Cubist Pharmaceuticals, Inc., Lexington, MA 02421, USA.
Int J Antimicrob Agents. 2013 May;41(5):421-5. doi: 10.1016/j.ijantimicag.2012.12.008. Epub 2013 Feb 5.
Patients with complicated infections may receive daptomycin for extended periods. This retrospective analysis was conducted to describe the safety profile of daptomycin in patients completing >14 days of therapy. In the Cubicin(®) Outcomes Registry and Experience (CORE(®)) 2005-2009, a retrospective, multicentre, observational registry, patients completing >14 days of daptomycin were studied. Investigators assessed adverse events (AEs) using ICH-E2A definitions of seriousness/severity ≤30 days after completing daptomycin. AEs were grouped by onset at ≤14, 15-28 and >28 days after starting daptomycin. In total, 2263 patients received >14 days of daptomycin. The most common indications were complicated skin and skin-structure infection (25.5%) and osteomyelitis (21.7%). Regarding AEs, 205 patients (9.1%) experienced AEs with an onset ≤14 days of therapy, 168 (7.4%) between 15-28 days and 108 (4.8%) >28 days; a total of 389/2263 patients experienced 814 AEs. The most common AE was increased blood creatine phosphokinase (CPK), occurring in 49 patients (2.2%) during ≤14 days of therapy, 32 (1.4%) between 15-28 days and 10 (0.4%) >28 days. In 183/2263 patients (8.1%), 264 AEs were possibly related to daptomycin. Serious AEs occurred in 153/2263 patients (6.8%). Eighty-nine (3.9%) of 2263 patients had daptomycin discontinued due to AEs, with 36 discontinued due to increased CPK. The overall mortality rate was 63/2263 (2.8%); 4 patients died of a possibly related AE. The most common AEs with onset <14 days were similar to those occurring between 15-28 days and >28 days. Daptomycin appears to be safe in patients treated for >14 days.
患有复杂感染的患者可能需要接受达托霉素治疗较长时间。本回顾性分析旨在描述完成 >14 天达托霉素治疗的患者的达托霉素安全性概况。在 Cubicin(®) Outcomes Registry and Experience (CORE(®)) 2005-2009 回顾性、多中心、观察性注册研究中，对完成 >14 天达托霉素治疗的患者进行了研究。研究者采用 ICH-E2A 在完成达托霉素治疗后 30 天内的严重程度/严重性定义，评估不良事件（AE）。根据达托霉素治疗开始后≤14、15-28 和>28 天发生的 AE 对 AE 进行分组。共 2263 例患者接受 >14 天达托霉素治疗。最常见的适应证为复杂性皮肤和皮肤结构感染（25.5%）和骨髓炎（21.7%）。关于 AE，205 例（9.1%）患者在治疗开始≤14 天内发生 AE，168 例（7.4%）患者在 15-28 天内发生 AE，108 例（4.8%）患者在>28 天内发生 AE；2263 例患者中共有 389 例患者发生 814 例 AE。最常见的 AE 是血肌酸磷酸激酶（CPK）升高，49 例（2.2%）患者在治疗开始≤14 天内发生该 AE，32 例（1.4%）患者在 15-28 天内发生该 AE，10 例（0.4%）患者在>28 天内发生该 AE。在 2263 例患者中，183 例（8.1%）患者的 264 例 AE 可能与达托霉素相关。2263 例患者中有 153 例（6.8%）发生严重 AE。89 例（3.9%）患者因 AE 停用达托霉素，36 例患者因 CPK 升高而停用达托霉素。总体死亡率为 63/2263（2.8%）；4 例患者死于可能与 AE 相关的原因。治疗开始后<14 天发生的最常见 AE 与 15-28 天和>28 天发生的 AE 相似。达托霉素治疗>14 天似乎是安全的。
