Howerton Michelle A, Suhrie Erin M, Gennari Amelia S, Jones Nancy, Ruby Christine M
Sr Care Pharm. 2019 Mar 1;34(3):192-205.
This study was conducted to evaluate direct oral anticoagulants (DOACs) prescribed to elderly patients in an outpatient setting, specifically evaluating if Food and Drug Administration (FDA) -approved dosing recommendations are followed.
This study was a retrospective quality improvement project.
This study was conducted at geriatric hospital-based primary care clinics at the University of Pittsburgh Medical Center (UPMC), UPMC Senior Care Institute and UPMC Benedum Geriatric Center.
Subjects included were 65 years of age or older; had an office visit at UPMC Senior Care Institute or UPMC Benedum Geriatric Center from September 1, 2015, to August 31, 2017; and had a DOAC on their home medications.
Data were obtained through retrospective chart review.
The primary objective of the study was to evaluate the appropriateness of dosing of DOACs based on FDA-labeled recommendations.
Of 232 patients included in analysis, 42.7% were found to have dosing inconsistent with FDAlabeled recommendations (47.3% apixaban, 35.8% rivaroxaban, and 31.6% dabigatran). No patients were prescribed edoxaban. The majority (72.7%) were dosed lower than FDA-recommended doses. Of all patients, the most frequent parameter (54.5%) for inappropriate dosing was patients meeting only 1 of 3 dose-reduction criteria when prescribed reduced-dose apixaban. Geriatrician and nongeriatrician prescribers had similar rates of prescribing DOACs with doses inconsistent with FDA-labeled recommendations (44.0% vs. 40.8%; = 0.62).
Results suggest that DOACs used in outpatient geriatric patients are frequently dosed inconsistent with FDA-approved dosing recommendations. Further research is needed regarding clinical outcomes in older patients receiving DOACs and in those with dose adjustments inconsistent with FDA-labeled recommendations.
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本研究旨在评估门诊环境中为老年患者开具的直接口服抗凝剂（DOACs），具体评估是否遵循了美国食品药品监督管理局（FDA）批准的给药建议。
本研究是一项回顾性质量改进项目。
本研究在匹兹堡大学医学中心（UPMC）的老年医院初级保健诊所、UPMC老年护理研究所和UPMC贝内德姆老年中心进行。
纳入的受试者年龄在65岁及以上；在2015年9月1日至2017年8月31日期间在UPMC老年护理研究所或UPMC贝内德姆老年中心就诊；且家庭用药中有DOAC。
数据通过回顾性病历审查获得。
该研究的主要目的是根据FDA标签建议评估DOAC给药的适宜性。
在纳入分析的232例患者中，发现42.7%的患者给药与FDA标签建议不一致（阿哌沙班为47.3%，利伐沙班为35.8%，达比加群为31.6%）。没有患者被开具依度沙班。大多数（72.7%）患者的给药剂量低于FDA推荐剂量。在所有患者中，给药不当最常见的参数（54.5%）是在开具减量阿哌沙班时仅符合3项剂量降低标准中的1项的患者。老年科医生和非老年科医生开具DOAC剂量与FDA标签建议不一致的比例相似（44.0%对40.8%；P = 0.62）。
结果表明，门诊老年患者使用的DOAC给药常常与FDA批准的给药建议不一致。对于接受DOAC的老年患者以及给药调整与FDA标签建议不一致的患者的临床结局，还需要进一步研究。
