TIME heart

This New FDA-Approved Cholesterol Drug Is a Game Changer

The FDA approved the first of a new class of drugs for treating high cholesterol. Here’s the story of how researchers went from a DNA mutation to a drug in 10 years

On Friday, the U.S. Food and Drug Administration (FDA) approved the first new class of cholesterol-lowering drugs since the statins flooded the market beginning in the 1980s. Similar to the way statins work, by binding up cholesterol made in the liver so less of it circulates in the blood, this new class, called PCSK-9 inhibitors, takes advantage of genetic mutations that regulate the level of LDL receptors in the liver. Less PCSK9 leads to more LDL receptors that can soak up LDL and therefore leave less cholesterol in the blood.

The FDA approved alirocumab (Praluent), an injectable drug made by Sanofi and Regeneron, in people with familial hypercholesterolemia, a genetic condition in which cholesterol levels are high, or those with a history of heart disease who can’t reduce their LDL levels enough with existing statin drugs. (Another PCSK9 inhibitor, evolocumab (Repatha) developed by Amgen, received approval in Europe but won’t be evaluated by the U.S. FDA until the end of August.)

MORE: The Next Big Drug to Treat Heart Disease

While PCSK9 drugs help to lower cholesterol, the story of how these medications developed began in a French family with the opposite problem. Their members had exceptionally high levels of LDL and greater than average rates of heart disease. But unlike others with similar cholesterol problems, this family did not have the usual mutations in cholesterol-regulating genes. Instead, French researchers studying them in 2003 found they had aberrations in PCSK9, a gene that produces a protein found primarily in the liver, kidneys and intestines.

An ocean and half a continent away, Jonathan Cohen and Dr. Helen Hobbs at the University of Texas, Southwestern Medical Center in Dallas (coincidentally the same institute where scientists discovered LDL, or the heart-disease contributing cholesterol and earned the Nobel Prize for their work), read the description of PSCK9 and wondered whether those with lower levels of PCSK9 would show the opposite effect of the French family and actually enjoy decreases in levels of LDL in the blood.

MORE: New Class of Cholesterol Drugs Shows Promise For Heart Disease

Cohen and Hobbs were involved in a large heart disease study involving nearly 15,000 participants, and decided to look for the PCSK9 mutations among their participants. They homed in on those with the highest and lowest levels of LDL cholesterol, and sequenced their genomes to see if any patterns emerged. Sure enough, they found 33 people whose LDL levels were about 40% lower than average and who shared mutations that effectively silenced PCSK9. Essentially, their LDL amounts were about the same as those who relied on statins to drop their cholesterol.

These PCSK9 mutations associated with the lowest LDL appeared predominantly in African-American participants. Those with one copy of the mutation in this gene showed an 88% lower risk of heart disease. Another mutation in the same PCSK9 gene that appeared more commonly in whites had the same effect, but to a lesser extent, dropping LDL by 15% and the risk of heart events by 47%.

“The results were quite compelling,” says Cohen, who published the findings along with his colleagues in the New England Journal of Medicine (NEJM) in 2006. “They told us that PCSK9 was likely an attractive therapeutic target.” Even more encouraging, in all of the people with the mutations and lower LDL levels, there didn’t seem to be any significant side effects. For all intents and purposes, these participants were healthy and had the added advantage of being at very low risk of heart disease.

To confirm this, Cohen searched for anyone in the study with two copies of the mutation, to see if having double the effect would trigger any adverse events. He found one woman, a 32 year old daughter of one of the participants, who had two different mutations in each of the PCSK9 copies she inherited from her mother and father. The result? An LDL of 14 and no other health problems. “If you measure the amount of PCSK9 in her blood, it’s basically absent, you can’t see any,” says Cohen. That contributed to an unprecedented low level of LDL cholesterol as well.

So far, he says, only one other individual has been described with two mutant copies of PCSK9, a 21 year old woman living in south Africa with an LDL of 20.

Those descriptions piqued the interest of researchers at Regeneron, a biotech company that specializes in turning genetic discoveries like this one into drugs. To confirm and better understand the effects of PCSK9, researchers there studied the effect of human versions of PCSK9 in mice, and then began trials of antibodies they developed that inhibit the function of this gene, much like the mutations do, in several thousand people.

