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Comparative Efficacy of Low-Dose Rosuvastatin vs Placebo and Dietary Supplements in Reducing the Levels of Lipids and Inflammatory Biomarkers
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Supplements are commonly used by individuals with indications for lipid-lowering therapy, but evidence of their effectiveness to lower low-density lipoprotein cholesterol (LDL-C) is lacking, particularly when compared with statins.
The trial objective was to compare the efficacy of a low-dose statin with placebo and 6 common supplements in impacting lipid and inflammatory biomarkers.
This was a single-center, prospective, randomized, single-blind clinical trial among adults with no history of atherosclerotic cardiovascular disease (ASCVD), an LDL-C of 70 to 189 mg/dL, and an increased 10-year risk of ASCVD. Participants were randomized to rosuvastatin 5 mg daily, placebo, fish oil, cinnamon, garlic, turmeric, plant sterols, or red yeast rice. The primary endpoint was the percent change in LDL-C from baseline for rosuvastatin 5 mg daily compared with placebo and each supplement after 28 days. The primary endpoint was evaluated in a hierarchical fashion with rosuvastatin first compared with placebo, then each supplement in a prespecified order using analysis of covariance.
A total of 190 participants completed the study. The percent LDL-C reduction with rosuvastatin was greater than all supplements and placebo (P < 0.001). The difference in LDL-C reduction with rosuvastatin compared with placebo was -35.2% (95% CI: -41.3% to -29.1%; P < 0.001). None of the dietary supplements demonstrated a significant decrease in LDL-C compared with placebo. Adverse event rates were similar across study groups.
Among individuals with increased 10-year risk for ASCVD, rosuvastatin 5 mg daily lowered LDL-C significantly more than placebo, fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice. (Supplements, Placebo, or Rosuvastatin Study [SPORT]; NCT04846231).
Disclosure statements are available on the authors' profiles:
Comparative Effects of Low-Dose Rosuvastatin, Placebo, and Dietary Supplements on Lipids and Inflammatory BiomarkersJ Am Coll Cardiol 2023 Jan 03;81(1)1-12, LJ Laffin, D Bruemmer, M Garcia, DM Brennan, E McErlean, DS Jacoby, ED Michos, PM Ridker, TY Wang, KE Watson, HG Hutchinson, SE Nissen
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
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Supplements and LDL-Cholesterol
A study is more likely to be published if the findings support the beliefs of a group even if the science is not of high quality. Many patients take supplements that are often not necessary and may create greater risk if they are used in place of proven, more effective therapies. This collective frustration in the medical community can create an implicit bias, leading to publication bias. This paper is an example of that.
There are many challenges with this paper. The primary endpoint was LDL-cholesterol (LDL-C) reduction after only 28 days of intervention. The study evaluated only lab values without the inclusion of clinical outcomes. It was unblinded, with an underpowered small sample size with a homogeneous cohort. It was completely sponsored by one large pharmaceutical company, which also supported many of the paper’s authors.
But the biggest gripe I have with this study is that the authors included supplements that have no evidence of benefit for lowering LDL-C. This is analogous to a study evaluating the treatment of strep throat with penicillin, lisinopril, acetaminophen, and metformin.
What was studied?
The money used on this study would have been better spent on public education strategies to prevent cardiovascular disease. Instead, it was used to promote less than an ideal science influenced by the implicit bias of a group. We can do better.