(BPT) - Cardiovascular (CV) disease affects nearly half of all adult Americans[i] and is the leading cause of death in the U.S. Although it constitutes one of the most significant challenges facing the medical community, confusion remains around which therapies are best to manage the disease and prevent heart attack, stroke and death. For the 48% of adults in the U.S. with heart disease,[i] the American College of Cardiology (ACC) and American Heart Association (AHA) continue to recommend statins for at-risk patients. However, doctors are prescribing statins alongside drugs that the latest research shows may not work.
Two Steps Forward, One Step Back
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.[ii],[iii] Then, statins were approved in the late 1980s to help prevent CV risks such as heart attack, stroke and death from heart disease.[iv] Since then, tens of millions of people have been prescribed statins, many in combination with extended release niacin or fenofibrates.[v]
However, in just the last decade, studies have shown that extended release niacin and fenofibrates are not effective in reducing the risk of cardiac events, such as a heart attack or stroke, even in combination with a statin.[vi],[vii] For example, in a randomized, placebo-controlled Lipid Study of ACCORD (Action to Control Cardiovascular Risk in Diabetes), researchers found a lack of efficacy for what was then a blockbuster drug — fenofibrate — in patients with diabetes who were taking statins.[vii] The largest study of extended release niacin, which included more than 25,000 people with heart disease, was published in The New England Journal of Medicine showing a similar lack of efficacy.[vi]
As data and studies continued to emerge, they illustrated that the potential benefit of extended release niacin and fenofibrates no longer outweigh the potential health risks when taken with statins.[vi],[vii] After this research was published, the Food and Drug Administration (FDA) took an unusual step in 2015 and withdrew its approval of extended release niacin and fenofibrates to treat cardiovascular disease in combination with statins.[viii] Yet, in 2018, the total number of prescriptions for these drugs was almost 11.5 million and many are prescribed in combination with statins.[ix],[x] It is important for consumers to reconsider if they should still be on these drugs.
“Statins have been a great advancement in the cardiovascular space,” said Norman Lepor, M.D., of Smidt/Cedars-Sinai Heart Institute and Geffen School of Medicine at UCLA. “But for many people, they’re not enough. Physicians, health care providers and patients should know that there are new scientific data regarding medications and treating cardiovascular risks, including elevated triglycerides and/or diabetes, and those that further reduce LDL-cholesterol.”
What You Can Do
Whether you have heart disease or not, playing an active role in and being aware of your health are critical for keeping your heart healthy. This includes diet, exercise, and consulting your doctor about new, proven options that can help reduce your risk of heart disease. The following questions, which you may want to discuss with your doctor, can help you take the first step in managing your heart health:
- What can I be doing to reduce my risk of heart disease?
- Is there new science available about the risks of heart disease?
- Is the treatment you’re prescribing approved by the FDA for treatment of my specific condition?
- Is there a newer, potentially more effective treatment out there?
- If I’m already using a statin, what is the best add-on for a holistic heart health treatment plan?
- If I’m using more than one medication for my heart health, how do I know it’s the most effective combination?
[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] Ganji SH, Kamanna SV, Kashyap ML. Niacin and cholesterol: role in cardiovascular disease (review). Nutr Biochem. 2003 Jun;14(6):298-305.
[iv] 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.
[v] 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
[vi] 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.
[vii] 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.
[viii] 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
[ix] Fenofibrates annual sales report.
[x] Lovaza annual sales report.