Those results, published in the NEJM last April, showed that PCSK9 inhibitors can lower LDL cholesterol by an additional 60% on average beyond that achieved by statins. Those findings formed the basis of the companies’ application to the FDA for approval of these first-in-class drugs.

For now, the agency says the drugs should only be prescribed to people with familial hypercholesterolemia, or those who have failed to reduce their LDL levels sufficiently using statins. For many, the new drugs will be taken in combination with statins and a heart-healthy diet. But doctors say they anticipate many patients outside of these groups, who have family histories of heart disease or other risk factors, such as hypertension or diabetes, may start asking about the medications. For them, doctors will have to weigh how well they are doing on statins before considering adding a PCSK9 inhibitor.

TIME Heart Disease

New Advice on Statins Is Leading to Less Heart Disease

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A recent shift in how doctors figure out heart disease risk may lead to 63,000 fewer heart-related health problems, a new study shows

In 2013, when the American Heart Association and the American College of Cardiology revised the guidelines that doctors use to decide which patients need cholesterol-lowering treatment for heart disease and which do not, there was more confusion than confidence in the new advice. Now, a new study published in JAMA may offer some answers about the effects of the updated treatment guidelines.

Rather than setting threshold levels of target cholesterol levels that were considered normal or high, for example, the new guidelines instead assessed a person’s overall risk of having a heart attack, stroke or other heart problem over the next 10 years. If these factors—which included cholesterol, family history of heart disease, age and other factors—contributed to a risk of 7.5% or higher, then the person would be eligible for taking the cholesterol-lowering drugs known as statins, which not only bring potentially troublesome fat levels in the blood down but also reduce inflammation, which can contribute to atherosclerosis and set the stage for a heart attack.

MORE: Should I Take a Statin? What You Need to Know About the New Cholesterol Guidelines

Heart experts weren’t all convinced that putting more people on statins would actually lead to fewer heart events. Their biggest concern was that the looser criteria would mean more otherwise healthy people who wouldn’t really benefit from statins would be taking the drugs. (Some estimates showed that as many as 12.8 million more people would be taking the medications under the new guidelines.). So Dr. Udo Hoffman, director of the cardiac MR, PET and CT Program at Massachusetts General Hospital and his colleagues decided to analyze the data to see if the new guidelines really were contributing to less heart disease.

In the new study, they compared 2,435 people who were the offspring or third generation descendants of the Framingham Heart Study, the pioneering heart disease trial that continues to follow people and track their lifestyle and health outcomes. Some of the participants in the current study were at higher risk of heart disease, and some were not. Using the older cholesterol-based heart risk guidelines, Hoffman found that 14% would have been given a statin. Nearly three times that proportion, 39%, would have qualified under the new 2013 guidelines.

MORE: New Guidelines for Cholesterol Treatments Represent “Huge Change”

When the researchers looked at how many of those people who were eligible to take statins went on to have heart events, it was more than twice as high using the newer guidelines. That means that a higher proportion of people who should be on statins, according to the newer guidelines, went on to have heart events, suggesting that the new criteria were better at predicting which people were at higher risk.

In addition, Hoffman also backed up his findings with tests of the amount of calcium in the heart vessels of the participants. Coronary artery calcium tends to be a good indicator of how stiff the vessels are becoming; more calcium suggests more atherosclerosis and therefore a higher risk of heart attack or other issues.

MORE: Statins May Seriously Increase Diabetes Risk

The findings were especially robust in those people considered to be at intermediate risk of heart disease—patients in the grey area where it’s not entirely clear how likely they are to have heart problems. Among them, those who qualified to take statins under the newer 2013 guidelines were nine times more likely to have a heart event than those who didn’t meet the criteria for needing the drugs. “If we looked at this group from the formal risk factor evaluation approach [using the older guidelines] there is no way we could guess which of these people were at higher risk of heart events,” says Hoffman. “So in this population, the new guidelines are helpful.”

The findings show that even if the revised guidelines cast a wider net of people who would be on statin drugs, the rate of heart events the new criteria are picking up remain about the same. That means that the people being captured are still those at higher risk of having events, and not healthy people who would be unnecessarily put on medications, as some critics of the new guidelines feared. “Overall, the new guidelines are a more accurate and efficient allocation of statin therapy,” says Hoffman.

