Inclisiran is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.2
Inclisiran was generally well-tolerated, with a safety profile similar to placebo apart from injection-site reactions1
Injection-site adverse reactions were more frequent with inclisiran than placebo, with between-group differences of 1.7% in ORION-10 and 4.2% in ORION-11; the majority of these reactions were mild, with none being severe or persistent.1
Discontinuation rates due to AEs were balanced among both treatment groups: 2.4% (n=19) vs 2.2% (n=17) in ORION-10 and 2.8% (n=23) vs 2.2% (n=18) in ORION-11, of patients treated with inclisiran and placebo, respectively.1
No clinically significant interactions with other medicinal products are expected with inclisiran.2
Laboratory results with respect to liver and kidney function, levels of creatine kinase and high-sensitivity C-reactive protein, and platelet count were also similar in the inclisiran and placebo groups in each trial.1
The effect of inclisiran on cardiovascular morbidity and mortality has not yet been determined.2
For further information please refer to the Summary of Product Characteristics by clicking here
* ASCVD risk equivalents included type 2 diabetes, FH, or a 10-year risk of a cardiovascular event of ≥20% as assessed by the Framingham Risk Score for Cardiovascular Disease or equivalent.1
‡ After an initial dose, inclisiran is administered again at 3 months, followed by every 6 months.2
AE, adverse event; ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; FH, familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol.
- Ray KK et al. N Engl J Med 2020;382(16):1507–1519.
- Leqvio® Summary of Product Characteristics.
- Ray KK et al. N Engl J Med 2020;382(16):1507–1519 (supplementary appendix).