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Authors: Zachary R. Noel, PharmD, BCPS; Brent N. Reed, PharmD, BCPS-AQ Cardiology
Dietary supplements – which include herbal medications, vitamins, minerals, amino acid supplements, and dietary substances (Figure 1) – have become a multi-billion dollar industry in the United States.1 Americans spend $15 billion annually on supplements, which is equivalent to roughly 1/3 of the total prescription drug cost expenditures in the United States.1 Today, approximately one-half of American adults reports using some form of dietary supplements.2 The purpose of this blog will be to briefly review evidence for common dietary supplements touted for heart health and to provide evidence-based resources for practitioners and patients to utilize.
Common Dietary Supplements
Fish oil contains the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), although the percentage of each varies by formulation. Fish oil is effective for reducing serum triglyceride concentrations, but it is unclear whether this confers an improvement in cardiovascular risk. A recent scientific statement published by the American College of Cardiology/American Heart Association suggests treatment with fish oil is reasonable for secondary prevention of outcomes in heart failure as well as for recurrent cardiovascular events and sudden cardiac death in patients with coronary heart disease.3
Niacin, or Vitamin B3, has been shown to reduce total cholesterol and low-density lipoprotein concentrations (LDL-C), although it does so less effectively than statins and has not been associated with comparable reductions in cardiovascular events. Although niacin also decreases triglycerides and increases high-density lipoprotein concentrations (HDL-C), these effects have not conferred improvements in cardiovascular outcomes among patients receiving statins.4 Moreover, its use for this purpose increases the risk of adverse effects, including impaired glucose control, gastrointestinal disturbances, and musculoskeletal effects.5 Although niacin may still have a role in patients with challenging dyslipidemias, its use should be limited to clinicians who specialize in this area. Of note, inositol hexanicotinate (IHN) or “flush free” niacin does not demonstrate lipid-lowering properties and should not be used for this purpose. Additionally, sustained-release formulations have been associated with an excess risk of hepatotoxicity.6
Co-enzyme Q10 (CoQ10), also known as ubiquinone or ubidecarenone, is a fat-soluble antioxidant synthesized endogenously and involved in a variety of metabolic processes. Supplementation with CoQ10 has been touted for reducing statin-associated muscle symptoms (SAMS); however, recent evidence has shown CoQ10 to have no apparent impact on SAMS.7,8 CoQ10 has also been studied in heart failure for its promising effects on myocardial contractility and exercise performance. However, these trials have shown mixed results and have been subject to significant flaws in methodology.9,10 Current guidelines do not recommend addition of CoQ10 in patients with heart failure.11
Red Yeast Rice
Red yeast rice is a fermented rice product that may contain monacolin K, an HMG-CoA reductase inhibitor identical to the active ingredient in lovastatin. In the late 1990s, the FDA prohibited red yeast rice products in the US from containing more than trace amounts of monacolin K and began taking legal action against manufacturers whose products were in violation of these regulations. Nonetheless, due to limitations in the agency’s ability to inspect manufacturers of dietary supplements, some products may still contain more than trace amounts of monacolin K as well as the nephrotoxin citrinin.12 A recent study of 28 different red yeast rice products found a 120-fold variation in monacolin K content per serving recommendation.13 Red yeast rice products that conform to FDA regulations often consist of proprietary blends of other ingredients that lack proven efficacy in the treatment of dyslipidemia.
Recommendations and Resources
Dietary supplements are frequently consumed by patients due in part to the sense of empowerment and control over health they provide.14 Although patients should be encouraged to actively participate in their care, these motivations should be driven towards dietary and lifestyle interventions associated with improvements in cardiovascular outcomes (e.g., limiting sedentary habits, exercising, and avoiding tobacco products). When non-pharmacologic therapies are insufficient for preventing or treating CVD, drug therapy may be warranted. Although prescription medications are generally the safest and most evidence-based approach, ongoing and future research may substantiate the role of certain dietary supplements for the treatment of CVD. For this reason, practitioners should remain up-to-date on the most current literature in this area. Table 1 contains a list of complementary and alternative medicine (CAM) resources for practitioners to use as a reference.