TIME Diet/Nutrition

Should I Eat Butter?

2.5/5 experts say yes*.

Americans eat almost 23 sticks of butter a year, so let’s be clear that none of us is suffering from acute butter deficiency. While few health experts would encourage that you eat more of it, the question of whether butter really is back—as many magazines, including this one, has said—has many experts disagreeing.

There was a time when butter would have been a clear-cut no. After all, it’s a block of fat made of churned milk (and sometimes salt), and most of it is saturated. Just one tablespoon of salted butter, which isn’t even enough to grease a grilled cheese, has 102 calories and 36% of the daily limit for saturated fat, if you are going by the Food and Drug Administration’s recommendations. For many years, official U.S. dietary guidelines vilified fat—especially saturated fat—as a key contributor to excess weight cardiovascular disease.

But recent research suggests that butter—or, rather, the saturated fat it contains—might be more benign than previously thought, says investigative journalist Nina Teicholz, author of the 2014 book The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet. “For saturated fat causing heart disease, the science has never been very strong,” she says. “That basically means you should let those foods that people have been avoiding for so long out of jail.” Saturated fat increases levels of LDL cholesterol, which are associated with higher rates of heart disease—but saturated fat also seems to raise HDL cholesterol, which might help ease those effects.

It’s safe in moderation and is a natural source of added fat, agrees Julia Zumpano, a dietitian at Cleveland Clinic’s Heart & Vascular Institute. She adds that it’s a much better choice than buttery spreads that contain hydrogenated or partially hydrogenated oils.

But Dr. David Katz, director of the Yale University Prevention Research Center, avoids butter—opting instead for olive oil, which is high in monounsaturated fats and proven to improve health. The recent research indicates that, “at best, some saturated fat is ‘not harmful’—there is no evidence indicating it is beneficial,” Katz says.

When thinking about butter’s place in a diet, Dr. Walter Willett imagines a spectrum ranging from super healthy (blueberries) to toxic (like a 20-oz Coke, he says). “I would put butter close to the middle, maybe a little closer to the Coke,” says Willett, chair of the department of nutrition at the Harvard School of Public Health.

“Thumb neutral,” concurs Dr. Dariush Mozaffarian, dean of the School of Nutrition Science and Policy at Tufts University (this represents the half-thumb* mentioned above). “No evidence it’s good for you, little evidence for major harm.”

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Illustration by Lon Tweeten for TIME
TIME medicine

The Next Big Drug to Treat Heart Disease

The Food and Drug Administration may soon approve blockbuster drugs that can lower cholesterol better than anything on the market today. Here’s what you need to know about the heart disease game changers.

There’s a well accepted dogma in heart disease: too much cholesterol flowing through the blood vessels can jam up heart byways and lead to heart attacks, stroke and other problems. So lowering cholesterol, by eating fewer high-fat foods or taking advantage of drugs that can keep levels under control, can protect you against heart trouble.

A drug that promises to drop cholesterol levels to unprecedented levels—some say to as low as those found in infants—has to be a good thing. That’s what a Food and Drug Administration (FDA) advisory committee decided after reviewing data on the first candidate in a new class of heart drugs since the cholesterol-lowering statins emerged in the 1980s. The committee looked at studies involving alirocumab, developed by Sanofi and Regeneron Pharmaceuticals, and will do the same for a similar compound, evolocumab from Amgen, on Wednesday. Another drug, developed by Pfizer, is further behind the approval process. All three belong to a new class called PCSK9 inhibitors, which work by pumping out more LDL cholesterol receptors on liver cells; these can pull cholesterol out of the blood like sponges and keep vessels clear of the artery-clogging fats.

The committee voted 13-3 to recommend approval of alirocumab, determining that it was safe enough and provided significant enough benefits over existing therapies that it should be approved. The FDA usually follows its advisory committee recommendations, but isn’t bound by the advice.

