Efficacy and safety of luseogliflozin in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.

IF 3.7 3区医学 Q2 Medicine Endocrine Pub Date : 2024-11-01 Epub Date: 2024-06-17 DOI:10.1007/s12020-024-03925-x

Reddikumar Reddy Galigutta, P N Hasik, Christy Thomas, Krishna Undela

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Abstract

Purpose: Owing to the absence of the most recent evidence on the efficacy and safety of luseogliflozin, our study aimed to conduct a systematic review and meta-analysis of luseogliflozin in patients with type 2 diabetes mellitus.

Methods: A comprehensive search of electronic databases like PubMed, Cochrane CENTRAL, and Google Scholar was performed from the inception to the 31^st of August 2023 to identify the randomized controlled trials (RCTs) that examined the glucose and body weight lowering efficacy and safety outcomes of luseogliflozin in comparison with control or other active treatments. The fixed or random-effect model was used based on the heterogeneity identified using the I² statistic and Cochran's Q test.

Results: Out of 50 non-duplicate articles identified through database searching, 8 RCTs (11 studies) with 1922 patients were included in this study. The efficacy outcomes like HbA1c (MD: -0.59%; 95% CI: -0.90, -0.29; P < 0.001), FPG (MD: -16.01 mg/dL; 95% CI: -19.46, -12.57; P < 0.001), PPG (MD: -36.63 mg/dL; 95% CI: -43.71, -29.55; P < 0.001) and body weight (MD: -1.66 kg; 95% CI: -2.23, -1.12; P < 0.001) were significantly reduced with luseogliflozin compared to the control group. Regarding the safety outcomes, there was no statistically significant difference between the two groups for hypoglycemia (OR: 1.14; 95% CI: 0.70, 1.84; P = 0.60). However, pollakiuria (OR: 4.08; 95% CI: 1.71, 9.69; P < 0.001) and any ADRs (OR: 2.04; 95% CI: 1.33, 3.14; P < 0.001) were significantly higher in the luseogliflozin group compared to the control.

Conclusion: The current study identified a significant improvement in efficacy outcomes of HbA1c, FPG, PPG, and body weight in the luseogliflozin group. Non-significant safety results may be due to a smaller population size and fewer studies. Hence, long-term multicentric RCTs are needed to identify the safety and efficacy in a diversified population.

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luseogliflozin对2型糖尿病患者的疗效和安全性：系统综述和荟萃分析。

目的：由于缺乏有关鲁塞格列净疗效和安全性的最新证据，我们的研究旨在对鲁塞格列净在2型糖尿病患者中的应用进行系统回顾和荟萃分析：方法：对PubMed、Cochrane CENTRAL和Google Scholar等电子数据库进行了全面检索，检索时间从开始至2023年8月31日，检索对象为研究luseogliflozin与对照组或其他积极治疗方法相比降低血糖和体重的疗效和安全性的随机对照试验（RCT）。根据使用 I2 统计量和 Cochran's Q 检验确定的异质性，采用了固定或随机效应模型：在数据库搜索到的 50 篇非重复文章中，本研究共纳入了 8 项 RCT（11 项研究），1922 名患者。疗效结果如 HbA1c（MD：-0.59%；95% CI：-0.90，-0.29；P 结论：本研究发现，luseogliflozin 组在 HbA1c、FPG、PPG 和体重等疗效方面有明显改善。安全性结果不显著可能是由于研究的人群规模较小且研究数量较少。因此，需要进行长期的多中心 RCT 研究，以确定不同人群的安全性和有效性。

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来源期刊

Endocrine 医学-内分泌学与代谢

CiteScore

6.40

自引率

5.40%

发文量

期刊介绍： Well-established as a major journal in today’s rapidly advancing experimental and clinical research areas, Endocrine publishes original articles devoted to basic (including molecular, cellular and physiological studies), translational and clinical research in all the different fields of endocrinology and metabolism. Articles will be accepted based on peer-reviews, priority, and editorial decision. Invited reviews, mini-reviews and viewpoints on relevant pathophysiological and clinical topics, as well as Editorials on articles appearing in the Journal, are published. Unsolicited Editorials will be evaluated by the editorial team. Outcomes of scientific meetings, as well as guidelines and position statements, may be submitted. The Journal also considers special feature articles in the field of endocrine genetics and epigenetics, as well as articles devoted to novel methods and techniques in endocrinology. Endocrine covers controversial, clinical endocrine issues. Meta-analyses on endocrine and metabolic topics are also accepted. Descriptions of single clinical cases and/or small patients studies are not published unless of exceptional interest. However, reports of novel imaging studies and endocrine side effects in single patients may be considered. Research letters and letters to the editor related or unrelated to recently published articles can be submitted. Endocrine covers leading topics in endocrinology such as neuroendocrinology, pituitary and hypothalamic peptides, thyroid physiological and clinical aspects, bone and mineral metabolism and osteoporosis, obesity, lipid and energy metabolism and food intake control, insulin, Type 1 and Type 2 diabetes, hormones of male and female reproduction, adrenal diseases pediatric and geriatric endocrinology, endocrine hypertension and endocrine oncology.