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Cited by 46Fatty Acid Research and HealthComplementary and Alternative Medicine StudiesLipoproteins and Cardiovascular Health

Critical Differences Between Dietary Supplement and Prescription Omega-3 Fatty Acids: A Narrative Review

Open access
Hilleman, Daniel E., Wiggins, Barbara S., Bottorff, Michael B.·2020·Advances in Therapy
DOI 10.1007/s12325-019-01211-1PMC PMC6999166
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Abstract

INTRODUCTION: Currently available omega-3 (OM-3) fatty acid products in the US are either nonprescription dietary supplements (e.g., fish oils) or prescription (Rx) medications. As such, we aimed to describe critical therapeutic differences among the OM-3 fatty acids, focusing on differences between fish oil supplements and Rx OM-3s. METHODS: A narrative review of known papers salient to this topic was conducted. RESULTS: Despite the multiple purported clinical benefits, the published evidence for OM-3 dietary supplements is generally insufficient, inconsistent, or negative. Rx OM-3 products are indicated as an adjunct to diet to reduce triglycerides (TG) in adults with severe hypertriglyceridemia (TG ≥ 500 mg/dl). Recently, the Rx eicosapentaenoic acid (EPA)-only OM-3, icosapent ethyl, demonstrated cardiovascular (CV) risk reduction among statin-treated patients at high risk of CV disease in a large CV outcomes trial (CVOT), and is now also indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated TG (≥ 150 mg/dL) and established CVD or diabetes mellitus and ≥ 2 additional risk factors for CVD. In contrast to the rigorous regulatory standards for safety, efficacy, and manufacturing of medications (whether Rx or over the counter), the Food and Drug Administration manages dietary supplements as food. Issues specific to OM-3 dietary supplements include variable content, labeling inconsistencies, and poor product quality/impurity. Given these issues, OM-3 dietary supplements should not be substituted for Rx OM-3 products. The efficacy of the EPA-only Rx OM-3 product in a large CVOT cannot be extrapolated to other OM-3 products. CONCLUSION: Consumers and health care providers need to recognize critical differences between Rx and OM-3 dietary supplements to ensure appropriate use of each OM-3 product.

AI snapshot

Written from the paper’s full text.

TL;DR

This narrative review argues that prescription omega-3 products and nonprescription omega-3 dietary supplements are not therapeutically equivalent, with key differences in regulation, purity, content, and clinical evidence. It highlights REDUCE-IT as showing cardiovascular risk reduction with prescription EPA-only icosapent ethyl, while combination DHA+EPA supplements and prescription products have not shown consistent cardiovascular benefit.

Key findings

  • In REDUCE-IT (N = 8,179), prescription EPA-only icosapent ethyl plus statin reduced major ischemic events versus placebo plus statin: 17.2% vs. 22.0%; hazard ratio 0.75 (95% CI 0.68–0.83; P < 0.001), with an absolute difference of 4.8% (95% CI 3.1–6.5) and number needed to treat of 21 (95% CI 15–33).
  • In contrast, the DHA+EPA combination trials ASCEND (N = 15,480) and VITAL (N = 25,871) showed no significant improvement in overall cardiovascular outcomes versus placebo.
  • Omega-3 dietary supplements are not FDA-approved to treat any disease, are regulated as food, and have documented issues including variable EPA/DHA content, labeling inconsistencies, poor product quality, impurities, saturated fats, and oxidation products.
  • DHA+EPA prescription combinations are not therapeutically equivalent to EPA-only icosapent ethyl and should not be substituted for it; DHA may raise LDL-C and/or blunt statin LDL-C–lowering effects.

Methods

  • Design: narrative review of known papers salient to the topic, based on previously conducted studies; the authors state it contains no studies with human participants or animals performed by them.
  • Data: synthesized evidence from recent omega-3 cardiovascular outcomes trials, including ASCEND, VITAL, and REDUCE-IT, plus regulatory, safety, product-quality, and non-cardiovascular literature.
  • Analysis: narrative synthesis with summary tables comparing trial results, regulatory requirements, and omega-3 product features.

