Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA.
Pharmacotherapy Education and Research Center, School of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA.
Drugs. 2017 Aug;77(12):1345-1351. doi: 10.1007/s40265-017-0785-2.
Ceftaroline fosamil is US Food and Drug Administration-approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, but it is not known how ceftaroline is being used in real-world settings or how adverse effects (AEs) and mortality compare to clinical trials.
This study describes ceftaroline use, AEs, and mortality in US Veterans Health Administration (VHA) hospital patients.
This phase IV, population-based, epidemiologic study analyzed patients ≥18 years old who received one or more ceftaroline doses within 14 days of admission to 69 VHA hospitals in 41 US states/territories from 1 October 2010 to 30 September 2014. VHA repository data were linked using unique patient identifiers. Diagnoses and AEs were determined using ICD9-CM and CSS codes. Demographics, AEs within 30 days of therapy initiation, and all-cause in-hospital mortality were summarized using descriptive statistics.
764 Patients met study criteria. Patients were 97% male and 56% White, with a median age of 61 years and a Charlson score of 6. Diagnoses included skin (40%), sepsis (30%), osteomyelitis (25%), diabetic foot (22%), pneumonia (16%), bacteremia (11%), endocarditis (6%), meningitis (2%), and device (2%) infections. Ceftaroline was used first-line (37%), second-line (56%), and third-line or greater (7%). Patients received ceftaroline a median of 3 days after hospital admission. All-cause in-hospital mortality rates were: overall (5%), skin (2%), sepsis (9%), osteomyelitis (3%), diabetic foot (1%), pneumonia (13%), bacteremia (6%), endocarditis (11%), meningitis (6%), and device (13%). Eosinophilia, leukopenia, leukocytosis, fibromyalgia, myalgia and myositis, and polymyalgia rates were <1% each.
Ceftaroline is used in VHA hospitals for various diagnoses. Mortality was low and comparable with rates from clinical trials. Additional studies comparing ceftaroline to other drugs used in similar situations are needed.
头孢洛林酯氨丁三醇已获美国食品药品监督管理局批准用于治疗急性细菌性皮肤和皮肤结构感染和社区获得性细菌性肺炎，但目前尚不清楚在真实环境中头孢洛林酯氨丁三醇的使用情况，以及不良反应（AE）和死亡率与临床试验相比如何。
本研究描述了美国退伍军人事务部（VA）医院患者中头孢洛林酯氨丁三醇的使用、AE 和死亡率。
这是一项基于人群的、四期、流行病学研究，分析了 2010 年 10 月 1 日至 2014 年 9 月 30 日期间，41 个美国州/地区的 69 家 VA 医院中 18 岁及以上患者在入院后 14 天内接受单次或多次头孢洛林酯氨丁三醇治疗的情况。使用唯一患者标识符将 VA 存储库数据进行链接。通过 ICD9-CM 和 CSS 代码确定诊断和 AE。使用描述性统计方法总结治疗开始后 30 天内的 AE 和全因住院死亡率。
764 名患者符合研究标准。患者 97%为男性，56%为白人，中位年龄为 61 岁，Charlson 评分为 6 分。诊断包括皮肤（40%）、脓毒症（30%）、骨髓炎（25%）、糖尿病足（22%）、肺炎（16%）、菌血症（11%）、心内膜炎（6%）、脑膜炎（2%）和器械（2%）感染。头孢洛林酯氨丁三醇作为一线（37%）、二线（56%）和三线或以上（7%）药物使用。患者在入院后中位 3 天接受了全因住院死亡率：总体（5%）、皮肤（2%）、脓毒症（9%）、骨髓炎（3%）、糖尿病足（1%）、肺炎（13%）、菌血症（6%）、心内膜炎（11%）、脑膜炎（6%）和器械（13%）。嗜酸性粒细胞增多症、白细胞减少症、白细胞增多症、纤维肌痛、肌痛和肌炎以及多肌痛的发生率均<1%。
头孢洛林酯氨丁三醇在美国 VA 医院用于多种诊断。死亡率较低，与临床试验中的比率相当。需要开展更多比较头孢洛林酯氨丁三醇与其他在类似情况下使用的药物的研究。
