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Heart Drug Slashed ‘Bad Fat’ 78% But Saved No LivesHealth
Pelacarsen cut the heart-risk particle Lp(a) by 78% in more than 8,300 patients, yet prevented no heart attacks or strokes, researchers reported on Saturday.
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A much-watched heart drug that cut a dangerous inherited cholesterol particle by 78 percent has failed to prevent a single heart attack or stroke, researchers reported on Saturday, in a result that stunned heart specialists gathered in Chicago.
The drug, pelacarsen, was tested for nearly five years in more than 8,300 patients who had already suffered a major heart event such as a heart attack. Half received a monthly 70-milligram dose of the drug and half a placebo, while their other risk factors — including cholesterol and blood pressure — were carefully controlled. The full results were presented at the American Heart Association’s annual meeting by Dr Steven Nissen of the Cleveland Clinic and published in the New England Journal of Medicine.
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Pelacarsen did exactly what it was designed to do: it lowered levels of lipoprotein(a), or Lp(a), a sticky, protein-wrapped fat in the blood, by about 78 percent. But that sharp fall made no difference to patients’ fate. Roughly the same share in both groups — about 12 percent — went on to suffer a serious heart-related event, and there was no sign the drug reduced deaths, heart attacks, strokes, or the need for a stent or bypass.
“It didn’t do anything. It was completely neutral,” Nissen said in an interview. “Everybody in the world, me included, thought that this was going to work.”
The disappointment had been signalled in September, when Novartis and its co-developer Ionis Pharmaceuticals announced that the drug had failed to meet the trial’s main goal. Even so, specialists had hoped the details might show some benefit for particular patients, such as those whose Lp(a) fell furthest. A separate statistical analysis, published in NEJM Evidence, looked at exactly those groups and still found no benefit. More patients also stopped taking pelacarsen because of side effects — 20.6 percent, against 7.5 percent on placebo. Novartis has decided to abandon the drug.
No treatment yet for high Lp(a)
There is still no approved treatment for high Lp(a), an inherited risk factor estimated to affect about one in five people worldwide, although few know they carry it. This year, for the first time, the American Heart Association and the American College of Cardiology recommended that every adult be tested for Lp(a) at least once in their lifetime.
The failure does not close the door on the idea. Two other experimental drugs that target Lp(a) — Amgen’s olpasiran and Eli Lilly’s lepodisiran — use a different technology and have cut Lp(a) by about 95 percent in earlier studies. Their large trials are still running, with results due in 2028 and 2029. Nissen, who is leading the lepodisiran trial, noted that those studies include many patients who have never had a heart attack or stroke, and said the newer drugs are also better tolerated — though whether that will translate into better outcomes remains to be seen.
A second study at the same meeting delivered a similar blow: Novo Nordisk’s anti-inflammatory drug ziltivekimab lowered inflammation as intended in 6,300 seriously ill heart patients, but did not reduce deaths, heart attacks or strokes. Together, the two failures have forced heart specialists to rethink some long-held theories about what drives heart disease — and, as one senior cardiologist put it, to try different compounds and strategies.
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