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Statins vs. supplements: New study finds one is 'vastly superior' to cut cholesterol

Allison Aubrey

Millions of Americans are prescribed statins to reduce the risk of heart disease, but many prefer to take supplements like fish oil, garlic and flaxseed. Peter Dazeley/Getty Images hide caption

Millions of Americans are prescribed statins to reduce the risk of heart disease, but many prefer to take supplements like fish oil, garlic and flaxseed.

If you were prescribed medicine to lower your risk of a heart attack or stroke, would you take it?

Millions of Americans are prescribed statins such as Lipitor, Crestor or generic formulations to lower their cholesterol. But lots of people are hesitant to start the medication.

Some people fret over potential side effects such as leg cramps, which may be — or may not be — linked to the drug. As an alternative, dietary supplements, often marketed to promote heart health, including fish oil and other omega-3 supplements (omega-3s are essential fatty acids found in fish and flaxseed), are growing in popularity .

So, which is most effective? Researchers at the Cleveland Clinic set out to answer this question by comparing statins to supplements in a clinical trial. They tracked the outcomes of 190 adults, ages 40 to 75. Some participants were given a 5 mg daily dose of rosuvastatin, a statin that is sold under the brand name Crestor for 28 days. Others were given supplements, including fish oil, cinnamon, garlic, turmeric, plant sterols or red yeast rice for the same period.

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The maker of Crestor, Astra Zeneca sponsored the study, but the researchers worked independently to design the study and run the statistical analysis.

"What we found was that rosuvastatin lowered LDL cholesterol by almost 38% and that was vastly superior to placebo and any of the six supplements studied in the trial," study author Luke Laffin, M.D. of the Cleveland Clinic's Heart, Vascular & Thoracic Institute told NPR. He says this level of reduction is enough to lower the risk of heart attacks and strokes. The findings are published in the Journal of the American College of Cardiology .

"Oftentimes these supplements are marketed as 'natural ways' to lower your cholesterol," says Laffin. But he says none of the dietary supplements demonstrated any significant decrease in LDL cholesterol compared with a placebo. LDL cholesterol is considered the 'bad cholesterol' because it can contribute to plaque build-up in the artery walls – which can narrow the arteries, and set the stage for heart attacks and strokes.

"Clearly, statins do what they're intended to do," the study's senior author Steve Nissen, a cardiologist and chief academic officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic told NPR. By comparison, he says this research shows that supplements are not effective. "They do not promote heart health. They do not improve levels of the bad cholesterol."

Nissen says supplements can be expensive compared to statin medications. Depending on insurance, he says people may pay less than $5 a month out-of-pocket for rosuvastatin.

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"Statins are the most effective heart attack and stroke prevention drugs that we have really ever seen," says Michael Honigberg , a cardiologist and researcher at Massachusetts General Hospital who is not affiliated with the new study. He says the new findings add to an already large body of evidence showing statins lower LDL cholesterol, and he's not surprised to see that the supplements were not as effective.

However, he says, not everyone with a family history of heart disease or slightly elevated cholesterol should be on a statin. The American College of Cardiology and American Heart Association developed some prescription guidelines. Typically, if a person's LDL cholesterol (bad cholesterol) is 190 or higher, they're often advised to start a statin. Health care professionals use a risk calculator to estimate a person's risk of having a heart attack or stroke over the next 10 years. If the risk is high enough, based on factors including age, blood pressure and smoking status, then a statin may be recommended.

Honigberg says for people who have slightly elevated cholesterol, but are not at high enough risk to be prescribed a statin, he recommends that they focus on diet and exercise, rather than buying supplements. "I tell my patients to save their money and instead spend that money on eating heart healthy, high quality food."

He points to studies that show heart-healthy diets, including Mediterranean diets which emphasize healthy fats, lots of fruits, vegetables and whole grains and the DASH diet , significantly reduce the risk of heart disease. "I think a formulation that we perhaps don't use enough is that food is medicine and is probably a more effective medicine than supplements," says Honigberg.