The recommendation isn’t a surprise given the encouraging data so far on the drugs, but it is a bit unusual because there aren’t any long-term data yet on how patients taking these drugs fare. Normally, the FDA likes to see studies that follow people taking heart drugs, for example, for several years, and that demonstrate that they have fewer heart-related events and are less likely to die from heart problems than people not taking the medications. But the PCSK9 inhibitors have a unique advantage on this issue that may have helped them shortcut that process.

Some people are born with mutations that make them deficient in the PCSK9 enzyme, which tends to eat up and degrade LDL receptors. These individuals are blessed with low LDL levels throughout their lifetime and don’t seem to show any other adverse health effects. “These people are effectively experiencing the functional equivalent of taking one of these drugs for their entire life,” says Dr. Elliott Antman, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School and president of the American Heart Association. “They almost never get vascular disease and tolerate their low levels of LDL very well. So they were the inspiration for developing drugs that inhibit PCSK9.”

Further studies of the drugs that mimicked the effect of the genetic mutation showed that almost everyone taking them enjoyed a drop in LDL cholesterol levels of up to 65%. Some people in the trials have seen their LDL levels go down to 25 mg/dL or below; in previous guidelines, heart experts advised people without a history of heart events to aim for LDL levels of 100 mg/dL or below and for heart attack patients to shoot even lower, for 70 mg/dL or less.

“These drugs are a big deal,” says Dr. Steven Nissen, chariman of cardiovascular medicine at Cleveland Clinic who is leading a study on the Amgen drug to see if it can not only lower cholesterol, but actually reverse existing plaques in the arteries. The dramatic effect that PCSK9 inhibitors have on cholesterol is making doctors also rethink how they treat heart disease. The latest guidelines from the American Heart Association and the American College of Cardiology did away with target cholesterol levels, and the new class of drugs may support that trend, pushing doctors to advise patients to go as low—meaning as close to zero cholesterol in their blood—as they can.

“I think right now that will scare most people,” says Dr. Seth Martin, assistant professor of medicine and cardiology at Johns Hopkins School of Medicine. “But the science supports that it’s safe.”

The FDA would still have to determine for which patients the drugs should be prescribed. Some panel members recommended that the first indication include only those with genetic conditions that make them more vulnerable to abnormally high cholesterol levels, or those who can’t tolerate statins. Because statins are generally effective, the new drugs may also be recommended as second line therapy, to be used only after patients have failed to respond to statins, Unlike statins, which remain the best-selling prescription drugs in the U.S., the PCSK9 inhibitors need to be self-injected, either every two weeks or once a month.

If approved, even for a limited group initially, the drugs are likely to make their way into the broader-based heart-disease patient population—and quickly. “I have patients keeping an eye on this, who said to me, ‘This sounds pretty good, how can I get some now?’” says Antman. “They asked me to give them a call if it gets approved.” Not all of them have a genetic predisposition to high cholesterol levels, but, Antman notes, “they are sophisticated patients and say ‘I’ve had a good response to statins, so if I took this on top of the statin, I could cut my current LDL in half. Doesn’t that mean good things for reduction of my risk?’ And the answer is yes, it does.”

If the FDA does decide to approve alirocumab and other PCSK9 inhibitors, the agency will likely require the manufacturers to keep registries of patients using the drugs and monitor any side effects or other adverse events that may arise.

TIME medicine

Memory Loss Not Caused By Cholesterol Drugs After All

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Some cholesterol-lowering drugs, called statins, could contribute to short-term memory lapses, but new data suggest that risk may not be real

About 25 million Americans currently take a drug to lower their cholesterol, so it’s no surprise that the most popular among them, statins, consistently top the list of best-selling prescription medications. But recent studies hinting that they were associated with memory problems have led some patients to shy away from them.

According to the latest data, though, there’s probably no need to avoid taking statins for this reason if a doctor prescribes them to protect against heart disease. In a report published in JAMA Internal Medicine, Dr. Brian Strom, chancellor of biomedical and health sciences at Rutgers University, and his colleagues say that while statins may contribute to short term memory issues, these tend to resolve over the long term and that such memory problems are not unique to the statins.

MORE: Who Really Needs To Take a Statin?

