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Ali4.5

Alirocumab (Praluent) – Forschung

Überwiegend Mechanismus / Beobachtung

9 begutachtete Studien

Was die Evidenz sagt

Überwiegend Mechanismus / Beobachtung

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

Die meiste Evidenz stammt aus mittelwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2015–2026 mit einer typischen Studiengröße von 2,341 Teilnehmenden.

Basierend auf 9 Studien · 1 Meta-Analyse · 4 RCTs · 22,206 Teilnehmende insgesamt

Konfidenz

Mittlere Konfidenz

Nach Outcome

LDL cholesterolSenkt LDL-C um ~50-60% zusätzlich zu Statinen; ODYSSEY OUTCOMES reduzierte schwerwiegende kardiovaskuläre Ereignisse nach kürzlich aufgetretenem akutem Koronarsyndrom · Wochen (Ereignisse: Monate bis Jahre)
Überwiegend Mechanismus / Beobachtung8 Studien
Cardiovascular outcomesSenkt LDL-C um ~50-60% zusätzlich zu Statinen; ODYSSEY OUTCOMES reduzierte schwerwiegende kardiovaskuläre Ereignisse nach kürzlich aufgetretenem akutem Koronarsyndrom · Wochen (Ereignisse: Monate bis Jahre)
Überwiegend Mechanismus / Beobachtung4 Studien

Aktives Forschungsgebiet

4 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2025

201520202026

1Systematische Übersicht2026

This review examines the current preclinical evidence for natural inhibitors of PCSK9 and their antiviral properties, discusses clinical assessments to date, and considers the potential future role of naturally occurring PCSK9i in antiviral development, acknowledging the substantial research gaps that remain.

Kareem RA, Sameer HN, Athab ZH, Adil M, Yaseen A, Allela OQB. · Archives of microbiology (2026)

Crucially, the majority of evidence for these natural substances remains preclinical, derived from in vitro and animal studies.
The contribution of PCSK9 inhibition to the reported antiviral effects remains unclear, as pleiotropic mechanisms may be involved.
Therefore, rather than being clinically proven substitutes for licensed PCSK9-targeted treatments, these molecules should be considered experimental or maybe supplementary medicines.

Quelle ansehen

2Systematische Übersicht2024

This article summarizes the milestones in the development of alirocumab leading to this first pediatric approval for HeFH.

Kang C. · Paediatric drugs (2024)

Alirocumab was approved a few months later in the US for use as an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged ≥ 8 years with HeFH to reduce LDL-C.
This article summarizes the milestones in the development of alirocumab leading to this first pediatric approval for HeFH.
Further research warranted to confirm findings

Quelle ansehen

3Beobachtungsstudie2024

As a result, PCSK9 inhibitors and vaccines may serve as viable host therapies for viral infections, as our research indicates that PCSK9 is significantly involved in the pathogenesis of viral infections.

Muzammil K, Hooshiar MH, Varmazyar S, Omar TM, Karim MM, Aadi S, Kalavi S, Yasamineh S. · Microbial cell factories (2024)

Conversely, using therapeutic, fully humanized antibodies to block PCSK9 leads to a significant reduction in high LDL cholesterol (LDL-C) levels.
Furthermore, PCSK9 inhibition has been suggested to protect against dengue virus (DENV) potentially and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viruses.
Recent evidence regarding the impact of PCSK9 on a variety of viral infections, including HCV, HIV, DENV, and SARS-CoV-2, is examined in this article.

Quelle ansehen

4RCTn=18,924 · very large study2018

Among patients with a recent acute coronary syndrome, alirocumab reduced the risk of major adverse cardiovascular events.

Schwartz, Steg, Szarek, Bhatt, Bittner, Diaz · The New England journal of medicine (2018)

ODYSSEY OUTCOMES randomized trial of ~18,900 patients 1–12 months after acute coronary syndrome on intensive statins
Alirocumab significantly reduced the composite of coronary-heart-disease death, non-fatal MI, ischemic stroke, and unstable-angina hospitalization
Showed a possible reduction in all-cause mortality, strongest in higher-risk subgroups

Quelle ansehen

5RCTn=2,341 · very large study2015

Alirocumab produced large and durable reductions in LDL cholesterol levels among patients at high cardiovascular risk.

Robinson, Farnier, Krempf, Bergeron, Luc, Averna · The New England journal of medicine (2015)

ODYSSEY LONG TERM randomized trial in high-cardiovascular-risk patients on maximally tolerated statins
Alirocumab reduced LDL cholesterol by roughly 60% versus placebo over 78 weeks
A post hoc analysis suggested fewer cardiovascular events

Quelle ansehen

6RCTn=735 · large study2015

Alirocumab provided substantial and sustained LDL cholesterol reductions in patients with heterozygous familial hypercholesterolaemia.

Kastelein, Ginsberg, Langslet, Hovingh, Ceska, Dufour · European heart journal (2015)

Pooled ODYSSEY FH I and FH II randomized trials in 735 heterozygous familial-hypercholesterolemia patients
Alirocumab produced large, sustained LDL-C reductions through 78 weeks on top of statins
Supports efficacy in a genetically high-LDL population

Quelle ansehen

7Systematische Übersicht2015

PCSK9 antibodies markedly reduced LDL cholesterol levels and were associated with lower all-cause mortality.

Navarese, Kolodziejczak, Schulze, Gurbel, Tantry, Lin · Annals of internal medicine (2015)

Systematic review and meta-analysis of PCSK9-antibody trials (including alirocumab) in adults with hypercholesterolemia
Pooled large LDL-C reductions and an associated reduction in all-cause and cardiovascular mortality
Early class-level confirmation of efficacy

Quelle ansehen

8RCTn=206 · medium study2019

From baseline to week 36, a numerically greater percent reduction in normalized total atheroma volume was observed with alirocumab vs. standard of care, which did not reach statistical significance.

Ako, Hibi, Tsujita, Hiro, Morino, Kozuma · Circulation journal (2019)

ODYSSEY J-IVUS randomized intravascular-ultrasound trial in Japanese acute-coronary-syndrome patients
Examined coronary atheroma (percent and total atheroma volume) with alirocumab added to statins
The atheroma-volume difference vs. statin alone was NOT statistically significant (between-group difference -1.6%, P=0.23), despite a 63.9% vs 13.4% LDL-C reduction

Quelle ansehen

9Meta-Analyse2025

PCSK9 inhibitors substantially reduced LDL cholesterol in patients with heterozygous familial hypercholesterolemia.

Movahedan, Ellis, Barry · American journal of cardiovascular drugs (2025)

Meta-analysis of PCSK9-inhibitor trials (alirocumab and evolocumab) in heterozygous familial hypercholesterolemia
Confirmed large, consistent LDL-C reductions in this high-risk genetic population
Reinforces the class efficacy seen in the ODYSSEY FH trials

Quelle ansehen

In der Forschungsbibliothek ansehen

Alirocumab (Praluent) – Forschung

Überwiegend Mechanismus / Beobachtung

Review: natural compounds as PCSK9 inhibitors for antiviral therapy

Alirocumab: Pediatric First Approval

Potential use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition and prevention method in viral infection

Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome.

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

ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia.

Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis.

Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients With Acute Coronary Syndrome - The ODYSSEY J-IVUS Trial.

Efficacy of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Patients with Heterozygous Familial Hypercholesterolemia: A Meta-analysis.