Effect of Low-Dose Statin Compared With Placebo and Six Dietary Supplements on Lipid and Inflammatory Biomarkers: The SPORT Randomized Clinical Trial

Presented at the AHA Scientific Sessions 2022 by: Luke J. Laffin, MD - Cleveland, OH, USA

Introduction and methods

In the SPORT (Supplement, Placebo, or Rosuvastatin Study) trial, the effect of several widely used dietary supplements on lipid and inflammatory biomarkers was investigated. For this prospective, single-center, single-blind RCT, 199 participants were randomized to receive 1 dietary supplement (fish oil, cinnamon, garlic, turmeric, plant sterols, or red yeast rice) or placebo or rosuvastatin 5 mg daily. Inclusion criteria were: 40–75 years of age, no established ASCVD, LDL-c level of 70–189 mg/dL, and 10-year ASCVD risk of 5%–20%.

At days 0 and 28, a lipid panel, a comprehensive metabolic panel, and hs-CRP were measured. The primary endpoint was the percent change in LDL-c level from day 0 to day 28. Secondary endpoints included percent change in lipid and inflammatory biomarkers between baseline and day 28.

Main results

• The reduction in LDL-c level was greater for the group treated with rosuvastatin (–37.86%) than for the groups treated with any of the supplements, such as red yeast rice (–6.55%) or plant sterols (–4.37%), or with placebo (–2.63%) (P<0.001 for all comparisons with rosuvastatin).
• Compared with the supplements and placebo, treatment with rosuvastatin also showed a larger change in total cholesterol (–24.42%; P<0.001 for all comparisons with rosuvastatin) and in triglycerides (–19.25%; P<0.05 for all comparisons with rosuvastatin).
• When the supplements were compared with placebo, none of them showed a significant decrease in LDL-c and the intake of garlic even resulted in an LDL-c increase of 7.8% (P=0.01).
• Of note, intake of plant sterols resulted in a 7.1%-decline in HDL-c compared with placebo (P=0.02).
• In addition, there were no differences in percent change in hs-CRP, total cholesterol, or triglycerides between any of the supplements and placebo.
• When looking at the percent change in LDL-c in individual participants, everyone in the rosuvastatin group had a ≥18% reduction in LDL-c and 50% had a >40% LDL-c reduction. In contrast, in each of the groups receiving placebo or any of the supplements, the LDL-c change ranged from –27% to 32%.
• The rates of adverse events (f.e., gastrointestinal, musculoskeletal, or neurological adverse events) did not differ between the 8 groups.

Conclusion

In individuals with an increased 10-year ASCVD risk but no established ASCVD, rosuvastatin 5 mg daily outperformed 6 widely used dietary supplements (fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice) and placebo in terms of LDL-c reduction. It also lowered total cholesterol and triglycerides more than the any of the supplements or placebo did, and had similar low rates of adverse events.

-Our reporting is based on the information provided at the AHA Scientific Sessions-