Department of Clinical Pharmacy and Outcomes Sciences, South Carolina College of Pharmacy, University of South Carolina, Columbia, South Carolina.
Pharmacotherapy. 2013 Dec;33(12):1322-30. doi: 10.1002/phar.1298. Epub 2013 May 26.
Data are limited for antimicrobial outcomes in obese patients. This study investigated the safety and clinical outcomes of daptomycin therapy in a hospitalized obese population in the southeastern United States.
Multicenter retrospective cohort study.
Thirteen hospitals in the southeastern United States.
A total of 126 hospitalized adult obese patients (body mass index [BMI] more than 30 kg/m(2) ) admitted from January 2005 through May 2010 who received daptomycin dosed on actual body weight for any indication for a minimum of 7 days.
Primary safety outcomes included incidence of creatine phosphokinase (CPK) elevations more than 1000 units/L, more than 500 units/L, myalgias, and discontinuation of therapy due to adverse drug events (ADEs). Patients were stratified by BMI class (I, II, or III) for analyses. The average weight was 121 kg, and 39% of patients were considered morbidly obese. Factors associated with an increased risk of primary safety outcomes were assessed through regression analysis. Clinical effectiveness was evaluated as a secondary outcome. CPK elevations more than 1000 units/L occurred in 8.4% of evaluable patients and specifically in 1 (3.6%), 3 (10.3%), and 4 (10.5%) patients in BMI class I, II, and III, respectively (p=0.554). CPK elevations more than 500 units/L occurred in 13.7% of patients with no statistically significant difference noted across BMI classes. Discontinuation due to ADEs occurred in 8 patients (6.3%). One patient developed rhabdomyolysis on day 9 of therapy. Clinical effectiveness was documented in 71% of patients and was consistent across BMI classes.
Although elevations in CPK increased in high-risk obese patients on daptomycin, discontinuation rates due to ADEs remained low. Further evaluation in a prospective trial is warranted.
肥胖患者的抗菌治疗结局数据有限。本研究在美国东南部的一家医院调查了住院肥胖人群中达托霉素治疗的安全性和临床结局。
多中心回顾性队列研究。
美国东南部的 13 家医院。
2005 年 1 月至 2010 年 5 月间，因任何适应症接受至少 7 天达托霉素实际体重剂量治疗的住院肥胖成年患者共 126 例（体重指数 [BMI]＞30kg/m²）。
主要安全性结局包括肌酸磷酸激酶（CPK）升高＞1000U/L、＞500U/L、肌痛和因药物不良反应（ADE）停药的发生率。患者按 BMI 类别（I、II 或 III）进行分层分析。平均体重为 121kg，39%的患者被认为是病态肥胖。通过回归分析评估与主要安全性结局风险增加相关的因素。临床疗效作为次要结局进行评估。可评估患者中，CPK 升高＞1000U/L 的发生率为 8.4%，分别在 BMI 类别 I、II 和 III 的 1（3.6%）、3（10.3%）和 4（10.5%）例患者中发生（p=0.554）。CPK 升高＞500U/L的发生率为 13.7%，各 BMI 类别间无统计学差异。因 ADE 停药的发生率为 8 例（6.3%）。1 例患者在治疗第 9 天发生横纹肌溶解症。71%的患者记录了临床疗效，且各 BMI 类别间一致。
尽管高风险肥胖患者使用达托霉素后 CPK 升高，但因 ADE 停药的发生率仍然较低。需要在前瞻性试验中进一步评估。
