Efficacy and safety of inclisiran monotherapy in Chinese adults with elevated low-density lipoprotein cholesterol: Results from the VICTORION-Mono China trial.

BACKGROUND

Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of death in China. Elevated low-density lipoprotein cholesterol (LDL-C) is a major, modifiable cardiovascular disease and mortality risk factor, but many patients fail to achieve guideline-recommended lipid goals. Although inclisiran provides sustained and effective LDL-C reductions alone or when combined with lipid-lowering therapies (LLTs), its effectiveness as monotherapy has not been investigated in patients from China.

OBJECTIVE

To evaluate the efficacy and safety of inclisiran monotherapy in Chinese adults with low/moderate ASCVD risk and elevated LDL-C not receiving LLT.

METHODS

VICTORION-Mono China (NCT05888103) was a phase 3, multicenter, randomized trial, comprising a double-blind, placebo-controlled, 6-month treatment period, and a 6-month open-label extension period. The primary endpoint was the percentage change in LDL-C from baseline to Day 150. Other lipid biomarkers and safety were also assessed.

RESULTS

In 207 randomized patients, inclisiran significantly reduced LDL-C vs placebo on Day 150 (least squares mean [LSM] difference: -47.50%; P < 0.0001), with reductions sustained through Day 360. Furthermore, on Day 150, inclisiran induced a significant (P < 0.0001) reduction in other atherogenic lipoproteins and lipid biomarkers (placebo-adjusted LSM difference: lipoprotein(a), -30.27%; nonhigh-density lipoprotein cholesterol, -40.57%; apolipoprotein B, -36.84%). Inclisiran was well-tolerated; the most common drug-related treatment-emergent adverse events were mild hepatic enzyme elevations, injection-site reactions, and nausea.

CONCLUSION

Inclisiran monotherapy provided sustained and effective LDL-C reductions with a favorable safety profile in Chinese adults with low/moderate ASCVD risk. These findings align with previous observations in statin-treated patients, supporting inclisiran monotherapy as a potential LDL-C-lowering option for Chinese patients.