Duquesne University School of Pharmacy, 600 Forbes Ave, Pittsburgh, PA, 15282, USA.
University of Pittsburgh Medical Center - Mercy Hospital, 1400 Locust St, Pittsburgh, PA, 15219, USA.
Clin Drug Investig. 2021 Apr;41(4):353-369. doi: 10.1007/s40261-021-01019-4. Epub 2021 Mar 7.
Rivaroxaban and apixaban are direct oral anticoagulants increasing in popularity as convenient alternatives to warfarin. However, current guidelines recommend against use in patients with a BMI > 40 kg/m or bodyweight > 120 kg unless drug-specific levels are measured, which may not be feasible across all clinical practices. Accordingly, the objective of this study was to broadly examine literature evaluating the clinical outcomes of rivaroxaban and/or apixaban in patients with increased body mass.
A systematic literature review (guided by PRISMA) was performed through January 27, 2021 using PubMed, Embase, and Scopus. Key search term clusters included drug and weight-related concepts (overweight/obese, body mass index [BMI], waist circumference). DistillerSR was utilized to review and process search results. Studies met inclusion if they analyzed the risk of bleeding and/or thrombosis in patients with increased body mass (i.e., via BMI or other criteria) receiving rivaroxaban or apixaban. Clinical guidelines, case reports/series, pharmacokinetic/dynamic analyses, and commentaries were excluded. Bias was examined qualitatively across studies.
After duplicates were removed, the original search rendered 1822 abstracts and 200 full-texts for screening, ultimately providing a final set of 24 studies for qualitative review. Of these studies, 13 (54.2%) enabled comparisons between patients of increased versus normal body mass, while 11 (45.8%) reported outcomes only for patients of increased body mass. The working definition of 'increased body mass' varied amongst the studies, including 11 (45.8%) studies that utilized BMI, seven (29.2%) with a combination of BMI and body measurement, two (8.3%) that relied on body weight alone, and four (16.7%) that identified obesity-related ICD codes. All 13 comparative studies found similar or reduced rates of safety and efficacy outcomes with rivaroxaban and apixaban.
The literature reports similar or lower bleeding and thrombotic risk for rivaroxaban and apixaban in patients of increased body mass compared to patients of normal body mass. Future prospective controlled studies are needed to further define guidelines for use in this population.
利伐沙班和阿哌沙班是越来越受欢迎的直接口服抗凝剂，作为华法林的方便替代药物。然而，目前的指南建议不要在 BMI>40kg/m2 或体重>120kg 的患者中使用，除非进行药物特异性水平检测，但这在所有临床实践中可能并不可行。因此，本研究的目的是广泛评估评估利伐沙班和/或阿哌沙班在体重增加患者中的临床结局的文献。
通过 PRISMA 指导，于 2021 年 1 月 27 日之前，使用 PubMed、Embase 和 Scopus 进行了系统文献综述。关键搜索词集群包括药物和体重相关概念（超重/肥胖、体重指数[BMI]、腰围）。使用 DistillerSR 审查和处理搜索结果。如果分析了接受利伐沙班或阿哌沙班治疗的体重增加（即通过 BMI 或其他标准）患者的出血和/或血栓形成风险的研究，则符合纳入标准。排除了临床指南、病例报告/系列、药代动力学/动力学分析和评论。对研究进行了定性偏倚检查。
去除重复项后，原始搜索生成了 1822 篇摘要和 200 篇全文进行筛选，最终有 24 项研究进行了定性审查。这些研究中，13 项（54.2%）能够比较体重增加和正常体重患者之间的结果，而 11 项（45.8%）仅报告了体重增加患者的结果。研究中“体重增加”的工作定义各不相同，包括 11 项（45.8%）研究使用 BMI，7 项（29.2%）研究结合 BMI 和身体测量，2 项（8.3%）研究仅依赖体重，4 项（16.7%）研究确定肥胖相关 ICD 代码。所有 13 项比较研究发现，利伐沙班和阿哌沙班在体重增加患者中的安全性和疗效结果与体重正常患者相似或降低。需要进一步开展前瞻性对照研究，以进一步确定该人群的使用指南。
