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Experimental cholesterol drugs could halve heart attack and stroke rates

A new class of experimental cholesterol drugs might sharply reduce the risk of heart attacks and strokes, preliminary research has found.

A new class of experimental cholesterol drugs may sharply reduce the risk of heart attacks and strokes, initial research has discovered.

by Andrew PollackA new class of experimental cholesterol drugs might sharply reduce the risk of heart attacks and strokes, researchers reported on Sunday, citing what they described as preliminary evidence.

The drugs, one being developed by Amgen and the other by Sanofi and Regeneron Pharmaceuticals, are already known to sharply reduce so-called bad cholesterol, sometimes to levels lower than those achieved by statins like Lipitor, the mainstay lipid-lowering medicines.

What has not been known, however, is whether the drugs do what patients and doctors really care about: protect against heart attacks, strokes and other cardiovascular problems or “events.”

Big benefits may be possible

The early results suggest that there might be such a benefit, maybe even a big one. In small studies sponsored by the manufacturers, both drugs reduced the rate of such cardiovascular problems by about half.

“To see a reduction in cardiovascular events already is very encouraging that we’re on the right track,” says Jennifer G. Robinson, the lead investigator in the trial of the Sanofi drug.

The studies were published in The New England Journal of Medicine and were presented at the annual meeting of the American College of Cardiology on  Monday in San Diego.

More research required

Researchers caution, however, that the studies were small and intended to assess whether the drugs lower the bad cholesterol and were safe, not whether they stave off heart attacks. That could make the conclusions about heart attack and stroke risk less trustworthy. Judging those effects will require larger trials involving tens of thousands of people; such studies are underway and are expected to be completed by 2017.

“I do not think that either study answers the question definitively of cardiovascular benefit,” says Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, referring to the drug makers’ research. He was not involved in either study.

Risk of memory problems

Researchers say long-term safety still must be assessed, especially since these drugs are reducing LDL cholesterol to levels never achieved by medicines before. While the drugs appear to be generally safe, there is evidence that they could cause memory problems.

Still, the findings could help smooth the way for regulatory approval, wider use of the drugs by doctors and possibly reimbursement by insurers.

The drugs, evolocumab from Amgen and alirocumab from Sanofi and Regeneron, inhibit a protein in the body called PCSK9 that helps regulate cholesterol. In the studies detailed on Sunday, both drugs reduced the bad cholesterol by about 60 percent, to about 50 milligrams per deciliter from about 120 at the start of the studies. In many cases such big reductions were achieved even though the patients were already taking statins.

Both drugs could win approval from the US Food and Drug Administration by the Northern summer. Analysts say the drugs will have billions of dollars in annual sales and will be taken by millions of people who cannot lower their cholesterol enough using statins alone or cannot tolerate statins. (However, the PCSK9 drugs are taken by injection every two weeks or four weeks, which could deter some users.)

Statins reduce cardiovascular risk and scientists believe it is because they decrease low-density lipoprotein, or LDL, the so-called bad cholesterol. But merely looking at cholesterol levels can be misleading. The drug niacin did not protect against heart attacks and strokes even though it raised so-called good cholesterol and modestly lowered bad cholesterol.

Insurers in particular might demand proof that the PCSK9 drugs stave off heart attacks, strokes, deaths from coronary disease and procedures to open arteries before agreeing to pay for them for many patients. Executives at CVS Health, a leading pharmacy benefits manager, recently said that PCSK9 inhibitors might cost $US7,000 to $US12,000 a year and would strain health care budgets because so many people might use them.

“Managed care pharmacy, indeed the health care system, has never seen a challenge like this to our resilience in absorbing costs,” they wrote in the Health Affairs blog.

Whether the results from these two small studies will be persuasive enough remains to be seen.

The New York Times

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Henry Sapiecha

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