OCEAN(a)-DOSE (olpasiran 225 mg every 12 weeks)
Trial question
What is the role of olpasiran in patients with established ASCVD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 110
110 patients (33 female, 77 male).
Inclusion criteria: patients with established ASCVD and a lipoprotein(a) concentration > 150 nmol/L.
Key exclusion criteria: severe renal dysfunction or active liver disease.
Interventions
N=56 olpasiran (at a dose of 225 mg every 12 week).
N=54 placebo (matching placebo every 12 week).
Primary outcome
Percent reduction in lipoprotein(a) concentration at week 36
97.5%
-3.6%
97.5 %
73.1 %
48.8 %
24.4 %
0.0 %
-24.4 %
Olpasiran
Placebo
Significant
increase ▲
NNT = 1
Significant increase in percent reduction in lipoprotein(a) concentration at week 36 (97.5% vs. -3.6%; AD 101.1%, 95% CI 96.5 to 105.8).
Secondary outcomes
Significantly greater reduction in LDL-C concentration at week 36 (16.8% vs. -6.3%; AD 23.1%, 95% CI 11.4 to 34.8).
Significantly greater reduction in ApoB concentration at week 36 (10.2% vs. -7.4%; AD 17.6%, 95% CI 10.1 to 25.1).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In patients with established ASCVD and a lipoprotein(a) concentration > 150 nmol/L, olpasiran was superior to placebo with respect to percent reduction in lipoprotein(a) concentration at week 36.
Reference
Michelle L O'Donoghue, Robert S Rosenson, Baris Gencer et al. Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease. N Engl J Med. 2022 Nov 17;387(20):1855-1864.
Open reference URL