Merck, the company that introduced statins to the world nearly 40 years ago, has an intensely powerful new pill that can reduce levels of dangerous LDL cholesterol to levels almost never seen in adults.
The new pill, enlicitide, blocks a liver protein, PCSK9, that slows the body’s ability to eliminate cholesterol. With most PCSK9 blocked, LDL levels plummet and heart attack and stroke rates in high-risk patients drop by up to 20% within the first year.
At least 6 million adults in the United States are eligible for drugs that block PCSK9.
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Merck’s head of research said the goal is to make the pill affordable. It would be an alternative to biweekly or monthly injections of monoclonal antibodies that do the same thing. But only about 1% of eligible patients use the shots, which include Praluent, from Regeneron and Sanofi, and Repatha, from Amgen. Many patients don’t want to get shots, and health plans put up obstacles to payment, cardiologists say. List prices for these medications exceed $500 per month.
This Saturday (8), at a meeting of the American Heart Association, Merck presented the results of a 24-week study of 2,912 people who had had a heart attack, stroke or other cardiovascular event, or were at risk of one. They were randomly assigned to take enlicitide or a placebo. Those taking enlicitide reduced their LDL levels by up to 60%, the same amount achieved by the injections.
There was no difference in side effects between those who took the pill and those who took the placebo.
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Several studies over the years have shown that the lower the LDL level, the better — heart attack and stroke rates drop as LDL levels decrease. And there appears to be no downside to having a surprisingly low LDL level, including levels in the 10s or 20s. Adults who don’t take cholesterol-lowering medications often have levels above 100.
“Smaller is better, for sure,” said Daniel Soffer, a cardiologist at the University of Pennsylvania.
An affordable pill, taken daily, that has the same effect as injectable drugs “could be a game-changer,” said Christopher Cannon, a cardiologist at Brigham and Women’s Hospital in Boston who consults for several pharmaceutical companies but not Merck.
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