|Table 1. Complementary and Alternative Medicine Resources|
|National Center for Complementary and Integrative Health
|Natural Medicines Comprehensive Database
|BMC Complementary and Alternative Medicine Open Access Journal
|Evidence-based Complementary and Alternative Medicine Open Access Journal
|FDA: Dietary Supplements
|MedlinePlus: Complementary and Alternative Medicine
Many patients do not disclose dietary supplement usage to cardiovascular team members. In fact, in studies evaluating dietary supplement use in patients with CVD, up to 92% of clinicians were unaware that their patients were taking supplements.15 Although this lack of awareness is multifactorial, some patients intentionally choose not to disclose supplement consumption for fear of disapproval. Others misperceive that supplements are not drugs, and unless directly asked, do not feel the need to report it to health care providers. Therefore, it is imperative that practitioners question patients regarding use of dietary supplements in order to prevent potentially inappropriate or harmful therapy.
In summary, the growing use of dietary supplements among adults in the US warrants greater awareness among cardiovascular team members. Although many products are promoted for their potential cardiovascular benefits, few have demonstrated them in controlled clinical trials. Nonetheless, patients may still inquire about dietary supplements or take them despite recommendations to the contrary, requiring that cardiovascular team members openly discuss them with patients, document them in the medical record, and understand their potential risks.
For more information regarding supplements and heart health, see our Expert Analysis posted on the American College of Cardiology website.
Tips for safe supplement use:
- Counsel patients to only use products that are independently verified by a third party for purity, quality, and good manufacturing practices (e.g., USP, National Sanitation Foundation [NSF])
- Encourage patients to talk with their pharmacist about potential drug-drug interactions with their prescription medications
- Encourage patients to minimize supplement consumption
- Monitor for potential adverse effects
- Counsel patients on using evidence-based resources to learn about the supplements they consume (Table 1)
Zachary R. Noel, PharmD, BCPS
Brent N. Reed, PharmD, BCPS-AQ Cardiology, FAHA
Dr. Reed is an associate professor in the Department of Pharmacy Practice and Science at the University of Maryland School of Pharmacy, and practices as a clinical pharmacy specialist in advanced heart failure at the University of Maryland Medical Center in Baltimore, MD. Follow him on his website or on Twitter @brentnreed.
- S. Food and Drug Administration. https://www.fda.gov/food/dietarysupplements/
- Bailey RL, Gahche JJ, Lentino CV, et al. Dietary supplement use in the United States, 2003-2006. J Nutr 2011;141:261-6.
- Omega-3 Polyunsaturated Fatty Acid (Fish Oil) Supplementation and the Prevention of Clinical Cardiovascular Disease. 2017;135:00–00.
- AIM-HIGH Investigators, Boden WE, Probstfield JL, et al. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med. 2011;365:2255-67.
- HPS2-THRIVE Collaborative Group, Landray MJ, Haynes R, et al. Effects of extended-release niacin with laropiprant in high-risk patients. N Engl J Med. 2014;371:203-12.
- McKenney JM, Proctor JD, Harris S, Chinchili VM. A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients. JAMA 1994;271:672-7.
- Taylor BA, Lorson L, White CM, Thompson PD. A randomized trial of coenzyme Q10 in patients with confirmed statin myopathy. 2015;238:329-35.
- Banach M, Serban C, Sahebkar A, et al. Effects of coenzyme Q10 on statin-induced myopathy: a meta-analysis of randomized controlled trials. Mayo Clin Proc. 2015;90:24-34.
- Mortensen SA, Rosenfeldt F, Kumar A, et al. The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial. JACC Heart Fail 2014;2:641-9.
- Sharma A, Fonarow GC, Butler J, Ezekowitz JA, Felker GM. Coenzyme Q10 and heart failure: a state-of-the-art review. Circ Heart Fail 2016;9:e002639.
- Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;62:e147-239.
- Childress L, Gay A, Zargar A, Ito MK. Review of red yeast rice content and current Food and Drug Administration oversight. J Clin Lipidol 2013;7:117-22.
- Cohen P. Variability in strength of red yeast rice supplements purchased from mainstream retailers. Eur J Preventive Cardiology. 2017
- Astin JA. Why patients use alternative medicine: results of a national study. JAMA. 1998;279:1548-53.
- Grant SJ, Bin YS, Kiat H, Chang DH. The use of complementary and alternative medicine by people with cardiovascular disease: a systematic review. BMC Public Health 2012;12:299.
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