Therapeutic Potential and Critical Analysis of the PCSK9 Monoclonal Antibodies Evolocumab and Alirocumab

White, C. Michael

doi:10.1177/1060028015608487

Cited by 25 publications

(23 citation statements)

References 36 publications

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“…The PCSK9 monoclonal antibodies have demonstrated clear therapeutic potential in the treatment of hypercholesterolemia, including patients with FH, exhibiting potent ability to lower LDL-C concentration, with an acceptable safety profile. 28 Preliminary findings, based on study-level data, also suggest a potential reduction in the risk of all-cause death, cardiovascular death, and myocardial infarction. 29 Cardiovascular outcomes with alirocumab are currently being investigated in a large ongoing study (http://clinicaltrials.gov/ show/NCT01663402), 30 and will be assessed in a pooled analysis from the overall ODYSSEY program.…”

Section: Teramoto T Et Almentioning

confidence: 99%

Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins　– ODYSSEY JAPAN Randomized Controlled Trial –

Teramoto

Kobayashi

Tasaki

et al. 2016

Circ J

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Section: Teramoto T Et Almentioning

confidence: 99%

Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins　– ODYSSEY JAPAN Randomized Controlled Trial –

Teramoto

Kobayashi

Tasaki

et al. 2016

Circ J

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“…The meta‐analysis by Lipinksi et al examined the effect of anti‐PCSK9 antibodies on lipids, but grouped data for alirocumab and evolocumab and did not examine the effects of these agents in different patient subgroups . Other meta‐analyses and literature reviews have used CV events as efficacy/safety endpoints to compare studies, but data are currently very limited . In contrast, because LDL‐C reduction was the primary endpoint of the Phase 3 studies described here, the studies were statistically powered to assess the true efficacy of anti‐PCSK9 antibodies regarding LDL‐C lowering.…”

Section: Discussionmentioning

confidence: 99%

Systematic review of published Phase 3 data on anti‐PCSK9 monoclonal antibodies in patients with hypercholesterolaemia

Gouni‐Berthold

Descamps

Fraass

et al. 2016

Brit J Clinical Pharma

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AimsTwo anti‐proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies, alirocumab and evolocumab, have been approved for the treatment of hypercholesterolaemia in certain patients. We reviewed data from Phase 3 studies to evaluate the efficacy and safety of these antibodies.MethodsWe systematically reviewed Phase 3 English‐language studies in patients with hypercholesterolaemia, published between 1 January 2005 and 20 October 2015. Congress proceedings from 16 November 2012 to 16 November 2015 were also reviewed.ResultsWe identified 12 studies of alirocumab and nine of evolocumab, including over 10 000 patients overall. Most studies enrolled patients with hypercholesterolaemia and used anti‐PCSK9 antibodies with statins. The ODYSSEY FH I, FH II and HIGH FH alirocumab studies and the RUTHERFORD‐2 evolocumab study exclusively recruited patients with heterozygous familial hypercholesterolaemia. Two evolocumab studies focused mainly on homozygous familial hypercholesterolaemia (HoFH): TESLA Part B and TAUSSIG (a TESLA sub‐study); only those data for HoFH are reported here. All comparator studies demonstrated a reduction in LDL cholesterol (LDL‐C) with the anti‐PCSK9 antibodies. No head‐to‐head studies were conducted between alirocumab and evolocumab. Up to 87% of patients receiving alirocumab and up to 98% receiving evolocumab reached LDL‐C goals. Both antibodies were effective and well tolerated across a broad population of patients and in specific subgroups, such as those with type 2 diabetes.ConclusionsUsing anti‐PCSK9 antibodies as add‐on therapy to other lipid‐lowering treatments or as monotherapy for patients unable to tolerate statins may help patients with high cardiovascular risk to achieve their LDL‐C goals.

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“…The summer of 2015 has seen the approval in the US of two new lipid-lowering medications of a completely new class, called PCSK9 inhibitors (alirocumab [Praluent™, marketed by Sanofi/Regeneron] and evolocumab [Repatha™ marketed by Amgen]) [18] with a third agent of this class in clinical trials (bocozicumab, developed by Pfizer) [19]. Their development had an unprecedented pace leading from discovery of PCSK9 to approved drugs, which potentially will be used by millions.…”

Section: Role Of Pcsk9 Inhibitorsmentioning

confidence: 99%

Lower is better: ezetimibe and PCSK9 inhibition join the mainstream of lipid‑lowering therapy

Wójcik

2016

RHC

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The focus of 2013 cholesterol guidelines to prevent atherosclerotic cardiovascular disease (ASCVD) released by American College of Cardiology (ACC) and American Heart Association (AHA) is the administration of high intensity statin therapy to specific four groups of patients, which were found to benefit the most from such therapy. They no longer promote achieving specific LDL-C goals with a combination therapy involving statins and other drugs, as advocated by the former ATP-III guidelines as well as current guidelines of European Atherosclerosis Society, International Atherosclerosis Society or National Lipid Association. Such approach has been dictated by the strict reliance on randomized controlled trials as the only acceptable level of evidence. However, since publication of the 2013 ACC/AHA guidelines, cardiovascular benefits of ezetimibe added to statin therapy have been established. Moreover, the advent of PCSK9 inhibitors, providing a powerful supplement and/or alternative to statin therapy, further complicates the therapeutic horizon in dyslipdiemias. It is very likely that a new set of ACC/AHA guidelines will be published in 2016, with a return of specific LDL-C and Non-HDL-C goals of therapy as well as integration of drugs other than statins. As the treatment of dyslipidemias becomes more complex, the need for the subspecialty of clinical lipidology to be officially recognized becomes more evident.

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Therapeutic Potential and Critical Analysis of the PCSK9 Monoclonal Antibodies Evolocumab and Alirocumab

Cited by 25 publications

References 36 publications

Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins　– ODYSSEY JAPAN Randomized Controlled Trial –

Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins　– ODYSSEY JAPAN Randomized Controlled Trial –

Systematic review of published Phase 3 data on anti‐PCSK9 monoclonal antibodies in patients with hypercholesterolaemia

Lower is better: ezetimibe and PCSK9 inhibition join the mainstream of lipid‑lowering therapy

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Therapeutic Potential and Critical Analysis of the PCSK9 Monoclonal Antibodies Evolocumab and Alirocumab

Cited by 25 publications

References 36 publications

Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins – ODYSSEY JAPAN Randomized Controlled Trial –

Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins – ODYSSEY JAPAN Randomized Controlled Trial –

Systematic review of published Phase 3 data on anti‐PCSK9 monoclonal antibodies in patients with hypercholesterolaemia

Lower is better: ezetimibe and PCSK9 inhibition join the mainstream of lipid‑lowering therapy

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Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins　– ODYSSEY JAPAN Randomized Controlled Trial –

Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins　– ODYSSEY JAPAN Randomized Controlled Trial –