A new kind of pill sharply reduced artery-clogging cholesterol in people who remain at high risk of heart attacks despite taking statins, researchers reported Wednesday.
It’s still experimental but the pill helps rid the body of cholesterol in a way that today can be done only with injected medicines. If approved by the Food and Drug Administration, the pill, named enlicitide, could offer an easier-to-use option for millions of people.
Statins block some of the liver’s production of cholesterol and are the cornerstone of treatment. But even taking the highest doses, many people need additional help lowering their LDL, or “bad,” cholesterol enough to meet medical guidelines.
In a major study, more than 2,900 high-risk patients were randomly assigned to add a daily enlicitide pill or a dummy drug to their standard treatment. The enlicitide users saw their LDL cholesterol drop by as much as 60% over six months, researchers reported in the New England Journal of Medicine.
There are other pills that patients can add to their statins “but none come close to the degree of LDL cholesterol lowering that we see with enlicitide,” said study lead author Dr. Ann Marie Navar, a cardiologist at UT Southwestern Medical Center.
That benefit dropped only slightly over a year, and there was no safety difference between those taking the pill or placebo, researchers found. One caveat: The pill must be taken on an empty stomach.
Heart disease is the nation’s leading cause of death and high LDL cholesterol, which causes plaque to build up in arteries, is a top risk factor for heart attacks and strokes. While an LDL level of 100 is considered fine for healthy people, doctors recommend lowering it to at least 70 once people develop high cholesterol or heart disease — and even lower for those at very high risk.
Statin pills like Lipitor and Crestor, or their cheap generic equivalents, are highly effective at lowering LDL. For additional help, some powerful injected drugs work differently, blocking a liver protein named PCSK9 that limits the body’s ability to clear cholesterol from blood. Yet only a small fraction of people who could benefit from PCSK9 inhibitors use them. While prices for the costly shots have dropped recently, patients still may dislike administering shots and Navar said they’re more complex for doctors to prescribe.
Merck funded Wednesday’s study, which provides some of the final data needed to seek FDA approval of enlicitide. The FDA has added the drug to a program promising ultra-fast reviews.
The research offers “compelling evidence” that the new pill lowers cholesterol about as much as those PCSK9 shots, Dr. William Boden of Boston University and the VA New England Healthcare System, who wasn’t involved with the study, wrote in the journal.
Boden cautioned there’s no data yet showing the pill’s cholesterol-reduction translates into fewer heart attacks, strokes and death. That takes much longer than a year to prove. Merck has a study of more than 14,000 patients underway to tell.
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