Rodriguez George D, Warren Nathan, Yashayev Roman, Chitra Surya, Amodio-Groton Maria, Wright Kelly
Division of Antimicrobial Stewardship, New York-Presbyterian Queens, Flushing, NY, United States.
Columbia University School of Nursing, New York, NY, United States.
Front Med (Lausanne). 2023 Jul 28;10:1225710. doi: 10.3389/fmed.2023.1225710. eCollection 2023.
The 2019 American Thoracic Society/Infectious Disease Society of America guidelines recommend respiratory fluoroquinolones to treat community-acquired bacterial pneumonia (CABP) in adults with comorbidities. Fluoroquinolones are effective against both typical and atypical pathogens. However, fluoroquinolone treatment has a risk of adverse effects, and the Food and Drug Administration has issued black box safety warnings for their use. Inpatient use of fluoroquinolones has reduced as a result; however, most antibiotic courses are completed as outpatients and discharge prescriptions account for the majority of fluoroquinolone use. As such, a new treatment option is needed to replace fluoroquinolones. Omadacycline is an aminomethylcycline antibiotic with a broad spectrum of activity and is available as a once-daily intravenous or bioequivalent oral formulation.
This study assessed the safety and clinical efficacy of omadacycline compared with moxifloxacin for the treatment of adult CABP patients with Pneumonia Severity Index (PSI) risk class II/III and ≥1 comorbidity through a analysis of the phase 3 OPTIC study (NCT02531438).
In total, 239 omadacycline- and 222 moxifloxacin-treated patients were assessed. The median age was similar between groups (omadacycline: 57 years; moxifloxacin: 58 years), with 26.0% and 26.6%, respectively, ≥65 years of age. Early clinical response was 91.6% for patients with ≥1 comorbidity treated with omadacycline and 91.4% for those treated with moxifloxacin. Post-treatment evaluation results for overall response were 89.1% in the omadacycline group and 87.4% in the moxifloxacin group.
Safety warnings have reduced inpatient use of fluoroquinolones; however, outpatient and discharge prescriptions account for the majority of fluoroquinolone use. Outpatients with comorbidities need an efficacious alternative to fluoroquinolones. Omadacycline maintains the similar efficacy and benefits of fluoroquinolones as a once-daily, monotherapy, bioequivalent oral option with potent activity against the most common CABP pathogens, including and atypical pathogens, but offers a materially different safety profile consistent with its tetracycline heritage. In conclusion, both omadacycline and moxifloxacin exhibited similar efficacy in patients with PSI risk class II/III and comorbidities. Omadacycline fulfills an unmet need as an oral monotherapy treatment option for adult patients with CABP, which will further reduce the use of fluoroquinolones.
https://www.clinicaltrials.gov/study/NCT02531438, identifer: NCT02531438; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-004071-13, identifier: EudraCT #2013-004071-13.
2019年美国胸科学会/美国传染病学会指南推荐使用呼吸喹诺酮类药物治疗合并症成人社区获得性细菌性肺炎（CABP）。喹诺酮类药物对典型病原体和非典型病原体均有效。然而，喹诺酮类药物治疗存在不良反应风险，美国食品药品监督管理局已针对其使用发布黑框安全警告。因此，住院患者对喹诺酮类药物的使用有所减少；然而，大多数抗生素疗程是在门诊完成的，出院处方占喹诺酮类药物使用的大部分。因此，需要一种新的治疗选择来替代喹诺酮类药物。奥马环素是一种具有广泛活性谱的氨基甲基环素类抗生素，有每日一次的静脉注射剂型或生物等效的口服剂型。
本研究通过对3期OPTIC研究（NCT02531438）进行分析，评估了奥马环素与莫西沙星治疗肺炎严重程度指数（PSI）风险等级为II/III且合并≥1种疾病的成人CABP患者的安全性和临床疗效。
总共评估了239例接受奥马环素治疗和222例接受莫西沙星治疗的患者。两组的中位年龄相似（奥马环素组：57岁；莫西沙星组：58岁），分别有26.0%和26.6%的患者年龄≥65岁。合并≥1种疾病且接受奥马环素治疗的患者早期临床缓解率为91.6%，接受莫西沙星治疗的患者为91.4%。治疗后总体缓解的评估结果在奥马环素组为89.1%，在莫西沙星组为87.4%。
安全警告减少了住院患者对喹诺酮类药物的使用；然而，门诊和出院处方占喹诺酮类药物使用的大部分。合并症门诊患者需要一种有效的喹诺酮类替代药物。奥马环素作为一种每日一次的单药治疗、生物等效的口服选择药物，对包括典型和非典型病原体在内的最常见CABP病原体具有强大活性，维持了与喹诺酮类药物相似的疗效和益处，但具有与其四环素类药物传统相符的显著不同的安全性。总之，奥马环素和莫西沙星在PSI风险等级为II/III且合并症的患者中表现出相似的疗效。奥马环素满足了成人CABP患者口服单药治疗选择这一未被满足的需求，这将进一步减少喹诺酮类药物的使用。
