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Background and Objectives <p>Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have become an important therapeutic option for patients with dyslipidemia. Evolocumab and alirocumab are monoclonal antibodies targeting circulating PCSK9, whereas inclisiran is a small interfering RNA (siRNA) agent that suppresses hepatic PCSK9 synthesis and requires only twice-yearly dosing. Although these agents are proven effective in clinical trials, direct real-world comparative evidence on lipid-lowering efficacy, apolipoprotein B (apoB) reduction, safety, and adherence remains limited.</p> Methods <p>This was a real-world, retrospective study conducted at a single center. A total of 198 patients were consecutively enrolled and assigned to three groups (<i>n</i> = 66 per group): inclisiran, evolocumab, or alirocumab. Baseline characteristics, including age, sex, and familial hypercholesterolemia (FH) status (assessed by DLCN criteria), were well-balanced across cohorts. All lipid parameters were analyzed using standardized automated biochemical analyzers at a centralized laboratory to ensure measurement consistency.</p> Results <p>At 180 days, all three agents achieved robust and significant reductions in LDL-C from baseline (<i>p</i> &lt; 0.001), with no significant differences observed between the groups. Notably, inclisiran demonstrated a numerical advantage in the reduction of apolipoprotein B (apoB) compared with evolocumab and alirocumab at 180 days (0.650&#xa0;g/Lvs.0.774&#xa0;g/L and 0.752&#xa0;g/L, respectively), although these between-group differences did not reach formal statistical significance (<i>p</i> &gt; 0.05). Treatment persistence was highest in the inclisiran group (69.7%), followed by evolocumab (56.1%) and alirocumab (50.0%). All therapies were well-tolerated with no new safety signals.</p> Conclusions <p>In this real-world study, Inclisiran, evolocumab, and alirocumab are all highly effective in lowering LDL-C in a real-world setting. Inclisiran may offer additional clinical value through superior treatment persistence and a favorable numerical trend toward enhanced apoB suppression.</p>

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Comparative effectiveness and safety of inclisiran versus evolocumab and alirocumab: a 180-day real-world study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月16日

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  • Jiafang Yao,
  • Qiyin Sun,
  • Dan Liu,
  • Junling Lin,
  • WenJuan Wang

摘要

Background and Objectives

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have become an important therapeutic option for patients with dyslipidemia. Evolocumab and alirocumab are monoclonal antibodies targeting circulating PCSK9, whereas inclisiran is a small interfering RNA (siRNA) agent that suppresses hepatic PCSK9 synthesis and requires only twice-yearly dosing. Although these agents are proven effective in clinical trials, direct real-world comparative evidence on lipid-lowering efficacy, apolipoprotein B (apoB) reduction, safety, and adherence remains limited.

Methods

This was a real-world, retrospective study conducted at a single center. A total of 198 patients were consecutively enrolled and assigned to three groups (n = 66 per group): inclisiran, evolocumab, or alirocumab. Baseline characteristics, including age, sex, and familial hypercholesterolemia (FH) status (assessed by DLCN criteria), were well-balanced across cohorts. All lipid parameters were analyzed using standardized automated biochemical analyzers at a centralized laboratory to ensure measurement consistency.

Results

At 180 days, all three agents achieved robust and significant reductions in LDL-C from baseline (p < 0.001), with no significant differences observed between the groups. Notably, inclisiran demonstrated a numerical advantage in the reduction of apolipoprotein B (apoB) compared with evolocumab and alirocumab at 180 days (0.650 g/Lvs.0.774 g/L and 0.752 g/L, respectively), although these between-group differences did not reach formal statistical significance (p > 0.05). Treatment persistence was highest in the inclisiran group (69.7%), followed by evolocumab (56.1%) and alirocumab (50.0%). All therapies were well-tolerated with no new safety signals.

Conclusions

In this real-world study, Inclisiran, evolocumab, and alirocumab are all highly effective in lowering LDL-C in a real-world setting. Inclisiran may offer additional clinical value through superior treatment persistence and a favorable numerical trend toward enhanced apoB suppression.