Bridge–TIMI 73a Trial
Olezarsen for Hypertriglyceridemia in Patients at High Cardiovascular Risk
A randomized, placebo-controlled, double-blind trial
Objective:
To assess the efficacy and safety of olezarsen for lowering triglyceride levels in patients with moderate hypertriglyceridemia plus elevated cardiovascular risk and in those with severe hypertriglyceridemia.
154 Patients
Inclusion Criteria:
- Aged ≥18 years
- Hypertriglyceridemia with fasting TG 150-499 mg/dl plus an increased risk of ASCVD or severe hypertriglyceridemia with fasting TG ≥ 500 mg/dL
- Receiving stable lipid-lowering therapy
Groups:
- A: Olezarsen 50 mg (n = 58)
- B: Olezarsen 80 mg (n = 57)
- C: Placebo (n = 39)
Primary Outcomes:
- Mean decrease in Triglyceride level at 6 months
- (A vs C): 57.1% (P < 0.001)
- (B vs C): 60.9% (P < 0.001)
- (C): 7.8%
Secondary Outcomes:
- Difference in % change from baseline in apolipoprotein C-III level at 6 months
- (A vs C): 64.2% (P < 0.001)
- (B vs C): 73.2% (P < 0.001)
Conclusion:
In patients with moderate hypertriglyceridemia and elevated cardiovascular risk and in those with severe triglyceridemia, the monthly administration of olezarsen at a dose of 50 mg or 80 mg significantly reduced triglyceride levels as compared with placebo without major safety concerns.
Reference:
Bergmark BA et al. N Engl J Med 2024; 390:1770-1780