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After just a bit more than a year and a half, 819, or 11.7 percent, of patients in the bempedoic acid group had one of the heart-related complications.
In the placebo group, 927 patients, or 13.3 percent, had such an event.
Participants did not have muscle aches or an increased risk of diabetes, the most common complaints with statins. With bempedoic acid, a small percentage in the trial experienced an increased risk of gout, an inflammation of joints that is treatable and increased risk of gallstones.
Now the question is, how important is this drug going to be?
Bempedoic acid is the sixth cholesterol-lowering drug, in addition to statins, that has been demonstrated to reduce heart attacks and strokes, noted Dr. Michael Davidson, director of the lipid clinic at the University of Chicago Pritzker School of Medicine who founded a company, New Amsterdam Pharma, that is developing a LDL lowering drug. The others are bile acid resins, niacin, ezetimibe, PCSK9 inhibitors and CETPi. They have varying effects on LDL and range from cheap to expensive. With this array of drugs, Dr. Davidson said he hoped doctors could start focusing on getting high-risk patients’ LDL levels as low as possible, whatever it takes.
Dr. Harlan Krumholz, a Yale cardiologist, said that given bempedoic acid’s modest effects and the fact that other drugs also lower LDL, it “is unlikely to be a game changer.”
Dr. Benjamin Ansell, a lipid expert at U.C.L.A., said that the drug was “better than nothing” but that “it isn’t enough” for people who have high LDL levels and are at high risk.
Lipid experts say that many who say they cannot tolerate statins actually can. Some mistakenly attribute muscle aches from other causes to the drug. For others, a different dose of a statin or a different statin is tolerable.
But primary care doctors may not have the time or inclination to go through all this with patients, especially because they have to tread delicately with patients who are adamant that they cannot or will not take the drugs.
“When you come in guns ablazing and say, ‘Take this medicine,’ it turns a lot of patients off,” Dr. Ansell said. “There’s a fear the patient will not come back.”