Postgraduate Program in Medicines and Pharmaceutical Assistance, School of Pharmacy, Federal University of Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.
SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES), Federal University of Minas Gerais, Belo Horizonte, Brazil.
Patient. 2018 Aug;11(4):377-389. doi: 10.1007/s40271-017-0291-3.
Insulin analog glargine (GLA) has been available as one of the therapeutic options for patients with type 1 diabetes mellitus to enhance glycemic control. Studies have shown that a decrease in the frequency of hypoglycemic episodes improves the quality of life (QoL) of diabetic patients. However, there are appreciable acquisition cost differences between different insulins. Consequently, there is a need to assess their impact on QoL to provide future guidance to health authorities.
A systematic review of multiple databases including Medline, LILACS, Cochrane, and EMBASE databases with several combinations of agreed terms involving randomized controlled trials and cohorts, as well as manual searches and gray literature, was undertaken. The primary outcome measure was a change in QoL. The quality of the studies and the risk of bias was also assessed.
Eight studies were eventually included in the systematic review out of 634 publications. Eight different QoL instruments were used (two generic, two mixed, and four specific), in which the Diabetes Treatment Satisfaction Questionnaire (DTSQ) was the most used. The systematic review did not consistently show any significant difference overall in QoL scores, whether as part of subsets or combined into a single score, with the use of GLA versus neutral protamine Hagedorn (NPH) insulin. Only in patient satisfaction measured by DTSQ was a better result consistently seen with GLA versus NPH insulin, but not using the Well-being Inquiry for Diabetics (WED) scale. However, none of the cohort studies scored a maximum on the Newcastle-Ottawa scale for quality, and they generally were of moderate quality with bias in the studies.
There was no consistent difference in QoL or patient-reported outcomes when the findings from the eight studies were collated. In view of this, we believe the current price differential between GLA and NPH insulin in Brazil cannot be justified by these findings.
胰岛素类似物甘精胰岛素（GLA）已作为治疗 1 型糖尿病患者的选择之一，以增强血糖控制。研究表明，低血糖发作频率的降低可以提高糖尿病患者的生活质量（QoL）。然而，不同胰岛素之间存在明显的获得成本差异。因此，需要评估它们对 QoL 的影响，为卫生当局提供未来的指导。
系统检索了包括 Medline、LILACS、Cochrane 和 EMBASE 在内的多个数据库，使用了多种经过协商的术语组合，涉及随机对照试验和队列研究，以及手动搜索和灰色文献。主要观察指标是 QoL 的变化。还评估了研究的质量和偏倚风险。
在 634 篇出版物中，最终有 8 项研究纳入系统评价。使用了 8 种不同的 QoL 工具（2 种通用工具、2 种混合工具和 4 种特定工具），其中糖尿病治疗满意度问卷（DTSQ）是最常用的工具。系统评价并未一致显示使用 GLA 与中性鱼精蛋白 Hagedorn（NPH）胰岛素相比，在 QoL 评分方面存在任何显著差异，无论是作为亚组的一部分还是综合为一个单一评分。仅在 DTSQ 测量的患者满意度方面，使用 GLA 与 NPH 胰岛素相比，结果始终更好，但使用 WED 量表则不然。然而，没有一项队列研究在纽卡斯尔-渥太华量表上的质量评分达到最高，而且它们通常具有中等质量，并且研究中存在偏倚。
当综合这 8 项研究的结果时，QoL 或患者报告的结果没有一致的差异。有鉴于此，我们认为，目前巴西 GLA 和 NPH 胰岛素之间的价格差异不能用这些发现来证明是合理的。
