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Evo4.5

Evolocumab (Repatha) Research

Mostly mechanism / observationalModerate safety

7 peer-reviewed studies

What the evidence says

Mostly mechanism / observational

Most Evolocumab (Repatha) studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.

Most evidence is from medium-quality randomised trials published 2015–2022 with a typical study size of 27,564 participants.

Based on 7 studies · 5 RCTs · 27,564 total participants

Confidence

High

By outcome

LDL cholesterol & lipids
Mostly mechanism / observational7 studies
Cardiovascular outcomes
Mostly mechanism / observational5 studies

Steady research

1 study in the last 5 years

20152022

1RCTn=27,564 · very large study2017

In FOURIER, evolocumab significantly reduced the risk of cardiovascular events in statin-treated patients with atherosclerotic disease.

Sabatine, Giugliano, Keech, Honarpour, Wiviott, Murphy · The New England journal of medicine (2017)

FOURIER randomized ~27,564 patients with atherosclerotic cardiovascular disease on statin therapy
Evolocumab lowered LDL cholesterol by about 59% and significantly reduced major cardiovascular events
The landmark cardiovascular-outcomes trial establishing evolocumab's event benefit on top of statins

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2Open-Label2022

Long-term evolocumab in the FOURIER open-label extension was associated with continued cardiovascular benefit and a reassuring safety profile.

O'Donoghue, Giugliano, Wiviott, Atar, Keech, Kuder · Circulation (2022)

FOURIER-OLE: open-label extension following patients on long-term evolocumab
Sustained low LDL cholesterol with continued — and possibly growing — cardiovascular benefit over time
No new safety signals with prolonged exposure

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3RCT2016

Adding evolocumab to statin therapy produced regression of coronary atherosclerotic plaque on intravascular ultrasound.

Nicholls, Puri, Anderson, Ballantyne, Cho, Kastelein · JAMA (2016)

GLAGOV randomized statin-treated patients to evolocumab or placebo with serial intravascular ultrasound
Evolocumab drove LDL to very low levels and produced regression of coronary atheroma volume
Imaging evidence that the LDL lowering translates into reduced plaque burden

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4RCT2015

Evolocumab markedly reduced LDL cholesterol in patients with heterozygous familial hypercholesterolaemia.

Raal, Stein, Dufour, Turner, Civeira, Burgess · Lancet (London, England) (2015)

RUTHERFORD-2 randomized patients with heterozygous familial hypercholesterolaemia on background lipid therapy
Evolocumab cut LDL cholesterol by roughly 60% versus placebo in this hard-to-treat population
Establishes dramatic LDL lowering where statins alone fall short

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5Systematic Review2020

PCSK9 monoclonal antibodies lowered LDL cholesterol and reduced the risk of cardiovascular events.

Schmidt, Carter, Pearce, Wilkins, Overington, Hingorani · Cochrane Database of Systematic Reviews (2020)

Cochrane systematic review of PCSK9 monoclonal antibodies (evolocumab and alirocumab)
Consistent large LDL reductions and reduced cardiovascular events across pooled randomized trials
Quantitative confirmation that the LDL lowering translates to clinical benefit at the class level

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6RCT2015

In the OSLER studies, evolocumab reduced LDL cholesterol and was associated with a lower rate of cardiovascular events.

Sabatine, Giugliano, Wiviott, Raal, Blom, Robinson · The New England journal of medicine (2015)

OSLER pooled the open-label extensions of earlier phase 2/3 evolocumab trials
Evolocumab lowered LDL cholesterol by about 61% and was associated with fewer cardiovascular events in exploratory analysis
An early signal of clinical benefit that FOURIER later confirmed in a dedicated outcomes trial

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7RCT2016

In statin-intolerant patients, evolocumab lowered LDL cholesterol substantially more than ezetimibe.

Nissen, Stroes, Dent-Acosta, Rosenson, Lehman, Sattar · JAMA (2016)

GAUSS-3 randomized patients with documented muscle-related statin intolerance
Evolocumab produced markedly greater LDL reduction than ezetimibe in patients who cannot tolerate statins
Supports a role when statins are not an option

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View in Research Library

Evolocumab (Repatha) Research

Mostly mechanism / observational

Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease.

Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease.

Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial.

PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial.

PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.

Efficacy and safety of evolocumab in reducing lipids and cardiovascular events.

Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial.