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决策分析:住院社区获得性细菌性肺炎且有艰难梭菌感染风险患者中,奥马环素相对于莫西沙星的疗效。

Decision Analysis: Omadacycline Relative to Moxifloxacin Among Hospitalized Community-Acquired Bacterial Pneumonia Patients at Risk of Clostridioides difficile Infection.

机构信息

Albany College of Pharmacy and the Health Sciences, 106 New Scotland Avenue, Albany, NY, 12189, USA.

PAREXEL Access Consulting, London, UK.

出版信息

Clin Drug Investig. 2021 Mar;41(3):269-275. doi: 10.1007/s40261-021-01005-w. Epub 2021 Feb 19.

Abstract

UNLABELLED

BACKGROUND AND OBJECTIVE: Omadacycline is an aminomethylcycline antibiotic approved in the USA as once-daily intravenous/oral monotherapy for adults with community-acquired bacterial pneumonia (CABP). Omadacycline demonstrated noninferiority to the fluoroquinolone moxifloxacin in a phase III CABP trial; adverse-event rates were similar between treatment groups except for Clostridioides difficile infection (CDI), which occurred in 2% of moxifloxacin-treated patients and 0% of patients on omadacycline. Conceptual healthcare-decision analytic models were developed to better understand the economic implications of antibiotic selection and CDI risk in acute-care facilities.

METHODS

A conceptual healthcare-decision analytic model was created to estimate incremental costs associated with treating 100 hospitalized CABP patients with an initial 5-day inpatient regimen of omadacycline instead of moxifloxacin. The underlying model assumption was that treatment with omadacycline has the potential to reduce CDI events relative to moxifloxacin. The model included excess costs associated with each treatment group from admission through discharge. Attributable CDI cost per case in the moxifloxacin group varied from $15,000 to $45,000 (US$). Omadacycline acquisition cost was $300-600/day for 5 days.

RESULTS

At a CDI attributable cost per case of $30,000 (base-case analyses), the incremental treatment cost (US$) per 100 patients ranged from $300,000 to $- 120,000 (cost savings). The excess CDI incidence in moxifloxacin-treated patients would need to be 5-10% for omadacycline to be cost-saving, assuming the attributable CDI cost is approximately $30,000.

CONCLUSION

Targeted omadacycline use may reduce economic burden associated with hospitalized CABP patients treated with moxifloxacin if it can reduce excess cases of moxifloxacin-associated CDI.

摘要

背景和目的

奥马环素是一种氨甲基环素抗生素,已获美国批准,可作为每日一次的静脉/口服单药疗法,用于治疗成人社区获得性细菌性肺炎(CABP)。在一项 III 期 CABP 试验中,奥马环素与氟喹诺酮类药物莫西沙星相比显示出非劣效性;除艰难梭菌感染(CDI)外,两组治疗的不良事件发生率相似,莫西沙星组有 2%的患者发生 CDI,奥马环素组无患者发生 CDI。为了更好地了解急性护理机构中抗生素选择和 CDI 风险的经济影响,开发了概念性医疗保健决策分析模型。

方法

创建了一个概念性医疗保健决策分析模型,以估计用奥马环素替代莫西沙星治疗 100 例住院 CABP 患者初始 5 天住院方案相关的增量成本。该模型的基本假设是,与莫西沙星相比,奥马环素治疗可能会降低 CDI 事件的发生。该模型包括每个治疗组从入院到出院的额外成本。莫西沙星组每个病例归因于 CDI 的成本从 15000 美元到 45000 美元不等(美元)。奥马环素的购买成本为每天 300-600 美元,共 5 天。

结果

在归因于 CDI 的每个病例成本为 30000 美元的情况下(基本分析),100 例患者的增量治疗成本(美元)范围为 300000 美元至-120000 美元(节省成本)。如果奥马环素可以降低莫西沙星相关 CDI 的额外病例数,则莫西沙星治疗患者的 CDI 发生率需要增加 5-10%,假设归因于 CDI 的成本约为 30000 美元。

结论

如果奥马环素可以降低莫西沙星相关 CDI 的额外病例数,则针对奥马环素的使用可能会降低接受莫西沙星治疗的住院 CABP 患者的经济负担。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25c8/8079290/a92f0b7537ed/40261_2021_1005_Fig1_HTML.jpg

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