Comprehensive clinical evaluation of hyzetimibe in the treatment of primary hypercholesterolemia
JIANG Li-fan
SHAN Wen-ya
LIU Lin
LI Lin
GAO Zhe
LÜ Duo
YANG Hong-yu
LU Xiao-yang
Abstract：Objective:This study aimed to conduct a comprehensive clinical evaluation of hyzetimibe,establishing an evidence-based foundation for its rational and standardized clinical use while providing references for relevant drug policy formulation.Methods:Following established guidelines,a rapid assessment methodology was employed.Evidence was synthesized through a systematic literature review.Within the context of currently marketed cholesterol absorption inhibitors in China,a multidimensional evaluation of hyzetimibe for treating primary hypercholesterolemia was conducted across six domains:safety,efficacy,economic efficiency,innovation,suitability,and accessibility.Results:Hyzetimibe demonstrated a safety profile comparable to that of ezetimibe with no significant differences observed,indicating manageable safety risks.It effectively reduced LDL-C,non-HDL-C,total cholesterol(TC),and Apo B levels in patients with primary hypercholesterolemia.When used in combination of statin therapy,hyzetimibe significantly enhanced the efficacy of LDL-C reduction beyond what is achieved with statin monotherapy alone.For patients who failed to achieve lipid targets with statins alone,combination therapy with hyzetimibe facilitated goal attainment,and potentially reduced cardiovascular event risks associated with suboptimal lipid control and subsequent treatment costs,suggesting a cost-effectiveness advantage.The drug exhibits innovative characteristics in structural optimization,metabolic pathways,and indigenous research and development,demonstrating both clinical value and social significance.With convenient oral administration and favorable short-and long-term tolerability profiles,it is suitable for statin-refractory patients or those requiring statin dose reduction.Patients with mild to moderate hepatic or renal impairment showed good tolerance without adverse events reported.Hyzetimibe is widely available across all 32 provincial-level administrative regions in China;its utilization has been steadily increasing along with reliable supply chains.Conclusion:As the first independently developed novel selective cholesterol absorption inhibitor in China,hyzetimibe is similar to ezetimibe in mechanism of action,efficacy,and safety,but has certain local advantages in chemical structure,production process(localization),and drug cost control.Combination with hyzetimibe shows potential cost-effectiveness advantages when LDL-C reduction targets cannot be achieved with statin monotherapy.
Keywords：primary hypercholesterolemiahyzetimibecholesterol absorption inhibitorcomprehensive clinical evaluation of drugs
Publication Date：2025-11-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 2336-2343 )