This transcript has been edited for clarity.
Tricia Ward: Hello. I'm Tricia Ward from Medscape Cardiology. I'm at the 2022 American Heart Association Scientific Sessions in Chicago, where I'm joined by Dr Luke Laffin of the Cleveland Clinic. Welcome, Dr Laffin.
Luke J. Laffin, MD: Thanks for having me.
Ward: You just presented the SPORT trial, which randomized some Ohio residents with LDL cholesterol between 70 and 189 mg/dL. They were not on statins or supplements. They were assigned to low-dose rosuvastatin vs one of six over-the-counter supplements. Would you tell us your key findings?
Laffin: Our key finding, based on the primary endpoint, was that rosuvastatin was vastly superior at lowering LDL cholesterol over the study time period compared with placebo and any of the supplements. We also found that it was better for lowering cholesterol and serum triglycerides.
Ward: Can you tell us what the supplements were?
Laffin: The supplements were turmeric, cinnamon, Garlique, fish oil, plant sterols, and red yeast rice.
Ward: Red yeast rice has been shown to lower LDL in some other trials. Why do you think it was different here?
Laffin: With any of these supplements, it's really dependent on the manufacturer as to what we see. One of the problems is that they're not FDA regulated, so you can have very different effects based on which one you choose.
Ward: How did you choose these six?
Laffin: Initially, we started by asking what our patients are taking. I would say that at least half of my patients that I see for preventive cardiology reasons are taking at least one of these. We looked at the most common ones and we looked at some market research about what people are taking for "heart health" or "cholesterol health," and we found these, which are very popular supplements.
Ward: It wasn't just that some of them didn't lower LDL, but there were even some opposite effects.
Laffin: Exactly. We also compared them directly to placebo. We saw that Garlique, which is the garlic supplement, increased LDL cholesterol compared with placebo by 7.8%, and plant sterols decreased HDL cholesterol compared with supplements. It wasn't completely neutral, but it was potentially even harmful.
Ward: There was a fish oil as well. That's an over-the-counter fish oil, so was that a combination EPA/DHA product?
Laffin: That was a combination product as well.
Ward: At a relatively low dose?
Laffin: Yes. We studied 2400 mg. What we used for any of these supplements was the dose right on the bottle. We didn't differ from what the manufacturers actually tell people to take.
Ward: This was a relatively short trial, at 4 weeks.
Laffin: It was. The reason is that's really all you need to see this difference. If you look at the 2018 American Heart Association/American College of Cardiology lipid guidelines, they recommend checking a repeat lipid panel after you do any type of lifestyle [intervention] or start a statin anywhere between 4 and 12 weeks. We chose 4 weeks.
Ward: You also looked at inflammatory markers with high-sensitivity CRP. What did you see there?
Laffin: We didn't see a change in inflammatory markers with rosuvastatin compared with placebo or any of the supplements. That's probably because it was a smaller trial, but most individuals in the trial had a normal CRP to begin with.
Ward: There probably wasn't any inflammation.
Ward: How would you describe these patients with that level of LDL who didn't have prior coronary artery disease?
Laffin: This was a primary prevention group and 60% of participants enrolled were women. They were generally in their mid-sixties, with a mean LDL cholesterol of 128 mg/dL. They were average patients that we would see. If we looked at their 10-year risk for a stroke or heart attack, it was right around 8%. We would classify these as intermediate-risk patients based on the current lipid guidelines.
Ward: What would you like people to take away from this? We've seen before that there have been negative data on supplements, but they seem to keep selling.
Laffin: I think that the head-to-head nature and the strict criteria that we used for the trial hopefully can inform discussions between physicians or any medical provider and these patients. They can show them a figure in the manuscript as well. If you see that you take a statin, your LDL cholesterol is going to go down. If you take one of these supplements, you might as well flip a coin to see if it is going to go up or down.
Ward: How do you think clinicians should speak to their patients about supplements or ask about supplements? Some patients don't want to tell their doctor they're taking them.
Laffin: I think it's important to ask, number one. It's not only because they don't do anything, but as we talked about, they could do harm. It's not only from a cardiovascular perspective. There are all kinds of drug-drug interactions that have been described with supplements and other noncardiovascular medicines, so it should be a discussion in our clinic.
We make sure that we mention and talk about supplements with patients. It doesn't have to be some religious sermon that we give them, saying, "You can't take this." It's giving them that education. Most people are pretty open to that, saying, "I can save my money. It's not helping me. Sure, I don't want to take another pill." It's being able to provide that background information and make them feel safe that they're doing that.
Ward: Is there anything else you want to share with our audience about what you hope will happen?
Laffin: I think that people should also understand that low-dose statins are very safe. There are many beliefs out there that statins have many adverse side effects, but we didn't see that. Numerically, plant sterols and red yeast rice in our trial had more adverse events or side effects than statins. They didn't cause muscle aches. They didn't cause any neurologic problems or a significant elevation in liver function tests. These are safe. Try to use the FDA-approved guideline-based therapies rather than over-the-counter supplements.
Ward: Thank you very much for joining me today.
Laffin: Thank you.
Ward: Thanks to our audience for listening.
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Cite this: Tricia Ward, Luke J. Laffin. Heart Supplements Flunk Lipid Lowering Test: SPORT Interview - Medscape - Nov 09, 2022.