Dear Editor,
I read with concern the recently posted meta-analysis by Sattar et al.1, titled “Cardiovascular outcomes of ethyl eicosapentaenoic acid (EPA) in diabetes mellitus: a meta-analysis,” published online in the December 2022 issue of the Annals of Medicine and Surgery. It the current form, this article contains inaccuracies and errors that will put patient care at harm and needs to be retracted immediately.
To conclude that Vascepa (Amarin Pharma, Inc. Bridgewater, NJ, US) [icosapent ethyl (IPE)] is ineffective in reducing cardiovascular events based mostly on studies that DID NOT utilize pure IPE is false and misleading and goes against regulatory health authority approvals of IPE at 4 g/day as well as guidelines and scientific statements that have incorporated IPE at 4 g/day for cardiovascular risk reduction in high-risk patient with diabetes and those with established atherosclerotic cardiovascular disease on statin therapy with persistently elevated and high triglyceride levels.2
The publication noted, “A total of four randomized control trials (33 092 patients; Vascepa n=16 586; Placebo n=16 506) were included in our analysis. The overall mean age was 64.3 years old (Vascepa=64.3 y; Placebo=64.3 y). The sample was 61.5% male (Vascepa=60.8%; Placebo=62.1%). In patients with diabetes mellitus, Vascepa was found to have no significant effect on the primary composite outcome.” However, the studies cited as part of the meta-analysis – ORIGIN, ASCEND and ALPHA-OMEGA – did not investigate the efficacy or safety of IPE. These studies instead investigated the efficacy and safety of omega-3 mixtures of EPA+docosahexaenoic acid with the exception of Japan EPA Lipid Intervention Study that contained a lower dose of EPA. Therefore, it is completely inaccurate, and potentially dangerous to patient care, to conclude that Vascepa (IPE) is not effective based on these facts when most of the studies did not use IPE or EPA.
In addition, it is clear from the reading of this paper that there is likely a fundamental misunderstanding among the authors regarding the differences between Vascepa, which is comprised of only highly purified 1 g per capsule of icosapent ethyl, an ethyl ester of EPA, as compared to omega-3 mixture products which contain EPA+docosahexaenoic acid.
The retraction of this publication should be made at the earliest possible date and a full correction be published to help address any confusion this publication has caused among the medical community and for patients.
Ethical approval
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Consent
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Sources of funding
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Author contribution
S.P. wrote the Letter to the Editor.
Conflicts of interest
Employee and stock shareholder of Amarin Pharma Inc.
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This is a Letter to editor and has no associated data.
Footnotes
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Published online 12 January 2023
References
- 1. Sattar Y, Suleiman ARM, Song D, et al. Cardiovascular outcomes of ethyl eicosapentaenoic acid in diabetes mellitus: a meta-analysis. Ann Med Surg 2022;84:104846. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2. Miller M, Tokgozoglu L, Parhofer KG, et al. Icosapent ethyl for reduction of persistent cardiovascular risk: a critical review of major medical society guidelines and statements. Exp Rev Cardiovasc Ther 2022;20:609–625. [DOI] [PubMed] [Google Scholar]