Background:Statins,a first-line therapeutic option for atherosclerotic cardiovascular disease(ASCVD),have prompted concerns regarding dysglycemia and diabetes,thus posing a dilemma in treating patients with prediabete...Background:Statins,a first-line therapeutic option for atherosclerotic cardiovascular disease(ASCVD),have prompted concerns regarding dysglycemia and diabetes,thus posing a dilemma in treating patients with prediabetes.Xuezhikang(XZK)decreases blood cholesterol levels without affecting glucose metabolism,and may serve as a potential substitute.Methods:The XTREME study is a prospective,randomized,open-label,multi-center trial evaluating whether XZK 1200 mg/d,compared with atorvastatin 20 mg/d,has favorable effects on HbA1c levels after 24 weeks of treatment in patients with dyslipidemia and prediabetes.After a 1-week run-in period for adherence assessment,the study will ran-domly assign(1:1)392 patients meeting the protocol inclusion criteria to one of two treatment groups:an experimental group(XZK 1200 mg/day)or a control group(atorvastatin 20 mg/day).All participants will be recruited from approxi-mately 20 Chinese medical centers.The last participant is planned to be recruited before December 2023.The primary endpoint will be change in HbA1c level from baseline to 24 weeks,or before anti-diabetic therapy initiation within 24 weeks.The key secondary outcomes will include other biomarkers reflecting blood glucose or lipid metabolism.Discussion:Delaying diabetes is desirable for individuals with prediabetes.The XTREME trial presents a unique oppor-tunity to demonstrate whether XZK might provide an alternative to statins for patients with dyslipidemia and prediabetes.展开更多
文摘Background:Statins,a first-line therapeutic option for atherosclerotic cardiovascular disease(ASCVD),have prompted concerns regarding dysglycemia and diabetes,thus posing a dilemma in treating patients with prediabetes.Xuezhikang(XZK)decreases blood cholesterol levels without affecting glucose metabolism,and may serve as a potential substitute.Methods:The XTREME study is a prospective,randomized,open-label,multi-center trial evaluating whether XZK 1200 mg/d,compared with atorvastatin 20 mg/d,has favorable effects on HbA1c levels after 24 weeks of treatment in patients with dyslipidemia and prediabetes.After a 1-week run-in period for adherence assessment,the study will ran-domly assign(1:1)392 patients meeting the protocol inclusion criteria to one of two treatment groups:an experimental group(XZK 1200 mg/day)or a control group(atorvastatin 20 mg/day).All participants will be recruited from approxi-mately 20 Chinese medical centers.The last participant is planned to be recruited before December 2023.The primary endpoint will be change in HbA1c level from baseline to 24 weeks,or before anti-diabetic therapy initiation within 24 weeks.The key secondary outcomes will include other biomarkers reflecting blood glucose or lipid metabolism.Discussion:Delaying diabetes is desirable for individuals with prediabetes.The XTREME trial presents a unique oppor-tunity to demonstrate whether XZK might provide an alternative to statins for patients with dyslipidemia and prediabetes.
