Industry responds to pharmaceutical study comparing a low-dose statin medication to dietary supplements

Photo © AdobeStock.com/Маргарита Медведева

Results from a recent study¹ funded by AstraZeneca, called the “Supplements, Placebo, or Rosuvastatin (SPORT)” Study, compared the effects of its prescription low-dose statin (Rosuvastatin) to placebo and six common dietary supplements, including fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice, over a four-week period. The primary endpoint of the study was the percent change of low-density lipoprotein cholesterol (LDL-C). Results showed that subjects taking the statin medication saw a significantly greater percent change in LDL-C, compared to placebo and all the dietary supplements, which saw no significant change in LDL-C over a four-week period.

Advocates for the dietary supplement industry are responding to the study, pointing out its limitations, and criticizing the comparison of a statin medication to dietary supplements, which are not designed for treatment of disease.

“SPORT completely misses the point of supplementation by comparing the effects of a prescription drug to dietary supplements in a short-term study. Dietary supplements are not intended to be quick fixes and their effects may not be revealed during the course of a study that only spans four weeks, particularly on a multifactorial condition like high cholesterol,” explained the Council for Responsible Nutrition’s (CRN; Washington, D.C.) vice president of scientific and regulatory affairs, Andrea Wong, PhD, in a press release. “This is a major—and author-acknowledged—limitation of the study. The most enthusiastic supporters of supplements wouldn’t expect disease markers to improve in 28 days from supplement use, even in conjunction with dietary changes and exercise.”

The Consumer Healthcare Products Association’s (CHPA; Washington, D.C.) senior vice president of dietary supplements, Duffy MacKay, issued a similar criticism, stating, “Dietary supplements – which are regulated as foods – should never be confused with prescription medications, which are specifically intended to diagnose, cure, mitigate, treat, or prevent specific diseases. Consumers should also not expect supplements to act like prescription drugs, but rather as products that support overall health and wellness – such as heart health, joint health, or gut health. Yet, here is another scientific study comparing the strength of prescription drugs against dietary supplements. Additionally, given the short four-week treatment timeline investigated in this study, the expectation for dietary supplements to produce drug-like effects is unfounded, as non-pharmacological interventions typically require more time to see results.”

Additionally, the selection of dietary supplements used was inconsistent with the primary endpoint researchers were investigating, said Wong. “While all the supplements included in the study are well-recognized for their benefits related to heart health, only three are marketed for their cholesterol lowering benefits,” she explained. “The other ingredients are better known for their effects on other health outcomes (like improvement of triglycerides or insulin modulation), so it is unclear why they were chosen to be assessed for their effects on LDL cholesterol.”

While dietary supplements are not meant to treat or cure disease, their long-term usage can provide broader health benefits, and FDA has expressly authorized health claims for plant sterols for reducing the risk of coronary heart disease, as well as omega-3s for reducing the risk of coronary heart disease and hypertension, adds Wong. “Both prescription drugs and dietary supplements have beneficial roles to play in achieving better health. Supplements are not intended to replace medications or other medical treatments. Instead, they support and maintain health, and in conjunction with a healthy diet, physical activity, and regular check-ups with a healthcare professional, they can help reduce disease risk,” she concludes.

Reference

1. Laffin LJ et al. “Comparative effects of low-dose Rosuvastatin, placebo and dietary supplements on lipids and inflammatory biomarkers.” Journal of the American College of Cardiology, Published online ahead of print on November 6, 2022