Limitations

  • The paper does not state limitations of the review itself.
  • Evident from the text: as a narrative review, it does not describe a systematic search strategy, formal study selection, or quality appraisal, so the evidence base may be selectively presented.
  • The paper notes that older positive trials such as GISSI-Prevenzione and GISSI-HF may have had inherent biases and were conducted before contemporary statin therapy, but this is a limitation of those trials rather than of the review.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1007/s12325-019-01211-1

Cites

66 of 66 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 165 cited sources checked · 0 supported · 0 flagged

  • Premisecitation

    There are no FDA-approved over-the-counter omega-3 medications in the USA.

    “Although OM-3 dietary supplements are available, there are no Food and Drug Administration (FDA)-approved over-the-counter (OTC) OM-3 medications in the USA.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [7] Fialkow J. Omega-3 fatty acid formulations in cardiovascular disease: dietary supplements are not substitutes for prescription products. Am J Cardiovasc Drugs. 2016;16:229–39. source

      Not checked in the free run.

  • Premisecitation

    Omega-3 dietary supplements are not subject to the rigorous regulatory standards required for medications.

    “OM-3 dietary supplements are not approved as over-the-counter medications, have no approved clinical indications, and are not subject to the rigorous regulatory standards required for medications; safety issues including variable content of EPA and/or DHA, inconsistencies with labeled quantities, poor product quality, and impurities have been documented.”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [43] Regulatory information: Dietary Supplement Health and Education Act of 1994. Food and Drug Administration Website 2009. http://health.gov/dietsupp/ch1.htm. Accessed Oct 3, 2019.

      Not checked in the free run.

    • cites [44] Cohen PA. Hazards of hindsight–monitoring the safety of nutritional supplements. N Engl J Med. 2014;370:1277–80. source

      Not checked in the free run.

    • cites [45] Lopez JAG, Ito MK. PLA chapter update: prescription fish oil and Blue Cross of Idaho. LipidSpin. 2010;8:32–4.

      Not checked in the free run.

  • Premisecitation

    The prescription omega-3 product icosapent ethyl contains only high-purity EPA.

    “Among available OM-3 products, most contain a combination of DHA and EPA, with the exception of the Rx OM-3 product, icosapent ethyl, which contains only high-purity EPA [8].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [8] Vascepa [package insert]. Bedminster, NJ: Amarin Pharma Inc.; 2019.

      Not checked in the free run.

  • Interpretationreasoning

    DHA/EPA combination omega-3 products are not therapeutically equivalent to the EPA-only product icosapent ethyl.

    “Among Rx OM-3s, DHA/EPA combination OM-3s should not be substituted for the EPA-only product (icosapent ethyl) as they are not therapeutically equivalent and DHA may raise low-density lipoprotein cholesterol.”
    Quote in the paperSubstantial claim
  • Interpretationcitation

    In the statin era, cardiovascular outcomes trials of combination omega-3 fatty acids (EPA and DHA) have not shown reduction in cardiovascular disease events.

    “In the statin era, CVOTs of combination OM-3 fatty acids [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] have not shown reduction in cardiovascular disease (CVD) events.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [10] ASCEND Study Collaborative Group, Bowman L, Mafham M, et al. Effects of n-3 fatty acid supplements in diabetes mellitus. N Engl J Med. 2018;379:1540–50. source

      Not checked in the free run.

    • cites [11] Manson JE, Cook NR, Lee IM, et al. Marine n-3 fatty acids and prevention of cardiovascular disease and cancer. N Engl J Med. 2019;380:23–32. source

      Not checked in the free run.

  • May combine two claims. 18
  • Classified as probably not a substantial claim. 7

  • May combine two claims.

    Premisecitation

    Safety issues including variable content of EPA and/or DHA, inconsistencies with labeled quantities, poor product quality, and impurities have been documented for omega-3 dietary supplements.

