University of Kentucky, Department of Pharmacy Practice and Science, Institute for Pharmaceutical Outcomes and Policy, Lexington, KY; University of Kentucky, Department of Epidemiology, Lexington, KY; University of Iowa, Department of Epidemiology, Iowa City, IA.
J Am Med Dir Assoc. 2013 Oct;14(10):749-60. doi: 10.1016/j.jamda.2013.03.008. Epub 2013 Apr 30.
To evaluate risks and benefits of bladder antimuscarinics (BAMs) among elderly long term care nursing home residents.
Retrospective cohort study using a new user design and propensity score matching.
Veterans Affairs (VA) Community Living Centers (Nursing Homes).
Older adults (65 and older) admitted for long term care between October 1, 2002, and September 30, 2009.
The study used multiple VA data sources (Minimum Data Set [MDS], inpatient, outpatient, and pharmacy prescriptions administrative files). The following outcomes were evaluated: (1) fractures (hip fracture and "any" fracture) identified from inpatient and/or outpatient data (ICD-9-CM codes) and from MDS; (2) cognitive performance measured using the validated MDS Cognitive Performance Scale; (3) improvement in urinary incontinence measured from MDS; (4) quality of life measured from MDS using 2 validated instruments: Index of Social Engagement and Health Status Index. Covariates included demographic characteristics, baseline continence status (bladder and bowel) and continence management, preexistent urinary tract infections, body mass index, comorbidities, other medication use, cognitive status, and mobility at baseline. These variables were used to calculate the predicted probability (propensity score) of being initiated on a BAM; the resulting propensity scores were used to match new users and nonusers. Outcomes were compared with Cox proportional hazards regression and generalized estimating equations methodology.
BAMs were used by 9.8% of the residents 65 years and older admitted for long term care; 44% (1195) were new users. Of these, all but 53 received nonselective immediate release preparations, predominantly oxybutynin chloride (75%). BAM initiation resulted in improved urinary continence status (odds ratio = 1.27, 95% confidence interval [CI] 1.07-1.5) and better social engagement (difference in mean index of social engagement score = 0.2074, 95% CI 0.055-0.3598). The risk of fractures was significantly increased in new users as compared to nonusers (hip fracture: hazard ratio [HR] = 3.67, 95% CI 1.46-9.34; "any" fracture: HR = 2.64, 95% CI 1.37-5.10). The number needed to treat (NNT) to obtain improvement in urinary incontinence after 90 days of treatment (NNT = 32, 95% CI 17-125) was similar to the number needed to harm (NNH) at 90 days in the hip fracture analysis (NNH = 36, 95% CI 12-209). There were no differences in cognitive performance or overall quality of life scores associated with BAM use.
These results question the continued use of BAMs, particularly immediate-release oxybutynin chloride in elderly nursing home residents.
评估老年长期护理养老院居民使用膀胱抗毒蕈碱药物(BAMs)的风险和获益。
使用新用户设计和倾向评分匹配的回顾性队列研究。
退伍军人事务部(VA)社区生活中心(养老院)。
2002 年 10 月 1 日至 2009 年 9 月 30 日期间入住长期护理的老年人(65 岁及以上)。
本研究使用了多个 VA 数据源(最低数据集[MDS]、住院、门诊和药房处方管理文件)。评估了以下结果:(1)从住院和/或门诊数据(ICD-9-CM 代码)和 MDS 中确定的骨折(髋部骨折和“任何”骨折);(2)使用经过验证的 MDS 认知表现量表测量的认知表现;(3)从 MDS 中评估的尿失禁改善情况;(4)使用 2 种经过验证的工具从 MDS 中评估的生活质量:社会参与指数和健康状况指数。协变量包括人口统计学特征、基线控尿状态(膀胱和肠道)和控尿管理、先前存在的尿路感染、体重指数、合并症、其他药物使用、认知状态和基线时的活动能力。这些变量用于计算开始使用 BAMs 的预测概率(倾向评分);由此产生的倾向评分用于匹配新用户和非用户。使用 Cox 比例风险回归和广义估计方程方法比较结果。
65 岁及以上入住长期护理的居民中有 9.8%使用了 BAMs;44%(1195 人)为新用户。其中,除 53 人外,所有人都接受了非选择性即时释放制剂,主要是奥昔布宁氯(75%)。BAM 起始治疗可改善尿控状态(优势比[OR] = 1.27,95%置信区间[CI] 1.07-1.5)和更好的社会参与度(社会参与指数平均得分差异= 0.2074,95%CI 0.055-0.3598)。与非使用者相比,新使用者的骨折风险显著增加(髋部骨折:风险比[HR] = 3.67,95%CI 1.46-9.34;“任何”骨折:HR = 2.64,95%CI 1.37-5.10)。在治疗 90 天后获得尿失禁改善的治疗需要人数(NNT = 32,95%CI 17-125)与髋部骨折分析中 90 天的需要治疗人数(NNH = 36,95%CI 12-209)相似。与 BAM 使用相关的认知表现或整体生活质量评分没有差异。
这些结果对在老年养老院居民中继续使用 BAMs,特别是即时释放奥昔布宁氯提出了质疑。