Previous studies had reported a possible connection between statins and memory loss, but those studies compared statin users to non-statin users. In his study, Strom included another group for comparison: people prescribed cholesterol-lowering drugs that were not statins. Among a large group of 482,543 statin users, 26,484 users of non-statin cholesterol-lowering drugs and 482,543 controls who weren’t on any drugs, Strom and his team found that both cholesterol-lowering drug groups showed short-term memory problems in the first 30 days after they started taking their medications compared to the controls. For statin users, the increased odds of memory lapses was four-fold, and for the other drug group, nearly the same, at 3.6-fold.

Because both groups taking drugs showed similar memory effects, Strom says that it’s unlikely that statins are uniquely to blame for the short-term cognitive issues. And because statins and the other cholesterol-lowering drugs work in vastly different ways, it’s also unlikely that the effect can be blamed on the drugs themselves. Strom proposes that the groups’ short-term memory issues, which were recorded by doctors in the patients’ medical records, is more likely the result of these patients simply being more aware of and sensitive to any changes in their functions after starting a new medication. In other words, people may have been having memory issues before they started their medications, and the problems might have occurred if they had not started taking them, but the symptoms became more noticeable because the users were more attuned to changes after filling their new prescription. The control group might have been experiencing similar memory issues but didn’t report them to their doctors; therefore, the issues might not have been recorded. “People on new medicines are more likely to notice a problem, more likely to blame problems on the drug and more likely to go back to the doctor and report these problems,” Strom says.

MORE: Statins May Seriously Increase Diabetes Risk

While it’s possible that the drug-taking group is also at higher risk to begin with for memory-related problems, since they have more potentially vessel-blocking cholesterol in their blood that can also impede blood flow to the brain, the results remained strong even after the group adjusted for risk factors such as diabetes and other blood-related conditions.

What’s more, Strom and his team also looked at users who might have been prescribed statins, stopped taking them because they were uncomfortable with the short-term memory issues, and then were prescribed them again at a later time. These patients did not report memory problems at the same rate, suggesting that the effect has less to do with the drugs themselves than with a hyper-vigilance for any changes associated with new drugs—the second time around, the drugs weren’t novel any more. “If the memory problems were real, we would expect that those who took statins for the second time would develop memory problems again,” he says. “The fact that we saw this as a problem so infrequently in this group suggests that it was more because the statins were a new drug the first time around.”

Based on the results, Strom says he informs his own patients that for some, statins may be linked to a short-term memory issue but that these tend to disappear over the long term. He also warns that even the short-term problems may not be a true effect of the drugs but rather a misinterpretation of the studies. “People should not steer away from statins because of a fear of short-term memory problems,” he says, “because they probably are not real.”

TIME Heart Disease

New Class of Cholesterol Drugs Shows Promise For Heart Disease

The experimental drugs show promise, but medical experts remain cautious

Experimental drugs intended to lower cholesterol may also significantly reduce the risk of heart attacks and strokes, according to two new studies.

New research published in The New England Journal of Medicine show that a new class of cholesterol drugs, called PCSK9 inhibitors, may not just lower levels of bad cholesterol, but may also reduce the likelihood of adverse heart events.

The two drugs, evolocumab (under development by Amgen) and alirocumab (under development by Sanofi and Regeneron) appeared to reduce the risk of cardiac events like heart attack by around half, according to new studies.

PCSK9 inhibitors keep levels of low-density lipoprotein (LDL) cholesterol in the blood in check. In some cases they’ve shown to be even more effective than statins, one of the most prescribed drug categories. The experimental drugs are given by injection.

As the New York Times reports, it’s still too early to tell whether the drugs could be used to prevent adverse heart disease events, and the initial studies were only meant to assess the safety of the drugs as cholesterol moderators. Many in the medical community want to see more data.

The drugs have long been shown to be effective at lowering cholesterol, but there may be more widespread use if they also significantly lower heart attack and death risk. Reuters reports that both companies have already submitted their drugs for approval by the U.S. Food and Drug Administration (FDA).

Both studies were presented at the American College of Cardiology annual meeting.

