICE II

ODYSSEY CHOICE II

Trial Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) Aim To evaluate the efficacy and safety or alirocumab as add-on to non-statin lipid modifying background therapy (ezetimibe or fenofibrate) or as monotherapy in comparison with…

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ODYSSEY CHOICE I

ODYSSEY CHOICE I

Trial Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1) Aim To determine if alirocumab is effective and safe compared with placebo, if used alone or added to…

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ODYSSEY ESCAPE

ODYSSEY ESCAPE

Trial Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy (ODYSSEY ESCAPE) Clinical Trials Number: NCT02326220 Aim to evaluate the effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments in patients with…

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ODYSSEY JAPAN

ODYSSEY JAPAN

Trial ODYSSEY JAPAN Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy Aim To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin…

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ODYSSEY KIDS

ODYSSEY KIDS

Alirocumab Trial An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia ClinicalTrials.gov Identifier: NCT02890992 Aim To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous…

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ODYSSEY LONG TERM

ODYSSEY LONG TERM

Trial Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular [CV] Risk Patients With Hypercholesterolemia (ODYSSEY Long Term) Aim To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk patients with hypercholesterolemia not adequately…

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ODYSSEY OUTCOMES

ODYSSEY OUTCOMES

Alirocumab Safety Alirocumab treatment was well tolerated; injection site reactions occurred in 3.8% of patients in the alirocumab group versus 2.1% on placebo. Trial ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab ClinicalTrials.gov Identifier: NCT01663402 Aim To test…

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Alirocumab: 1-year data in heterozygous familial hypercholesterolaemia (HeFH)

Alirocumab: 1-year data in heterozygous familial hypercholesterolaemia (HeFH)

Trial Alirocumab: 1-year data in heterozygous familial hypercholesterolaemia (HeFH) Aim To report safety and efficacy data after 52 weeks of a 4- year extension to an earlier 12-week trial (R727-CL-1003) of alirocumab or placebo in patients with HeFH on statin ± ezetimibe Study design Phase…

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Alirocumab effects on lipoprotein particles

Alirocumab effects on lipoprotein particles

Trial Effects of alirocumab on lipoprotein particle concentrations Aim To determine the effects of alirocumab on LDL particle (LDL-P) and other lipid particle concentrations to assess cardiovascular risk Study design Sub-study of phase 2, randomised, double blind efficacy study Patient population Patients with LDL-C ≥100mg/dL…

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Alirocumab combination with ezetimibe or fenofibrate

Alirocumab combination with ezetimibe or fenofibrate

Trial Alirocumab ± ezetimibe or fenofibrate in healthy subjects: PK and PD data Aim To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe (EZE) or fenofibrate (FEN), based on LDL-C Study design Open-label, partial-blind, 3 parallel group pharmacodynamics study…

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Alirocumab single dose study

Alirocumab single dose study

Trial Alirocumab single dose study: bioavailability, pharmacodynamics, and safety Aim To assess the bioavailability of a single dose of alirocumab after injection in the abdomen, upper arm, and thigh Study design Single-centre, open-label, randomized Phase 1 study Patient population Healthy subjects (aged 18-45 years) in…

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Alirocumab shows benefit in SAMS with myotonic dystrophy

Alirocumab shows benefit in SAMS with myotonic dystrophy

There are currently few options for patients with statin intolerance and myotonic dystrophy. In this case report, a 74-year-old male with hypercholesterolaemia (serum LDL cholesterol 210 mg/dL), hypogonadism, insulin-controlled type 2 diabetes mellitus, and minimally elevated serum creatine kinase levels (184 U/L, ref. range 38-174),…

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Alirocumab effective against the spectrum of mutations causative for familial hypercholesterolaemia

Alirocumab effective against the spectrum of mutations causative for familial hypercholesterolaemia

Alirocumab treatment was effective in patients heterozygous for mutations in LDLR, APOB, and PCSK9 genes. This analysis investigated the efficacy of alirocumab in 1191 patients with familial hypercholesterolaemia (FH, inherited high cholesterol) included in 6 trials; 758 were treated with alirocumab. One or more specific…

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ADA 2017: Alirocumab shows benefit in diabetes patients

ADA 2017: Alirocumab shows benefit in diabetes patients

Data from the ODYSSEY trials, including a pooled analysis of nearly 1,000 patients, reported at the American Diabetes Association (ADA) 2017 Scientific Sessions showed that alirocumab was effective in type 1 and 2 diabetes patients, including those with mixed dyslipidaemia, with no impact on HbA1c….

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ODYSSEY APPRISE offers insights into the real world use of PCSK9 inhibitor

ODYSSEY APPRISE offers insights into the real world use of PCSK9 inhibitor

What do we know about patients receiving a PCSK9 inhibitor in real world practice? In the case of alirocumab, what will be the usual dose regimen? These and other questions were the driver for the ODYSSEY APPRISE study, the first European/Canadian study which focused on…

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ESC Poster news: More reassurance on alirocumab safety at very low LDL cholesterol

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

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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ODYSSEY JAPAN shows benefit of alirocumab

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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Alirocumab for Autosomal Recessive Hypercholesterolemia

Alirocumab for Autosomal Recessive Hypercholesterolemia

Results from this in vitro study suggest that PCSK9 inhibition with alirocumab on top of statin treatment may have the potential to lower LDL cholesterol in some patients with autosomal recessive hypercholesterolemia (ARH), a phenocopy of homozygous familial hypercholesterolaemia (FH, inherited high cholesterol). ARH is…

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Positive results with ODYSSEY ESCAPE in severe FH

Positive results with ODYSSEY ESCAPE in severe FH

Topline results from ODYSSEY ESCAPE showed that in patients with heterozygous familial hypercholesterolaemia (FH, inherited high cholesterol) who required regular lipoprotein apheresis, on top of maximally tolerated lipid lowering therapy, addition of alirocumab significantly reduced the requirement for apheresis. The frequency of apheresis therapy with…

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