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Effectiveness and safety of insulin glargine versus detemir analysis in patients with type 1 diabetes: systematic review and meta-analysis

机译:甘精胰岛素与地特米尔分析在1型糖尿病患者中的有效性和安全性:系统评价和荟萃分析

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Diabetes mellitus type 1 (DM1) is an autoimmune disease characterized by metabolic destruction of pancreatic cells responsible for insulin production, with treatment based on replacing insulin. Long-acting insulin analogs are indicated for patients with DM1 who exhibit important oscillations of their daily glycemia, despite its higher cost. Our study objective was to evaluate the effectiveness and safety of two long-acting insulins, insulin glargine and detemir, in treating patients with DM1. We undertook a systematic review with meta-analysis of observational studies (cohort and registry) available in the databases and the gray literature, and a complementary search in the Diabetes Care journal. Outcomes assessed were: glycated hemoglobin concentration; fasting plasma or capillary glucose; occurrence of episodes of severe hypoglycemia and occurrence of nocturnal hypoglycemia. The assessment of methodological quality was performed using the Newcastle score. The meta-analyses were performed on software Review Manager? 5.2. Out of 705 publications, 8 cohort studies were included. The quality of these studies was classified as high. In the meta-analysis, results regarding episodes of severe hypoglycemia (p = 0.02) and fasting glucose (p = 0.01) were in favor of detemir. The glycated hemoglobin (p = 0.49; I2 = 89) showed high heterogeneity and no statistically significant difference between the two. The meta-analysis of total insulin dose favored glargine (p = 0.006; I2 = 75). The rates of nocturnal hypoglycemia (NH) were evaluated only for one study and showed a significant reduction of NH after therapy with detemir, (p 0.0001). Although some outcomes were favorable to detemir insulin analog, it has not been possible to identify important differences of effectiveness and safety between the two analogs. These results can help in the current debate on the inclusion of long-acting analogs on the list of reimbursed medicines in Brazil, especially with the recent introduction of an insulin glargine biosimilar at a considerably lower price.
机译:1型糖尿病(DM1)是一种自身免疫性疾病,其特征在于负责胰岛素产生的胰腺细胞代谢破坏,其治疗基于替代胰岛素。长效胰岛素类似物适用于DM1患者,尽管其成本较高,但他们的每日血糖水平出现重要波动。我们的研究目标是评估两种长效胰岛素(甘精胰岛素和地特米尔)在治疗DM1患者中的有效性和安全性。我们对数据库和灰色文献中的观察性研究(队列和注册表)进行了荟萃分析,进行了系统评价,并在《糖尿病护理》杂志上进行了补充搜索。评估的结果是:糖化血红蛋白浓度;空腹血浆或毛细血管葡萄糖;严重低血糖发作的发生和夜间低血糖的发生。使用纽卡斯尔评分进行方法学质量评估。荟萃分析是在软件评论管理器上进行的? 5.2。在705篇出版物中,纳入了8项队列研究。这些研究的质量被归类为高。在荟萃分析中,有关严重低血糖发作(p = 0.02)和空腹血糖(p = 0.01)的结果有利于地特米尔。糖化血红蛋白(p = 0.49; I2 = 89)显示出较高的异质性,两者之间无统计学差异。对总胰岛素剂量的荟萃分析偏向于甘精胰岛素(p = 0.006; I2 = 75)。一项研究仅评估了夜间低血糖(NH)的发生率,并显示了使用detemir治疗后NH的显着降低(p <0.0001)。尽管某些结果有利于Detemir胰岛素类似物,但尚无法确定两种类似物在有效性和安全性上的重要区别。这些结果可以帮助当前有关将长效类似物纳入巴西报销药物清单的辩论,特别是最近以较低的价格推出甘精胰岛素生物仿制药。

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