Department of Endocrinology, Center for Endocrinology, Diabetes, Arthritis & Rheumatism (CEDAR) Super-speciality Healthcare, Dwarka, New Delhi, India.
Department of Medicine, Kalpana Chawla Government Medical College, Karnal, Haryana, India.
Diabetes Metab Syndr. 2023 Mar;17(3):102742. doi: 10.1016/j.dsx.2023.102742. Epub 2023 Mar 13.
BACKGROUND & AIMS: No meta-analysis is available analysing the role of luseogliflozin in type-2 diabetes. We undertook this meta-analysis to address this knowledge-gap.
Electronic databases were searched for RCTs involving diabetes patients receiving luseogliflozin in intervention arm, and placebo/active comparator in control arm. Primary outcome was to evaluate changes in HbA1c. Secondary outcomes were to evaluate alterations in glucose, blood pressure, weight, lipids, and adverse events.
From initially screened 151 articles, data from 10 RCTs involving 1304 patients was analysed. Individuals receiving luseogliflozin 2.5 mg/d had a significantly lower HbA1c [MD -0.76% (95% CI: 1.01 to -0.51); P < 0.01; I = 83%], fasting glucose [MD -26.69 mg/dl (95% CI: 35.41 to -17.96); P < 0.01; I = 80%], systolic blood pressure [MD -4.19 mm Hg (95% CI: 6.31 to -2.07); P < 0.01; I = 0%], body-weight [MD -1.61 kg (95% CI: 3.14 to -0.08); P = 0.04; I = 0%], triglycerides PCG [MD -12.60 mg/dl (95% CI: 24.25 to -0.95); P = 0.03; I = 0%], uric acid [MD -0.48 mg/dl (95% CI: 0.73 to -0.23); P < 0.01; I = 49%] and alanine aminotransferase [MD -4.11 IU/L (95% CI: 6.12 to -2.10); P < 0.01; I = 0%] compared to placebo. Occurrence of treatment-emergent adverse-events [RR 0.93 (95% CI: 0.72-1.20); P = 0.58; I = 0%], severe adverse-events [RR 1.19 (95% CI: 0.40-3.55); P = 0.76; I = 0%], hypoglycaemia [RR 1.56 (95% CI: 0.85-2.85); P = 0.15; I = 0%] and genital infections [RR 1.42 (95% CI: 0.48-4.18); P = 0.53; I = 0%] were not increased with luseogliflozin. Cardiovascular outcome trials are lacking and are urgently required.
Luseogliflozin has good glycaemic and non-glycaemic benefits similar to other SGLT2 inhibitors and is well tolerated.
目前尚无荟萃分析研究评估芦格列净在 2 型糖尿病中的作用。因此，我们进行了本次荟萃分析以填补这一知识空白。
检索了电子数据库中涉及接受芦格列净治疗的糖尿病患者的随机对照试验（RCT），并以安慰剂/活性对照作为对照组。主要结局为评估糖化血红蛋白（HbA1c）的变化。次要结局为评估血糖、血压、体重、血脂和不良事件的变化。
最初筛选出 151 篇文章，对其中 10 项 RCT 涉及的 1304 名患者的数据进行了分析。接受芦格列净 2.5mg/d 治疗的患者 HbA1c 显著降低[MD -0.76%（95%CI：1.01 至-0.51）；P<0.01；I ² = 83%]，空腹血糖[MD -26.69mg/dl（95%CI：35.41 至-17.96）；P<0.01；I ² = 80%]，收缩压[MD -4.19mmHg（95%CI：6.31 至-2.07）；P<0.01；I ² = 0%]，体重[MD -1.61kg（95%CI：3.14 至-0.08）；P=0.04；I ² = 0%]，甘油三酯[MD -12.60mg/dl（95%CI：24.25 至-0.95）；P=0.03；I ² = 0%]，尿酸[MD -0.48mg/dl（95%CI：0.73 至-0.23）；P<0.01；I ² = 49%]和丙氨酸氨基转移酶[MD -4.11IU/L（95%CI：6.12 至-2.10）；P<0.01；I ² = 0%]与安慰剂相比均有显著降低。与安慰剂相比，芦格列净治疗的不良事件发生率[RR 0.93（95%CI：0.72-1.20）；P=0.58；I ² = 0%]、严重不良事件[RR 1.19（95%CI：0.40-3.55）；P=0.76；I ² = 0%]、低血糖[RR 1.56（95%CI：0.85-2.85）；P=0.15；I ² = 0%]和生殖器感染[RR 1.42（95%CI：0.48-4.18）；P=0.53；I ² = 0%]并未增加。目前尚无心血管结局试验，因此迫切需要开展此类试验。
芦格列净具有良好的血糖和非血糖获益，与其他 SGLT2 抑制剂相似，且具有良好的耐受性。