TIME Heart Disease

Statins May Seriously Increase Diabetes Risk

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Statins can lower cholesterol and even tamp down inflammation to keep the risk of heart disease down. But these commonly prescribed drugs may increase the risk of diabetes, and by a considerable amount

Doctors may have to weigh a serious potential risk before prescribing statins, the cholesterol-lowering drugs that are among most prescribed drugs in America. In a study published in Diabetologia, scientists from Finland found that men prescribed statins to lower their cholesterol had a 46% greater chance of developing diabetes after six years compared to those who weren’t taking the drug. What’s more, the statins seemed to make people more resistant to the effects of insulin—which breaks down sugar—and to secrete less insulin. The impact on insulin seemed to be greatest among those who started out with the lowest, and closest to normal, levels of blood glucose. And the higher the dose of the statin, and the longer the patients took them, the greater their risk of diabetes.

Previous studies have suggested that statins can raise blood sugar levels, and increase the risk of diabetes by anywhere from 10% to 20%, but none have documented an effect this large. Doctors often consider statins for patients who are at higher risk of heart disease, and one of the risk factors for future heart trouble is diabetes. So how do these results affect that decision?

“It’s a good news-bad news scenario,” says Dr. Robert Eckel, past president of the American Heart Association and professor of medicine at University of Colorado School of Medicine. “Although there is convincing evidence that patients on statins are at increased risk of new-onset diabetes, the benefit accrued [from statins] in reducing risks of heart attack, stroke and fatal heart disease trumps the effects of being new onset diabetics.”

In other words, the good that statins can do for people who are not yet diabetic but at higher risk of heart problems outweighs the increased risk of diabetes.

MORE New Guidelines for Cholesterol Treatments Represent “Huge Change”

And while the increased risk that the Finnish scientists found — 46% — is noteworthy, Eckel points out that the study involved only white men, and therefore may not be generalizable to a broader population. It’s not clear what the men’s family history or personal history of diabetes was; some may have had other risk factors for the disease that put them at higher risk of developing diabetes anyway, even if they didn’t take a statin.

Those who developed diabetes while taking statins were similar on many metabolic measures to those who developed diabetes but weren’t taking statins, suggesting that “that statin treatment increased the risk of diabetes independently of the risk profile of the background population,” the authors write. In a separate, U.S.-based study on statins, researchers found that those who went on to develop diabetes while taking statins also had risk factors for the disease before they started taking the medications.

MORE Should You Take Statins? Study Says Heart Benefits Outweigh Diabetes Risk

Which means that for confused patients, and their doctors, the current advice about who should take statins doesn’t change. The results, in fact, highlight the need for a discussion rather than just working through a checklist before prescribing statins. For patients who may not yet be diabetic, but are vulnerable to developing the disease and also may need a statin, Dr. Neil Stone, lead author of the 2013 American College of Cardiology and American Heart Association cholesterol guidelines, says he stresses the importance of lifestyle changes in diet and exercise.

“If you have a patient who is prone to developing diabetes, you’re getting into a higher risk group, because they also have risk factors associated with heart disease. So they have the potential to benefit from statins. If they are going to take a statin, I tell them we are going to help you get more fit, and work with your lifestyle. It’s even more important because if you don’t do that, and the patient decides to take the statin and go on with their unhealthy habits, then they are going to be even more prone to developing diabetes,” says Stone.

The patient’s family history of diabetes is another important part of the decision to start someone on a statin. It’s all about making sure that each patient’s risks and benefits are weighed carefully. And the potentially greater risk of diabetes created by statins should be part of that consideration. “Communication here is everything,” says Eckel.

Read next: New Hormone Discovered That Curbs Weight Gain, Diabetes Just Like Exercise

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TIME Diet/Nutrition

5 Things You Should Know About Cholesterol

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Recent research shows no substantial relationship between the consumption of dietary cholesterol and blood cholesterol levels

Cholesterol seems to be one of those words that’s in everyone’s vocabulary, but many of my clients are incredibly confused about what cholesterol is, and how it affects their health. It also happens to be buzzing in the media at the moment, thanks to a new report from the Dietary Guidelines Advisory Committee, a group of top nutrition researchers who advise the government about what and how Americans should be eating.

If you’re feeling a little perplexed by all this cholesterol talk, here’s a simple breakdown of what you really need to know.

