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

Why You (Yes, You) Need to Learn CPR

Two new studies says CPR saves lives — no mouth-to-mouth with strangers required.

New research shows bystanders who offer CPR to a person in need can improve survival rates and reduce neurological issues, such as brain damage, that can result from cardiac arrest.

The new study, published in the journal JAMA, looked at 4,961 cardiac arrest cases between the years 2010 to 2013 in North Carolina. During that time period, the state launched a campaign called The HeartRescue Project, which encourages bystander chest-compression CPR—the new gold-standard form of resuscitation—and the use of automated external defibrillators. There was a greater likelihood for both survival and survival with positive neurological outcomes among people who received CPR from a bystander.

The data also shows that during the time frame, the number of people with cardiac arrest who got bystander CPR and use of defibrillators by first responders increased from around 14% in 2010 to 23.1% in 2o13. The researchers only observed an increase in positive neurological outcomes among patients who received bystander CPR, underling the importance of the procedure.

Prior research has shown chest compressions alone—which is different from the CPR many people have been taught—can save brain damage and lives. (See how to do it with this video from the American Heart Association.)

The study is limited since it was observational, but the researchers still conclude that during the period, the number of people that received bystander CPR increased—as did their survival rates. In an email to TIME, study author Dr. Carolina Malta Hansen of the Duke Clinical Research Institute said that while they can’t give a definitive reason for the association, it’s possible that when a bystander steps in, a person receives CPR much faster than if a bystander doesn’t, and that could make a difference.

A second study also published Tuesday in JAMA looked at 167,912 patients with bystander-witnessed out-of-hospital cardiac arrest between 2005 and 2010. During the time period, they found that the number of events increased, as did the rate of bystander chest compression and bystander defibrillation (many public places have defibrillators on site). Additional defibrillation from first responders also went up. The researchers also noticed an association between these higher rates and a small increase in the likelihood that people survived without neurological damage.

Some of the study authors of the first study have received funding from medical device companies, and the North Carolina program was funded by the Medtronic Foundation. The researchers say the funders had no other role in the study.

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 Heart Disease

Breakthrough Heart Failure Drug Approved

The U.S. Food and Drug Administration (FDA) has approved a new drug for heart failure that some say could replace current drugs and procedures used to treat the condition.

On Tuesday, the FDA approved drug company Novartis’ Entresto, formally known as LCZ696, for clinical use. In trials, the drug cut deaths or hospitalization from heart disease by 20%.

Novartis developed the drug hoping to replace ACE inhibitors, which are one of the go-tos for heart failure treatment. In a previous trial, an ethics council had requested that Novartis end the trial early since the data showed that trial participants using LCZ696 lived longer without being hospitalized for heart failure compared to people using the common ACE inhibitor, enalapril.

Patients swallow two tablets a day, which cost about $12.50 (or $4500 a year). So far, the side effects include low blood pressure and a drop in kidney function, as well as some swelling in the face, but experts, and the FDA, believe the benefits in improving heart function generally outweigh these potential adverse events.

Early reports suggest the drug will be a “blockbuster” on Wall Street.

Read more about Entresto here.

TIME Research

90% of Americans Eat Too Much Salt

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A new report sheds light on Americans' sodium habits

Consuming too much sodium can be a risk factor for heart problems, and new federal data shows more than 90% of Americans eat too much.

The findings show that from 2011 to 2012, the average daily sodium intake among U.S. adults was 3,592 mg, which is well above the public health target set by the U.S. Department of Health and Human Services (HHS) of 2,300 mg. The data comes from the U.S. Centers for Disease Control and Prevention’s (CDC) 2013 survey of 180,000 American adults in 26 states, D.C. and Puerto Rico. The findings were published Thursday in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Some Americans, however, are taking action to cut back, the report shows. About half of the U.S. adults surveyed said they were monitoring or reducing their sodium intake, and 20% said they had received medical advice to do so. People with high blood pressure were more likely to report they were doing something about their sodium consumption, and overall, people in Southern states were more likely to report such action or advice from medical providers.

Public health experts argue that people without high blood pressure could also benefit from cutting back. “Among adults without hypertension, most did not report taking action to reduce sodium intake, and an even smaller proportion reported receiving professional advice to reduced sodium,” the study authors write. “These findings suggest an opportunity for promoting strategies to reduce sodium consumption among all adults, with and without hypertension.”

Sodium intake recommendations have been the focus of controversy, with some researchers arguing that sodium levels are safe and that cutting back to very low recommended levels could be harmful. Others argue that high sodium consumption is related to serious health complications and contributes to millions of deaths every year. Some groups recommend limits that are even lower than the HHS; for instance, the American Heart Association recommends less than 1,500 mg a day.

In the new CDC report, researchers say that a high sodium habit doesn’t come cheap; medical costs for cardiovascular disease are predicted to triple from $273 billion to $818 billion between 2010 to 2030, and cutting back on sodium intake by 1,200 mg a day could save $18 billion in costs each year, they say.

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 Research

This Is the Healthiest Month to Be Born In, According to Science

A new study identified 55 diseases associated with birth month

Read an interview with the study’s author.

