Novartis experimental drug lowers lipoprotein(a) but does not reduce heart attacks or strokes
A study of 8,350 patients presented at the American Heart Association's annual meeting surprised experts; according to CNN, the drugmaker has decided to drop pelacarsen.
Translated from the Portuguese original by the Panorama newsroom. Read in Portuguese
Summary written by the Panorama newsroom from the sources listed below. Facts are attributed to the original publications.
A large study of pelacarsen, an experimental drug from Novartis, showed that the medication lowered lipoprotein(a), or Lp(a), in the blood but missed its main goal of reducing the risk of major cardiovascular events, such as heart attacks, strokes and cardiovascular deaths, CNN en Español reported. The results were presented on Saturday (7th) at the American Heart Association's annual meeting and published in the New England Journal of Medicine. According to CNN, Novartis has decided to abandon the drug; the company had already reported earlier this year that pelacarsen did not reduce the risk of major cardiovascular events.
Lp(a) is a protein-coated fat particle; excess levels are believed to promote clot formation in the arteries and increase inflammation. Cardiologist Steven Nissen of the Cleveland Clinic, who led the research, says the disorder affects more than 1 billion people; according to CNN, there is no specific treatment for high Lp(a) levels.
The trial randomly assigned 8,350 people who had already had a cardiovascular event, such as a heart attack or stroke, and had elevated Lp(a): half received the drug and half a placebo, with follow-up of almost five years for most. Pelacarsen lowered Lp(a) by about 77% on average, but roughly 12% of patients in each group had a major cardiac event.
Experts interviewed by CNN said they were surprised. Cardiologist Fatima Rodriguez of Stanford University said negative trials can be even more important than positive ones, because they force researchers to reconsider whether the marker, the drug or the population studied is wrong. Nissen offers hypotheses: participants were older, had well-controlled LDL cholesterol, and Lp(a) may need to be lowered by 90% to 95%.
This year, the American Heart Association and the American College of Cardiology began recommending that every adult get an Lp(a) test at least once in their lifetime. For those with high levels, Nissen recommends controlling other risk factors through exercise, weight loss and a statin to lower LDL.