Cholesterol is only found in animal-based foods

There are two types: dietary cholesterol and blood cholesterol. Dietary cholesterol is the cholesterol found in foods, and only foods of animal origin contain it, because animals’ bodies naturally produce this waxy, fat-like substance. So when you eat an animal-based food (think eggs, dairy, meat, seafood) you’re ingesting cholesterol that an animal’s body produced. Plant-based foods do not contain any cholesterol, so if you see a jar of nut butter marked “cholesterol free” know that they didn’t remove the cholesterol—it just wasn’t there to begin with.

Read more: 16 Most Misleading Food Labels

Cholesterol is essential for your health

Even if you ate zero animal foods, you’d still have cholesterol in your body. That’s because your liver produces cholesterol and it’s needed for several key functions, including the making of hormones, vitamin D, and substances that help you digest food. While cholesterol is vital, it isn’t considered to be an essential nutrient, meaning something you must obtain from foods, like vitamin C or potassium. That’s because your body produces all of the cholesterol it needs.

Read more: 27 Mistakes Healthy People Make

There are “good” and “bad” types of cholesterol in your blood

The two types of blood cholesterol you hear about most often are HDL (the “good” kind; think happy cholesterol) and LDL (the “bad” kind; think lousy cholesterol). HDL and LDL are actually carriers of cholesterol called lipoproteins. HDL is good because it carries cholesterol away from arteries and back to the liver, where it can be removed from your body. LDL—the bad type—has the opposite effect. Too much LDL can lead to a build-up, which clogs and narrows arteries, and creates inflammation. This chain of events can lead to a sudden rupture, which sends a clot into the bloodstream, causing a heart attack and/or stroke.

Read more: 9 Subtle Signs You Could Have a Heart Problem

Dietary cholesterol may not impact blood cholesterol as much as previously thought

The old thinking was that consuming dietary cholesterol added to the cholesterol that your body naturally produces, thus raising the amount in your blood. This was perceived to be risky, because too much blood cholesterol has been shown to up the risk of heart disease, the top killer of both men and women. One often-cited statistic is that every 1% increase in total blood cholesterol is tied to a 2% increase in the risk of heart disease.

For many years, the Dietary Guidelines for Americans recommended that dietary cholesterol should be limited to no more than 300 mg per day. To put that in perspective, one egg yolk contains about 185 mg, three ounces of shrimp contains about 130 mg, two ounces of 85% lean ground beef about 60 mg, and one tablespoon of butter about 30 mg. The brand new report eliminated this cap, however, because the committee believes that the research shows no substantial relationship between the consumption of dietary cholesterol and blood cholesterol levels. As such, they concluded, “Cholesterol is not a nutrient of concern for overconsumption.”

Read more: 14 Things Heart Doctors Tell Their Friends

The new guidelines aren’t carte blanche to other kinds of animal fat

Nearly every media outlet covered the release of the report from the Dietary Guidelines committee, zeroing in on the omission of cholesterol limits—but that doesn’t mean it’s now healthy to go out and down cheeseburgers and pepperoni pizzas. The committee is still concerned about the relationship between blood cholesterol and saturated fat from foods like cheese.

You may have heard about another recent report, which concluded that a lower intake of saturated fat wasn’t linked to a lower risk of heart disease. That’s true, but it’s not the whole story, because the risk really lies in what you replace the saturated fat-laden foods with. When people curb saturated fat, but eat more carbohydrates, they lower protective levels of “good” HDL cholesterol, and drive up triglycerides (a type of blood fat), a combo that may actually up the risk of heart disease. But numerous studies have shown that replacing foods like butter and cheese with plant-based fats like almond butter, avocado, and olive oil can help lower heart disease risk.

Bottom line: the number one message from the new Dietary Guidelines report is that we all need to be eating less sugar and processed foods, and more plants, including vegetables, fruits, whole grains, beans and lentils. So if you have cholesterol from something like eggs, pair them with other whole, nutrient-rich plant foods, like veggies and avocado, combined with some fruit, black beans, sweet potato, or quinoa. That’s good nutrition.

Cynthia Sass, MPH, RD, is Health’s contributing nutrition editor, and privately counsels clients in New York, Los Angeles, and long distance. Cynthia is currently the sports nutrition consultant to the New York Rangers NHL team and the Tampa Bay Rays MLB team, and is board certified as a specialist in sports dietetics.

This article originally appeared on Health.com.