Your birthday may be more important than you think when it comes your health.

Scientists at Columbia University used an algorithm to identify “significant associations” between the time a year a person is born and 55 diseases, including ADHD, asthma and heart disease. The new study, which was published in the Journal of American Medical Informatics Association, concludes that people born in May have the lowest overall risk for disease, while people born in October have the highest.

Though previous research had explored the connection between disease risk and birth season, this study confirmed 39 associations as well as laid out 16 new ones. Researchers looked at more than 1,600 diseases and 1.7 million patients treated in New York between 1985 and 2013 to identify the months most associated with asthma (October and July babies), ADHD (November babies, matching a Swedish study), and nine kinds of heart disease. They plan to replicate the study in other locations, to better identify the environmental factors contributing to such disparities.

“It’s important not to get overly nervous about these results because even though we found significant associations the overall disease risk is not that great,” said Nicholas Tatonetti, the study’s senior author and an assistant professor at Columbia University Medical Center. “The risk related to birth month is relatively minor when compared to more influential variables like diet and exercise.”

For more on the study, read an interview with Columbia’s Tatonetti here.

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

Cancer Is Now the Number 1 Killer of Men in the UK

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Women are still more likely to die of heart disease than cancer

A new report shows that in the U.K., cancer has surpassed cardiovascular disease as the most common cause of death, but only among men.

The research published in The BMJ looked at the national data on both cancer and heart disease in countries in the U.K. from 2012 to 2013. Among men, fewer were dying of heart-related disease like high blood pressure and stroke than they have been in the past. Thirty-two percent of deaths among men were cancer-related and 29% were from heart disease. For women, 27% of deaths were from cancer and 28% from heart disease.

Overall, in 2012 the researchers reported that the proportion of deaths from cancer was 29% and cardiovascular disease related-deaths came out to 28%. England had the lowest rate of heart conditions and Scotland had the highest.

It’s unclear what precisely is responsible for the drop in heart-related disease, but it’s known that in some cases, heart disease is preventable with lifestyle changes.

TIME Heart Disease

How Much Alcohol Is Too Much? A New Study Has Answers

Alcohol, at least in moderation, can help the heart, but too much can be toxic. The latest study tells you where to draw the line

For decades, there’s been a steady line of literature welcomed by anyone who enjoys a regular drink or two: that moderate drinking can actually protect you from having a heart attack by keeping your vessels clear and relatively plaque-free. But there’s another set of data that shows too much alcohol can start to poison the heart. So where does the line between good-for-you and bad-for-you lie?

Researchers led by Dr. Scott Solomon, professor of medicine at Harvard Medical School and director of non-invasive cardiology at Brigham and Women’s Hospital, and his colleagues provide some clues Tuesday in their latest report in the journal Circulation: Cardiovascular Imaging. The scientists combed through data collected from 4,466 elderly people about their alcohol consumption. They also agreed to echocardiograms of their hearts. Solomon wanted to see if there were any changes in the structure of the heart that had anything to do with how much the volunteers reported they drank each week.

MORE: Should Alcohol Be Forced to List Calories?

The not-so-good news: The more the participants drank, the more likely they showed abnormal changes in their heart structure and function. In men, the changes started accumulating after more than two drinks per day, or 14 or more drinks a week. In these men, the pumping chambers of their hearts increased slightly compared to those in non drinkers, a sign that the heart had to work harder to pump the same amount of blood, which can cause it enlarge and weaken. In women, these changes appeared when women drank much less, just above the one drink a day. In addition, among the women who imbibed more than a drink a day, the scientists found slight drops in heart function compared to women who drank less.

“A little bit of alcohol may be beneficial, but too much is clearly going to be toxic,” says Solomon. “Once you get beyond two drinks a day in men, you get into the realm where you start to see subtle evidence of cardiotoxic effects on the heart that might over the long term lead to problems. And that threshold might be lower in women.”

The study provides valuable information about how alcohol affects the heart, and how much alcohol exposure can trigger changes to the heart’s structure and more importantly, how it functions. But where the tipping point lies with each individual between the benefits and harms of a having a few drinks isn’t clear yet. More studies investigating which genetic factors may predispose people, and in particular women, to the toxic effects of alcohol will need to done before more refined advice about how much is too much can be discussed.

Those investigations might start with potential differences in the way men and women process alcohol. The effects Solomon and his team saw remained strong even after they adjusted for body mass index, and other studies have hinted, for example, that the different hormone environments in men and women might be responsible for the increased vulnerability of women’s heart tissues to the toxic effects of alcohol.

Future work may also delve deeper into the question of how long people drink; like any exposure, the effects of alcohol may also be cumulative. Because the participants in the study were relatively elderly, with an average age of 76, their heart changes reflected decades of exposure to alcohol but it’s not clear whether there is a threshold for when the harmful effects dominate over the potentially beneficial ones.

“What is clear is that at more than two drinks a day is the point at which we start to think we are beyond the safe level for men, and with women, it’s likely to be even lower than that,” says Solomon.

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