Efficacy of atomoxetine versus midodrine for neurogenic orthostatic hypotension
Efficacy of atomoxetine versus midodrine for neurogenic orthostatic hypotension
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DOI：
10.1002/acn3.50968
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发表时间：
2019-12-19
影响因子：
5.3
通讯作者：
Chu, Kon
中科院分区：
文献类型：
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作者：
Byun, Jung-Ick;Kim, Do-Yong;Chu, Kon
目的比较托莫西汀与米多君治疗1个月的疗效和安全性。研究了3个月托莫西汀和联合治疗的额外获益。方法对50例有症状的神经源性直立性低血压患者进行前瞻性、开放性、随机对照研究。患者接受托莫西汀18 mg每日或米多君5 mg每日2次，并在1个月和3个月后进行评估。那些在1个月时仍符合nOH标准的患者再接受米多君和托莫西汀治疗2个月，如果不符合，则继续其初始药物治疗。主要结局是1个月时直立位血压（BP）下降（从仰卧位到站立后3分钟的最大BP变化）的改善。次要终点为症状评分、1个月和3个月时nOH患者百分比。结果米多君或托莫西汀治疗的患者在直立位BP下降方面表现出比较性的改善，总体上只有26.2%的患者在1个月时出现nOH，这在治疗组之间相似。仅托莫西汀在1个月时导致症状显著改善。对于那些在1个月时没有nOH的患者，在3个月时他们的初始药物治疗有额外的症状改善。对于1个月时患有nOH的患者，联合治疗未导致额外的改善。11.6%的患者报告了轻度至中度不良事件。解释1个月托莫西汀治疗在nOH患者中有效且安全。托莫西汀改善直立性血压变化的效果与米多君相当，在改善nOH症状方面更好。
Objective The efficacy and safety of 1-month atomoxetine and midodrine therapies were compared. Three-month atomoxetine and combination therapies were investigated for additional benefits. Methods This prospective open-label randomized trial included 50 patients with symptomatic neurogenic orthostatic hypotension (nOH). The patients received either atomoxetine 18 mg daily or midodrine 5 mg twice daily and were evaluated 1 and 3 months later. Those who still met the criteria for nOH at 1 month received both midodrine and atomoxetine for an additional 2 months, and if not, they continued their initial medication. The primary outcome was an improvement in orthostatic blood pressure (BP) drop (maximum BP change from supine to 3 min after standing) at 1 month. The secondary endpoints were symptom scores, percentage of patients with nOH at 1 and 3 months. Results Patients with midodrine or atomoxetine treatment showed comparative improvement in the orthostatic BP drop, and overall only 26.2% of the patients had nOH at 1 month, which was similar between the treatment groups. Only atomoxetine resulted in significant symptomatic improvements at 1 month. For those without nOH at 1 month, there was additional symptomatic improvement at 3 months with their initial medication. For those with nOH at 1 month, the combination treatment resulted in no additional improvement. Mild-to-moderate adverse events were reported by 11.6% of the patients. Interpretation One-month atomoxetine treatment was effective and safe in nOH patients. Atomoxetine improved orthostatic BP changes as much as midodrine and was better in terms of ameliorating nOH symptoms.