“I am stunned,” said Dr

Pelacarsen Trial Results Disappoint Cardiologists at AHA Scientific Sessions

I am stunned, said Dr. Fatima Rodriguez, chief of preventive cardiology at Stanford University, following the presentation of new clinical trial data at the American Heart Association scientific sessions in Chicago, as reported by cnnespanol.cnn.com. Novartis is largely abandoning the development of its experimental cardiovascular drug pelacarsen after the Phase 3 Lp(a) HORIZON trial showed it failed to reduce heart attacks, strokes, and cardiovascular deaths. The seven-year study evaluated 8,322 patients with pre-existing cardiovascular disease and elevated levels of lipoprotein(a), or Lp(a). The trial results appeared simultaneously in the New England Journal of Medicine. Dr. Steven Nissen, academic director of the Cleveland Clinic Heart, Vascular and Thoracic Institute and lead author of the study, described the findings to Bloomberg as completely neutral, noting that there was no evidence that the drug affected the risk of death from heart disease, stroke or stroke.

Details of the Lp(a) HORIZON Trial Findings

Researchers divided 8,350 participants with elevated Lp(a) levels and a history of cardiovascular events into two groups. Half received pelacarsen while the other group received a placebo for nearly five years. The primary endpoint measured major adverse cardiovascular events. While the medication reduced circulating Lp(a) levels by an average of 77% to 78%, it produced no clinical benefit in reducing cardiovascular events. Approximately 12% of patients in both the treatment and placebo groups experienced a serious cardiac event.

Novartis Shifts Strategy Following Trial Failure

Novartis has decided to drop the experimental drug as a blockbuster cardiovascular therapy following the negative trial data. The company will maintain only a mid-stage clinical study to test whether pelacarsen can slow calcific aortic valve stenosis, a condition involving heart valve calcification, according to Investing. Wall Street analysts and cardiologists had anticipated that targeting Lp(a) would establish a new pillar in preventive cardiology.

Dr. Fatima Rodriguez noted that the trial patients were older and may already have advanced past the stage of heart disease where lowering Lp(a) could offer a benefit.