Orion 10
Results: Efficacy1
After 17 months, between-groups treatment difference in LDL-C was −52.3%
Change in LDL-C over time – observed values in ITT population*
*Using observed numbers and not imputed for missing data
After 17 months, inclisiran achieved 83.3% reduction in PCSK9 levels
Change in PCSK9 over time – observed values in ITT population*
*Using observed numbers and not imputed for missing data
ORION-10 Study Design
Randomized 1:1 inclisiran 300 mg vs. placebo – with maximally tolerated statins
We conducted two randomized, double blind, placebo-controlled, parallel-group, phase 3 trials.1
Adapted from ref.4
Objective: to assess the efficacy, safety, and adverse-event profile of inclisiran over a period of 18 months in patients at high risk for cardiovascular disease in whom LDL cholesterol levels were elevated despite receiving statin therapy at the maximum tolerated dose with or without additional lipid-lowering therapy.1
Orion 11
Results: Efficacy1
After 18 months, between-groups treatment difference in LDL-C was −50%
Change in LDL-C over time – observed values in ITT population*
*Using observed numbers and not imputed for missing data
After 18 months, inclisiran achieved 79.3% change reduction in PCSK9 levels
Change in PCSK9 over time – observed values in ITT population*
*Using observed numbers and not imputed for missing data
ORION-11 Study Design
Randomized 1:1 inclisiran 300 mg vs. placebo – with maximally tolerated statins
We conducted two randomized, double blind, placebo-controlled, parallel-group, phase 3 trials.1
Adapted from ref.4
Objective: to assess the efficacy, safety, and adverse-event profile of inclisiran over a period of 18 months in patients at high risk for cardiovascular disease in whom LDL cholesterol levels were elevated despite receiving statin therapy at the maximum tolerated dose with or without additional lipid-lowering therapy.1
Orion 8
Results: Efficacy2
The proportion (95% CI) of patients achieving the primary pre-specified LDL-C goal at end-of-study was 78.4% (95% CI: 76.8–80.0) of 2731 patients.
At each visit in ORION-8, more than 70% of the patients achieved the prespecified LDL-C goals.
Overall safetypopulation
*Baseline value of LDL-C was taken from the baseline of the parent trials.
The percentage change from the parent trial baseline in LDL-C over time
Overall safetypopulation
ORION-8 Study Design
Study Design: ORION-8 was a multi-centre long-term extension trial of the Phase 2
(ORION-3) and Phase 3 (ORION-9, ORION-10, and ORION-11) lipid-lowering trials.3
Adapted from ref.2
*Patients from ORION-3 did not receive any drug administration on Day 1. Only patients on placebo in ORION-9, ORION-10, and ORION-11 received an active inclisiran injection at Day 1, while patients who received inclisiran in those trials received blinded placebo at this visit;
†EOS is either day 1080 or ≥ 90 days following the last dose of inclisiran. D, Day; EOS, end-of-study
Objective: we report the final results from ORION-8, an open-label extension trial of ORION-9, ORION-10, ORION-11, and ORION-3, the largest and longest assessment to date of the efficacy and tolerability of inclisiran.3
Orion 9
Results: Efficacy3
For the first primary end point, the percent change in the LDL cholesterol level from baseline to day 510 was a decrease of 39.7% (95% confidence interval [CI], −43.7 to −35.7) in the inclisiran group and an increase of 8.2% (95% CI, 4.3 to 12.2) in the placebo group, for a between-group difference of −47.9 percentage points (95% CI, −53.5 to −42.3; P<0.001)
At day 510, the percent change in the PCSK9 level was a decrease of 60.7% (95% CI, −64.4 to −57.0) in the inclisiran group and an increase of 17.7% (95% CI, 13.9 to 21.4) in the placebo group for a between-group difference of −78.4 percentage points (95% CI, −83.7 to −73.0; P<0.001)
ORION-9 Study Design
Randomized 1:1 inclisiran 300 mg vs. placebo – with maximally tolerated statins
ORION-9 was a double-blind, randomized, placebo- controlled trial that was conducted in 8 countries at 46 sites.3
Adapted from ref.5
Objective: To evaluate the use of inclisiran in a large cohort of adult patients with heterozygous familial hypercholesterolemia who had been
treated with a maximally accepted dose of statin therapy.3
Leqvio® API
Leqvio® API
References
Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. New England journal of medicine. 2020 Apr 16;382(16):1507-19.
Wright RS, Raal FJ, Koenig W, et al. Inclisiran administration potently and durably lowers LDL-C over an extended-term follow-up: the ORION-8 trial. Cardiovascular research. 2024 Aug;120(12):1400-10
Raal FJ, Kallend D, Ray KK, et al. Inclisiran for the treatment of heterozygous familial hypercholesterolemia. New England Journal of Medicine. 2020 Apr 16;382(16):1520-30.
Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol (supplementary appendix). New England journal of medicine. 2020 Apr 16;382(16):1507-19.
Raal FJ, Kallend D, Ray KK, et al. Inclisiran for the treatment of heterozygous familial hypercholesterolemia (supplementary appendix). New England Journal of Medicine. 2020 Apr 16;382(16):1520-30.
Approved by Egyptian Drug Authority: HF0424OA4729/092025. Invalidation date: 23/09/2027.
Kindly report any violated online promotional, educational and awareness material not having this message to The General administration for Regulation of Marketing & Advertising Materials at: www.edaegypt.gov.eg
Image
|
HF0424OA4729/092025 |
Adverse Events Reporting We encourage using the following Electronic reporting tool for reporting into the safety database directly: |