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Abstract：
BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a complex metabolic disorder that increases the risk for cardiovascular disease in patients with type 2 diabetes mellitus (T2DM). Global longitudinal strain (GLS) is an indicator of left ventricular (LV) mechanics and can detect subclinical myocardial dysfunction. We compared the effects of pioglitazone and empagliflozin on GLS in patients with T2DM and NAFLD without established atherosclerotic cardiovascular disease.
METHODS: This study was a 24-week randomized, single-blind, and parallel-group (1: 1 ratio) clinical trial. Seventy-three participants with T2DM (being treated with metformin) and NAFLD but without established atherosclerotic cardiovascular disease (ASCVD) were randomized to empagliflozin or pioglitazone. Liver steatosis and fibrosis were measured using transient elastography, and GLS was measured by echocardiography. The primary endpoint was the change in GLS from baseline to week 24. Secondary end points include changes in controlled attenuation parameter (CAP) and Liver stiffness measure (LSM).
RESULTS: In this study, GLS improved by 1.56 ± 2.34% (P < 0.01) in the pioglitazone group and 1.06 ± 1.83% (P < 0.01) in the empagliflozin group without a significant difference between the two groups (P = 0.31). At baseline, GLS was inversely associated with the severity of liver fibrosis: r = - 0.311, P = 0.007. LSM in the pioglitazone and empagliflozin group [(-0.73 ± 1.59) and (-1.11 ± 1.33)] kpa (P < 0.01) decreased significantly. It was without substantial difference between the two groups (P = 0.26). Empagliflozin and pioglitazone both improved controlled attenuation parameter. The improvement was more critical in the empagliflozin group: -48.22 + 35.02 dB/m vs. -25.67 + 41.50 dB/m, P = 0.01.
CONCLUSIONS: Subclinical cardiac dysfunction is highly important in patients with T2DM and with NAFLD. Empagliflozin and Pioglitazone improve LV mechanics and fibrosis in patients without established ASCVD. This has a prognostic importance on cardiovascular outcomes in high-risk patients with T2DM. Moreover, empagliflozin ameliorates liver steatosis more effectively them pioglitazone. This study can serve as a start point hypothesis for the future. Further studies are needed to explore the concept in larger populations.
BACKGROUND: This trial was registered in the Iranian Registry of Clinical Trials (IRCT): \"A Comparison between the Effect of Empagliflozin and Pioglitazone on Echocardiographic Indices in Patients with Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease\" IRCT20190122042450N5, 29 November 2020. https://www.irct.ir/search/result?query=IRCT20190122042450N5 .
METHODS: This study was a 24-week randomized, single-blind, and parallel-group (1: 1 ratio) clinical trial. Seventy-three participants with T2DM (being treated with metformin) and NAFLD but without established atherosclerotic cardiovascular disease (ASCVD) were randomized to empagliflozin or pioglitazone. Liver steatosis and fibrosis were measured using transient elastography, and GLS was measured by echocardiography. The primary endpoint was the change in GLS from baseline to week 24. Secondary end points include changes in controlled attenuation parameter (CAP) and Liver stiffness measure (LSM).
RESULTS: In this study, GLS improved by 1.56 ± 2.34% (P < 0.01) in the pioglitazone group and 1.06 ± 1.83% (P < 0.01) in the empagliflozin group without a significant difference between the two groups (P = 0.31). At baseline, GLS was inversely associated with the severity of liver fibrosis: r = - 0.311, P = 0.007. LSM in the pioglitazone and empagliflozin group [(-0.73 ± 1.59) and (-1.11 ± 1.33)] kpa (P < 0.01) decreased significantly. It was without substantial difference between the two groups (P = 0.26). Empagliflozin and pioglitazone both improved controlled attenuation parameter. The improvement was more critical in the empagliflozin group: -48.22 + 35.02 dB/m vs. -25.67 + 41.50 dB/m, P = 0.01.
CONCLUSIONS: Subclinical cardiac dysfunction is highly important in patients with T2DM and with NAFLD. Empagliflozin and Pioglitazone improve LV mechanics and fibrosis in patients without established ASCVD. This has a prognostic importance on cardiovascular outcomes in high-risk patients with T2DM. Moreover, empagliflozin ameliorates liver steatosis more effectively them pioglitazone. This study can serve as a start point hypothesis for the future. Further studies are needed to explore the concept in larger populations.
