非酒精性脂肪肝（NAFLD）/非酒精性脂肪性肝炎（NASH）患者服用沙格列扎尔和维生素 E 的疗效和安全性的前瞻性随机四臂干预对比研究 -SVIN 试验

IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY

Journal of Clinical and Experimental Hepatology Pub Date : 2024-03-18 DOI:10.1016/j.jceh.2024.101398

Bilal A. Mir , Brij Sharma , Rajesh Sharma , Vishal Bodh , Ashish Chauhan , Tahir Majeed , Inaamul Haq , Neetu Sharma , Dikshant Sharma

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引用次数: 0

摘要

背景和目的维生素 E 被广泛用于治疗非酒精性脂肪性肝炎（NASH）。沙格列扎是一种新型的过氧化物酶体增殖激活受体ɑ/γ双重激动剂，在印度被批准用于治疗非酒精性脂肪肝。目前还没有关于维生素 E 和沙格列扎的头对头比较研究。我们对非酒精性脂肪肝/NASH 中沙格列扎尔和维生素 E 的疗效和安全性进行了研究。材料和方法我们对 175 名非酒精性脂肪肝患者进行了前瞻性随机分组，分为四组：每日单用沙格列扎尔 4 毫克组（n = 44）、每日单用维生素 E 800IU 组（n = 41）、维生素 E 和沙格列扎尔组合组（n = 47）以及对照组（n = 43）。记录了所有基线变量，包括肝脏硬度测量（LSM）和受控衰减参数（CAP）。结果平均年龄为 45 ± 11 岁，体重指数为 26 ± 3.6 kg/m2。与对照组相比，使用沙格列扎尔、维生素 E 和联合疗法后，丙氨酸氨基转移酶水平显著下降（95% 置信区间 [CI]：6.27-28.25，P = 0.002；95% CI：-3.39 至 18.88，P = 0.047；95% CI：8.10-29.54，P = 0.001）。沙格列扎及联合疗法可显著降低 CAP（95% CI：-31.94 至 11.99，P = 0.015；95% CI：-10.48 至 30.51，P = 0.026）。只有联合疗法能显著降低 LSM（95% CI：0.41-1.68，P = 0.001）。在血糖参数中，单用沙格列扎尔和联合疗法都能显著改善糖化血红蛋白水平（分别为 P = 0.001 和 P = 0.015），只有联合疗法能显著改善稳态模型评估估计的胰岛素抵抗（P = 0.047）。结论 Saroglitazar 和维生素 E 的联合治疗显示 LSM 和 CAP 以及生化、血糖和血脂参数均有统计学意义的显著降低。

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A Prospective Randomised Comparative Four-arm Intervention Study of Efficacy and Safety of Saroglitazar and Vitamin E in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH)-SVIN TRIAL

Background and aim

Vitamin E is widely prescribed for non-alcoholic steatohepatitis (NASH). Saroglitazar, a novel dual peroxisome proliferator-activator receptor ɑ/γ agonist, is approved in India for non-alcoholic fatty liver disease (NAFLD). No head-to-head comparative study for vitamin E and saroglitazar is available. We studied the efficacy and safety of saroglitazar and vitamin E in NAFLD/NASH.

Materials and methods

We prospectively randomised 175 NAFLD patients into four arms as Saroglitazar 4 mg daily alone (n = 44), vitamin E 800IU daily alone (n = 41), vitamin E and saroglitazar combination (n = 47), and control arm (n = 43). All the baseline variables including liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) were recorded. Reassessment was done after 24 weeks of treatment.

Results

The mean age and body mass index was 45 ± 11 years and 26 ± 3.6 kg/m², respectively. Compared to control, the decrease in alanine amino transferase levels with saroglitazar, vitamin E, and combination therapy was significant (95% confidence interval [CI]: 6.27–28.25, P = 0.002, 95% CI: −3.39 to 18.88, P = 0.047 and 95% CI: 8.10–29.54, P = 0.001, respectively). The reduction in CAP was significant with saroglitazar and combination therapy (95% CI: −31.94 to 11.99, P = 0.015 and 95% CI: −10.48 to 30.51, P = 0.026, respectively). Only combination therapy shows significant reduction in LSM (95% CI: 0.41–1.68, P = 0.001). Among glycaemic parameters, both saroglitazar alone and combination therapy significantly improved glycosylated haemoglobin levels (P = 0.001 and P = 0.015, respectively), and only combination therapy significantly improved homoeostasis model assessment–estimated insulin resistance (P = 0.047). Saroglitazar alone showed significant reduction in triglyceride and low-density lipoprotein levels (P = 0.038 and P = 0.018, respectively), and combination therapy showed significant increase in high-density lipoprotein levels (P = 0.024).

Conclusions

Combination of Saroglitazar and vitamin E showed statistically significant reduction of LSM and CAP along with biochemical, glycaemic, and lipid parameters.