Takeaway
Why this matters
- These results confirm preliminary findings and open the way to another therapeutic option in this high-risk patient group.
Key results
- ORION-10 included 1561 patients, and ORION-11 included 1617.
- Most patients were on high-intensity statins:
- ORION-10: 68.0%.
- ORION-11: 78.6%.
- Mean baseline LDL:
- ORION-10: 104.7±38.3 mg/dL.
- ORION-11: 105.5±39.1 mg/dL.
- At 510 days, LDL reductions from baseline with inclisiran vs placebo:
- ORION-10: 52.3% (95% CI, 48.8%-55.7%).
- ORION-11: 49.9% (95% CI, 46.6%-53.1%).
- Both P<.001 vs placebo.>
- Serious adverse events vs placebo:
- ORION-10: 22.4% vs 26.3%.
- ORION-11: 22.3% vs 22.5%.
- These rates included deaths, as follows:
- ORION-10: 1.5% vs 1.4%.
- ORION-11: 1.7% vs 1.9%.
Study design
- 2 randomized controlled trials.
- Inclisiran 284 mg administered via subcutaneous injection, day 1, day 90, and every 6 months thereafter to 540 days.
- Funding: Medicines Company.
Limitations
- Small number of nonadjudicated cardiovascular events.
- Defined clinical population; generalizability not clear.
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