OCEAN(a)-DOSE (olpasiran 225 mg every 24 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
37.0% female
63.0% male
N = 109
109 patients (40 female, 69 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=55 olpasiran (at a dose of 225 mg every 24 week).
N=54 placebo (matching placebo every 12 week).
Primary outcome
Percent reduction in lipoprotein(a) concentration at week 36
96.9%
-3.6%
96.9 %
72.7 %
48.5 %
24.2 %
0.0 %
-24.2 %
Olpasiran
Placebo
Significant
increase ▲
NNT = 1
Significant increase in percent reduction in lipoprotein(a) concentration at week 36 (96.9% vs. -3.6%; AD 100.5%, 95% CI 95.8 to 105.2).
Secondary outcomes
Significantly greater reduction in LDL-C concentration at week 36 (18.5% vs. -6.3%; AD 24.8%, 95% CI 13 to 36.5).
Significantly greater reduction in ApoB concentration at week 36 (11.4% vs. -7.4%; AD 18.8%, 95% CI 11.2 to 26.3).
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.
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