Department of Endocrinology, Center for Endocrinology, Diabetes, Arthritis & Rheumatism (CEDAR) Super-speciality Clinics, Dwarka, New Delhi, India.
Department of Endocrinology, Max Superspeciality Hospitals, Patparganj, New Delhi, India.
Diabetes Metab Syndr. 2020 Nov-Dec;14(6):1759-1768. doi: 10.1016/j.dsx.2020.08.039. Epub 2020 Sep 6.
Saroglitazar is commonly used in India for managing hypertriglyceridemia in diabetes. This meta-analysis evaluated the efficacy and safety of saroglitazar in hypertriglyceridemia.
Electronic databases were searched for RCTs involving diabetes patients receiving saroglitazar in intervention arm, and placebo/lipid/diabetes medication in the control arm. Primary outcome was to evaluate change in serum triglyceride and HbA1c. Secondary outcomes were to evaluate changes in other lipid parameters, glycaemia and adverse effects. Analysis for lipid and glycaemic parameters were done separately for controls receiving anti-lipid medications (statins/fibrates) [active control group (ACG)] and those receiving placebo/diabetes medications [passive control group (PCG)].
Following 12 weeks therapy, individuals receiving saroglitazar had significantly lower triglycerides when compared to PCG [MD -71.67 mg/dl (95% CI: -123.67 to -19.66 mg/dl); P < 0.01; I = 91% (considerable heterogeneity); low certainty of evidence (LCE)], but not ACG [MD -37.38 mg/dl (95% CI: -84.55-9.79 mg/dl; P = 0.12; I = 98% (considerable heterogeneity); LCE]. Individuals receiving saroglitazar had significantly lower fasting glucose when compared to PCG [MD -24.61 mg/dl (95% CI: -44.13 to -5.09 mg/dl); P = 0.01; I = 65% (moderate heterogeneity); LCE], but not ACG [MD -13.5 mg/dl (95% CI: -33.1-6.10 mg/dl; P = 0.18; I = 98% (considerable heterogeneity); LCE]. HbA1c, total cholesterol, LDL-C, apolipoprotein-B and HDL-C were not significantly different among study groups. Creatinine was significantly higher in patients receiving saroglitazar as compared to controls [MD 0.12 mg/dl (95% CI: 0.04-0.21 mg/dl); P < 0.01; I = 29% (low heterogeneity); high certainty of evidence].
This meta-analysis reinforces the excellent triglyceride lowering of saroglitazar, but highlights significant increase in creatinine.
在印度，沙格列汀通常用于治疗糖尿病患者的高三酰甘油血症。本荟萃分析评估了沙格列汀在高三酰甘油血症中的疗效和安全性。
检索了涉及接受沙格列汀干预组和安慰剂/脂质/糖尿病药物对照组的糖尿病患者的 RCT 的电子数据库。主要结局是评估血清三酰甘油和 HbA1c 的变化。次要结局是评估其他脂质参数、血糖和不良反应的变化。分别对接受降脂药物（他汀类药物/贝特类药物）的对照组（主动对照组，ACG）和接受安慰剂/糖尿病药物的对照组（被动对照组，PCG）进行脂质和血糖参数的分析。
经过 12 周的治疗，与 PCG 相比，接受沙格列汀治疗的个体三酰甘油显著降低[MD -71.67mg/dl（95% CI：-123.67 至-19.66mg/dl）；P<0.01；I=91%（高度异质性）；低证据确定性（LCE）]，但与 ACG 相比无显著差异[MD -37.38mg/dl（95% CI：-84.55 至-9.79mg/dl；P=0.12；I=98%（高度异质性）；LCE）]。与 PCG 相比，接受沙格列汀治疗的个体空腹血糖显著降低[MD -24.61mg/dl（95% CI：-44.13 至-5.09mg/dl）；P=0.01；I=65%（中度异质性）；LCE]，但与 ACG 相比无显著差异[MD -13.5mg/dl（95% CI：-33.1 至-6.10mg/dl；P=0.18；I=98%（高度异质性）；LCE]。各组之间的 HbA1c、总胆固醇、LDL-C、载脂蛋白 B 和 HDL-C 无显著差异。与对照组相比，接受沙格列汀治疗的患者肌酐显著升高[MD 0.12mg/dl（95% CI：0.04-0.21mg/dl）；P<0.01；I=29%（低异质性）；高证据确定性]。
本荟萃分析再次证实了沙格列汀在降低三酰甘油方面的优异效果，但也突出了肌酐显著升高的问题。
