The clinical efficacy and safety of inclisiran have been demonstrated through the ORION trial series, with ORION-9, 10, and 11 being the major phase III trials.

ORION-9 examined inclisiran usage in patients with heterozygous familial hypercholesterolemia (HeFH), showing significant reductions in LDL-C levels compared to placebo. Similarly, ORION-10 and ORION-11 trials demonstrated the effectiveness of inclisiran therapy in patients with clinical atherosclerotic cardiovascular disease (ASCVD) and those with ASCVD risk equivalents, respectively.

While cardiovascular outcomes have not been primary endpoints in completed trials, ongoing trials such as ORION-4 and VICTORIAN-2 PREVENT aim to address this gap.

Inclisiran received FDA approval in 2021 as an adjunct to maximal statin therapy for patients with clinical ASCVD and those with HeFH requiring additional LDL-C reduction. It has also been approved for primary prevention in patients with hyperlipidemia.

Administration involves subcutaneous injection, with the initial dose followed by subsequent injections at intervals, making it convenient for patients.

Inclisiran has demonstrated good tolerability across various patient populations, with minimal reports of serious adverse effects.

Common side effects include injection site reactions and bronchitis, but these are generally mild and well managed.

Meta-analyses of data suggest a favorable safety profile, supporting its use in clinical practice.

Recent cost-effectiveness analyses of inclisiran in patients with atherosclerotic cardiovascular disease report favorable findings.

The annual price falls below USD 9000, with a calculated incremental cost-effectiveness ratio (ICER) within an acceptable range. These findings indicate inclisiran's potential to provide significant clinical benefits at a reasonable cost.