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首页> 外文期刊>British Journal of Clinical Pharmacology >Observational study on safety and tolerability of duloxetine in the treatment of female stress urinary incontinence in German routine practice
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Observational study on safety and tolerability of duloxetine in the treatment of female stress urinary incontinence in German routine practice

机译：德国常规实践中度洛西汀治疗女性压力性尿失禁的安全性和耐受性的观察性研究

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Aims: To evaluate the safety and tolerability of duloxetine during routine clinical care in women with stress urinary incontinence (SUI) in Germany, and in particular, to identify previously unrecognized safety issues as uncommon adverse reactions, and the influence of confounding factors present in clinical practice on the safety profile of duloxetine. Methods: Office-based urologists, gynaecologists and primary care physicians were asked to document women newly started on treatment for moderate to severe symptoms of SUI. Six thousand eight hundred and fifty-four patients from urologist/gynaecologist practices and 5879 primary care patients were assessed. In a two-armed, observational study with parallel 12week (urologists and gynaecologists) or 24week (primary care physicians) design, patients were treated with duloxetine or other conservative treatment. The main outcome measure was the occurrence of adverse events (AEs). Results: Baseline characteristics differed slightly between patient groups and studies. Duloxetine doses in most patients were lower than recommended. Overall, AE frequency with duloxetine was lower than in controlled studies (15.9% (95% CI 14.9, 16.9) and 9.1% (95% CI 8.2, 10.0) in the 12and 24week treatment groups, respectively), but exhibited a similar qualitative spectrum. In the logistic regression models, the following factors were associated with greater AE risk: investigator specialization (gynaecologist vs. urologist and primary care physician), initial duloxetine dose (80 vs. 20mgday-1) and use of any concomitant medication. Within the 24week study, a positive screen for depressive disorder was surprisingly common, but no case of attempted suicide was reported in either study. Conclusions: Our results from German clinical practice show that women with SUI were often treated with duloxetine doses lower than recommended. This was associated with a low incidence of AEs. Suicide attempts were not reported.
机译：目的：评估在德国患有压力性尿失禁（SUI）的妇女进行常规临床护理期间度洛西汀的安全性和耐受性，尤其是确定先前未认识到的安全问题为罕见的不良反应以及临床中存在的混杂因素的影响关于度洛西汀的安全性实践。方法：要求办公室泌尿科医生，妇科医生和基层医疗医生记录新近开始接受SUI中度至重度症状治疗的女性。评估了来自泌尿科/妇科医师实践的684名患者和5879名初级保健患者。在一项平行的12周（泌尿科医师和妇科医师）或24周（初级保健医师）设计的两臂观察性研究中，患者接受度洛西汀或其他保守治疗。主要结局指标是不良事件（AE）的发生。结果：患者组和研究之间的基线特征略有不同。大多数患者的度洛西汀剂量低于推荐剂量。总体而言，度洛西汀的AE频率低于对照研究（在12周和24周治疗组中分别为15.9％（95％CI 14.9、16.9）和9.1％（95％CI 8.2、10.0）），但表现出相似的定性光谱。在逻辑回归模型中，以下因素与更高的AE风险相关：研究人员的专业化（妇科医生，泌尿科医师和初级保健医师），初始度洛西汀剂量（80 vs. 20mgday-1）和使用任何伴随药物。在为期24周的研究中，令人沮丧的是，对抑郁症的筛查非常普遍，但是在任何一项研究中均未报告自杀未遂的案例。结论：我们从德国临床实践中得出的结果表明，患有SUI的女性经常接受比推荐剂量低的度洛西汀治疗。这与不良事件的发生率低有关。没有自杀未遂的报道。

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