Patients with NASH with elevated triglycerides (≥150 and <500 mg/dL) were randomized to Vascepa 2 g twice daily (n = 33) or fenofibrate 145 mg daily (n = 33) for 2 weeks, followed by the addition of CILO 30 mg and FIR 20 mg daily for 6 weeks. Safety, lipids, and liver biochemistry were monitored.
All treatments were well-tolerated; most treatment-emergent adverse events were Grade 1 to 2 severity, and there were no discontinuations due to adverse events. At baseline, median (interquartile range [IQR]) triglycerides were similar in the Vascepa and fenofibrate groups (median, 177 [IQR, 154-205] vs 190 [IQR, 144-258] mg/dL, respectively). Median changes from baseline in triglycerides for Vascepa vs fenofibrate after 2 weeks of pretreatment were -12 mg/dL (IQR, -33 to 7 mg/dL; P = .09) vs -32 mg/dL (IQR, -76 to 6 mg/dL; P = .012) and at 6 weeks were +41 mg/dL (IQR, 16-103 mg/dL; P < .001) vs -2 mg/dL (IQR, -42 to 54 mg/dL; P = .92). In patients with baseline triglycerides <250 mg/dL, fenofibrate was more effective vs Vascepa in mitigating triglyceride increases after 6 weeks of combination treatment (+6 vs +39 mg/dL); similar trends were observed in patients with baseline triglycerides ≥250 mg/d (-61 vs +99 mg/dL).
In patients with NASH with hypertriglyceridemia treated with CILO and FIR, fenofibrate was safe and effectively mitigated increases in triglycerides associated with acetyl-CoA carboxylase inhibition.
gov, Number: NCT02781584.
方法:将甘油三酯升高(≥150和<500mg/dL)的NASH患者随机分为Vascepa2g,每天两次(n=33)或非诺贝特145mg,持续2周。然后每天添加CILO30mg和FIR20mg,持续6周。安全,脂质,和肝脏生化监测。
结果:所有治疗均耐受良好;大多数治疗引起的不良事件严重程度为1至2级,并且没有因不良事件而停药.在基线,Vascepa和非诺贝特组的甘油三酯中位数(四分位距[IQR])相似(中位数,177[IQR,154-205]vs190[IQR,144-258]mg/dL,分别)。预处理2周后,Vascepa与非诺贝特的甘油三酯相对于基线的中位数变化为-12mg/dL(IQR,-33至7mg/dL;P=.09)与-32mg/dL(IQR,-76至6mg/dL;P=.012),6周时为+41mg/dL(IQR,16-103mg/dL;P<.001)与-2mg/dL(IQR,-42至54毫克/分升;P=.92)。在基线甘油三酯<250mg/dL的患者中,联合治疗6周后,非诺贝特在缓解甘油三酯升高方面比Vascepa更有效(+6vs+39mg/dL);基线甘油三酯≥250mg/d的患者中观察到类似趋势(-61vs+99mg/dL).
结论:在用CILO和FIR治疗的高甘油三酯血症NASH患者中,非诺贝特是安全的,有效地减轻了与乙酰辅酶A羧化酶抑制相关的甘油三酯的增加。
结果:政府,编号:NCT02781584。