DaVita Clinical Research, Minneapolis, Minnesota, USA,
DaVita Institute for Patient Safety, Inc, Denver, Colorado, USA,
Am J Nephrol. 2018;48(5):381-388. doi: 10.1159/000494806. Epub 2018 Nov 13.
Intradialytic hypotension (IDH) is a frequent complication of hemodialysis, and is associated with significant morbidity and mortality. Off-label use of the alpha-1 andrenergic receptor agonist midodrine to reduce the frequency and severity of IDH is common. However, limited data exist to support this practice. This study sought to examine real-world efficacy of midodrine with respect to relevant clinical and hemodynamic outcomes.
Here, we compared a variety of clinical and hemodynamic outcomes among adult patients who were prescribed midodrine (n = 1,046) and matched controls (n = 2,037), all of whom were receiving in-center hemodialysis treatment at dialysis facilities in the United States (July 2015 - September 2016). Mortality, all-cause hospitalization, cardiovascular hospitalization, and hemodynamic outcomes were considered from the month following the initiation of midodrine (or corresponding month for controls) until censoring for discontinuation of dialysis, transplant, loss to follow-up, or study end (September 30, 2016). Rate outcomes were compared using Poisson models and quantitative outcomes using linear mixed models; all models were adjusted for imbalanced patient characteristics.
Compared to non-use, midodrine use was associated with higher rates of death (adjusted incidence rate ratio 1.37, 95% CI 1.15-1.62), all-cause hospitalization (1.31, 1.19-1.43) and cardiovascular hospitalization (1.41, 1.17-1.71). During follow-up, midodrine use tended to be associated with lower pre-dialysis systolic blood pressure (SBP), lower nadir SBP, greater fall in SBP during dialysis, and a greater proportion of treatments affected by IDH.
Although residual confounding may have influenced the results, the associations observed here are not consistent with a potent beneficial effect of midodrine with respect to either clinical or hemodynamic outcomes.
透析中低血压（IDH）是血液透析的常见并发症，与较高的发病率和死亡率相关。米多君是一种非适应证α-1 肾上腺素能受体激动剂，常被用于降低 IDH 的发生频率和严重程度。然而，目前仅有有限的数据支持这种用法。本研究旨在评估米多君在真实世界中的有效性及其与相关临床和血液动力学结局的关系。
我们比较了美国透析中心接受米多君治疗（n=1046）和匹配对照者（n=2037）的各种临床和血液动力学结局。所有患者均接受中心血液透析治疗。从米多君起始治疗（或对照者相应月份）后至透析停止、移植、失访或研究结束（2016 年 9 月 30 日），评估死亡率、全因住院、心血管住院和血液动力学结局。使用泊松模型比较发生率结局，使用线性混合模型比较定量结局；所有模型均对不平衡的患者特征进行了调整。
与不使用相比，米多君的使用与更高的死亡率（调整后的发病率比 1.37，95%置信区间 1.15-1.62）、全因住院（1.31，1.19-1.43）和心血管住院（1.41，1.17-1.71）相关。在随访期间，米多君的使用与更低的透析前收缩压（SBP）、更低的 SBP 最低点、透析期间 SBP 下降幅度更大以及更多的治疗受到 IDH 影响相关。
尽管残余混杂可能影响了结果，但本研究中的关联与米多君在临床或血液动力学结局方面的潜在有益效应并不一致。
