Cognitive Research Corporation, St Petersburg, FL 33701, USA.
Clin Drug Investig. 2012 Oct 1;32(10):707-14. doi: 10.1007/BF03261924.
Oxybutynin is a common antimuscarinic therapy for overactive bladder. Transdermally administered oxybutynin chloride topical gel 10% (OTG) has a low propensity for anticholinergic adverse effects and possibly also a low risk of cognitive impairment. A randomized, double-blind, placebo- and active-controlled study evaluated the effects of OTG on cognitive and psychomotor functions in older healthy adults.
Healthy adults aged 60-79 years were assigned randomly (1:1:1) to 1-week's treatment with OTG (1 g [100 mg oxybutynin] applied once daily on rotating sites of upper arms/shoulders, abdomen or thighs) plus oral placebo, immediate-release oxybutynin (OXB-IR; 5 mg capsule three times/day) plus placebo gel, or double placebo. Delayed recall Name-Face Association Test (NFAT) score was the primary end point. Treatments were compared by analysis of covariance.
Of 152 participants (mean age, 68 years), 49 received OTG, 52 OXB-IR and 51 placebo. NFAT Delayed Recall tests revealed no significant treatment differences (overall, p = 0.2733; OTG vs placebo, p = 0.1551; OXB-IR vs placebo, p = 0.1767). However, a significant effect (p = 0.0294) was noted for the Misplaced Objects Test, with scores declining only for OXB-IR. Approximately twice as many participants receiving OXB-IR (n = 10) as those receiving OTG (n = 5) or placebo (n = 6) showed a significant decline (≥6 points) in Total Recall score for the Hopkins Verbal Learning Test-Revised. No significant effects on psychomotor reaction time were observed. The most common adverse event, dry mouth, occurred in 6.1%, 73.1% and 7.8% of participants receiving OTG, OXB-IR and placebo, respectively.
OTG applied for 1 week had no clinically meaningful effect on recent memory or other cognitive functions in healthy, older adults.
Registered as NCT00752141 at www.clinicaltrials.gov.
奥昔布宁是治疗膀胱过度活动症的常用抗毒蕈碱药物。经皮给予的盐酸奥昔布宁透皮贴剂 10%（OTG）具有较低的抗胆堿能不良反应倾向，可能也具有较低的认知障碍风险。一项随机、双盲、安慰剂和阳性对照研究评估了 OTG 对老年健康成年人认知和精神运动功能的影响。
年龄在 60-79 岁的健康成年人按 1:1:1 的比例随机分配，接受为期 1 周的治疗，分别给予 OTG（1g[100mg 奥昔布宁]每天一次涂抹在上臂/肩部、腹部或大腿的旋转部位）加口服安慰剂、即释奥昔布宁（OXB-IR；5mg 胶囊每日 3 次）加安慰剂凝胶，或双安慰剂。延迟回忆命名面孔关联测试（NFAT）评分是主要终点。采用协方差分析比较治疗效果。
152 名参与者（平均年龄 68 岁）中，49 名接受 OTG，52 名接受 OXB-IR，51 名接受安慰剂。NFAT 延迟回忆测试显示治疗无显著差异（总体，p=0.2733；OTG 与安慰剂，p=0.1551；OXB-IR 与安慰剂，p=0.1767）。然而，在放置物品测试中观察到显著的效果（p=0.0294），只有 OXB-IR 的评分下降。接受 OXB-IR（n=10）的参与者中，约有两倍（n=10）比接受 OTG（n=5）或安慰剂（n=6）的参与者的霍普金斯言语学习测试修订版总回忆得分有显著下降（≥6 分）。未观察到对精神运动反应时间的显著影响。最常见的不良事件是口干，分别有 6.1%、73.1%和 7.8%的接受 OTG、OXB-IR 和安慰剂的参与者发生。
在健康的老年成年人中，OTG 应用 1 周对近期记忆或其他认知功能无明显影响。
在 www.clinicaltrials.gov 上注册为 NCT00752141。