The National Center for Complementary and Integrative Health, part of the National Institutes of Health, has also concluded, based on prior research, that omega-3 supplements do not reduce the risk of heart disease , but eating fish – which contains omega-3 fatty acids – is linked to a reduced risk. This suggests that omega-3 fatty acids are most beneficial as part of a healthy diet.

And it's worth noting that the NIH review concludes that omega-3 supplements may help relieve symptoms of rheumatoid arthritis. Omega-3s are also added to baby formulas to promote brain development. The NIH review also concludes that omega-3 supplements can lower triglycerides, a type of fat found in the blood. But Honigberg says this may be recommended for a "small subset of patients" with very high triglyceride levels.

As for people whose risk of heart disease is high enough to warrant a statin prescription, Honigberg says he spends a fair amount of time talking through concerns with patients.

"We talk about the excellent safety profile and the very, very low risk of side effects," he says. He describes the risk of serious side effects as "vanishingly small."

Sometimes patients stop taking a statin because they believe it's causing a certain side effect. But Honigberg points to a double-blind research study that showed when patients were given a placebo in place of a statin, patients reported feeling most of the same side effects.

"So the punch line of the trial is people blame statins for side effects the statins aren't really causing," he says.

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Studies find drug protects against heart disease in high-risk groups

Two new studies found that statins, the most prescribed class of drugs to treat high cholesterol, are protective for high-risk groups who haven’t yet had a heart attack or stroke but could be at risk of one, according to Harvard-affiliated Brigham and Women’s Hospital.

The results provide additional context to a longstanding debate among the medical community about whether there are benefits to initiating statin use in people who don’t already have high cholesterol or cardiovascular disease. The studies appear in the JAMA Network Open and the Journal of the American Geriatrics Society.

“Statins are a first line class of drugs that can lower cholesterol and lower the risk of a second heart attack or stroke in people who have already had one — there’s no question about that,” said corresponding author Ariela Orkaby of the Brigham’s Division of Aging . “However, many clinicians still don’t agree on whether statins should be used as a preventative treatment for people who haven’t had a heart attack or stroke yet but are at high risk due to age or other factors.

“Our findings demonstrate statins have a protective effect even in people who haven’t had their first major cardiac event, which means there are still benefits to prescribing these medications for primary prevention of heart disease,” said Orkaby, who is also an investigator in the Veterans Affairs Geriatric Research Education and Clinical Center.

For most people, statins are well-tolerated and don’t have significant side-effects. However, some doctors over the last few years have called for these medications to stop being prescribed for certain people, including those with chronic kidney disease. Notably, cardiovascular disease is the leading cause of death for older adults with kidney disease.

“Our results suggest that for statins, frailty status doesn’t decrease benefit, and it may be the frailest older adults who benefit the most.” Ariela Orkaby, Brigham and Women’s Hospital

“There has been some chatter about statins causing muscle pains but, for the vast majority of people, these are very safe and effective medications,” said Orkaby. “The problem is that we’re still missing a lot of clinical evidence about their effectiveness in certain groups, which has made some doctors deprescribe statins out of caution.”

In their study of 14,828 people with chronic kidney disease, the researchers found that starting statins was associated with 9 percent reduced mortality and a 4 percent lower risk of heart attack or stroke. The team also looked at a much larger group of older adults without kidney disease, of whom 12 percent were frail. Among this group of 710,313 people, they found that statin therapy was associated with a 39 percent lower risk of mortality and 14 percent lower risk of a first heart attack or stroke. Both studies used data from the Veteran’s Affairs Healthcare System.

Notably, the researchers found that these reductions in mortality and disease risk were independent of frailty, which the researchers measured through a score that accounted for dozens of age-related health conditions.

“When we’re talking about the risk-benefit analysis of using a certain medication in older populations, we need to consider frailty because medications may not work as well or may cause more side effects in people who are frailer,” said Orkaby. “Our results suggest that for statins, frailty status doesn’t decrease benefit, and it may be the frailest older adults who benefit the most.”

While the two studies benefited from the large patient population and long-term follow-up afforded by working with VA data, the researchers caution that their conclusions drawn from past patient data should be validated in new clinical trials that prospectively address these questions.

