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Ico4.2

Icosapent-Ethyl (Vascepa) – Forschung

Überwiegend Mechanismus / Beobachtung

7 begutachtete Studien

Was die Evidenz sagt

Überwiegend Mechanismus / Beobachtung

Die meisten Studien zu Icosapent-Ethyl (Vascepa) 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 2011–2025 mit einer typischen Studiengröße von 8,179 Teilnehmenden.

Basierend auf 7 Studien · 1 Meta-Analyse · 5 RCTs · 29,436 Teilnehmende insgesamt

Konfidenz

Hohe Konfidenz

Nach Outcome

Triglycerides & lipidsIn REDUCE-IT senkte den kombinierten Endpunkt schwerwiegender kardiovaskulärer Ereignisse um ~25 % bei statinbehandelten Hochrisikopatienten; senkt Triglyzeride um ~20-35 % bei 4 g/Tag · Monate bis Jahre
Überwiegend Mechanismus / Beobachtung6 Studien
Cardiovascular eventsIn REDUCE-IT senkte den kombinierten Endpunkt schwerwiegender kardiovaskulärer Ereignisse um ~25 % bei statinbehandelten Hochrisikopatienten; senkt Triglyzeride um ~20-35 % bei 4 g/Tag · Monate bis Jahre
Überwiegend Mechanismus / Beobachtung5 Studien
Metabolic & cardiometabolic risk
Überwiegend Mechanismus / Beobachtung3 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung3 Studien

Stetige Forschung

2 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2022

201120182025

1RCTn=8,179 · very large study2019

Among patients with elevated triglyceride levels despite statin therapy, the risk of ischemic events was significantly lower among those who received 2 g of icosapent ethyl twice daily.

Bhatt, Steg, Miller, Brinton, Jacobson, Ketchum · The New England journal of medicine (2019)

REDUCE-IT: 8,179 statin-treated patients with elevated triglycerides and high cardiovascular risk
~25% relative reduction in the primary composite of cardiovascular death, MI, stroke, revascularization, and unstable angina
Landmark outcome trial establishing icosapent ethyl's cardiovascular benefit

Quelle ansehen

2RCTn=13,078 · very large study2020

Among statin-treated patients at high cardiovascular risk, the addition of a high-dose omega-3 carboxylic acid did not significantly reduce major adverse cardiovascular events versus corn oil.

Nicholls, Lincoff, Garcia, Bash, Ballantyne, Barter · JAMA (2020)

STRENGTH: ~13,000 high-risk statin-treated patients given mixed EPA/DHA omega-3 vs corn-oil placebo
NO significant reduction in major adverse cardiovascular events; trial stopped for futility
Critical contrast to REDUCE-IT — benefit did not generalize to a mixed EPA/DHA formulation

Quelle ansehen

3RCTn=8,179 · very large study2019

Icosapent ethyl reduced total ischemic events, including first, subsequent, and total events.

Bhatt, Steg, Miller, Brinton, Jacobson, Ketchum · Journal of the American College of Cardiology (2019)

REDUCE-IT secondary analysis of total (first plus recurrent) ischemic events
Benefit extended beyond first events to subsequent and total events
Strengthens the magnitude and consistency of the cardiovascular benefit

Quelle ansehen

4RCT2011

AMR101 4 g/day significantly reduced triglyceride levels in patients with very high triglycerides without raising LDL cholesterol.

Bays, Ballantyne, Kastelein, Isaacsohn, Braeckman, Soni · The American journal of cardiology (2011)

MARINE: randomized, placebo-controlled trial in patients with very high triglycerides (≥500 mg/dL)
4 g/day lowered triglycerides ~33% without increasing LDL cholesterol
Pivotal triglyceride-lowering trial supporting the first approval

Quelle ansehen

5RCT2012

AMR101 significantly reduced triglyceride levels in statin-treated patients with persistent high triglycerides.

Ballantyne, Bays, Kastelein, Stein, Isaacsohn, Braeckman · The American journal of cardiology (2012)

ANCHOR: randomized trial in statin-treated patients with persistent high triglycerides (200–500 mg/dL)
4 g/day lowered triglycerides ~21.5% on top of statin therapy
Demonstrates added triglyceride-lowering in the statin-treated population later studied in REDUCE-IT

Quelle ansehen

6Meta-Analyse2022

Omega-3 supplements were not statistically significantly associated with reduced all-cause mortality, cardiac death, MI, or stroke, with the exception of reduced cardiac mortality only for the equivalent dose of 2 capsules/day (RR 0.55) ... higher doses and particularly for the unique type of omega-3 icosapent ethyl ester should be further addressed.

Markozannes, Ntzani, Tsapas, Mantzoros, Tsiara, Xanthos · Clinical nutrition (Edinburgh, Scotland) (2022)

Random-effects meta-analysis of 19 double-blind omega-3 RCTs (97,709 participants) on major adverse cardiovascular events, with EPA-dose meta-regression and trial-sequential analysis
Omega-3 was NOT significantly associated with all-cause mortality, cardiac death, MI or stroke overall; the only positive signal was reduced cardiac mortality at the equivalent of 2 capsules/day (RR 0.55)
Meta-regression on EPA dose was not statistically significant; the authors conclude that higher doses, and icosapent ethyl specifically, should be further addressed rather than assumed beneficial

Quelle ansehen

7Beobachtungsstudie2025

The REDUCE-IT randomized trial demonstrated a cardiovascular benefit of icosapent ethyl but also raised potential safety signals for atrial fibrillation and serious bleeding.

Patil, Gregory, Savona, Jarmukli, Leonard · Clinical drug investigation (2025)

Retrospective active-comparator cohort in US Veterans Affairs data (icosapent ethyl vs mixed omega-3)
Examined real-world rates of new-onset atrial fibrillation and major bleeding
Provides real-world context for the AF and bleeding safety signals from REDUCE-IT

Quelle ansehen

In der Forschungsbibliothek ansehen

Icosapent-Ethyl (Vascepa) – Forschung

Überwiegend Mechanismus / Beobachtung

Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.

Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial.

Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT.

Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the MARINE trial).

Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study).

Dose-related meta-analysis for Omega-3 fatty acids supplementation on major adverse cardiovascular events.

Evaluating the Real-World Safety of Icosapent Ethyl Versus Omega-3 Polyunsaturated Fatty Acid in Nationwide US Veterans Cohort: Examining Atrial Fibrillation and Bleeding Endpoints.