November 06, 2022
3 min read
Laffin LJ, et al. LBS.05. Late Breaking Science: Changing how we prevent cardiovascular and renal disease. Presented at: American Heart Association Scientific Sessions; Nov. 5-7, 2022; Chicago (hybrid meeting).
The SPORT study was sponsored by AstraZeneca. Laffin reports receiving consultant fees, research funding or serving on steering committees for AstraZeneca, CRISPR Therapeutics, Eli Lilly, Medtronic and Mineralys Therapeutics and holds equity in Gordy Health and LucidAct Health. Please see the study for all other authors’ relevant financial disclosures.
CHICAGO — Daily rosuvastatin lowered LDL, total cholesterol and serum triglycerides significantly more than placebo and six common over-the-counter dietary supplements, with no supplement lowering LDL more than placebo, researchers reported.
“Many of us cardiologists and primary care physicians see our patients’ medication lists littered with a variety of over-the-counter dietary supplements,” Luke J. Laffin, MD, co-director of the Center for Blood Pressure Disorders at Cleveland Clinic, told Healio. “When we look at the data, three-quarters of Americans take some form of dietary supplement and, unfortunately, almost 20% of those are doing so for so-called ‘heart health’ or ‘cholesterol health.’ In that vein, we know there are not any peer-reviewed data to support claims made about these supplements.”
For the SPORT study, presented at the American Heart Association Scientific Sessions, researchers randomly assigned participants 5 mg daily of rosuvastatin, placebo or one of six dietary supplements: fish oil (Nature Made), cinnamon (Nutriflair), garlic (Garlique), turmeric (Bioschwartz), plant sterols (Nature Made CholestOff Plus) or red yeast rice (Arazo Nutrition).
Comparing supplements vs. statin
The eight-arm, randomized, double-blind, investigator-initiated study included 190 adults aged 40 to 75 years who had LDL between 70 and 189 mg/dL, no history of atherosclerotic CVD and an increased 10-year risk of ASCVD (mean age, 64 years; 59% women; 89% white). Mean baseline LDL was 128.2 mg/dL, median high-sensitivity C-reactive protein was 1.4 mg/L, mean total cholesterol was 206.5 mg/dL and median serum triglycerides were 87.5 mg/dL.
Luke J. Laffin
“We chose those [inclusion] criteria because, in line with the current lipid guidelines, those people should at least have a discussion about a statin,” Laffin told Healio.
After randomization, the researchers measured fasting lipids, conducted a complete metabolic panel and assessed high-sensitivity C-reactive protein at baseline and day 28; adherence was measured using pill counts from returned bottles.
The primary endpoint was percent change in LDL from baseline for rosuvastatin compared in a hierarchical order with placebo and each supplement after 28 days.
The percent LDL reduction with rosuvastatin was greater than all supplements and placebo (P < .001). Mean percent decrease in LDL for rosuvastatin was –37.9% (95% CI –42.1 to –33.6). The difference in LDL reduction with rosuvastatin compared with placebo was –35.2% (95% CI, –41.3 to –29.1; P < .001). None of the dietary supplements demonstrated a significant decrease in LDL compared with placebo; however, garlic showed a significant increase in LDL of 7.8% (95% CI 1.7 to 13.8; P = .01), according to the results.
Patients randomized to the low-dose statin group had a 24.4% reduction in total cholesterol from baseline (95% CI, –27.6 to –21.3) compared with placebo and all supplements (P < .001 for all comparisons). The statin group also experienced significant serum triglyceride lowering from baseline (–19.3%, 95% CI –27.6 to –9.9), which was greater than all comparators (P < .001 for all comparisons), according to the results.
Adverse event rates were similar across study groups; there were no reports of musculoskeletal or neurological adverse events in the statin arm.
Supplement data ‘sobering’
“What we saw was not necessarily surprising,” Laffin told Healio. “Rosuvastatin lowered LDL by almost 38% and was vastly superior to any of the supplements and placebo. Additionally, supplements did not lower LDL cholesterol, inflammatory markers, total cholesterol or triglycerides any more than placebo. One of the surprising features was garlic actually increased cholesterol. This was sobering and I’m glad we have this data for the public.”
Laffin noted that SPORT was not a CV outcomes trial; the lack of an impact on inflammatory biomarkers with rosuvastatin was likely due to the small sample size. Additionally, the short study duration may not fully capture the impact of supplements on lipid and inflammatory biomarkers, he said.
“Just because a supplement may be marketed as ‘natural’ does not mean it is safe,” Laffin told Healio. “With these supplements, we do have to worry about drug-drug interactions. The way these are metabolized, they can interact with certain prescription drugs. We know that fish oil does not improve CV outcomes, but it may increase risk for atrial fibrillation. These supplements still come in pill form; they are not coming from a garden.”