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Comparative Efficacy of Low-Dose Rosuvastatin vs Placebo and Dietary Supplements in Reducing the Levels of Lipids and Inflammatory Biomarkers
TAKE-HOME MESSAGE
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This randomized single-blind trial was performed to compare the effect of low-dose rosuvastatin with placebo and common dietary supplements on LDL-C level reduction in individuals with an increased 10-year risk of atherosclerotic cardiovascular disease. Moderate-intensity rosuvastatin significantly decreased LDL-C levels compared with placebo, fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice. These dietary supplements did not significantly decrease LDL-C levels compared with placebo.
- This study provides evidence regarding the comparative efficacy of different options that patients consider to decrease their lipid levels, which are questions commonly encountered in a primary care setting. When considering dietary supplements for decreasing lipid levels, physicians can help patients save money on dietary supplements that are not effective for decreasing LDL-C levels.
abstract
This abstract is available on the publisher's site.
Access this abstract now Full Text Available for ClinicalKey SubscribersBACKGROUND
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.
OBJECTIVES
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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).
Additional Info
Disclosure statements are available on the authors' profiles:
Comparative Effects of Low-Dose Rosuvastatin, Placebo, and Dietary Supplements on Lipids and Inflammatory Biomarkers
J 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 NissenFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Supplements and LDL-Cholesterol
Publication bias
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.
References