OCEAN(a)-DOSE (olpasiran 10 mg)
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
27.0% female
73.0% male
N = 112
112 patients (30 female, 82 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=58 olpasiran (at a dose of 10 mg every 12 week).
N=54 placebo (matching placebo every 12 week).
Primary outcome
Percent reduction in lipoprotein A concentration at week 36
66.9%
-3.6%
66.9 %
50.2 %
33.5 %
16.7 %
0.0 %
-16.7 %
Olpasiran
Placebo
Significant
increase ▲
NNT = 1
Significant increase in percent reduction in lipoprotein A concentration at week 36 (66.9% vs. -3.6%; AD 70.5%, 95% CI 65.9 to 75.1).
Secondary outcomes
Significantly greater reduction in LDL-C concentration at week 36 (17.4% vs. -6.3%; AD 23.7%, 95% CI 12.2 to 35.3).
Significantly greater reduction in ApoB concentration at week 36 (11.5% vs. -7.4%; AD 18.9%, 95% CI 11.5 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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