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Heart Drug Fails Major Trial Despite Cutting Risk by 77%Health
Novartis’s drug pelacarsen cut the inherited heart-risk marker Lp(a) by 77 percent, yet patients suffered heart attacks and strokes at the same rate as those on placebo, and the company is abandoning it.
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A drug that looked like a breakthrough for people born with a high inherited heart risk has failed its biggest test, stunning the doctors who ran the trial and leaving patients with no targeted treatment for the condition.
Novartis’s experimental drug pelacarsen was designed to lower lipoprotein(a), known as Lp(a), a cholesterol-like particle that is inherited and raises the risk of heart attacks and strokes. In the HORIZON trial, the drug cut Lp(a) levels by about 77 percent on average, yet it made no difference to patients’ outcomes, and Novartis has decided to abandon it.
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The trial followed 8,350 people who had already suffered a cardiovascular event and had high Lp(a). Half received pelacarsen and half a placebo, with neither patients nor doctors knowing who got which, for nearly five years. The results were presented at the American Heart Association conference and published in the New England Journal of Medicine.
About 12 percent of patients in each group suffered a serious cardiovascular event, such as a heart-related death, a non-fatal heart attack or stroke, or an urgent procedure to reopen a blocked artery. The lead investigator, Dr Steven Nissen of the Cleveland Clinic, said the result was not a near miss and the drug simply had no effect on outcomes, while Stanford’s Dr Fatima Rodriguez said there was no signal of benefit at all.
High Lp(a) is passed down through families, and people with the highest levels are two to four times more likely to have a heart attack, according to the American Heart Association. Dr Nissen said the disorder affects more than a billion people worldwide.
The American Heart Association and the American College of Cardiology this year recommended that every adult be tested for Lp(a) at least once in their life, but there is currently no treatment specifically for high Lp(a). Researchers now believe patients may need a reduction of 90 to 95 percent, far more than pelacarsen achieved, or that other factors in these older patients, whose LDL cholesterol was already well controlled, limited the benefit.
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