TIME Drugs

FDA Approves New Cholesterol-Lowering Drug

Repatha

It’s the second in a new class of drugs that works in a different way from statins to bring cholesterol levels down

The U. S. Food and Drug Administration approved a new drug for treating high cholesterol levels on Thursday. Evolocumab, called Repatha, is made by Amgen and is the second of a new class of lipid-lowering agents that are hitting the market.

Known as PCSK9 inhibitors, these drugs work by suppressing genes that slow down production of cholesterol receptors on the liver. With these medications, more receptors that are free to emerge and act like sponges can soak up LDL cholesterol and lower their levels in the blood.

MORE: This New FDA-Approved Cholesterol Drug Is a Game Changer

Evolocumab was approved first by the European Medicines Agency in July. In the same month, the U.S. FDA approved another drug in the same class, alirocumab (Praluent), made by Sanofi and Regeneron. In studies, both drugs helped to lower cholesterol levels in the blood by 60% more than the amount achieved by statins. The drugs carry labels that say medications should be used first in people with a strong family history of high cholesterol conditions, or in people who have tried and not responded to statin medications.

PCSK9 inhibitors were discovered among a group of people who happened to have genetic mutations that gave them extremely low cholesterol levels. Researchers studied this rare population, and found they did not have any negative health effects from their mutation other than the beneficial effect on their lipids. So drug makers began investigating ways to replicate the condition with a medication.

MORE: Memory Loss Not Caused By Cholesterol Drugs After All

Having another drug that can lower cholesterol levels will be a boon to treating heart disease, which remains the leading killer of Americans each year. Keeping cholesterol levels down, in addition to eating a healthy diet and exercising to maintain weight are crucial to lowering the risk of heart events.

TIME Mental Health/Psychology

This Graphic Shows What Stress Does to Your Body

Americans need to relax.

Over 40% of people in the U.S. say they are not doing enough to manage their stress, and the consequences of that could lead to all sorts of health-related problems. A recent study published in the journal Neuron showed people who are stressed have more difficulty with self-control and are more likely to choose to eat unhealthy food. If you’re like many Americans, you often be stressed about work and money, but there are good reasons to take time out of your day to relax. Here’s some examples of how stress affects your entire body.

Heather Jones

Read next: How To Calm Your Monkey Mind and Get Things Done

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TIME Diet/Nutrition

This Is the Worst Kind of Fat for Your Heart

High in fat
Mark Poprocki—Mark Poprocki

Not all fats are created equal, and the latest study shows that one in particular can lead to higher rates of heart disease, deaths from heart related problems, and diabetes.

As confusing as the diet message can be at times, one thing is clear. There are good fats and bad fats in the foods we eat, and some can really wreak havoc on the heart and its delicate vessels.

In a study published in the BMJ, scientists say that trans fats are linked to the highest rates of death from all causes, deaths from heart disease and heart problems. The trans fat risk surpassed even that associated with saturated fat, which is found in formerly taboo-for-the-heart foods like butter, eggs and red meat.

Russell de Souza, a dietician and epidemiologist from McMaster University, and his colleagues sifted through the published studies involving hundreds of thousands of participants on trans and saturated fats and their health effects. They found that those eating more trans fats had a 34% higher rate of dying from any cause compared to those eating less, a 28% higher risk of dying from heart disease, and a 21% greater risk of having heart-related health issues.

MORE: This Is Why FDA Is Banning Trans Fats

In contrast, eating saturated fat was not linked to a higher risk of early death, heart-related problems, stroke, or type 2 diabetes.

That doesn’t mean, however, that saturated fats now get a green light. de Souza points out that many people who try to cut back on saturated fats tend to substitute them with less healthy fats like those from margarine or with carbohydrates, which can contribute to heart disease. So while saturated fats when compared to trans fats did not substantially increase heart disease risk, that doesn’t mean saturated fats are actually heart healthy. It’s just that in the hierarchy of heart-friendly fats, trans fats are the worst and saturated fats are the next worst. “We didn’t find any evidence for increasing the allowable amount of saturated fat in the diet,” says de Souza.

MORE: Trans Fats Are Hiding All Over Your Grocery List

The group that showed the lowest risk of early death or heart disease were those who consumed the most vegetable oils such as olive and canola. “If there is one message to go away with from these results, it’s that substituting saturated and trans fats with whole grains and vegetable oils is a step in the right direction,” says de Souza.

The results, he says, support current dietary guidelines for how much of different types of fats people should eat to maintain healthy hearts and lower their risk of chronic diseases. For now, he says, the advice to consume no more than 10% of daily calories in saturated fat and to limit trans fats to less than 1% of calories, is reasonable.