BACKGROUND: This trial was registered in the Iranian Registry of Clinical Trials (IRCT): \"A Comparison between the Effect of Empagliflozin and Pioglitazone on Echocardiographic Indices in Patients with Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease\" IRCT20190122042450N5, 29 November 2020. https://www.irct.ir/search/result?query=IRCT20190122042450N5 .
摘要：
背景：非酒精性脂肪性肝病（NAFLD）是一种复杂的代谢紊乱，可增加2型糖尿病（T2DM）患者的心血管疾病风险。全局纵向应变（GLS）是左心室（LV）力学的指标，可以检测亚临床心肌功能障碍。我们比较了吡格列酮和依帕列净对无动脉粥样硬化性心血管疾病的T2DM和NAFLD患者GLS的影响。
方法：这项研究是一项为期24周的随机研究，单盲,和平行组（1：1比例）临床试验。73名患有T2DM（接受二甲双胍治疗）和NAFLD但没有确定的动脉粥样硬化性心血管疾病（ASCVD）的参与者被随机分为依帕列净或吡格列酮。肝脏脂肪变性和纤维化使用瞬时弹性成像测量，通过超声心动图测量GLS。主要终点是从基线到第24周的GLS变化。次要终点包括受控衰减参数(CAP)和肝脏硬度测量(LSM)的变化。
结果：在这项研究中，吡格列酮组GLS提高1.56±2.34％（P<0.01），依帕列净组提高1.06±1.83％（P<0.01），两组间差异无统计学意义（P=0.31）。在基线,GLS与肝纤维化的严重程度呈负相关：r=-0.311，P=0.007。吡格列酮和依帕列净组LSM[(-0.73±1.59)和(-1.11±1.33)]kpa显著降低(P<0.01)。两组间差异无统计学意义(P=0.26)。Empagliflozin和吡格列酮均改善了受控衰减参数。在empagliflozin组中，改善更为关键：-48.2235.02dB/m与-25.67+41.50dB/m,P=0.01。
结论：亚临床心功能不全在T2DM和NAFLD患者中非常重要。Empagliflozin和吡格列酮可改善无ASCVD患者的LV力学和纤维化。这对T2DM高危患者的心血管预后具有重要意义。此外，empagliflozin改善肝脏脂肪变性更有效他们吡格列酮。这项研究可以作为未来的起点假设。需要进一步的研究来探索更大人群中的概念。
背景：该试验已在伊朗临床试验注册中心（IRCT）中注册：“Empagliflozin和吡格列酮对2型糖尿病和非酒精性脂肪肝患者超声心动图指标影响的比较”IRCT20190122042450N5，2020年11月29日。https://www.irct.ir/search/result?query=IRCT20190122042450N5.
方法：这项研究是一项为期24周的随机研究，单盲,和平行组（1：1比例）临床试验。73名患有T2DM（接受二甲双胍治疗）和NAFLD但没有确定的动脉粥样硬化性心血管疾病（ASCVD）的参与者被随机分为依帕列净或吡格列酮。肝脏脂肪变性和纤维化使用瞬时弹性成像测量，通过超声心动图测量GLS。主要终点是从基线到第24周的GLS变化。次要终点包括受控衰减参数(CAP)和肝脏硬度测量(LSM)的变化。
结果：在这项研究中，吡格列酮组GLS提高1.56±2.34％（P<0.01），依帕列净组提高1.06±1.83％（P<0.01），两组间差异无统计学意义（P=0.31）。在基线,GLS与肝纤维化的严重程度呈负相关：r=-0.311，P=0.007。吡格列酮和依帕列净组LSM[(-0.73±1.59)和(-1.11±1.33)]kpa显著降低(P<0.01)。两组间差异无统计学意义(P=0.26)。Empagliflozin和吡格列酮均改善了受控衰减参数。在empagliflozin组中，改善更为关键：-48.2235.02dB/m与-25.67+41.50dB/m,P=0.01。
结论：亚临床心功能不全在T2DM和NAFLD患者中非常重要。Empagliflozin和吡格列酮可改善无ASCVD患者的LV力学和纤维化。这对T2DM高危患者的心血管预后具有重要意义。此外，empagliflozin改善肝脏脂肪变性更有效他们吡格列酮。这项研究可以作为未来的起点假设。需要进一步的研究来探索更大人群中的概念。
背景：该试验已在伊朗临床试验注册中心（IRCT）中注册：“Empagliflozin和吡格列酮对2型糖尿病和非酒精性脂肪肝患者超声心动图指标影响的比较”IRCT20190122042450N5，2020年11月29日。https://www.irct.ir/search/result?query=IRCT20190122042450N5.
