Abstract：
BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have been used for almost a decade and have proven to be effective not only in managing Type 2 diabetes (T2D), but their cardio and renal protective features make them very useful in managing patients with risk of multiple comorbidities. This systematic review was undertaken by the authors because there is no evidence currently available in India that has studied the suitability of SGLT2i as a first-line agent in patients newly diagnosed with T2D in India.
METHODS: First, literature was searched to identify features that are considered important when deciding on a first-line agent for managing T2D. A total of 5 broad topics were identified-glycemic control, extra glycemic effects, antihyperglycemic combination therapy, safety, and cost-effectiveness. These domains had further subheadings, and a total of 16 domains were identified. Metformin is the drug of choice as a first-line agent in such situations and has been considered the gold standard for evaluating the effects of SGLT2i across these domains. A systematic literature review on each domain was conducted to compare SGLT2i with the gold standard in Indian patients newly diagnosed with T2D. Evidence was graded (levels of evidence (LoE)-A, B, and C), and recommendations (class of recommendation (CoR)-I, II, and III) were classified by the expert group as defined in the methodology.
RESULTS: According to the systematic reviews conducted, 11 domains had Level A evidence, 2 domains (impact on lipids and gut microbiome) had Level B, and 3 domains had Level C (β-cell function, renal protection, and glycemic variability) evidence. Based on evidence and expert opinion, the authors recommend SGLT2i as a first-line agent for managing newly diagnosed patients with T2D with a Class I recommendation for 13 domains and Class II for the remaining 3 (impact on lipids, gut microbiome, and β-cell function). Although a poorer level of evidence (Level C) was available for the glycemic variability domain, the authors still reported this as Class I recommendations according to their expert opinion and consensus.
CONCLUSIONS: This article advocates adopting SGLT2 inhibitors as the primary treatment choice for treating patients with newly diagnosed T2D in India.
METHODS: First, literature was searched to identify features that are considered important when deciding on a first-line agent for managing T2D. A total of 5 broad topics were identified-glycemic control, extra glycemic effects, antihyperglycemic combination therapy, safety, and cost-effectiveness. These domains had further subheadings, and a total of 16 domains were identified. Metformin is the drug of choice as a first-line agent in such situations and has been considered the gold standard for evaluating the effects of SGLT2i across these domains. A systematic literature review on each domain was conducted to compare SGLT2i with the gold standard in Indian patients newly diagnosed with T2D. Evidence was graded (levels of evidence (LoE)-A, B, and C), and recommendations (class of recommendation (CoR)-I, II, and III) were classified by the expert group as defined in the methodology.
RESULTS: According to the systematic reviews conducted, 11 domains had Level A evidence, 2 domains (impact on lipids and gut microbiome) had Level B, and 3 domains had Level C (β-cell function, renal protection, and glycemic variability) evidence. Based on evidence and expert opinion, the authors recommend SGLT2i as a first-line agent for managing newly diagnosed patients with T2D with a Class I recommendation for 13 domains and Class II for the remaining 3 (impact on lipids, gut microbiome, and β-cell function). Although a poorer level of evidence (Level C) was available for the glycemic variability domain, the authors still reported this as Class I recommendations according to their expert opinion and consensus.
CONCLUSIONS: This article advocates adopting SGLT2 inhibitors as the primary treatment choice for treating patients with newly diagnosed T2D in India.
摘要：
背景：钠-葡萄糖协同转运蛋白-2抑制剂（SGLT2i）已经使用了近十年，并且已被证明不仅在治疗2型糖尿病（T2D）方面有效，但是它们的心脏和肾脏保护功能使它们在管理具有多种合并症风险的患者方面非常有用。作者进行了这项系统评价，因为印度目前尚无证据研究SGLT2i作为印度新诊断为T2D患者的一线药物的适用性。
方法：首先，检索文献以确定在决定管理T2D的一线药物时被认为重要的特征。总共确定了5个主要主题-血糖控制，额外的血糖影响，抗高血糖联合治疗，安全,和成本效益。这些领域有更多的副标题，共鉴定出16个结构域。在这种情况下，二甲双胍是首选的一线药物，被认为是评估SGLT2i在这些领域的作用的黄金标准。对每个领域进行了系统的文献综述，以比较SGLT2i与新诊断为T2D的印度患者的金标准。证据被分级(证据水平(LoE)-A，B,andC),和推荐(推荐类别(CoR)-I，II,和III）由专家组按照方法中的定义进行分类。
结果：根据进行的系统评价，11个领域有A级证据,2个结构域(对脂质和肠道微生物组的影响)具有B级，和3个结构域具有C级(β细胞功能，肾脏保护,和血糖变异性）证据。根据证据和专家意见,作者推荐SGLT2i作为治疗新诊断的T2D患者的一线药物，其中13个领域为I类推荐，其余3个领域为II类（对脂质的影响，肠道微生物组，和β细胞功能）。尽管血糖变异性领域的证据水平较差（C级），根据他们的专家意见和共识,作者仍将此报告为I类建议.
结论：本文主张采用SGLT2抑制剂作为印度新诊断的T2D患者的主要治疗选择。
方法：首先，检索文献以确定在决定管理T2D的一线药物时被认为重要的特征。总共确定了5个主要主题-血糖控制，额外的血糖影响，抗高血糖联合治疗，安全,和成本效益。这些领域有更多的副标题，共鉴定出16个结构域。在这种情况下，二甲双胍是首选的一线药物，被认为是评估SGLT2i在这些领域的作用的黄金标准。对每个领域进行了系统的文献综述，以比较SGLT2i与新诊断为T2D的印度患者的金标准。证据被分级(证据水平(LoE)-A，B,andC),和推荐(推荐类别(CoR)-I，II,和III）由专家组按照方法中的定义进行分类。
结果：根据进行的系统评价，11个领域有A级证据,2个结构域(对脂质和肠道微生物组的影响)具有B级，和3个结构域具有C级(β细胞功能，肾脏保护,和血糖变异性）证据。根据证据和专家意见,作者推荐SGLT2i作为治疗新诊断的T2D患者的一线药物，其中13个领域为I类推荐，其余3个领域为II类（对脂质的影响，肠道微生物组，和β细胞功能）。尽管血糖变异性领域的证据水平较差（C级），根据他们的专家意见和共识,作者仍将此报告为I类建议.
结论：本文主张采用SGLT2抑制剂作为印度新诊断的T2D患者的主要治疗选择。
