Qi Litong, Shen Hua, Chai Meng, Chen Beijian, He Yongming, Shi Xiaoxia, Lian Qiufang, Zhao Wang, Qu Yanling, Qian Lei, Zhang Jianwei, Li Haoyu, Zhou Yujie, Huo Yong
Department of Cardiology, Peking University First Hospital, Beijing, China.
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University Beijing Institute of Heart Lung and Blood Vessel Disease, Beijing Key Laboratory of Precision Medicine of Coronary Atherosclerotic Disease, Clinical Center for Coronary Heart Disease, Capital Medical University, No.2 Anzhen Road, ChaoYang District, Beijing, 100029, China.
Cardiovasc Diabetol. 2025 Jul 3;24(1):264. doi: 10.1186/s12933-025-02816-3.
This study evaluated the efficacy and safety of tafolecimab in patients with type 2 diabetes (T2D) and hypercholesterolemia by a post-hoc analysis of pooled data from three phase 3 trials.
Data from up to 12 weeks were analyzed to assess the effects of tafolecimab 450 mg every four weeks (Q4W) in patients with T2D and hypercholesterolemia. The primary endpoint was the percentage change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to week 12. Secondary endpoints included the proportion of participants achieving LDL-C levels below 1.8 mmol/L at weeks 12, the proportion of patients achieving LDL-C ≥ 50% reduction and LDL-C < 1.4 mmol/L, as well as percentage changes from baseline to week 12 in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), lipoprotein(a) [Lp(a)], and triglyceride (TG) levels.
The reduction in LDL-C from baseline was significantly greater in patients receiving tafolecimab than in those receiving placebo (estimated treatment difference: - 64.02%, 95% confidence interval: [- 68.08%, - 59.96%], P < 0.0001). The proportion of patients achieving a reduction of over 50% and an absolute LDL-C value below 1.4 mmol/L was significantly higher in the tafolecimab group than that in the placebo group (P < 0.0001). Furthermore, a significantly greater proportion of patients in the tafolecimab group achieved LDL-C levels below 1.8 mmol/L at week 12 compared to the placebo group (P < 0.0001). The tafolecimab group also showed significant reductions in TG, non-HDL-C, apo B, and Lp(a) from baseline to week 12 compared to the placebo group (all P < 0.001). The incidence of adverse events was generally similar between the two groups.
Tafolecimab 450 mg Q4W demonstrated a superior lipid-lowering efficacy and favorable safety profile compared to placebo. This suggests it could be a promising new treatment option for Chinese patients with T2D and hypercholesterolemia.
本研究通过对三项3期试验的汇总数据进行事后分析，评估了tafolecimab在2型糖尿病（T2D）和高胆固醇血症患者中的疗效和安全性。
分析长达12周的数据，以评估每四周一次给予tafolecimab 450mg（Q4W）对T2D和高胆固醇血症患者的影响。主要终点是从基线到第12周低密度脂蛋白胆固醇（LDL-C）水平的百分比变化。次要终点包括在第12周时LDL-C水平低于1.8mmol/L的参与者比例、LDL-C降低≥50%且LDL-C<1.4mmol/L的患者比例，以及从基线到第12周非高密度脂蛋白胆固醇（non-HDL-C）、载脂蛋白B（apo B）、脂蛋白（a）[Lp（a）]和甘油三酯（TG）水平的百分比变化。
接受tafolecimab治疗的患者LDL-C从基线的降低幅度显著大于接受安慰剂的患者（估计治疗差异：-64.02%，95%置信区间：[-68.08%，-59.96%]，P<0.0001）。tafolecimab组中LDL-C降低超过50%且绝对LDL-C值低于1.4mmol/L的患者比例显著高于安慰剂组（P<0.0001）。此外，与安慰剂组相比，tafolecimab组在第12周时LDL-C水平低于1.8mmol/L的患者比例显著更高（P<0.0001）。与安慰剂组相比，tafolecimab组从基线到第12周时TG、non-HDL-C、apo B和Lp（a）也有显著降低（所有P<0.001）。两组不良事件的发生率总体相似。
每四周一次给予tafolecimab 450mg与安慰剂相比显示出卓越的降脂疗效和良好的安全性。这表明它可能是中国T2D和高胆固醇血症患者一种有前景的新治疗选择。
