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Studies Confirm Who's Helped by Statins, Who Needs Other Drugs

A batch of new studies show that heart drugs called statins can help even people who aren’t considered to have a high risk of heart disease.

A batch of studies released over the weekend show that the immensely popular heart drugs called statins can help even people who aren’t considered to have a high risk of heart disease, and offer some hope for people who cannot tolerate the cholesterol-lowering treatment.

People who took fairly low doses of a statin drug for five years or longer lowered their risk of a heart attack, stroke, or other major heart problem by about 25 percent, according to the studies presented at a meeting of the American College of Cardiology.

And one of the studies also showed that about half the people who believe they have a painful reaction to statin pills actually do seem to be right. Most of them were able to switch to a new, injected drug called a PCSK9 inhibitor.

Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, says the studies should help heart doctors who are trying to decide who needs to take drugs, and which ones.

One of the studies, also published in the New England Journal of Medicine, involved more than 12,700 people of various ethnic backgrounds in 21 countries.

“Treatment with rosuvastatin at a dose of 10 mg per day resulted in a significantly lower risk of cardiovascular events than placebo,” the researchers wrote.

“Certainly it extends the benefits of statins to a somewhat lower-risk population."

None was considered at high risk of heart disease and none would normally have been prescribed a statin drug. “In this study many of these patients had abdominal obesity, about a quarter of them were smokers, so they had risk factors,” Nissen told NBC News.

“Their LDL cholesterol, the bad cholesterol, was around 130 on average. That's not entirely normal, so these are not normal healthy people — they are people at increased risk. They're just not people at very high risk.”

They got a cholesterol-lowering drug called rosuvastatin, provided by the drug company that helped sponsor the trial. After five and a half years, 3.7 percent of the volunteers who got the drug had a heart attack, stroke, heart failure or other serious heart issue. But 4.8 percent of those given a placebo, or dummy pill, had a serious event.

Those numbers are not high overall but it adds up to a 26 percent reduction in risk. It suggests that people who normally would not be considered for statins might be helped by them, Nissen said.

“Certainly it extends the benefits of statins to a somewhat lower-risk population,” he said.

“However, it should be kept in mind that during the time the study was done, our guidelines have begun to recommend treatment of those lower-risk patients and so at least half of the patients in this study would have qualified for statins under the current American guidelines.”

In 2013 new guidelines from the American Heart Association and the American College of Cardiology broadened the definition of who should get cholesterol-lowering statins, which are among the most widely prescribed drugs in the world.

Experts estimate they made another 8 million to 13 million Americans eligible for statins.

Statins, which include Lipitor, Mevacor, Crestor and Zocor, are extremely popular. About 28 percent of Americans over 40 take a cholesterol-lowering drug and more than 90 percent of these take a statin.

Muscle symptoms

But they have serious side effects. They can damage muscle in 5 to 15 percent of patients, and the Food and Drug Administration has updated labeling on statins to include warnings about confusion and memory loss, elevated blood sugar leading to Type 2 diabetes, and muscle weakness.

“It’s not just a psychosomatic illness.”

In another study released at the meeting of heart specialists, Nissen and colleagues checked to see if people were perhaps imagining the problems.

“We set out to find out objectively whether in fact there are many people who can't tolerate statins,” he said.

“What we did is without patients knowing which drug they were getting they got either either a placebo pill or a medium dose of a statin,” Nissen added.

“We found that 42.6 percent of patients had symptoms on the statin but not on the placebo.”

That’s not quite half, but it’s a lot of people, Nissen said.

“It's actually millions of Americans who tell us that they can’t tolerate these,” he said. “It’s not just a psychosomatic illness.”

The researchers then gave most of the patients non-statin cholesterol-lowering drugs, either Zetia, known generically as ezetimibe or evolocumab, which is one of the new PCSK9 inihibitors.

Fewer patients reacted to these. “Muscle symptoms were reported in 28.8 percent of ezetimibe-treated patients and 20.7 percent of evolocumab-treated patients,” the team wrote.

But only 7 percent of the patients who got ezetimibe and fewer than 1 percent of those who got evolocumab quit taking the drugs because of the symptoms.

“This confirms for the first time that muscle intolerance to statins is a real and a reproducible problem that is very common affecting a significant portion of patients with those patients,” Nissen said.

“Now we need to go to alternatives to treat them.”

Zetia is a pill. Evolocumab, the PCSK9 inhibitor sold under the brand name Repatha, must be injected. And it’s in a class of biotech drugs called monoclonal antibodies. Repatha and a similar drug called Praluent cost about $14,000 a year.