Broadstreet Health Economics and Outcomes Research, 203-343 Railway St., Vancouver, BC, V6A 1A4, Canada.
Humana Healthcare Research Inc, 500 West Main St., Louisville, KY, 40202, USA.
Adv Ther. 2019 Sep;36(9):2247-2259. doi: 10.1007/s12325-019-01035-z. Epub 2019 Aug 5.
As continuous exposure to anticholinergics has been associated with adverse outcomes, accurately measuring exposure is important. However, no gold standard measure is available, and the performance of existing measures has not been compared. Our objective was to compare the properties of the Cumulative Anticholinergic Burden (CAB) measure against two existing measures of anticholinergic exposure and to assess their compatibility for use in observational studies based on claims data.
The average daily dose, cumulative dose and CAB measures were evaluated on: the applicability for use with anticholinergic burden scales, the ability to consider duration and/or accumulation of exposure, and consideration of anticholinergic dose, potency, and residual effect. To calculate each measure empirically, Truven MarketScan claims data from 2012 to 2015 were analyzed. Cumulative anticholinergic exposure over 1-year post-enrollment was calculated for each measure using Anticholinergic Cognitive Burden scale scores. Median [interquartile range (IQR)] and ranges of measure scores, and Spearman's correlation coefficients between measures, were estimated. Due to the differing methods of calculation, the absolute values of each score cannot be compared.
The properties of the different measures varied, with only the CAB considering both dose and theoretical potency. The cohort included 99,742 individuals (mean age = 73.1 years; 54.9% female). Among individuals prescribed anticholinergics (n = 55,969), 1-year median (IQR) scores based on average daily dose, cumulative dose and CAB measures were 0.9 (0.3-1.5), 16.9 (7.3-33.9) and 203 (68-500), respectively. Measures were highly inter-correlated (r = 0.74-0.83).
Considering both potency and dose, the CAB may prove a more comprehensive measure of anticholinergic burden; however, additional research is necessary to demonstrate whether it has any association with relevant health-related outcomes.
Astellas Pharma Global Development, Inc.
由于持续接触抗胆碱能药物与不良结局相关，因此准确测量接触量很重要。然而，目前尚无金标准测量方法，并且现有测量方法的性能尚未进行比较。我们的目的是比较累积抗胆碱能负担（CAB）测量值与两种现有的抗胆碱能药物暴露测量值的特性，并根据索赔数据评估它们在观察性研究中的适用性。
评估平均日剂量、累积剂量和 CAB 测量值的适用性：用于抗胆碱能负担量表的适用性、考虑暴露的持续时间和/或积累的能力，以及考虑抗胆碱能药物剂量、效力和残留效应的能力。为了从经验上计算每个测量值，分析了 2012 年至 2015 年 Truven MarketScan 索赔数据。使用抗胆碱能认知负担量表评分计算每个测量值在入组后 1 年内的累积抗胆碱能暴露量。估计了各测量值的中位数[四分位距（IQR）]和范围，以及各测量值之间的斯皮尔曼相关系数。由于计算方法不同，每个分数的绝对值无法进行比较。
不同测量值的特性不同，只有 CAB 同时考虑了剂量和理论效力。该队列包括 99742 人（平均年龄 73.1 岁；54.9%为女性）。在接受抗胆碱能药物治疗的个体中（n=55969），基于平均日剂量、累积剂量和 CAB 测量值的 1 年中位数（IQR）评分分别为 0.9（0.3-1.5）、16.9（7.3-33.9）和 203（68-500）。各测量值高度相关（r=0.74-0.83）。
考虑到效力和剂量，CAB 可能是抗胆碱能负担的更全面测量方法；然而，需要进一步的研究来证明它是否与相关的健康相关结局有关。
安斯泰来制药全球开发公司。
