RonIsWrong
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How Cardiologists’ High Hopes for Two Drugs Were Dashed
By every measure, the drugs were no better than placebos, full data revealed on Saturday. Was it the fault of the design of the studies, or our very hypotheses about heart disease?
Cardiologists have been on edge for months, waiting for the details surrounding recent reports of the stunning failures of two new heart drugs.
The drugs — pelacarsen and ziltivekimab — were widely expected to usher in a new era in preventing heart disease. Companies, betting on the drugs’ promise, made huge investments in developing them.
So when doctors saw preliminary announcements that the drugs were not helping patients in large clinical trials, many felt blindsided, although still hopeful that there was more to the story than they knew.
“The whole cardiovascular community was gobsmacked,” said Dr. Karol Watson, a director of UCLA’s preventive cardiology program.
Were the drugs close to succeeding, just barely missing a statistically significant benefit? Or were there at least subgroups of patients who were helped?
Now the answers are in. There was not a shred of evidence that the drugs helped anyone. By every measure, they were no better than placebos.
The results, Dr. Watson noted, “are about as neutral as they can be.” The full data were presented on Saturday morning at the annual meeting of the American Heart Association and in simultaneous publications in The New England Journal of Medicine.
One drug, pelacarsen, by Novartis, is known to make levels of the Lp(a) blood protein plunge. The protein is widely believed to cause heart attacks and strokes. The other, ziltivekimab, by Novo Nordisk, stops inflammation, thought to be a major component of plaques in arteries. Neither drug made a dent in heart disease outcomes during these clinical trials.
Dr. Paul Ridker of Mass General Brigham, who was the principal investigator for the inflammation trial — known as the Zeus study — had been a true believer.
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