TIME Heart Disease

Why Your Heart Disease Risk Might Be Lower Than You Think

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Of the five popular tools that doctors rely on to predict whether you’re headed for heart trouble, four of them have a pretty major flaw

For decades, doctors have relied on the undisputed champion of heart disease risk assessment: the Framingham Risk Score. It emerged from a massive study of heart disease risk factors in more than 5,000 men and women and pointed out advanced age, being male, smoking, having diabetes, high total cholesterol, low levels of good cholesterol and high blood pressure. Scoring higher on these factors meant you had a greater chance of developing heart problems in the next 10 years, and most successive models included some version of these core culprits.

Now, scientists led by Dr. Michael Blaha, director of clinical research at the Ciccarone Center for Prevention of Heart Disease at Johns Hopkins Medicine, have published a new study in the Annals of Internal Medicine that finds that those risk calculators—four of which doctors use regularly—tend to overestimate the risk of heart attack in patients.

MORE: New Guidelines for Cholesterol Treatments Represent “Huge Change”

“It’s not that scientists made mistakes when coming up with the [calculators],” says Blaha, “They did the best job they could with the data they had. But there may be inherent problems in using historical data to predict things now.”

The diet and lifestyle of Americans have changed considerably since the Framingham days, when heart attacks occurred more frequently in younger people and more often in men than women. Americans on average now eat more trans fat and salt and have lower exposure to secondhand smoke, which can all affect heart disease rates.

MORE: Cholesterol Whiplash: What to Make of the New Heart-Risk Calculator

But even the most recent guidelines for predicting heart disease risk, released in 2013 by the American Heart Association and the American College of Cardiology, relied on the Framingham Risk factors. In the current analysis, these guidelines overestimated heart attack risk by 86% in men and 67% in women when Blaha and his team compared the predicted risk to actual rates of heart events in a group of more than 4,000 people aged 50 to 74 years, who were followed up for an average of 10 years. The other models overshot the risk by anywhere from 37% to 154% for men, and from 8% to 67% for women.

That’s a lot of extra heart disease that, under current guidelines, doctors may start treating with blood pressure medications, insulin and cholesterol-lowering drugs. All of those come with potential side effects and complications. In fact, the study found that statins to keep cholesterol in check were least effective among those with the lowest risk of having future heart events, meaning the benefits may not outweigh the risks for many.

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“We’re getting close to the idea of re-thinking risk,” says Blaha. Instead of relying on decades-old data that draws conclusions and recommendations on a population level, ideally everyone’s risk should be more individualized and based on his own particular history. The Framingham model, for example, includes data collected from a single measurement of blood pressure and cholesterol, and a yes-or-no answer on whether the patient smokes. But someone who has smoked for years and just quit is physiologically different from someone who never lit up at all, just as having blood pressure that’s under control thanks to medication is not the same as never having hypertension to begin with. The most accurate way to predict someone’s risk of having a heart attack is to survey his blood pressure and cholesterol readings over his lifetime, or at least for many years. That may soon be possible with electronic health records and the popularity of medical monitoring bracelets. But until then, any model that relies on population-based data like Framingham may suffer from overestimating someone’s heart danger, Blaha says.

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“These data point squarely to the idea that we need to be rethinking risk prediction,” he says. That may require not just combing through more data per patient, but also folding in other factors that may be more sensitive to the health of a person’s heart. Imaging techniques, including coronary calcium scores that measure the amount of calcium—a foundation for the plaques that eventually rupture to cause heart attacks—may provide more valuable and accurate information on a person’s risk, for example.

In the meantime, Blaha isn’t advocating for the elimination of current risk predictors or guidelines that help doctors decide when a patient’s risk warrants treatment with a drug. “The guidelines are still useful, but patients and doctors have to understand the caveats and limitations to them,” he says. Whatever score a patient receives from these calculators, that number should be the starting point of a discussion between doctor and patient about that patient’s particular risk factors—including his family history, whether and how much he smoked, and how much exercise he gets on a regular basis. “Patients need to demand, or ask their doctors to go beyond the number and say, ‘Do you really think I need to starting taking medicine?’ or ‘How much risk do I really have of having a heart attack?’” That kind of conversation is far more valuable than a single-risk calculator will ever be.

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