ArticleClinical drug investigation2015
Effect of concomitant icosapent ethyl (eicosapentaenoic acid ethyl ester) on the pharmacokinetics of atorvastatin.
Article in Clinical drug investigation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 9 citations in OpenAlex.
- Prescription omega-3 fatty acid products containing highly purified eicosapentaenoic acid (EPA).Lipids in health and disease · 2017Review
- Prescription omega-3 fatty acid products: considerations for patients with diabetes mellitus.Diabetes, metabolic syndrome and obesity : targets and therapy · 2016Review
- Omega-3 carboxylic acids monotherapy and combination with statins in the management of dyslipidemia.Vascular health and risk management · 2016Review
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveIcosapent ethyl is a high-purity prescription form of eicosapentaenoic acid ethyl ester approved as an adjunct to diet to reduce triglyceride levels in adult patients with triglyceride levels ≥500 mg/dL (≥5.65 mmol/L). The objective of this open-label, drug-drug interaction study was to examine the effects of icosapent ethyl on the steady-state pharmacokinetics of atorvastatin, a commonly prescribed medication in patients with dyslipidaemia.
methodsThirty healthy subjects received atorvastatin 80 mg/day on days 1-7, icosapent ethyl 4 g/day on days 8-28, and co-administration on days 29-35. Primary end-points were natural log-transformed maximum plasma concentration (C(max)) and area under the concentration-versus-time curve from 0 to 24 h (AUC(0-24)) for atorvastatin, 2-hydroxyatorvastatin, and 4-hydroxyatorvastatin with and without icosapent ethyl.
resultsOf the 30 subjects enrolled, 26 completed the study. The 90% confidence intervals for C(max) and AUC(0-24) least-squares geometric mean ratios were within the 0.80-1.25 bounds. Concomitant administration of icosapent ethyl and atorvastatin was safe and well tolerated and icosapent ethyl did not significantly change the steady state C(max) and AUC(0-24) of atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin.
conclusionsAt steady-state concentrations, icosapent ethyl did not have an effect on the pharmacokinetics of atorvastatin. Co-administration of icosapent ethyl and atorvastatin was safe and well tolerated in healthy adult subjects.
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Registered trials
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