Taylor Katherine, Williamson John, Luther Vera, Stone Tyler, Johnson James, Gruss Zachary, Russ-Friedman Courtney, Ohl Chris, Beardsley James
Wake Forest Baptist Health Department of Pharmacy, Winston-Salem, NC 27157, USA.
Section of Infectious Diseases, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.
Infect Dis Rep. 2022 Apr 11;14(2):266-272. doi: 10.3390/idr14020032.
(1) Background: Dalbavancin is a long-acting lipoglycopeptide antibiotic approved for skin and soft-tissue infections. Post-marketing experience suggests dalbavancin is being used for off-label indications that normally require long-term intravenous (IV) antibiotics; however, data assessing this off-label usage are limited. The purpose of this study was to evaluate the real-world efficacy, safety, and financial impact of off-label dalbavancin use. (2) Methods: This is a retrospective, observational study conducted within a 4-hospital health system. Adult patients who received dalbavancin from January 2018 to January 2021 for an off-label indication were included. The primary outcome was clinical success at 90 days. Secondary outcomes included safety (nephrotoxicity and hepatotoxicity). A pharmacoeconomic analysis was performed by comparing the cost of dalbavancin to the anticipated cost of patient stay if standard IV therapy was given. (3) Results: Forty-eight patients met study criteria. Indications included osteomyelitis (54%), endocarditis (23%), bacteremia (15%), and prosthetic joint infection (8%). The predominant organism was (60%), with 42% caused by methicillin-resistant . Overall, 41 (85%) patients achieved clinical success at 90 days, including 85% with osteomyelitis, 82% with endocarditis, and 86% with bacteremia. There were no instances of nephrotoxicity or hepatotoxicity. Estimated cost avoidance per patient was USD 5313 and USD 1683 if traditional IV therapy would have been completed in the hospital and skilled nursing facility, respectively. (4) Conclusion: Dalbavancin was associated with a relatively high success rate for the treatment of off-label indications and may be a cost-effective alternative to traditional IV antibiotic therapy.
(1) 背景：达巴万星是一种长效脂糖肽类抗生素，已被批准用于治疗皮肤和软组织感染。上市后经验表明，达巴万星正被用于通常需要长期静脉注射抗生素的非标签适应症；然而，评估这种非标签用法的数据有限。本研究的目的是评估达巴万星非标签使用的实际疗效、安全性和财务影响。(2) 方法：这是一项在4家医院的医疗系统内进行的回顾性观察研究。纳入了2018年1月至2021年1月因非标签适应症接受达巴万星治疗的成年患者。主要结局是90天时的临床成功。次要结局包括安全性（肾毒性和肝毒性）。通过比较达巴万星的成本与给予标准静脉治疗时患者住院的预期成本进行药物经济学分析。(3) 结果：48名患者符合研究标准。适应症包括骨髓炎（54%）、心内膜炎（23%）、菌血症（15%）和人工关节感染（8%）。主要病原体是（60%），42% 由耐甲氧西林的引起。总体而言，41名（85%）患者在90天时取得了临床成功，其中骨髓炎患者的成功率为85%，心内膜炎患者为82%，菌血症患者为86%。没有肾毒性或肝毒性的病例。如果在医院和熟练护理机构完成传统静脉治疗，每位患者估计可避免的成本分别为5313美元和1683美元。(4) 结论：达巴万星在治疗非标签适应症方面成功率相对较高，可能是传统静脉抗生素治疗的一种具有成本效益的替代方案。
