Drug May Help Lower Bad Cholesterol Beyond Statins
Injectable therapy shows promise in global trial but more study needed, researchers say
According to the findings, evolocumab had adverse events and side effects comparable to those experienced by people taking either statins or ezetimibe. "Because it's a very specific antibody, it seems to be very well-tolerated without any drug interactions or any side effects," Robinson said.
Evolocumab will be mostly helpful in treating people with a genetic disorder that causes them to have high cholesterol, Robinson said. About 1 in 500 people have this disorder, according to the U.S. National Institutes of Health.
It also could help people with high cholesterol who can't take large doses of statins, Robinson added, estimating that as many as 10 percent of people with heart disease or diabetes can't tolerate the recommended dose of statins.
However, a spokeswoman for the American Heart Association cautioned that the drug's impact on the risk of a heart attack or a stroke has not been tested yet.
Dr. Mary Ann Bauman, who is also medical director for Women's Health and Community Relations at INTEGRIS Health in Oklahoma City, said, "I do think that this study did what it was supposed to do . . . to show it was safe, reasonably well-tolerated and did have an effect on LDL cholesterol."
But, she added, "The real question will be whether decreasing cholesterol levels with this medication makes a difference in cardiovascular events."
Statins have been proven to prevent heart attacks and strokes, but Bauman noted that clinical trials of ezetimibe have had mixed results. The drug lowers cholesterol, but does not necessarily prevent heart attacks.
Robinson said a follow-up study is underway to evaluate the drug's longer-term outcomes and safety. But if it does gain U.S. Food and Drug Administration approval, she noted, the drug will be expensive. Similar antibody drugs already are used to treat arthritis patients, and those can cost patients thousands of dollars a year.
"It's not going to be for everybody, but it's going to be very important for certain people," those with genetic cholesterol disorders and those who can't take large doses of statins, Robinson added.