Results of a Cleveland Clinic trial show that six dietary supplements commonly used and marketed to improve heart health did not reduce “bad cholesterol” compared to a low-dose cholesterol-lowering drug (also called a statin) or a placebo. The six supplements studied included fish oil, garlic, cinnamon, turmeric, plant sterols and red yeast rice.
The results of the supplement, placebo, or rosuvastatin (SPORT) study were presented today in a late-breaking scientific session at the 2022 Scientific Sessions of the American Heart Association and simultaneously published in the Journal of the American College of Cardiology.
“If you’re taking over-the-counter supplements for heart health or cholesterol lowering, you should reconsider,” said Luke Laffin, MD, study author and co-director of the Center for Blood Pressure Disorders in the Heart, Vascular & Cleveland Clinic Chest Institute. “Unfortunately, many American consumers believe that cholesterol supplements are safer than prescription drugs and believe that supplements are as effective, or even more effective, than statins.”
The marketing of dietary supplements is regulated by the Dietary Supplement Health and Education Act of 1994 and overseen by the US Federal Trade Commission rather than the Food and Drug Administration. Therefore, supplements do not need to meet the safety and efficacy standards required for pharmaceutical marketing.
Elevated low-density lipoprotein (LDL), also known as bad cholesterol, is a major cause of coronary heart disease. LDL cholesterol causes fatty deposits to build up in the arteries, reducing or blocking the flow of blood and oxygen that the heart needs. This can lead to heart attack or stroke. Numerous studies show that lowering LDL cholesterol reduces the risk of coronary heart disease.
In the single-center, prospective, randomized, single-blind clinical trial, researchers analyzed health data from 190 adults aged 40 to 75 with no history of cardiovascular disease. Participants were randomized to receive a low-dose rosuvastatin statin (5 mg daily), placebo, fish oil, cinnamon, garlic, turmeric, plant sterols, or yeast of red rice. The primary endpoint was percent change in LDL cholesterol from baseline for rosuvastatin 5 mg daily compared to placebo and each supplement after 28 days.
The results showed that the percentage reduction in LDL cholesterol with rosuvastatin was greater than all supplements and placebo. None of the dietary supplements demonstrated a significant decrease in LDL cholesterol compared to placebo. Rosuvastatin also had a beneficial impact on blood triglycerides and total cholesterol, which helps reduce cardiovascular risk.
The average reduction in LDL cholesterol after 28 days was 37.9% in participants taking the statin, while changes in LDL cholesterol levels in those taking either dietary supplement were similar to those in the placebo group. Participants in the statin group had an average 24% decrease in total cholesterol, while the placebo group and all dietary supplements showed no benefit. Rosuvastatin caused a 19% decrease in blood triglycerides compared to placebo, but there was no difference in triglycerides for any of the dietary supplements.
Adverse event rates were similar across all groups, although numerically higher among participants randomized to receive plant sterols or red yeast rice. Additionally, no significant adverse changes in liver function tests, estimated glomerular filtration rate, or blood glucose levels have been observed with the use of rosuvastatin.
“Sales of dietary supplements are estimated at nearly $50 billion annually in the United States, and many supplements are marketed as natural alternatives for heart protection and cholesterol management,” said lead author Steven Nissen. , MD, Academic Director of the Heart, Vascular & Thoracic Institute. at the Cleveland Clinic. “For the management of hypercholesterolemia, supplements are often used by patients instead of statins, in the absence of high quality evidence. This represents a major public health problem. »
The SPORT trial was funded by AstraZeneca with an unrestricted grant. The Cleveland Clinic has full control over the study methodology, data analysis, and discussion of clinical implications.
Dr. Laffin has been a consultant or board member of Medtronic, Eli Lilly, Mineralys Therapeutics, AstraZeneca. He is an advisor for LucidAct Health and Gordy Health.
Dr. Nissen has consulted for numerous pharmaceutical companies and has overseen clinical trials for Amgen, AstraZeneca, Cerenis, Eli Lilly, Novartis, Novo Nordisk, The Medicines Company, Ordemanden, Takeda and Pfizer. However, it does not accept fees, consulting fees or other compensation from commercial entities.