Comparative Effects of Low-Dose Rosuvastatin, Placebo, and Dietary Supplements on Lipids and Inflammatory Biomarkers
- PMID: 36351465
- DOI: 10.1016/j.jacc.2022.10.013
Comparative Effects of Low-Dose Rosuvastatin, Placebo, and Dietary Supplements on Lipids and Inflammatory Biomarkers
Abstract
Background: 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).
Keywords: LDL-C; hypercholesterolemia; hyperlipidemia; lipids; statin; supplements.
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures This trial was funded by AstraZeneca Pharmaceuticals. Dr Laffin has been a consultant and/or served on steering committees for Medtronic, Lilly, Mineralys Therapeutics, AstraZeneca, and Crispr Therapeutics; has received research funding from AstraZeneca; and has ownership interest in LucidAct Health and Gordy Health. Dr Bruemmer has been a consultant and served on a steering committee for Esperion. Dr Jacoby has been a consultant and served on a steering committee for AstraZeneca. Dr Michos has been a consultant and/or served on steering committees for AstraZeneca, Bayer, Boehringer Ingelheim, Esperion, Novartis, Novo Nordisk, and Pfizer; and has received research funding from the American Heart Association and the National Institutes of Health. Dr Ridker has been a consultant and/or served on steering committees for Agepha, AstraZeneca, Civi Biopharm, Flame Inc, Health Outlook, IQVIA, Janssen Pharmaceuticals, Novartis, Novo Nordisk, Omeicos, and Sirnanomics; and has received research funding from Amarin, Kowa Pharmaceuticals, the National Heart, Lung, and Blood Institute, and Novartis. Dr Wang has been a consultant and/or served on steering committees for AstraZeneca and Novartis; and has received research funding from Abbott Laboratories, Artivion, Boston Scientific, Bristol Myers Squibb, and Chiesi. Dr Watson has been a consultant and/or served on steering committees for Amari, Amgen, Boehringer Ingelheim, Esperion, Novartis, and Lilly; and has been a speaker for Boehringer Ingelheim. Dr Hutchinson is an employee of AstraZeneca. Dr Nissen has received institutional research funding from AbbVie, AstraZeneca, Amgen, Bristol Myers Squibb, Cerenis, Eli Lilly, Esperion, Medtronic, MyoKardia, Novartis, Pfizer, The Medicines Company, Silence Therapeutics, Takeda, and Orexigen; and is an unpaid consultant for Respira, Alnylam, Beren Therapeutics, Prolaio, TenSixteen Bio, Altimmune, MetroBiotech, and Intercept. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Comment in
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Statins outperform dietary supplements for LDL-C lowering.Nat Rev Cardiol. 2023 Jan;20(1):6. doi: 10.1038/s41569-022-00809-3. Nat Rev Cardiol. 2023. PMID: 36376434 No abstract available.
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Caution Against Rejecting All Dietary Supplements for LDL Cholesterol Reduction.J Am Coll Cardiol. 2023 Jan 3;81(1):13-15. doi: 10.1016/j.jacc.2022.11.004. J Am Coll Cardiol. 2023. PMID: 36599607 No abstract available.
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Gesunde Ernährung allein reicht oft nicht.MMW Fortschr Med. 2023 Feb;165(3):73. doi: 10.1007/s15006-023-2359-4. MMW Fortschr Med. 2023. PMID: 36759485 German. No abstract available.
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The Nuance of Studying and Prescribing Supplements.J Am Coll Cardiol. 2023 May 2;81(17):e149. doi: 10.1016/j.jacc.2023.01.048. J Am Coll Cardiol. 2023. PMID: 37100494 No abstract available.
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Reply: The Nuance of Studying and Prescribing Supplements.J Am Coll Cardiol. 2023 May 2;81(17):e151. doi: 10.1016/j.jacc.2023.02.046. J Am Coll Cardiol. 2023. PMID: 37100495 No abstract available.
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