■2019年美国胸科学会/美国传染病学会指南推荐呼吸道氟喹诺酮类药物治疗成人合并疾病的社区获得性细菌性肺炎(CABP)。氟喹诺酮类药物对典型和非典型病原体均有效。然而,氟喹诺酮治疗有不良反应的风险,食品和药物管理局已经发布了黑匣子安全警告。因此,氟喹诺酮类药物的住院使用减少;然而,大多数抗生素疗程都是在门诊患者中完成的,出院处方占氟喹诺酮类药物使用的大部分。因此,需要一种新的治疗方案来替代氟喹诺酮类药物.Omadacycline是一种具有广谱活性的氨甲基环素抗生素,可作为每天一次的静脉内或生物等效口服制剂获得。
■本研究通过对3期OPTIC研究(NCT02531438)的事后分析,评估了与莫西沙星相比,奥马环素治疗成人CABP患者的安全性和临床疗效。
■总共,对239例奥马环素和222例莫西沙星治疗的患者进行了评估。两组的中位年龄相似(omadacycline:57岁;莫西沙星:58岁),分别为26.0%和26.6%,分别,年龄≥65岁。使用omadacycline治疗的≥1合并症患者的早期临床反应为91.6%,使用莫西沙星治疗的患者的早期临床反应为91.4%。奥马环素组治疗后总体反应评估结果为89.1%,莫西沙星组为87.4%。
■安全警告减少了住院患者氟喹诺酮类药物的使用;然而,门诊和出院处方占氟喹诺酮类药物使用的大部分。有合并症的门诊患者需要有效的替代氟喹诺酮类药物。Omadacycline与氟喹诺酮类药物保持相似的疗效和益处,每天一次,单一疗法,生物等效的口服选择,对最常见的CABP病原体具有有效的体外活性,包括肺炎链球菌和非典型病原体,但提供了与其四环素遗产一致的实质性不同的安全概况。总之,奥马环素和莫西沙星在PSI风险级别为II/III级和合并症的患者中的疗效相似.作为成人CABP患者的口服单一疗法治疗选择,Omadacycline满足了未满足的需求。这将进一步减少氟喹诺酮类药物的使用。
■https://www.clinicaltrials.gov/study/NCT02531438,identifer:NCT02531438;https://www.临床试验登记。eu/ctr-search/search?query=2013-004071-13,标识符:EudraCT#2013-004071-13。
UNASSIGNED: 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.
UNASSIGNED: 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 post-hoc analysis of the phase 3 OPTIC
study (NCT02531438).
UNASSIGNED: 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.
UNASSIGNED: 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 in vitro activity against the most common CABP pathogens, including S. pneumoniae 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.
UNASSIGNED: https://www.clinicaltrials.gov/
study/NCT02531438, identifer: NCT02531438; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-004071-13, identifier: EudraCT #2013-004071-13.