    “OM-3 dietary supplements are not approved as over-the-counter medications, have no approved clinical indications, and are not subject to the rigorous regulatory standards required for medications; safety issues including variable content of EPA and/or DHA, inconsistencies with labeled quantities, poor product quality, and impurities have been documented.”
    Quote in the paperSubstantial claim0 of 4 sources checked
    • cites [50] Tucker J, Fischer T, Upjohn L, Mazzera D, Kumar M. Unapproved pharmaceutical ingredients included in dietary supplements associated with US Food and Drug Administration warnings. JAMA Netw Open. 2018;1:e183337. source

      Not checked in the free run.

    • cites [51] Harel Z, Harel S, Wald R, Mamdani M, Bell CM. The frequency and characteristics of dietary supplement recalls in the United States. JAMA Intern Med. 2013;173:926–8. source

      Not checked in the free run.

    • cites [53] Tainted products marketed as dietary supplements. 2018. https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=&sortColumn=1d&sd=tainted_supplements_cder&displayAll=true. Accessed Feb 25, 2019.

      Not checked in the free run.

    • cites [54] Statement from FDA commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight. 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631065.htm. Accessed Feb 21, 2019.

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    Additional factors that may influence cardiovascular outcomes trial findings include omega-3 dose, definition of primary composite cardiovascular endpoint, and study population.

    “Additional factors that may influence CVOT findings include OM-3 dose, definition of primary composite CV endpoint, and study population.”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [9] Bhatt DL, Steg G, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11–22. source

      Not checked in the free run.

    • cites [10] ASCEND Study Collaborative Group, Bowman L, Mafham M, et al. Effects of n-3 fatty acid supplements in diabetes mellitus. N Engl J Med. 2018;379:1540–50. source

      Not checked in the free run.

    • cites [11] Manson JE, Cook NR, Lee IM, et al. Marine n-3 fatty acids and prevention of cardiovascular disease and cancer. N Engl J Med. 2019;380:23–32. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    The absolute difference in primary cardiovascular endpoint events between icosapent ethyl and placebo in REDUCE-IT was 4.8% (95% CI 3.1-6.5), with a number needed to treat of 21 (95% CI 15-33).

    “This corresponded to an absolute difference of 4.8% (95% CI 3.1–6.5) between groups and a number needed to treat of 21 (95% CI 15–33).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [9] Bhatt DL, Steg G, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11–22. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Based on high-quality evidence, EPA and DHA do not have important positive or negative effects on either mortality or cardiovascular events.

    “A systematic review of 79 clinical studies of OM-3 dietary supplementation concluded that, based on high-quality evidence, EPA and DHA “do not have important positive or negative effects” on either mortality or CV events.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [22] Abdelhamid AS, Brown TJ, Brainard JS, et al. Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2018;11:Cd003177.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Premisenone given

    GISSI-Prevenzione is a much older study, conducted before the modern statin and contemporary medical era.

    “GISSI-Prevenzione and GISSI-HF had positive findings despite relatively low doses of OM-3s (≤ 1 g daily); however, these studies may have had inherent biases, and GISSI-Prevenzione is a much older study, conducted before the modern statin and contemporary medical era.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    The FDA manages dietary supplements as food, in contrast to the rigorous regulatory standards for safety, efficacy, and manufacturing of medications.

    “In contrast to the rigorous regulatory standards for safety, efficacy, and manufacturing of medications (whether Rx or over the counter), the Food and Drug Administration manages dietary supplements as food.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [43] Regulatory information: Dietary Supplement Health and Education Act of 1994. Food and Drug Administration Website 2009. http://health.gov/dietsupp/ch1.htm. Accessed Oct 3, 2019.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    The FDA-approved prescription omega-3 products have clinically proven efficacy and safety.

