Pill sharply lowers LDL with minimal side effects in trials
For years, patients who needed more aggressive cholesterol reduction than statins could provide had only one alternative: injectable PCSK9 inhibitors, a class of drugs that block a liver protein to lower LDL cholesterol. Merck’s Lipfendra — the brand name for enlicitide — changes that by delivering the same mechanism in a daily pill.
Dr. Paja Banka, associate vice president for global clinical development at Merck and a pediatric cardiologist, said the approval addresses a persistent problem in cardiovascular care. “Seventy per cent of patients are not getting to their LDL goal,” Banka said.
Statins, the most prescribed medication in the United States, have been the standard therapy for decades. But they sometimes cause side effects such as muscle aches, and they do not always lower cholesterol enough to meet recommended levels, Banka said. The new pill, she said, would be taken “in conjunction” with statins, though in some cases could be taken alone. She added that side effects in trials were “like the placebo,” with no muscle aches reported.
The New York Times reported the drug can bring LDL “down to 50 or 60 or even lower,” a level far below what is typically achieved with statins alone. The American College of Cardiology and the American Heart Association guidelines recommend LDL levels below 100 mg/dL for people at borderline or intermediate risk, below 70 for those at high risk, and below 55 for people with atherosclerotic cardiovascular disease at very high risk.
Merck said the drug would be available within weeks. The list price is $10.50 a day, or more than $300 per month, though the company said it expects out-of-pocket costs to be lower for many patients.
As MSI previously reported, a large study published in the New England Journal of Medicine in February found that enlicitide lowered LDL by as much as 60% over six months in high-risk patients who remained above goal despite statin therapy.
Heart disease is the leading cause of death in the United States, Banka noted. High LDL cholesterol is known to cause atherosclerotic cardiovascular disease — a buildup of plaque in the arteries that can lead to heart attacks and strokes.