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Efficacy and Safety of Inclisiran in Asian Patients: Results From ORION-18.

Department of Cardiology, Peking University First Hospital, Beijing, China. Novartis Pharma, Basel, Switzerland. Asan Medical Center, University of Ulsan, Seoul, Korea. General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and Yang Ming Chiao Tung University, Taipei, Taiwan. Department of Cardiology, National University Heart Centre Singapore and Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea. China Novartis Institutes for Biomedical Research Co., Shanghai, China. Beijing Novartis Pharma, Beijing, China. Mongolia People's Hospital, Hohhot, China. Fudan University Hua Shan Hospital, Shanghai, China.

JACC. Asia. 2024;(2):123-134
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Abstract

BACKGROUND Management of low-density lipoprotein cholesterol (LDL-C) in Asia remains suboptimal, with ∼50% of patients who are treated with lipid-lowering therapies (LLTs) unable to achieve their guideline-recommended LDL-C goals. Asian-representative studies of the use of inclisiran are needed. OBJECTIVES The authors sought to evaluate the efficacy and safety of inclisiran in Asian patients with atherosclerotic cardiovascular disease (ASCVD) or high risk of ASCVD, as an adjunct to diet and maximally tolerated statin dose, with or without additional LLTs. METHODS The ORION-18 was a phase 3 double-blind trial in which patients were randomized 1:1 to receive either 300 mg inclisiran sodium or matching placebo on days 1, 90, and 270. Percentage change in LDL-C from baseline to day 330 was the primary endpoint. RESULTS A total of 345 patients (mean age 59.5 years, mean baseline LDL-C 109 mg/dL, 74.7% male) were randomized to inclisiran or placebo. Baseline characteristics were similar in both groups. The percentage decrease in LDL-C from baseline to day 330 was 57.2% (P < 0.001); proprotein convertase subtilisin/kexin type 9 was reduced by 78.3% (P < 0.001). Time-adjusted percentage reduction in LDL-C from baseline after day 90 and up to day 360 was 56.3%. At day 330, 71.7% of participants with inclisiran achieved ≥50% reduction in LDL-C compared with 1.5% with placebo. Over the study period, total cholesterol, apolipoprotein B, and non-high-density lipoprotein cholesterol (HDL-C) levels were decreased significantly, and HDL-C levels increased. The incidence of adverse events with inclisiran was similar to that with placebo. CONCLUSIONS In Asian patients with ASCVD or high risk of ASCVD, inclisiran was effective and safe. (Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease [ASCVD] or ASCVD High Risk and Elevated Low-Density Lipoprotein Cholesterol [LDL-C] [ORION-18]; NCT04765657).