New Drug Shows Promise in Reducing Pancreatitis Risk for Patients with Severely High Triglycerides
A new drug, olezarsen, has demonstrated a important reduction in the risk of acute pancreatitis in patients with severe hypertriglyceridemia – a condition characterized by very high levels of triglycerides, a type of fat in the blood - according to research presented at the American Heart Association Scientific Sessions and published in The New England Journal of Medicine. Researchers from Mass General Brigham led the two randomized, placebo-controlled trials (CORE-TIMI 72a and CORE2-TIMI 72b) that yielded these promising results.
Approximately 1 in 100 people in the U.S. are affected by severe hypertriglyceridemia,which elevates their risk for acute pancreatitis,a possibly life-threatening inflammation of the pancreas. The trials,a collaboration between the TIMI Study Group at Mass General Brigham and Ionis Pharmaceuticals,assessed olezarsen’s ability to both lower triglyceride levels and mitigate this risk.
A total of 1,063 participants from 33 countries with fasting triglyceride levels of 500 mg/dL or higher, and already undergoing lipid-lowering therapy, were enrolled in the study. Participants received monthly injections of either 50 mg or 80 mg of olezarsen, or a placebo, for a period of 12 months.
The results showed a substantial enhancement in triglyceride control with olezarsen. In 590 patients with available baseline and follow-up measurements, over 85% of those receiving either dose of olezarsen achieved triglyceride levels below 500 mg/dL, compared to just 35% in the placebo group.
Crucially, the study also demonstrated a significant reduction in acute pancreatitis events. Across both trials, there were 29 reported cases. The incidence rate was 1.1 event per 100 patient years in the groups receiving olezarsen, compared to 6.2 per 100 patient years in the placebo group – representing an 85% relative risk reduction.
“These findings support olezarsen’s potential to become a cornerstone therapy for severe hypertriglyceridemia, especially for preventing a serious and potentially life-threating condition,” stated lead author Nicholas Marston, MD, MPH, a cardiologist with the Mass General Brigham Heart and Vascular Institute. “Prevention is key in medicine, and our findings underscore the importance of clinical trials in evaluating the efficacy and safety of new treatments to improve health outcomes.”
the long-term effectiveness and safety of olezarsen are currently being investigated in an ongoing open-label extension study.
