Cardiovascular disease is the leading cause of death in the United States and affects nearly half of all adult Americans.[i] Misinterpretation in the cardiovascular field acts as a barrier for determining the best therapies to manage overall risk. For the 48% of adults in the U.S. with heart disease, the American College of Cardiology (ACC) and American Heart Association (AHA) continue to recommend statin therapy for at-risk patients. However, doctors often prescribe statins alongside drugs such as extended-release niacin and fenofibrates, neither of which are effective at decreasing cardiovascular risk according to current research.[ii],[iii]
Time to double check the research
Doctors began prescribing extended-release niacin in the 1950s and fenofibrates in the 1970s, first in France and then eventually in the U.S., to help patients with heart disease lower their cholesterol.[iv],[v] In the late 1980s statins were Food and Drug Administration (FDA) approved to help prevent cardiovascular (CV) events such as heart attack, stroke and death from heart disease.[vi] Since then, tens of millions of people have been prescribed statins, many in combination with extended-release niacin or fenofibrates.[vii]
However, in just the last decade, studies have shown that extended-release niacin and fenofibrates are not effective in reducing the risk of CV events, such as a heart attack or stroke, even in combination with a statin.[viii],[ix]
Additional studies showed that the potential benefit of extended-release niacin and fenofibrates no longer outweighed the potential health risks when taken with statins.[vi] After this research emerged, the FDA took action in 2016 by withdrawing its approval of extended-release niacin and fenofibrates for use in lowering cardiovascular risk in combination with statins.[x] Despite the FDA’s decision, however, more than 50% of 1,000 consumers surveyed in the U.S. believe fenofibrates are approved for use by the FDA or they are unsure of the drug’s current status.[xi] Furthermore, in 2018 the total number of prescriptions for extended-release niacin and fibrate drugs was almost 11.5 million with many prescribed in combination with statins.[xii],[xiii] The persistent lack of knowledge about the ineffectiveness of extended-release niacin and fenofibrates alongside statins is dangerous, particularly for those who are at high risk of having a CV event like a heart attack or stroke.
Approved treatments exist
Luckily, there are FDA-approved treatment options available beyond — and in combination with — statins that further reduce cardiovascular risk. Even though medical societies and associations constantly update their guidelines based on these new treatment options, unfortunately knowledge gaps continue to put people at risk.
Are you doing your due diligence?
While only half of consumers surveyed say they are keeping up “somewhat well” with advancements in treatments for heart disease, they are much more likely to have confidence in their doctors to stay abreast of the latest treatment options.[xi] Thankfully 92% of 500 primary care physicians and cardiologists surveyed consult treatment guidelines multiple times a year to inform their treatment plans for patients.[xiv]
These guidelines show that there are FDA-approved treatments available that reduce CV events beyond statins and it’s likely your healthcare provider is in the know. Make an appointment to consult with your doctor on these approved options to learn what can be done to further reduce your risk even if you are already on statin therapy.
Visit truetoyourheart.com to learn more about cardiovascular disease and what you can do to reduce your risk.
[i] American Heart Association. Cardiovascular diseases affect nearly half of American adults, statistics show. January 31, 2019. Available at: https://www.heart.org/en/news/2019/01/31/cardiovascular-diseases-affect-nearly-half-of-american-adults-statistics-show (Accessed on February 22, 2019).
[ii] Landray MJ, Haynes R, et al. Effects of Extended-Release Niacin with Laropiprant in High-Risk Patients. N Engl J Med 2014; 371:203-212.
[iii] ACCORD Study Group, Ginsberg HN, Elam MB, Lovato LC, Crouse JR 3rd, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J, Grimm RH, Ismail-Beigi F, Bigger JT, Goff DC Jr, Cushman WC, Simons-Morton DG, Byington RP. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1563-74.
[iv] Ganji SH, Kamanna SV, Kashyap ML. Niacin and cholesterol: role in cardiovascular disease (review). Nutr Biochem. 2003 Jun;14(6):298-305.
[v] Lalloyer F, Staels B. Fibrates, glitazones, and peroxisome proliferator-activated receptors. Arterioscler Thromb Vasc Biol. 2010;30(5):894–899. doi:10.1161/ATVBAHA.108.179689.
[vi] Harrington RA. Statins-Almost 30 Years of Use in the United States and Still Not Quite There. JAMA Cardiol. 2017 Jan 1;2(1):66. doi: 10.1001/jamacardio.2016.4709.
[vii] Salami JA, Warraich H, Valero-Elizondo J, et al. National Trends in Statin Use and Expenditures in the US Adult Population From 2002 to 2013: Insights From the Medical Expenditure Panel Survey. JAMA Cardiol. 2017;2(1):56–65. doi:10.1001/jamacardio.2016.4700
[viii] Landray MJ, Haynes R, et al. Effects of Extended-Release Niacin with Laropiprant in High-Risk Patients. N Engl J Med 2014; 371:203-212.
[ix] ACCORD Study Group, Ginsberg HN, Elam MB, Lovato LC, Crouse JR 3rd, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J, Grimm RH, Ismail-Beigi F, Bigger JT, Goff DC Jr, Cushman WC, Simons-Morton DG, Byington RP. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1563-74.
[x] Food and Drug Administration. Withdrawal of approval of indications related to the coadministration with statins in applications for niacin extended-release tablets and fenofibric acid delayed-release capsules. 4/18/2016. Available via this link: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-08887.pdf
[xi] APCO Insight, “Amarin Unbranded Campaign: Consumer Survey”: Results from 1,336 interviews including a representative sample of 1,000 US consumers; Feb 6-11, 2020
[xii] Fenofibrates annual sales report.
[xiii] Lovaza annual sales report.
[xiv] APCO Insight, “Amarin Unbranded Campaign: HCP Survey”: Results from 598 HCP’s; Dec 27, 2019 – Jan 2, 2020