Kamrul-Hasan A B M, Alam Muhammad Shah, Talukder Samir Kumar, Hannan Mohammad Abdul, Dutta Deep, Nagendra Lakshmi, Selim Shahjada
Department of Endocrinology Mymensingh Medical College, Mymensingh, Bangladesh.
Department of Medicine Army Medical College Cumilla, Cumilla, Bangladesh.
J Diabetes Res. 2024 Sep 24;2024:5553327. doi: 10.1155/2024/5553327. eCollection 2024.
No comprehensive meta-analysis has evaluated the efficacy and safety of ertugliflozin compared to a placebo in patients with Type 2 diabetes (T2D) until now. This meta-analysis fills this gap in knowledge. A systematic search was carried out in electronic databases to identify randomized controlled trials (RCTs) that included patients with T2D receiving ertugliflozin in the treatment group and placebo in the control group. The change in HbA1c from the baseline values was the primary outcome, whereas changes in plasma glucose and other metabolic parameters and adverse events (AEs), including hypoglycemia, were the secondary outcomes. Seven RCTs involving 7283 subjects met the inclusion criteria. Ertugliflozin outperformed placebo in reducing HbA1c in both 5 mg (MD -0.62%, 95% CI [-0.80, -0.44], < 0.00001, = 91%) and 15 mg (MD -0.69%, 95% CI [-0.91, -0.47], < 0.00001, = 93%) doses. A higher proportion of patients achieved HbA1c < 7.0% with ertugliflozin than with placebo. Ertugliflozin was also superior to placebo in lowering fasting plasma glucose (FPG), body weight, and systolic and diastolic blood pressure (BP). Ertugliflozin and placebo had comparable AE profiles, including urinary tract infection (UTI) and hypoglycemia, except for the greater risk of genital mycotic infections (GMIs) with ertugliflozin. Ertugliflozin 5 and 15 mg have equivalent efficacy and safety profiles except for greater weight reduction with ertugliflozin 15 mg. Ertugliflozin has a good glycemic efficacy and a reassuring safety profile in managing T2D. Registration number: CRD42023456450.
迄今为止，尚无全面的荟萃分析评估与安慰剂相比，依鲁格列净在2型糖尿病（T2D）患者中的疗效和安全性。本荟萃分析填补了这一知识空白。我们在电子数据库中进行了系统检索，以识别随机对照试验（RCT），这些试验中治疗组为接受依鲁格列净的T2D患者，对照组为接受安慰剂的患者。糖化血红蛋白（HbA1c）相对于基线值的变化是主要结局，而血浆葡萄糖和其他代谢参数的变化以及不良事件（AE），包括低血糖，是次要结局。七项涉及7283名受试者的RCT符合纳入标准。依鲁格列净在降低HbA1c方面优于安慰剂，5毫克剂量组（平均差值[MD] -0.62%，95%置信区间[CI][-0.80，-0.44]，P<0.00001，I² = 91%）和15毫克剂量组（MD -？0.69%，95% CI [-0.91，-0.47]，P<0.00001，I² = 93%）均如此。与安慰剂相比，接受依鲁格列净治疗的患者中，HbA1c<7.0%的比例更高。依鲁格列净在降低空腹血糖（FPG）、体重以及收缩压和舒张压（BP）方面也优于安慰剂。依鲁格列净和安慰剂的AE谱具有可比性，包括尿路感染（UTI）和低血糖，但依鲁格列净发生生殖器真菌感染（GMI）的风险更高。除了15毫克依鲁格列净减重效果更明显外，5毫克和15毫克依鲁格列净的疗效和安全性相当。依鲁格列净在治疗T2D方面具有良好的血糖疗效和令人放心的安全性。注册号：CRD42023456450 。 （注：原文中“MD -？0.69%”疑似有误，翻译时保留原样）