    “These Rx OM-3 products have clinically proven efficacy and safety and are indicated as an adjunct to dietary interventions to reduce TG in adults with severe hypertriglyceridemia (TG ≥ 500 mg/dl) at 4 g/day.”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [15] Hilleman D, Smer A. Prescription omega-3 fatty acid products and dietary supplements are not interchangeable. Manag Care. 2016;1:46B–52B.

      Not checked in the free run.

    • cites [16] Bradberry JC, Hilleman DE. Overview of omega-3 fatty acid therapies. Pharm Ther. 2013;38:681–91.

      Not checked in the free run.

    • cites [17] Ito MK. A comparative overview of prescription omega-3 fatty acid products. Pharm Ther. 2015;40:826–57.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Any statement claiming a benefit for a dietary supplement must be accompanied by a disclaimer noting that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease.

    “In fact, any statement claiming a benefit for a dietary supplement must be accompanied by a disclaimer noting that the stated claim “has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” [43].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [43] Regulatory information: Dietary Supplement Health and Education Act of 1994. Food and Drug Administration Website 2009. http://health.gov/dietsupp/ch1.htm. Accessed Oct 3, 2019.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    OM-3 dietary supplements are widely available and popular among consumers.

    “OM-3 dietary supplements are widely available and popular among consumers [42, 56].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [42] Kantor ED, Rehm CD, Du M, White E, Giovannucci EL. Trends in dietary supplement use among US adults from 1999–2012. JAMA. 2016;316:1464–74. source

      Not checked in the free run.

    • cites [56] Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002–2012. Natl Health Stat Rep. 2015;20:1–16.

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    Dietary supplements are intended for general consumer health and are not intended to treat any medical condition or disease.

    “As such, they are intended for general consumer health and are not intended to treat any medical condition or disease [43], despite advertising that often implies improvements in clinical conditions.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [43] Regulatory information: Dietary Supplement Health and Education Act of 1994. Food and Drug Administration Website 2009. http://health.gov/dietsupp/ch1.htm. Accessed Oct 3, 2019.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    The FDA has no authority to review the safety and effectiveness of dietary supplements before they are marketed and only has the authority to order removal of dietary supplements from the market if found to be unsafe or to have false or misleading claims.

    “In fact, the FDA has no authority to review the safety and effectiveness of dietary supplements before they are marketed and only has the authority to order the removal of dietary supplements from the market if found to be unsafe or to have false or misleading claims [49].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [49] Dietary supplements: what you need to know. 2017. https://www.fda.gov/food/resourcesforyou/consumers/ucm109760.htm. Accessed Jan 7, 2019.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Dietary supplements have been estimated to be implicated in more than 20,000 emergency department visits and 2000 hospitalizations in the US annually.

    “Given the public perception that dietary supplements are safe, it would likely be a surprise to consumers that dietary supplements have been estimated to be implicated in more than 20,000 emergency department visits and 2000 hospitalizations in the US annually [55].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [55] Geller AI, Shehab N, Weidle NJ, et al. Emergency department visits for adverse events related to dietary supplements. N Engl J Med. 2015;373:1531–40. source

      Not checked in the free run.

  • May combine two claims.

    Premisereasoning

    Dietary supplements are considered safe until proven otherwise, whereas medications must prove efficacy and safety to be made available to the general population.

    “Thus, dietary supplements are considered safe until proven otherwise, whereas medications must not only prove efficacy, but must also prove safety to be made available to the general population.”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [43] Regulatory information: Dietary Supplement Health and Education Act of 1994. Food and Drug Administration Website 2009. http://health.gov/dietsupp/ch1.htm. Accessed Oct 3, 2019.

      Not checked in the free run.

    • cites [44] Cohen PA. Hazards of hindsight–monitoring the safety of nutritional supplements. N Engl J Med. 2014;370:1277–80. source

      Not checked in the free run.

    • cites [45] Lopez JAG, Ito MK. PLA chapter update: prescription fish oil and Blue Cross of Idaho. LipidSpin. 2010;8:32–4.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Dietary supplements do not meet the regulatory standards required for over-the-counter drugs and are not approved to treat any disease.

