Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Epidemiology, The Johns Hopkins University School of Public Health, Baltimore, MD, USA.
Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
J Clin Epidemiol. 2019 Sep;113:92-100. doi: 10.1016/j.jclinepi.2019.03.014. Epub 2019 May 3.
The benefits and harms of diabetes treatments need to be carefully weighed in people with type II diabetes mellitus (DM) and multiple chronic conditions (MCCs). Our objective was to quantitatively assess the benefits and harms of the addition of basal insulin (insulin) vs. sulfonylurea (SU) to metformin in people with DM and MCCs.
Data inputs into the benefit-harms analysis included (1) baseline risks of patient-centered outcomes (death, myocardial infarction, stroke, severe hypoglycemia, diarrhea, nausea) from cohorts and trials; (2) treatment effects for the addition of insulin vs. SU from a network meta-analysis; and (3) patient preference survey for outcome weights. Statistical analysis calculated the probability that adding insulin has greater benefits than harms, when compared with an SU, overall and by prespecified subgroups.
Including the six outcomes, the probability of net benefit for insulin compared with SU was similar, across subgroups by age and diabetes duration (probability range, using conditional logit weights: 0.44-0.56). Adding patient preferences for treatment burden associated with insulin injections shifted the probability to favor SU over insulin (probability range, using conditional logit weights: 0.01-0.12).
In people with DM and MCCs, we demonstrated incomplete evidence to conclude if basal insulin or SU should be added in people with DM and MCCs on metformin alone. The benefit-harm balance was sensitive to treatment preferences, that is., perceived treatment burden, indicating the importance of shared-decision making in caring for people with MCCs who are at high risk for experiencing harms associated with diabetes management.
在患有 2 型糖尿病（DM）和多种合并症（MCCs）的人群中，需要仔细权衡糖尿病治疗的益处和危害。我们的目的是定量评估在 DM 和 MCC 患者中添加基础胰岛素（胰岛素）与磺酰脲（SU）相比的益处和危害。
效益-危害分析的数据输入包括：（1）来自队列和试验的以患者为中心的结局（死亡、心肌梗死、中风、严重低血糖、腹泻、恶心）的基线风险；（2）来自网络荟萃分析的添加胰岛素与 SU 的治疗效果；（3）对结局权重的患者偏好调查。统计分析计算了与 SU 相比，添加胰岛素具有更大益处的概率，总体上和按预定亚组计算。
包括六个结局，在按年龄和糖尿病病程划分的亚组中，与 SU 相比，胰岛素的净获益概率相似（使用条件逻辑回归权重的概率范围：0.44-0.56）。添加与胰岛素注射相关的治疗负担的患者偏好会改变支持 SU 而不是胰岛素的概率（使用条件逻辑回归权重的概率范围：0.01-0.12）。
在患有 DM 和 MCCs 的人群中，我们提供的证据不足以确定在单独使用 metformin 的 DM 和 MCCs 患者中添加基础胰岛素或 SU 应该优先选择哪种治疗方案。效益-危害平衡对治疗偏好（即感知的治疗负担）敏感，这表明在照顾患有与糖尿病管理相关危害风险较高的 MCCs 患者时，共同决策的重要性。
