New heart drug from Novartis falls short in clinical trial: ‘Not the results we hoped for’
Pelacarsen, an investigational heart drug developed by Novartis, was unable to reduce the risk of major adverse cardiovascular events (MACEs) compared to a placebo in the highly anticipated Lp(a)HORIZON trial
The idea behind Lp(a)HORIZON was to see if decreasing lipoprotein(a) levels—also known as Lp(a) levels—could improve a patient’s cardiovascular outcomes. For the sake of this study, a MACE was defined a cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or urgent coronary revascularization.
Lp(a)HORIZON included data from a total of 8,323 high-risk heart patients with elevated Lp(a) levels. Patients were randomized to undergo treatment with pelacarsen or receive a placebo. Overall, pelacarsen did lower Lp(a) levels. However, taking the drug in addition to guideline-directed treatments did not significantly reduce the risk of experiencing a MACE.
“Lp(a)HORIZON was a pioneering cardiovascular outcomes trial designed to answer one of the most important unanswered questions in cardiovascular medicine by evaluating whether lowering Lp(a) can reduce residual cardiovascular risk beyond optimized, guideline-directed care, when other major cardiovascular risk factors are already being managed,” Shreeram Aradhye, president of development and chief medical officer of Novartis, said in a prepared statement. "Although lower Lp(a) levels were observed with pelacarsen, the findings did not demonstrate that this translated into reduced cardiovascular risk in the overall study population. These are not the results we hoped for, but they provide important evidence that advances scientific understanding of the relationship between Lp(a) lowering and cardiovascular outcomes and may help inform future approaches to cardiovascular risk management. We thank the more than 8,000 trial participants and investigators who made this study possible, and remain committed to driving cardiovascular innovation.”
According to Novartis, full results from Lp(a)HORIZON will be presented at a future medical conference.
Lipoprotein(a) levels remain a hot topic in cardiology
Lp(a) levels are believed to be responsible for many surprise heart attacks, and they received an added amount of attention in recent cholesterol guidelines published by the American College of Cardiology and American Heart Association.
Despite this trial’s failure to show a significant improvement in cardiovascular outcomes, the pharmaceutical industry is expected to remain focused on researching new potential treatments for cardiovascular disease that revolve around lowering Lp(a) levels.
“Lp(a) is a major, major killer,” Nathaniel Lebowitz, MD, a cardiologist with Hackensack University Medical Center, told Cardiovascular Business in February. “And most of the population, and even most doctors, don't know the exact degree of how dangerous it really is.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.