Lipids & metabolic liver disease
Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial
Authors' conclusion
Twice-yearly inclisiran provided sustained reductions in LDL cholesterol and PCSK9 concentrations and was well tolerated over 4 years in the extension study. This is the first prospective long-term study to assess repeat hepatic exposure to inclisiran.
Study context
- Population
- Patients with prevalent atherosclerotic CVD or high-risk primary prevention and elevated LDL cholesterol despite maximally tolerated statins or other LDL-lowering treatments, or with documented statin intolerance, who completed ORION-1ORION-1 cohort 497
- Participants
- 290 vs 92
- Comparison
- Inclisiran-only vs switching
- Inclisiran-onlyn = 290
- Switchingn = 92
- Primary endpoint
- Percentage change in LDL cholesterol with inclisiran from start of ORION-1 to day 210 of the extension in the inclisiran-only arm (≈570 days of total inclisiran exposure)
- Follow-up
- Day 210
Methodological details4-year extension, multicentre (52 sites, five countries), Conducted between March 24, 2017, and Dec 17, 2021
- 4-year extension
- Multicentre (52 sites, five countries)
- Conducted between March 24, 2017, and Dec 17, 2021
Primary result
As reported in the abstract
Percentage change in LDL cholesterol
Inclisiran-only
47.5%
95% CI 50.7–44.3
Further findings
- 4-year averaged mean reduction of LDL cholesterol · 4 years — Inclisiran-only
- mean 44.2% (95% CI 47.1–41.4)
- 4-year averaged mean reduction of LDL cholesterol — Reductions in PCSK9
- 62.2% to 77.8%
Safety
Injection-site adverse events
Denominator Inclisiran-only 284 · Switching 87
Treatment-emergent serious adverse events possibly related to study drug
Denominator Inclisiran-only 284 · Switching 87
Original publication
Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol. Published 5 January 2023. doi:10.
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