Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research-Guwahati, Sila Katamur (Halugurisuk), Changsari, Kamrup District, Guwahati, Assam, 781101, India.
Clin Drug Investig. 2022 Dec;42(12):1049-1064. doi: 10.1007/s40261-022-01219-6. Epub 2022 Nov 4.
The incidence of cardiometabolic diseases is increasing because of an increase in the standard of living. Currently, clinical treatment strategies for cardiometabolic diseases mainly focus on maintaining glycemic and lipid profiles. The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of saroglitazar in patients with metabolic disease and provide evidence for clinical decision making.
We searched electronic databases (PubMed, Cochrane Central Register of Controlled Trials [CENTRAL], and Google Scholar) for randomized controlled trials that examined saroglitazar for the treatment of patients with cardiometabolic disease. A total of seven randomized controlled trials were included for the qualitative and quantitative synthesis. Mean difference (MD) and risk ratio with a 95% confidence interval (CI) were applied for continuous and dichotomous data, respectively.
The overall effect of saroglitazar showed significant changes in triglycerides, total cholesterol, low-density lipoprotein, non-high-density lipoprotein, high-density lipoprotein, very low-density lipoprotein, alkaline phosphatase, and gamma-glutamyl transferase levels [MD: - 40.50; 95% CI - 58.09 to - 22.92; p < 0.00001; I = 78%], [MD: - 7.49; 95% CI - 11.33 to - 3.65; p = 0.0001; I = 41%], [MD: - 3.53; 95% CI - 6.91 to - 0.15; p = 0.04; I = 19%], [MD: - 8.08; 95% CI - 15.63 to - 0.54; p = 0.04; I = 58%], [MD: 2.04; 95% CI 0.17 to 3.92; p = 0.03; I = 69%], [MD: - 6.10; 95% CI - 9.40 to - 2.80; p = 0.0003; I = 65%], [MD: - 5.89; 95% CI - 7.50 to - 4.28; p < 0.00001; I = 98%], and [MD: - 1.64; 95% CI - 2.83 to - 0.45; p = 0.007; I = 95%], respectively. A subgroup analysis showed favorable outcomes with sarogiltazar 4 mg. There was a statistically non-significant reduced risk of adverse event occurrence in the saroglitazar treatment group.
Our study results conclude that the overall effect of saroglitazar was beneficial only in terms of lipid profiles and liver function parameters, whereas saroglitazar 4 mg showed a better therapeutic role in maintaining lipid and glycemic parameters in patients with cardiometabolic disease.
由于生活水平的提高，心血管代谢疾病的发病率不断上升。目前，心血管代谢疾病的临床治疗策略主要集中在维持血糖和血脂谱上。本系统评价和荟萃分析的目的是评估沙格列汀治疗代谢性疾病患者的疗效和安全性，并为临床决策提供证据。
我们检索了电子数据库（PubMed、Cochrane 对照试验中心注册库 [CENTRAL] 和 Google Scholar），以查找评估沙格列汀治疗心血管代谢疾病患者的随机对照试验。共有 7 项随机对照试验被纳入定性和定量综合分析。连续数据和二分类数据分别采用均数差（MD）和风险比（RR）及其 95%置信区间（CI）。
沙格列汀的总体疗效显示甘油三酯、总胆固醇、低密度脂蛋白、非高密度脂蛋白、高密度脂蛋白、极低密度脂蛋白、碱性磷酸酶和γ-谷氨酰转移酶水平有显著变化[MD：-40.50；95%CI：-58.09 至-22.92；p<0.00001；I=78%]，[MD：-7.49；95%CI：-11.33 至-3.65；p=0.0001；I=41%]，[MD：-3.53；95%CI：-6.91 至-0.15；p=0.04；I=19%]，[MD：-8.08；95%CI：-15.63 至-0.54；p=0.04；I=58%]，[MD：2.04；95%CI：0.17 至 3.92；p=0.03；I=69%]，[MD：-6.10；95%CI：-9.40 至-2.80；p=0.0003；I=65%]，[MD：-5.89；95%CI：-7.50 至-4.28；p<0.00001；I=98%]，[MD：-1.64；95%CI：-2.83 至-0.45；p=0.007；I=95%]。亚组分析显示沙格列汀 4mg 组疗效较好。沙格列汀治疗组发生不良事件的风险有统计学意义，但无显著降低。
本研究结果表明，沙格列汀的总体疗效仅在血脂谱和肝功能参数方面有益，而沙格列汀 4mg 对维持心血管代谢疾病患者的血脂和血糖参数显示出更好的治疗作用。