    “It is important to educate patients that dietary supplements do not meet the regulatory standards required for OTC drugs and are not approved to treat any disease [43].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [43] Regulatory information: Dietary Supplement Health and Education Act of 1994. Food and Drug Administration Website 2009. http://health.gov/dietsupp/ch1.htm. Accessed Oct 3, 2019.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In REDUCE-IT, a nonsignificant increase in the risk of bleeding, without an increased risk in life-threatening bleeding, was observed in the icosapent ethyl group.

    “A nonsignificant increase in the risk of bleeding, without an increased risk in life-threatening bleeding, was also observed in the icosapent ethyl group.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [9] Bhatt DL, Steg G, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11–22. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Variable content of EPA and/or DHA, and inconsistencies with labeled quantities, have been documented for OM-3 dietary supplements.

    “For example, variable content of EPA and/or DHA, and inconsistencies with labeled quantities have been documented (Fig. 1) [57–61].”
    • Also stated in: § Substitution · plain
      “inconsistent/variable amounts of EPA and DHA [57–59]”
    Quote in the paperSubstantial claim0 of 5 sources checked
    • cites [57] Shim SM, Santerre CR, Burgess JR, Deardorff DC. Omega-3 fatty acids and total polychlorinated biphenyls in 26 dietary supplements. J Food Sci. 2003;68:2436–40. source

      Not checked in the free run.

    • cites [58] Kleiner AC, Cladis DP, Santerre CR. A comparison of actual versus stated label amounts of EPA and DHA in commercial omega-3 dietary supplements in the United States. J Sci Food Agric. 2015;95:1260–7. source

      Not checked in the free run.

    • cites [59] Ritter JC, Budge SM, Jovica F. Quality analysis of commercial fish oil preparations. J Sci Food Agric. 2013;93:1935–9. source

      Not checked in the free run.

    • cites [60] Mason RP, Sherratt SCR. Omega-3 fatty acid fish oil dietary supplements contain saturated fats and oxidized lipids that may interfere with their intended biological benefits. Biochem Biophys Res Commun. 2017;483:425–9. source

      Not checked in the free run.

    • cites [61] Albert BB, Derraik JG, Cameron-Smith D, et al. Fish oil supplements in New Zealand are highly oxidised and do not meet label content of n-3 PUFA. Sci Rep. 2015;5:7928. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

    Interpretationreasoning

    The fact that a health care provider writes the prescription and is engaged in decision-making provides patients with the benefit of medical supervision for their therapy.

    “In addition to the regulatory rigor required for Rx OM-3s, the simple fact that a health care provider writes the Rx and is therefore engaged in the decision-making provides patients with the benefit of medical supervision for their therapy.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    The American Pharmacists Association has recognized issues with OM-3 dietary supplements, noting that dietary supplements are not required to meet strict FDA drug standards for safety, efficacy, and manufacturing and are not intended to treat serious medical conditions like very high triglycerides.

    “The American Pharmacists Association has recognized issues with OM-3 dietary supplements”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [73] Agarwal P. APhA convenes stakeholders on appropriate omega-3 fish oil use for VHT. 2015. https://www.pharmacist.com/apha-convenes-stakeholders-appropriate-omega-3-fish-oil-use-vht. Accessed Jan 7, 2019.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    This is in line with updated recommendations from the ESC/EAS and the NLA.

    “This is in line with updated recommendations from the ESC/EAS and the NLA [31, 32].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [31] Mach F, Baigent C, Catapano AL, et al. ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk: The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J. 2019;2019:1–78.

      Not checked in the free run.

    • cites [32] NLA position on the use of icosapent ethyl in high and very-high risk patients. 2019. https://www.lipid.org/nla/nla-position-use-icosapent-ethyl-high-and-very-high-risk-patients. Accessed Sep 16, 2019.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Dietary supplements are not indicated for severe hypertriglyceridemia or any other medical condition or disease.

