Researchers at Mass General Brigham have discovered that olezarsen, a medication aimed at lowering triglyceride levels, significantly reduces the risk of acute pancreatitis among patients with severely elevated triglyceride levels. This finding was presented at the American Heart Association Scientific Sessions and published in The New England Journal of Medicine.
Acute pancreatitis is a serious condition that can arise from hypertriglyceridemia, which affects approximately one in 100 people in the United States. The condition is characterized by dangerously high triglyceride levels, specifically those exceeding 500 mg/dL. The trials, named CORE-TIMI 72a and CORE2-TIMI 72b, were conducted to evaluate the safety and efficacy of olezarsen in a diverse group of participants.
A total of 1,063 participants across 33 countries, all with fasting triglyceride levels of ≥500 mg/dL, were enrolled in these randomized, placebo-controlled trials. Participants received monthly injections of either olezarsen (at doses of 50 mg or 80 mg) or a placebo over a period of 12 months.
Among the 590 patients with available follow-up data, over 85% of those receiving olezarsen experienced a reduction in triglyceride levels below 500 mg/dL. In contrast, only 35% of patients in the placebo group achieved similar results.
The trials reported a total of 29 acute pancreatitis events. Notably, the incidence rate of acute pancreatitis was 1.1 per 100 patient years in the pooled olezarsen groups, compared to 6.2 per 100 patient years in the placebo group. This translates to an impressive 85% relative risk reduction for patients treated with olezarsen.
Lead author Dr. Nicholas Marston, a cardiologist at the Mass General Brigham Heart and Vascular Institute, emphasized the significance of these findings. “These findings support olezarsen’s potential to become a cornerstone therapy for severe hypertriglyceridemia, particularly for preventing a serious and potentially life-threatening condition,” he stated.
The ongoing evaluation of olezarsen’s long-term effectiveness and safety is being conducted through an open-label extension study, which aims to further assess its impact on patients with severe hypertriglyceridemia.
Overall, this research underscores the importance of clinical trials in developing new treatments that could improve health outcomes for those at risk of serious health complications. Further studies will clarify the potential role of olezarsen in clinical practice.
