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Ali4.5

Alirocumab (Praluent) Research

Mostly mechanism / observationalLimited safety

6 peer-reviewed studies

What the evidence says

Mostly mechanism / observational

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

Most evidence is from medium-quality meta-analyses and randomised trials published 2015–2025 with a typical study size of 2,341 participants.

Based on 6 studies · 1 meta-analysis · 4 RCTs · 22,206 total participants

Confidence

Moderate

By outcome

LDL cholesterol
Mostly mechanism / observational5 studies
Cardiovascular outcomes
Mostly mechanism / observational4 studies

Steady research

1 study in the last 5 years · Latest meta-analysis: 2025

201520202025

1RCTn=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

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2RCTn=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

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3RCTn=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

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4Systematic Review2015

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

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5RCTn=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

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6Meta-Analysis2025

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

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View in Research Library

Alirocumab (Praluent) Research

Mostly mechanism / observational

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.