    “While all Rx OM-3 products are indicated for treatment of severe hypertriglyceridemia [8, 18–20], dietary supplements are not indicated for this or any other medical condition or disease [43].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [43] Regulatory information: Dietary Supplement Health and Education Act of 1994. Food and Drug Administration Website 2009. http://health.gov/dietsupp/ch1.htm. Accessed Oct 3, 2019.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    DHA may raise LDL-C and/or blunt statin LDL-C-lowering effects.

    “This is particularly important because DHA may raise LDL-C and/or blunt statin LDL-C–lowering effects [15].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [15] Hilleman D, Smer A. Prescription omega-3 fatty acid products and dietary supplements are not interchangeable. Manag Care. 2016;1:46B–52B.

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    OM-3 dietary supplements may not be cost-effective as there is no CV benefit.

    “OM-3 dietary supplements are not considered by the FDA to be equivalent to Rx products and may not be cost-effective as there is no CV benefit.”
    Quote in the paperSubstantial claim
22 of 22

  • The paper relies on this without support.

    “Natural” products are commonly perceived as safer than products manufactured by pharmaceutical companies.

    “however, there is a prevailing misconception that “natural” products are safer than products manufactured by pharmaceutical companies.”

  • The paper relies on this without support.

    Consumers are selecting supplements based on incorrect assumptions regarding their efficacy.

    “In addition, consumers may be selecting supplements based on incorrect assumptions regarding their efficacy.”

  • The paper relies on this without support.

    Patients may be inclined to use OM-3 dietary supplements in lieu of Rx OM-3 products because of perceptions regarding cost or convenience.

    “Patients may be inclined to use OM-3 dietary supplements in lieu of Rx OM-3 products because of perceptions regarding cost or convenience”
3 of 3

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Cites

Flagged first, then by citations

2 of the 68 references couldn’t be matched to a known paper.

Research works printed but not linked: 2

  1. Lopez JAG, Ito MK. PLA chapter update: prescription fish oil and Blue Cross of Idaho. LipidSpin. 2010;8:32–4.
  2. Truong P, Johnson C, Gabriel D. Variability of cholesterol and saturated fat content in dietary supplements [abstract P72]. Circulation. 2007;115:e238.

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Related

Authors
Hilleman, D. E., Wiggins, B. S., & Bottorff, M. B.
Affiliations
  • Creighton University (US)
  • Medical University of South Carolina (US)
  • Manchester University (US)
Corresponding author
Hilleman, Daniel E.
ORCID
Venue
Advances in Therapy
Publisher
Springer Science and Business Media LLC
Published
2020-01-09
Volume
37
Issue
2
Pages
656-670
ISSN
  • 0741-238X (ISSN-L)
  • 1865-8652
DOI
10.1007/s12325-019-01211-1
PMC
PMC6999166
OpenAlex
W2999479781
Semantic Scholar
17b42522c151e81ffee4396c103f4e5aaa450980
Cited by
46
References
68
Citations by year
2026: 3 · 2025: 6 · 2024: 6 · 2023: 8 · 2022: 5 · 2021: 12 · 2020: 6
FWCI
0.95
Type
journal article
Language
en
Open access
Licence
Locations
  • Advances in Therapy (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Funders
Amarin Pharma
Topics
  • Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
  • Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
Keywords
omega-3 fatty acids, dietary supplements, fish oil supplements, icosapent ethyl, eicosapentaenoic acid, hypertriglyceridemia, cardiovascular risk reduction, statin therapy, supplement regulation, cardiovascular disease, diabetes mellitus
MeSH terms
Adult, Aged, Aged, 80 and over, Cardiovascular Diseases, Nonprescription Drugs, Female, Humans, Male, Middle Aged, United States, Eicosapentaenoic Acid, Fatty Acids, Omega-3, Dietary Supplements, Prescription Drugs

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