Department of Pharmacy Practice, Indo-Soviet Friendship College of Pharmacy, Moga, Punjab, India.
Rady Faculty of Health Sciences, Department of Pharmacology and Therapeutics, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.
PLoS One. 2022 Jul 1;17(7):e0269531. doi: 10.1371/journal.pone.0269531. eCollection 2022.
Saroglitazar is a newer antidiabetic agent approved to manage dyslipidemia. The objective is tevaluate the efficacy and safety profiles of saroglitazar in patients with dyslipidemia.
A systematic search was conducted using PubMed, Cochrane Library, Scopus, and Google Scholar from the inception until January 2022. Interventional studies comparing the anti-hyperlipidaemic effect and safety of saroglitazar with or without a control group(s) were included. The efficacy of saroglitazar was assessed concerning its effect on total cholesterol, low density lipoprotein (LDL) and high density lipoprotein (HDL)-cholesterol, triglycerides, fasting plasma glucose, and non-HDL cholesterol. The effects on serum creatinine levels, bodyweight reduction, alanine aminotransferase and aspartate aminotransferase were considered to be safety endpoint.The Cochrane risk of bias assessment tool was used to assess the methodological quality of the included studies.
A total of six studies with 581 adults with a mean age ranging from 40.2 to 62.6 years were included in this study. A significant decrease in low-density lipoprotein cholesterol was observed with saroglitazar 4 mg therapy compared to saroglitazar 2 mg [standardized mean difference (SMD): -0.23 mg/dL, 95% CI: -0.47 to 0.00; p = 0.05; 2 studies], and control [SMD: -0.36 mg/dL, 95% CI -0.59 to -0.12; p = 0.0026; 3 studies]. Also, a significant decrease in the total cholesterol was observed with saroglitazar 4 mg therapy compared to saroglitazar 2 mg [SMD - 0.28 mg/dL, 95% CI: - 0.52 to -0.04; p < 0.01; 2 studies], and control [SMD - 0.49 mg/dL, 95% CI: - 0.72 to -0.26; p < 0.0001; 3 studies]. Saroglitazar was not associated with adverse effects such as increase in serum creatinine levels, alanine aminotransferase and aspartate aminotransferase and bodyweight reduction.
Saroglitazar appeared to be an effective and safer therapeutic option for improving dyslipidemia in patients. However, comparative studies of saroglitazar with the other pharmacological agents are warranted.
沙格列汀是一种新的抗糖尿病药物，已被批准用于治疗血脂异常。本研究旨在评估沙格列汀在血脂异常患者中的疗效和安全性。
我们对 PubMed、Cochrane 图书馆、Scopus 和 Google Scholar 进行了系统检索，检索时间从建库至 2022 年 1 月。我们纳入了比较沙格列汀与对照组（1 个或多个）的抗高脂血症效果和安全性的干预性研究。我们评估了沙格列汀对总胆固醇、低密度脂蛋白（LDL）和高密度脂蛋白（HDL）-胆固醇、甘油三酯、空腹血糖和非高密度脂蛋白胆固醇的影响。血清肌酐水平、体重减轻、丙氨酸氨基转移酶和天冬氨酸氨基转移酶的变化被视为安全性终点。我们使用 Cochrane 偏倚风险评估工具评估纳入研究的方法学质量。
本研究共纳入了 6 项研究，共 581 名年龄在 40.2 至 62.6 岁之间的成年人。与沙格列汀 2mg 治疗相比，沙格列汀 4mg 治疗可显著降低 LDL 胆固醇[标准化均数差（SMD）：-0.23mg/dL，95%CI：-0.47 至 0.00；p=0.05；2 项研究]和对照组[SMD：-0.36mg/dL，95%CI：-0.59 至 -0.12；p=0.0026；3 项研究]。此外，与沙格列汀 2mg 治疗相比，沙格列汀 4mg 治疗还可显著降低总胆固醇[SMD：-0.28mg/dL，95%CI：-0.52 至 -0.04；p<0.01；2 项研究]和对照组[SMD：-0.49mg/dL，95%CI：-0.72 至 -0.26；p<0.0001；3 项研究]。沙格列汀不会引起血清肌酐水平、丙氨酸氨基转移酶和天冬氨酸氨基转移酶升高以及体重减轻等不良反应。
沙格列汀似乎是改善血脂异常患者血脂异常的有效且更安全的治疗选择。然而，需要开展沙格列汀与其他药理学药物的比较研究。
