Faculty of Health Sciences, University of Brasilia, Brasilia, Federal District, Brazil.
Faculty of Medical Sciences, University of Brasilia, Brasilia, Federal District, Brazil.
PLoS One. 2018 Apr 12;13(4):e0194801. doi: 10.1371/journal.pone.0194801. eCollection 2018.
The comparison between long acting insulin analogues (LAIA) and human insulin (NPH) has been investigated for decades, with many randomized controlled trials (RCTs) and systematic reviews giving mixed results. This overlapping and contradictory evidence has increased uncertainty on coverage decisions at health systems level.
To conduct an overview of systematic reviews and update existing reviews, preparing new meta-analysis to determine whether LAIA are effective for T1D patients compared to NPH.
We identified systematic reviews of RCTs that evaluated the efficacy of LAIA glargine or detemir, compared to NPH insulin for T1D, assessing glycated hemoglobin (A1C) and hypoglycemia. Data sources included Pubmed, Cochrane Library, EMBASE and hand-searching. The methodological quality of studies was independently assessed by two reviewers, using AMSTAR and Jadad scale. We found 11 eligible systematic reviews that contained a total of 25 relevant clinical trials. Two reviewers independently abstracted data.
We found evidence that LAIA are efficacious compared to NPH, with estimates showing a reduction in nocturnal hypoglycemia episodes (RR 0.66; 95% CI 0.57; 0.76) and A1C (95% CI 0.23; 0.12). No significance was found related to severe hypoglycemia (RR 0.94; 95% CI 0.71; 1.24).
This study design has allowed us to carry out the most comprehensive assessment of RCTs on this subject, filling a gap in diabetes research. Our paper addresses a question that is important not only for decision makers but also for clinicians.
长效胰岛素类似物（LAIA）与人胰岛素（NPH）的比较已研究了数十年，许多随机对照试验（RCT）和系统评价得出的结果喜忧参半。这种重叠和矛盾的证据增加了卫生系统层面覆盖决策的不确定性。
对系统评价进行综述，并更新现有评价，开展新的荟萃分析，以确定 LAIA 与 NPH 相比是否对 1 型糖尿病患者有效。
我们确定了评估 LAIA 甘精胰岛素或地特胰岛素与 NPH 胰岛素治疗 1 型糖尿病的疗效的 RCT 系统评价，评估糖化血红蛋白（A1C）和低血糖。数据来源包括 Pubmed、Cochrane 图书馆、EMBASE 和手工检索。使用 AMSTAR 和 Jadad 量表，两名评审员独立评估研究的方法学质量。我们发现了 11 项符合条件的系统评价，其中包含 25 项相关临床试验。两名评审员独立提取数据。
我们发现 LAIA 比 NPH 更有效，估计显示夜间低血糖发作（RR 0.66；95%CI 0.57；0.76）和 A1C（95%CI 0.23；0.12）减少。与严重低血糖（RR 0.94；95%CI 0.71；1.24）无关。
这种研究设计使我们能够对该主题的 RCT 进行最全面的评估，填补了糖尿病研究的空白。我们的论文解决了一个不仅对决策者而且对临床医生都很重要的问题。
