Experimental cholesterol-lowering pill may offer new option for millions
WASHINGTON– A new type of pill significantly 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 only be achieved with injected medications. If approved by the Food and Drug Administration, the pill, called enlicitide, could provide an easier-to-use option for millions of people.
Statins block part of the liver’s production of cholesterol and are the cornerstone of treatment. But even taking the highest doses, many people need additional help to lower 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 dummy medication to their standard treatment. Enlicitide users saw their LDL cholesterol levels drop by up to 60% in six months, researchers reported in the New England Journal of Medicine.
There are other pills that patients can add to their statins “but none achieve the degree of LDL cholesterol reduction that we see with enlicitide,” said the study’s lead author, Dr. Ann Marie Navar, a cardiologist at UT Southwestern Medical Center.
This benefit declined only slightly over a year, and there was no difference in safety between those who took the pill or the placebo, the researchers found. Warning: 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 buildup in the arteries, is a leading risk factor for heart attacks and strokes. Although an LDL level of 100 is considered acceptable for healthy people, doctors recommend lowering it to at least 70 once people develop high cholesterol or heart disease — and even lower for people at very high risk.
Statin pills like Lipitor and Crestor, or their cheap generic equivalents, are very effective in lowering LDL. For additional help, some powerful injectable medications work differently, blocking a liver protein called PCSK9 that limits the body’s ability to remove cholesterol from the blood. Yet only a small fraction of people who might benefit from PCSK9 inhibitors use them. Although prices for expensive injections have fallen recently, patients still may not like administering injections and Navar said they are more complex for doctors to prescribe.
Merck funded Wednesday’s study, which provides some of the final data needed to gain FDA approval of enlicitide. The FDA added the drug to a program promising lightning-fast reviews.
The research offers “compelling evidence” that the new pill reduces cholesterol about as much as PCSK9 injections, Dr. William Boden of Boston University and the VA New England Healthcare System, who was not involved in the study, wrote in the journal.
Boden cautioned that there is no data yet showing that lowering cholesterol with the pill translates into fewer heart attacks, strokes and deaths. This takes much more than a year to prove. Merck has an ongoing study involving more than 14,000 patients.
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