A long-acting cholesterol medicine cut the risk of having a heart attack or some other serious problems by 15 percent to 20 percent in a big study that’s likely to spur fresh debate about what drugs should cost.
Statins such as Lipitor and Crestor are cheap and lower LDL or bad cholesterol, but some people can’t tolerate or get enough help from them. The new drug, Amgen’s Repatha, is given as a shot once or twice a month and is part of a novel class of medicines that drop LDL to unprecedented levels.
It costs more than $14,000 a year, and insurers have balked at paying without proof that it lowers heart risks, not just the cholesterol number. The new study gives that evidence, but the benefit is not as great as some doctors had hoped.
For every 200 people treated with Repatha for roughly two years, three fewer people would suffer a heart attack, stroke or heart-related death. But looked at by themselves, deaths were not reduced by the drug.
"That’s a big benefit," said Dr. Marc Sabatine, the study leader, from Brigham and Women’s Hospital in Boston. For millions of people with heart disease or high risk for it like those in the study, "it’s worth it to be on this medicine."
But Dr. Donald Lloyd-Jones, preventive medicine chief at Northwestern University and an American Heart Association spokesman, called the results modest and "not quite what we hoped or expected."
Dr. Mark Hlatky, a Stanford University cardiologist and cost effectiveness researcher, said, "people were hoping for a breakthrough, a lot bigger result than 20 percent."
For patients like Susan Goodreds, whose insurance copay for Repatha is $356 a month, it’s not an easy choice.
"It’s an expensive, expensive drug," the 74-year-old Florida woman said. "You have to make some real decisions about whether to stay on it."
The results were published Friday by the New England Journal of Medicine and discussed at an American College of Cardiology conference.
The study tested Repatha in more than 27,500 people like this who had LDL above 70 (the recommended upper limit for such patients) despite maximum statin use.
After about two years, Repatha, used along with statins, reduced LDL from a median of 92 to 30. It also proved safe – side effects were similar to those from a dummy drug.