Hurley Daniel J, Turner Catherine L, Yalcin Ilker, Viktrup Lars, Baygani Simin K
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):120-8. doi: 10.1016/j.ejogrb.2005.08.006. Epub 2005 Sep 26.
The objective was to characterize the safety of duloxetine for treatment of stress urinary incontinence (SUI) in women, using an integrated database generated from four published placebo-controlled clinical trials.
The database included 1913 women randomized to duloxetine (N=958) or placebo (N=955), examining adverse events (AEs), serious adverse events (SAEs), vital signs, electrocardiograms, and laboratory analytes. AEs occurring initially or worsening during the double-blind treatment period were considered treatment-emergent (TEAE). Differences between duloxetine-treated and placebo-treated groups were compared statistically.
Common TEAEs included: nausea (23.2%), dry mouth (13.4%), fatigue (12.7%), insomnia (12.6%), constipation (11.0%), headache (9.7%), dizziness (9.5%), somnolence (6.8%), and diarrhea (5.1%). Most TEAEs that emerged early were mild to moderate, rarely worsened, and resolved quickly. Overall AE discontinuation rates were 20.5% for duloxetine and 3.9% for placebo (P<.001). Most discontinuations (83%) occurred within the first month of treatment. SAEs were uncommon and did not differ between treatments. Statistically significant, but clinically unimportant mean increases in heart rate (2.4 bpm) and systolic and diastolic blood pressure (<or=2 mmHg) occurred. No arrhythmogenic potential was observed and any rare, transient, asymptomatic increases in hepatocellular enzymes normalized.
Duloxetine was safe and tolerable, although transient AEs were not uncommon.
利用从四项已发表的安慰剂对照临床试验生成的综合数据库，对度洛西汀治疗女性压力性尿失禁（SUI）的安全性进行特征描述。
该数据库纳入了1913名随机分组接受度洛西汀（N = 958）或安慰剂（N = 955）治疗的女性，对不良事件（AE）、严重不良事件（SAE）、生命体征、心电图和实验室分析物进行了检查。在双盲治疗期间最初出现或加重的AE被视为治疗中出现的不良事件（TEAE）。对度洛西汀治疗组和安慰剂治疗组之间的差异进行统计学比较。
常见的TEAE包括：恶心（23.2%）、口干（13.4%）、疲劳（12.7%）、失眠（12.6%）、便秘（11.0%）、头痛（9.7%）、头晕（9.5%）、嗜睡（6.8%）和腹泻（5.1%）。大多数早期出现的TEAE为轻至中度，很少加重，且很快缓解。度洛西汀的总体AE停药率为20.5%，安慰剂为3.9%（P<0.001）。大多数停药事件（83%）发生在治疗的第一个月内。SAE不常见，且治疗组之间无差异。心率（2.4次/分钟）以及收缩压和舒张压（≤2 mmHg）出现了具有统计学意义但临床不重要的平均升高。未观察到致心律失常潜力，肝细胞酶的任何罕见、短暂、无症状升高均恢复正常。
度洛西汀是安全且可耐受的，尽管短暂的AE并不罕见。