TIME Heart Disease

Here’s How Much You Should Stand Each Day

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Getty Images

More evidence suggests getting off your seat and moving around is good for your health

We know that the amount of time we spend sitting each day wreaks havoc on our health, and in a new paper, researchers show that spending just two hours standing or moving around instead of sitting may have a real positive impact on our health.

In the new study published Thursday in the European Heart Journal, researchers had 782 men and women wear activity trackers 24 hours a day for seven days. The monitors tracked how much time the men and women spent stepping, sitting, standing, sleeping or lying down. The participants also provided blood samples and other measurements like blood pressure and weight.

With the data gathered from the trackers, the researchers used a mathematical model to estimate how the allotted time in each condition would impact the men and women’s health. Interestingly, they found that spending two extra hours a day standing instead of sitting was linked to better blood sugar levels and lower levels of fat in the blood (triglycerides). Specifically, more time spent standing was associated with a 2% lower average blood sugar levels and a 11% lower levels of triglycerides. Cholesterol levels showed improvement as well.

The findings also showed that spending an extra two hours moving instead of sitting was linked to a significant lower body mass index (BMI) and waist circumference.

The study cannot definitely prove that these tweaks to the amount of time spent sitting directly causes improvements in health markers, but the researchers note that the findings do fall in line with what’s known about the impact on the body of being active (or at least not being sedentary).

More research is still needed, but the findings support the longstanding advice that moving around is better for our health than lounging around, and suggest that any decisions to purchase a standing desk are not made in vain.

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 space

New Horizons Finds Second Mountain Range in Pluto’s Heart

New Horizons Pluto Heart Mountain Range
NASA/Johns Hopkins University Applied Physics Laboratory/Southwest Research Institute A newly discovered mountain range lies near the southwestern margin of Pluto’s heart-shaped Tombaugh Regio (Tombaugh Region), situated between bright, icy plains and dark, heavily-cratered terrain.

The newly discovered peaks are as high as the Appalachian Mountains

Pluto’s heart continues to divulge its secrets as NASA announced the discovery of a new mountain range on the lower-left edge of the planet’s heart-shaped region.

These frozen peaks are estimated to be one-half mile to one mile high, which is about the same height as the Appalachian Mountains, NASA has revealed in a new image.

The newly discovered peaks, which have yet to be named, are located about 68 miles northwest of the Norgay Montes, the frozen mountains that were discovered on July 15 in the first series of photographs that New Horizons beamed back to Earth.

“There is a pronounced difference in texture between the younger, frozen plains to the east and the dark, heavily-cratered terrain to the west,” said Jeff Moore, leader of the New Horizons Geology, Geophysics and Imaging Team at NASA’s Ames Research Center in Moffett Field, California. “There’s a complex interaction going on between the bright and the dark materials that we’re still trying to understand.”

NASA believes that Sputnik Planum, the left lobe of Pluto’s heart-shaped region, was formed less than 100 million years ago while the darker region, seen on the newly-released image, is probably older by billions of years.

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 medicine

Memory Loss Not Caused By Cholesterol Drugs After All

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Chris Gallagher—Getty Images/Photo Researchers RM

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 Innovation

Five Best Ideas of the Day: March 13

The Aspen Institute is an educational and policy studies organization based in Washington, D.C.

1. Amid the rancor and theatrics in Washington, it’s easy to forget how remarkable it is that the U.S. and Iran are talking at all.

By George Perkovich at the Carnegie Endowment for International Peace

2. A critical step in drug research is understanding the impact on the heart. That’s why bioengineers built a beating heart on a silicone chip.

By Sarah Yang at the University of California at Berkeley

3. Americans are quitting their way to a stronger economy.

By Aaron Nathans in the Daily Economy

4. Just because we’re able to edit the DNA of tomorrow’s children, does that mean we should?

By Antonio Regalado in MIT Technology Review

5. America has its own ion collider, and its funding is in danger.

By Natalie Walchover in Quanta

The Aspen Institute is an educational and policy studies organization based in Washington, D.C.

TIME Ideas hosts the world's leading voices, providing commentary and expertise on the most compelling events in news, society, and culture. We welcome outside contributions. To submit a piece, email ideas@time.com.

TIME Heart Disease

7 Weird Things That Can Mess With Your Heartbeat

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Getty Images

Heart symptoms should never be taken lightly, but factors as innocent as caffeine and thirst may be the cause

A few weeks ago I thought I was having a heart attack. My morning started out normal: I woke up at my usual hour, feeling what I thought was a little bit of tiredness. But as I went about my morning routine, things grew scary. I broke out in a cold sweat as I brushed my teeth. My skin turned white as paper. And then, scariest of all: my heart was pounding like crazy. As a health writer I know these aren’t textbook signs of a heart attack, but I also know that dangerous cardiovascular events in women can be more subtle than those in men.

