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Abstract：
BACKGROUND: Saroglitazar-a unique dual peroxisome proliferator-activated receptor agonist was approved marketing authorization in India in 2013 for diabetic dyslipidemia. Postmarketing studies have additionally shown improvement in liver parameters in diabetic dyslipidemia patients with nonalcoholic fatty liver disease (NAFLD) who received saroglitazar.
OBJECTIVE: The aim of this study was to evaluate the effect of saroglitazar on liver function test, liver fibrosis score by FibroScan, lipid profiles, HbA1c in NAFLD patients with diabetic dyslipidemia in southern India.
METHODS: A prospective, interventional, pilot study was performed to study the safety and efficacy of saroglitazar in NAFLD patients having type 2 diabetes mellitus. About 97 patients were screened, of which 85 patients were involved in the study based on the inclusion criteria. The clinical parameters and liver stiffness were measured at the baseline and also after 12 weeks of treatment with administration of saroglitazar 4 mg once daily. The change in the parameters at the baseline and after the end of the treatment was measured and was subjected to statistical analysis using SPSS software.
RESULTS: The recruited patients received saroglitazar and were followed up for a period of 12 weeks. The clinical parameters such as fasting blood sugar, postprandial blood sugar, HbA1c, total cholesterol, triglycerides, SGPT, and liver stiffness showed significant difference after 12 weeks of treatment when compared with the baseline values. No adverse drug reaction was reported in patients receiving saroglitazar during the study.
CONCLUSIONS: Saroglitazar was found to show significant improvement in liver parameters in NAFLD patients with a significant reduction in liver fibrosis and triglycerides level.
OBJECTIVE: The aim of this study was to evaluate the effect of saroglitazar on liver function test, liver fibrosis score by FibroScan, lipid profiles, HbA1c in NAFLD patients with diabetic dyslipidemia in southern India.
METHODS: A prospective, interventional, pilot study was performed to study the safety and efficacy of saroglitazar in NAFLD patients having type 2 diabetes mellitus. About 97 patients were screened, of which 85 patients were involved in the study based on the inclusion criteria. The clinical parameters and liver stiffness were measured at the baseline and also after 12 weeks of treatment with administration of saroglitazar 4 mg once daily. The change in the parameters at the baseline and after the end of the treatment was measured and was subjected to statistical analysis using SPSS software.
RESULTS: The recruited patients received saroglitazar and were followed up for a period of 12 weeks. The clinical parameters such as fasting blood sugar, postprandial blood sugar, HbA1c, total cholesterol, triglycerides, SGPT, and liver stiffness showed significant difference after 12 weeks of treatment when compared with the baseline values. No adverse drug reaction was reported in patients receiving saroglitazar during the study.
CONCLUSIONS: Saroglitazar was found to show significant improvement in liver parameters in NAFLD patients with a significant reduction in liver fibrosis and triglycerides level.
摘要：
背景：Saroglitazar-一种独特的双重过氧化物酶体增殖物激活受体激动剂于2013年在印度被批准用于糖尿病血脂异常。上市后研究还显示，接受saroglitazar治疗的糖尿病血脂异常合并非酒精性脂肪性肝病（NAFLD）患者的肝脏参数有所改善。
目的：本研究的目的是评估saroglitazar对肝功能测试的影响，肝纤维化评分通过FibroScan，脂质分布，印度南部糖尿病血脂异常的NAFLD患者的HbA1c。
方法：前瞻性，介入,我们进行了初步研究,以研究在患有2型糖尿病的NAFLD患者中使用saroglitazar的安全性和有效性.大约97名患者接受了筛查，其中85例患者根据纳入标准参与研究.临床参数和肝脏硬度在基线和治疗12周后测量，每天一次施用4mg的saroglitazar。测量基线时和治疗结束后参数的变化，并使用SPSS软件进行统计分析。
结果：招募的患者接受了saroglitazar，并随访了12周。空腹血糖等临床参数，餐后血糖,HbA1c,总胆固醇,甘油三酯，SGPT,与基线值相比，治疗12周后，肝脏硬度显示出显着差异。在研究期间，接受saroglitazar的患者未报告药物不良反应。
结论：在NAFLD患者中，Saroglitazar显示肝脏参数显著改善，肝纤维化和甘油三酯水平显著降低。
目的：本研究的目的是评估saroglitazar对肝功能测试的影响，肝纤维化评分通过FibroScan，脂质分布，印度南部糖尿病血脂异常的NAFLD患者的HbA1c。
方法：前瞻性，介入,我们进行了初步研究,以研究在患有2型糖尿病的NAFLD患者中使用saroglitazar的安全性和有效性.大约97名患者接受了筛查，其中85例患者根据纳入标准参与研究.临床参数和肝脏硬度在基线和治疗12周后测量，每天一次施用4mg的saroglitazar。测量基线时和治疗结束后参数的变化，并使用SPSS软件进行统计分析。
结果：招募的患者接受了saroglitazar，并随访了12周。空腹血糖等临床参数，餐后血糖,HbA1c,总胆固醇,甘油三酯，SGPT,与基线值相比，治疗12周后，肝脏硬度显示出显着差异。在研究期间，接受saroglitazar的患者未报告药物不良反应。
结论：在NAFLD患者中，Saroglitazar显示肝脏参数显著改善，肝纤维化和甘油三酯水平显著降低。
