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Inclisiran in Patients with CKD: Post Hoc Pooled Analysis of Three Phase 3 Trials
Ulf Landmesser1, Kausik K Ray2, Frederick J Raal3
1Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Charité-Universitätsmedizin Berlin, Berlin Institute of Health, DZHK, Partner Site Berlin, Friede Springer Cardiovascular Prevention Center at Charité, Berlin, Germany.
Journal of the American Society of Nephrology : JASN
|January 28, 2026
Summary
Inclisiran effectively lowers LDL cholesterol in patients with atherosclerotic cardiovascular disease and chronic kidney disease. This treatment showed sustained efficacy and a favorable safety profile across all estimated glomerular filtration rate (eGFR) levels.
Area of Science:
- Cardiovascular Medicine
- Nephrology
- Pharmacology
Background:
- Lowering low-density lipoprotein cholesterol (LDL cholesterol) is crucial for reducing atherosclerotic cardiovascular disease (ASCVD) risk in patients with chronic kidney disease (CKD).
- The efficacy and safety of inclisiran were evaluated in patients with and without CKD through a post hoc analysis of three Phase 3 trials.
Purpose of the Study:
- To investigate the efficacy and safety of inclisiran in reducing LDL cholesterol in patients with varying degrees of kidney function.
- To assess the effectiveness of inclisiran across different baseline estimated glomerular filtration rate (eGFR) strata.
Main Methods:
- A pooled analysis of three Phase 3 trials (ORION-9, -10, -11) involving patients with heterozygous familial hypercholesterolemia or ASCVD risk.
- Patients received subcutaneous inclisiran or placebo, with stratification based on baseline eGFR (≥90, 60-89, 45-59, and 15-44 mL/min/1.73m²).
- Co-primary endpoints included percentage change in LDL cholesterol at day 510 and time-adjusted percentage change from day 90 to 540; safety was also assessed.
Main Results:
- Inclisiran demonstrated significant placebo-corrected LDL cholesterol reduction across all eGFR groups at day 510 (range: -44.7% to -54.7%) and from day 90 to 540 (range: -48.4% to -55.6%).
- Significant reductions were observed in total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol, and lipoprotein(a) in all eGFR groups.
- Inclisiran was well tolerated, with no new safety concerns identified across the study population.
Conclusions:
- Inclisiran provides sustained and effective LDL cholesterol reduction in patients at risk for ASCVD, irrespective of their baseline kidney function, including those with eGFR as low as 15 mL/min/1.73m².
- The safety profile of inclisiran remained consistent across all evaluated eGFR levels, supporting its use in patients with CKD.
Keywords:
CKDPCSK9 inhibitoratherosclerosisatherosclerotic cardiovascular diseaseeGFRinclisiranlipid therapylow-density lipoprotein cholesterolMore Related Videos
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