Later that day I went to urgent care, but an EKG and blood tests showed nothing out of the ordinary. Turns out my heartbeat went haywire as a result of a side effect from a medication. The technical term for this: heart palpitations, which can be brought on by many things.

“When a person says they’re having heart palpitations they’re referring to a sensation of their heart beating differently. Or they may simply have an awareness of their heart beating,” explains Shephal Doshi, MD, director of cardiac electrophysiology at Providence Saint John’s Health Center in Santa Monica, California.

Learn about some top triggers of palpitations, plus what to do about them.

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

Panic attacks

If you feel as if your heart is racing like it’s going to beat out of your chest, it could be a panic attack, Dr. Doshi says. Shaking, sweats, and an overwhelming feeling of impending doom are also common symptoms. Panic attacks are generally not dangerous, though they can feel absolutely terrifying. “Sometimes you may have an arrhythmia [an abnormal heart rhythm caused by a disruption in the heart’s electrical signaling] that’s actually causing the panic attacks, so see a doctor to rule out something more serious,” Dr. Doshi adds. Otherwise, recurring panic attacks can be treated with talk therapy to identify triggers and anti-anxiety medications.

Read more: 12 Signs You May Have an Anxiety Disorder

Caffeine

So your heart’s beating faster than normal. Before you start worrying, did you just have a big cup of Joe? “Caffeine is a stimulant,” says Brian Kolski, MD, an interventional cardiologist with St. Joseph Hospital in Orange, California. This means that it “stimulates the autonomic nervous system (the involuntary nervous system which controls heart rate and more), which can cause an increase in palpitations.” Dr. Kolski recommends seeing your doctor if palpitations become excessive or are accompanied by dizziness, lightheadedness, or chest pain—even if you suspect it’s caused by caffeine.

Read more: 12 Surprising Sources of Caffeine

Decongestants

Decongestants such as pseudoephedrine (the active ingredient in Sudafed) are also stimulants. “Some people who may be sensitive to these drugs can experience heart palpitations,” adds Dr. Doshi. Over-the-counter meds are usually safe, but you should talk to your doctor or pharmacist if you have any other medical conditions. If you have a heart arrhythmia, for example, your doctor may advise against taking certain decongestants, Dr. Doshi says.

Read more: 10 Products to Help You Find Sinus Relief

Dehydration

Losing too much fluid, not drinking enough, or a combination of the two can quickly lead to dehydration, which, when severe, can lead to heart palpitations along with dry mouth, dark urine, and muscle cramping. “Dehydration can cause changes in your body’s electrolytes and also lowers blood pressure,” Dr. Doshi says. “This puts stress on the body and, as a result, could cause an abnormal heartbeat.” Prevent it with regular trips to the water cooleryour body needs 2.2 liters (or about nine cups of fluid) every day to function properly, per the Institute of Medicine.

Read more: 7 Easy Ways to Drink More Water

Prescription meds

Many prescription medications, including those for asthma or thyroid problems, can cause palpitations, says Dr. Kolski. “Some medications affect how other medications are metabolized, while others cause changes in the electrical conduction system of the heart.” These heartbeat changes aren’t normally a cause for alarm, but they can be bothersome. Make sure your doctor knows about every drug or supplement you’re taking before you start any new medications. Also, pay close attention to the possible side effects listed on the drug information that comes with your medicine when you pick it up from the pharmacy, so you won’t freak out if it happens. If your regular medicines are messing with your heartbeat day-to-day, talk to your doctor to see if there’s a different drug that might work better for you.

Read more: 19 Signs Your Thyroid Isn’t Working Right

Anemia

Most commonly caused by iron deficiency, anemia means your body isn’t making enough healthy red blood cells to carry adequate oxygen to your tissues. Although it doesn’t always cause heart palpitations, people with anemia may sometimes feel their heart beating harder, says Kolski. “Since you have fewer red blood cells, a faster heart beat increases oxygen delivery when you’re anemic.” Other symptoms include fatigue and hair loss.

Read more: 15 Signs You May Have an Iron Deficiency

Heavy metals

People who work in construction, as metal workers, or in other industrial settings can be exposed to mercury, cadmium, and other heavy metals regularly. Long-term exposure can lead to inflammation, blood clots (thrombosis), and other heart-related problems. “Heavy metal exposure can be directly toxic to heart muscle,” Dr. Kolski says. “[It] can also cause problems with electrolytes. Anything that causes a derangement in electrolytes can cause heart palpitations.”

Read more: 10 Best Foods for Your Heart

In general, heart symptoms should never be taken lightly; if you ever feel like something’s up with your heart, see a doctor ASAP (in the ER or an urgent care center) for a full evaluation.

This article originally appeared on Health.com.

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