University of Alberta, Edmonton, Alberta, Canada.
Eur Urol. 2013 Jul;64(1):74-81. doi: 10.1016/j.eururo.2013.01.002. Epub 2013 Jan 11.
Compared with younger people, the elderly are more likely to suffer from overactive bladder (OAB) and to have other chronic conditions that affect physical or cognitive function. Despite this, there are few data on the cognitive safety of antimuscarinic agents in older patients and none that examine the effect of these agents on those with mild cognitive impairment (MCI).
To evaluate cognitive effects during chronic stable dosing with solifenacin and oxybutynin versus placebo in older (≥75 yr) subjects with MCI.
DESIGN, SETTING, AND PARTICIPANTS: A randomised, double-blind, triple-crossover trial in 26 elderly volunteers with MCI. Cognitive function was assessed using Cognitive Drug Research (CDR) computerised testing.
Three treatment periods of 21 d each with solifenacin 5mg once daily, oxybutynin 5mg twice daily, or placebo, separated by 21-d washout periods.
The primary end point was change from baseline in cognitive function with solifenacin at 6h postdose and oxybutynin at 2h postdose (time points close to their predicted time to peak concentration). Secondary end points included change in cognitive function at additional time points, and safety and tolerability assessments.
Neither agent was associated with significant changes from baseline in any of the five standard, composite outcomes of cognitive function (power of attention, continuity of attention, quality of working memory, quality of episodic memory, and speed of memory). In a secondary analysis, oxybutynin was associated with significant decreases in power and continuity of attention versus placebo at 1-2h postdose. Both agents were well tolerated, with the most frequently reported adverse event being mild or moderate dry mouth.
Solifenacin had no detectable effect on cognition in this group of elderly people with MCI.
与年轻人相比，老年人更容易患有膀胱过度活动症（OAB），并且更容易患有影响身体或认知功能的其他慢性疾病。尽管如此，关于老年患者中抗毒蕈碱药物的认知安全性的数据很少，也没有研究这些药物对轻度认知障碍（MCI）患者的影响。
评估在患有 MCI 的老年（≥75 岁）受试者中，慢性稳定剂量给予索利那新和奥昔布宁与安慰剂相比的认知影响。
设计、地点和参与者：一项在 26 名患有 MCI 的老年志愿者中进行的随机、双盲、三交叉试验。认知功能使用认知药物研究（CDR）计算机测试进行评估。
索利那新 5mg 每日一次、奥昔布宁 5mg 每日两次或安慰剂，每个治疗期 21 天，每个治疗期之间有 21 天的洗脱期。
主要终点是与基线相比，索利那新在 6 小时后和奥昔布宁在 2 小时后的认知功能变化（接近其预测的达峰时间点）。次要终点包括在其他时间点的认知功能变化，以及安全性和耐受性评估。
两种药物均未导致任何五个标准复合认知功能结果（注意力的力量、注意力的连续性、工作记忆的质量、情景记忆的质量和记忆的速度）发生显著变化。在二次分析中，奥昔布宁在 1-2 小时后与安慰剂相比，注意力的力量和连续性显著下降。两种药物均耐受良好，最常见的不良事件是轻度或中度口干。
在患有 MCI 的老年人群中，索利那新对认知无明显影响。
