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首页> 外文期刊>The American journal of geriatric pharmacotherapy >Safety and clinical outcomes among older adults receiving daptomycin therapy: Insights from a patient registry.
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Safety and clinical outcomes among older adults receiving daptomycin therapy: Insights from a patient registry.

机译：接受达托霉素治疗的老年人的安全性和临床结果：来自患者注册表的见解。

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Background: Serious gram-positive bacterial infections are an important cause of morbidity and mortality among older adults and can present significant challenges to clinicians. Data evaluating the safety and effectiveness of newer agents in this population are limited. Objective: Daptomycin is a lipopeptide with activity against resistant gram-positive organisms. To better understand the overall safety and effectiveness of daptomycin in older adults (>/=66 years of age), the authors reviewed the data that were collected as part of an ongoing registry maintained by Cubist Pharmaceuticals, Inc. (Lexington, Massachusetts), the manufacturer of daptomycin. Methods: The Cubicin Outcomes Registry and Experience (CORE) is a multicenter, retrospective registry designed to collect postmarketing clinical data on patients who received daptomycin. The CORE data collected from 58 institutions across the United States between January 1, 2005, and December 31, 2007, were analyzed to better understand the overall safety profile of daptomycin and the clinical outcomes of older adults who were treated with this agent. Patients were considered to be nonevaluable if the medical record did not contain sufficient information to determine response at the end of therapy. Nonevaluable patients were excluded from the clinical outcome analysis but included in the safety analysis. Results: The registry contained 1073 patients aged >/=66 years who received daptomycin; 23.8% (255/1073) were >/=81 years of age. Overall, 18.1% (194/1073) of patients experienced 324 adverse events, and 6.2% (67/1073) of patients experienced 97 adverse events that were considered possibly related to treatment with daptomycin. The most frequently reported adverse events that were considered possibly treatment related included creatine phosphokinase (CPK) elevations, gastrointestinal disorders, and skin rashes. Among the 67 patients who experienced >/=1 adverse event that was possibly related to daptomycin, 30 discontinued therapy due to the adverse event (13 due to CPK elevation). Overall, 78.7% (844/1073) of patients were considered evaluable for clinical outcomes. The clinical success rate for all evaluable patients was 90.2% (761/844). The success rate for evaluable patients >/=81 years of age (88.6% [171/193]) was comparable to that of the overall population. Conclusion: Experience with daptomycin in this group of older adults suggests good tolerability and clinical outcomes that are consistent with the results of other studies published to date.
机译：背景：严重的革兰氏阳性细菌感染是老年人发病和死亡的重要原因，并且可能对临床医生提出重大挑战。评价该人群中新药安全性和有效性的数据有限。目的：达托霉素是一种脂肽，具有抗革兰氏阳性菌的活性。为了更好地了解达托霉素在老年人（> / = 66岁）中的总体安全性和有效性，作者回顾了作为Cubist Pharmaceuticals，Inc.（马萨诸塞州列克星敦市）维护的正在进行的注册管理机构一部分收集的数据，达托霉素的制造商。方法：Cubicin结果结局和经验（CORE）是一个多中心回顾性注册中心，旨在收集接受达托霉素患者的上市后临床数据。分析了2005年1月1日至2007年12月31日期间从美国58个机构收集的CORE数据，以更好地了解达托霉素的总体安全性以及接受该药物治疗的老年人的临床结局。如果病历中没有足够的信息来确定治疗结束时的反应，则认为患者无价值。无价值的患者被排除在临床结果分析之外，但包括在安全性分析中。结果：登记册中包含1073名年龄≥66岁的患者接受达托霉素治疗; 23.8％（255/1073）是> / = 81岁。总体而言，18.1％（194/1073）的患者经历了324例不良事件，而6.2％（67/1073）的患者经历了97例不良事件，这些不良事件可能与达托霉素治疗有关。被认为可能与治疗有关的最常见的不良事件包括肌酸磷酸激酶（CPK）升高，胃肠道疾病和皮疹。在67位经历了> / = 1可能与达托霉素有关的不良事件的患者中，有30位因不良事件而中止治疗（13位由于CPK升高）。总体而言，78.7％（844/1073）的患者被认为可评估临床结局。所有可评估患者的临床成功率为90.2％（761/844）。 ≥81岁的可评估患者的成功率（88.6％[171/193]）与总体人群的成功率相当。结论：在这一组老年人中使用达托霉素的经验表明，良好的耐受性和临床结局与迄今发表的其他研究结果一致。

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