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Evo4.5

Evolocumab (Repatha) – Forschung

Überwiegend Mechanismus / Beobachtung

7 begutachtete Studien

Was die Evidenz sagt

Überwiegend Mechanismus / Beobachtung

Die meisten Studien zu Evolocumab (Repatha) sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.

Die meiste Evidenz stammt aus mittelwertigen randomisierten Studien, veröffentlicht 2015–2022 mit einer typischen Studiengröße von 27,564 Teilnehmenden.

Basierend auf 7 Studien · 5 RCTs · 27,564 Teilnehmende insgesamt

Konfidenz

Hohe Konfidenz

Nach Outcome

LDL cholesterol & lipidsSenkt LDL-C um ~60% zusätzlich zu Statinen; FOURIER zeigte signifikant weniger schwere kardiovaskuläre Ereignisse bei mit Statinen behandelten Patienten mit atherosklerotischer Erkrankung · Wochen (Ereignisse: Monate bis Jahre)
Überwiegend Mechanismus / Beobachtung7 Studien
Cardiovascular outcomesSenkt LDL-C um ~60% zusätzlich zu Statinen; FOURIER zeigte signifikant weniger schwere kardiovaskuläre Ereignisse bei mit Statinen behandelten Patienten mit atherosklerotischer Erkrankung · Wochen (Ereignisse: Monate bis Jahre)
Überwiegend Mechanismus / Beobachtung5 Studien

Stetige Forschung

1 Studie in den letzten 5 Jahren

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

Quelle ansehen

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

Quelle ansehen

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

Quelle ansehen

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

Quelle ansehen

5Systematische Übersicht2020

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

Quelle ansehen

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

Quelle ansehen

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

Quelle ansehen

In der Forschungsbibliothek ansehen

Evolocumab (Repatha) – Forschung

Überwiegend Mechanismus / Beobachtung

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.