OCEAN(a)-DOSE (olpasiran 75 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
37.0% female
63.0% male
N = 112
112 patients (41 female, 71 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 75 mg every 12 week)
N=54 placebo (matching placebo every 12 week)
Primary outcome
Percent reduction in lipoprotein(a) concentration at week 36
93.8
-3.6
93.8 %
70.3 %
46.9 %
23.4 %
0.0 %
-23.4 %
Olpasiran
Placebo
Significant
increase ▲
NNT = 1
Significant increase in percent reduction in lipoprotein(a) concentration at week 36 (93.8% vs. -3.6%; AD 97.4%, 95% CI 92.8 to 102)
Secondary outcomes
Significant increase in reduction in LDL-C at week 36 (16.3% vs. -6.3%; AD 22.6%, 95% CI 11 to 34.1)
Significant increase in reduction in ApoB concentration at week 36 (9.3% vs. -7.4%; AD 16.7%, 95% CI 9.3 to 24.1)
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.
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