Efficacy and safety of inclisiran based on background lipid-lowering treatment
Authors' conclusion
Sustained and effective LDL-C lowering with inclisiran was observed irrespective of background LLT treatment.
Study context
- Population
- Patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk equivalents, stratified by background lipid-lowering therapy (LLT) (statin plus ezetimibe, statin, ezetimibe, none)pooled ORION-10 and ORION-11
- Participants
- 3,178 patients
- Comparison
- Inclisiran vs placebo, by background LLT
- Primary endpoint
- Time-adjusted, placebo-corrected percentage change in LDL-C, by background LLT
- Follow-up
- After Day 90 to Day 540
Methodological detailsPhase 3
- Phase 3
Primary result
As reported in the abstract
Placebo-corrected % change in LDL-C with inclisiran, by background LLT (subgroups)
Inclisiran vs PlaceboMean placebo-corrected % change (95% CI)
Combination (statin plus ezetimibe), n=214
−57.0%(−63.8 to −50.1)
None, n=199
−43.1%(−48.7 to −37.6)
Mean placebo-corrected % change
- Statin, n=2711
- −51.5.% (95% CI −53.4 to −49.7)
- Ezetimibe, n=54
- −50.5.% (95% CI −59.6 to −41.5)
Further findings
| Outcome | Mean absolute change (mmol/L) (95% CI) | |
|---|---|---|
| Placebo-corrected absolute change in LDL-C with inclisiran, by background LLT (subgroups) · after Day 90 to Day 540Inclisiranvs PlaceboCombination | −1.5 (−1.7 to −1.3) | |
| Placebo-corrected absolute change in LDL-C with inclisiran, by background LLT (subgroups) · after Day 90 to Day 540Inclisiranvs PlaceboStatin | −1.3 (−1.4 to −1.3) | |
| Placebo-corrected absolute change in LDL-C with inclisiran, by background LLT (subgroups) · after Day 90 to Day 540Inclisiranvs PlaceboEzetimibe | −1.7 (−2.0 to −1.4) | |
| Placebo-corrected absolute change in LDL-C with inclisiran, by background LLT (subgroups) · after Day 90 to Day 540Inclisiranvs PlaceboNone | −1.7 (−1.9 to −1.5) | |
| −3−2−101Difference, mmol/L (linear scale) |
Baseline LDL-C, by background LLT
Original publication
Efficacy and safety of inclisiran based on background lipid-lowering treatment. Eur J Prev Cardiol. Published 17 April 2025. doi:10.
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