“We’re still missing some of the evidence we need to fully understand the scope of what these medications do,” said Orkaby. “However, these studies tell us that until we have clinical data that suggests otherwise, statins are safe and effective for older people and those with chronic kidney disease.”

Disclosures: Ariela Orkaby accepted personal fees from Anthos Therapeutics during this research, unrelated to this work. Luc Djosse reports current research funding from Novartis, unrelated to this work.

This research was supported by grants from the National Institute on Aging (R03-AG060169) and Veterans Affairs (IK2-CX001800, I01 CX001025) .  

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March 6, 2023

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Study finds residual inflammation after statin therapy strongly predicts cardiovascular events, death

by Brigham and Women's Hospital

New evidence released today from a study of 31,245 patients already taking statin therapy indicates that inflammation may be a more powerful predictor of risk of future cardiovascular events—such as heart attack and stroke—than "bad" cholesterol.

Treatments that aggressively lower vascular inflammation need to be incorporated into daily practice if doctors are to maximize patient outcomes , according to the study's corresponding author, Paul Ridker, MD, a preventive cardiologist at Brigham and Women's Hospital, a founding member of the Mass General Brigham health care system. Ridker presented the findings at the American College of Cardiology meeting in New Orleans. Results are published simultaneously in The Lancet .

"The new data should be a wake-up call for preventive cardiologists and their patients," said Ridker. "Virtually all patients with or at risk for atherosclerotic disease are appropriately treated with aggressive statin therapy . Yet, in our study of patients already taking a statin, hsCRP—a measure of residual inflammatory risk—was a more powerful determinant of having a future heart attack or dying from cardiovascular disease than was LDL-cholesterol—a measure of residual cholesterol risk. The data are a powerful demonstration that to beat heart disease, we need to lower both cholesterol and inflammation, not just cholesterol alone."

Once a patient is on statin therapy, cardiologists typically describe two conditions: "residual cholesterol risk," which can be further reduced with additional lipid-lowering therapy, and "residual inflammatory risk," which can be further reduced with certain drugs that impact vascular inflammation. Whether clinicians should choose to focus on further lowering cholesterol or inflammation has been uncertain and controversial.

Ridker and colleagues examined data from three recently conducted clinical trials (PROMINENT, REDUCE-IT and STRENGTH) of patients with or at high risk for atherosclerotic disease to understand the relative importance of "residual inflammatory risk" as compared to "residual cholesterol risk" among contemporary statin-treated patients.

All patients were receiving aggressive guideline directed medical care including statins, usually at high doses. But cardiovascular event rates in all three trials approached 10 percent at five years. In all three trials, blood levels of high-sensitivity C-reactive protein (hs-CRP, a measure of vascular inflammation) were significantly associated with major adverse cardiovascular events (MACE), cardiovascular mortality and all-cause mortality.

Moreover, the researchers report that hs-CRP was a more potent predictor of future cardiovascular risk than LDL-cholesterol. For example, among aggressively treated patients already on higher intensity statins, the risks of cardiovascular death and all-cause mortality were more than twice as high among those with the highest levels of CRP when compared to those with the highest levels of cholesterol, differences that were highly statistically significant.

The data have immediate implications for patient care today and for future research, according to the authors.

"There is no doubt that lower is better for LDL-cholesterol and we need to aggressively reduce cholesterol whenever possible. But if cardiologists want to eliminate cardiovascular disease, they clearly must target inflammation as well," Ridker said.

Inflammation inhibition has been found in several clinical trials to reduce cardiovascular risk, yet uptake of anti-inflammatory therapy in daily practice has been limited. This has been particularly true for colchicine, an inexpensive anti-inflammatory therapy that reduced cardiovascular event rates in two major randomized trials with a benefit at least as large as that associated with much more expensive cholesterol -lowering drugs. Ridker notes the importance of weighing the potential benefits of anti-inflammatory agents, in addition to statin therapy and lifestyle modifications, to lower cardiovascular risk.

"Beyond statins and consideration of anti-inflammatory agents, physicians should not lose sight of diet, exercise, and smoking cessation, all of which lower vascular inflammation and save lives," Ridker said.

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