&lt;p&gt;Efficacy and Safety of Nemonoxacin in Outpatients with Community-Acquired Pneumonia&lt;/p&gt;

Zhao, Bo; Yu, Xiaoxu; Chen, Rui; Zheng, Rui

doi:10.2147/idr.s248092

Cited by 5 publications

(2 citation statements)

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“…We included three Phase II/III comparator studies with levofloxacin conducted in South Africa, Chinese mainland, and Taiwan, one Phase IV study, two postmarketing PK studies, four observational studies (the results of two studies have been published) (Zhao et al, 2020;Wenjin et al, 2021), and data from nearly 257,420 patients from an ADR monitoring report from Mainland China (Table 1). Additionally, no single case of adverse reactions was reported.…”

Section: Resultsmentioning

confidence: 99%

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Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

et al. 2022

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Background: Postmarketing safety analysis is an effective supplement for new drugs in clinical practice. Therefore, we aimed to systematically assess the safety of oral nemonoxacin malate, the first approved C-8-methoxy non-fluorinated quinolone, in clinical studies and via postmarketing safety surveillance.Methods: We electronically and manually searched and screened safety data (including premarketing and postmarketing data) of oral nemonoxacin from clinical registries. We standardized and summarized the reported adverse events according to the Medical Dictionary for Regulatory Activities System Organ Class and Preferred Terms. We summarized and reported the number and frequency (%) of the AEs and serious AEs in patients with community-acquired pneumonia and in specific patients.Results: Three Phase II/III comparator studies (n = 670, nemonoxacin), one Phase IV study (n = 461), two special population pharmacokinetic studies (n = 40), four observational studies (n = 1,852), and one 5-year postmarketing surveillance project (n = 257,420) were included in this study. The Phase II/III studies showed that the commonly reported drug-related AEs were similar for oral 500 mg nemonoxacin and levofloxacin treatments, which mainly included increased alanine aminotransferase levels (4.4% vs. 2.5%), neutropenia (2.5% vs. 4.4%), nausea (2.5% vs. 1.6%), and leukopenia (2.3% vs. 3.2%). No drug-related deaths were reported. Postmarketing safety surveillance revealed that known adverse drug reaction characteristics were generally unchanged. Pharmacokinetic data suggested that dose adjustment was not necessary in elderly patients, which was confirmed by a Phase IV study in an elderly population, in patients with renal impairment with CLcr ≥50 ml/min, and in those with mild-to-moderate hepatic impairment.Conclusion: Clinical trial data of approximately 1,450 patients and postmarketing data of >257,420 patients suggest that nemonoxacin is generally well tolerated and can be a suitable alternative to fluoroquinolones for patients with CAP.

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Section: Resultsmentioning

confidence: 99%

“…A total of 1852 patients from four studies (14 patients were lost during the follow-up period) treated with 500 mg qd from 2017 to 2020 were identified (Zhao et al, 2020;Wenjin et al, 2021). Twenty-three (1.25%) ADRs, including mild nausea, pruritus, and rash, were reported (Table 4).…”

Section: Observational Studiesmentioning

confidence: 99%

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

et al. 2022

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Nemonoxacin

2020

Reactions Weekly

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The remaining unsolved problems for rational antibiotic therapy use in pediatric community-acquired pneumonia

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Argentiero

et al. 2022

Expert Opinion on Pharmacotherapy

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<p>Efficacy and Safety of Nemonoxacin in Outpatients with Community-Acquired Pneumonia</p>

Abstract: Purpose: To evaluate the efficacy and safety of 500 mg of nemonoxacin administered orally once daily to outpatients with community-acquired pneumonia (CAP). Patients and Methods: Patients with CAP who received nemonoxacin monotherapy were selected from outpatients who visited the

Cited by 5 publications

References 18 publications

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

Nemonoxacin

The remaining unsolved problems for rational antibiotic therapy use in pediatric community-acquired pneumonia

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