Prevention & lipidsRandomised controlled trial
Two Phase 3 Trials of Inclisiran in Patients with Elevated Low-density Lipoprotein (LDL) Cholesterol
- Two randomised controlled trials (ORION-10 and ORION-11)
- placebo-controlled
- 1:1 randomisation
- coprimary end points
Authors' conclusion
Reductions in LDL cholesterol levels of approximately 50% were obtained with inclisiran, administered subcutaneously every 6 months. More injection-site adverse events occurred with inclisiran than with placebo.
Study context
- Population
- Patients with atherosclerotic CVD (ORION-10) or atherosclerotic CVD or risk equivalent (ORION-11) with elevated LDL-C despite maximum tolerated statin1,561 ORION-10 · ORION-10 1,561 · ORION-11 1,617
- Comparison
- Inclisiran vs placebo
- Primary endpoint
- Coprimary: placebo-corrected % change in LDL-C from baseline to day 510; time-adjusted % change in LDL-C from baseline after day 90 and up to day 540
- Follow-up
- Day 510; after day 90 up to day 540
Primary result
As reported in the abstract
Placebo-corrected reduction in LDL-C
Inclisiran vs PlaceboEstimate (95% CI)P value
ORION-10
LDL-C reduction at day 510 52.3 %(48.8–55.7)
P < 0.001ORION-11
LDL-C reduction at day 510 49.9 %(46.6–53.1)
P < 0.001ORION-10
time-adjusted LDL-C reduction 53.8 %(51.3–56.2)
P < 0.001ORION-11
time-adjusted LDL-C reduction 49.2 %(46.8–51.6)
P < 0.001Safety
Injection-site adverse events (ORION-10) · generally mild, none severe or persistent
Injection-site adverse events (ORION-11) · generally mild, none severe or persistent
Adverse events overall
- Generally similar in inclisiran and placebo groups in each trial
Original publication
Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. Published 18 March 2020. doi:10.1056/nejmoa1912387
Summarised from the published abstract; every number is checked against it