Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance
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 surv...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-12-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.1067686/full |
| _version_ | 1811178304433029120 |
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| author | Jinyi Yuan Xiaoping Zhang Jing Chen Yueyuan Zhang Fengjia Zhu Haihui Huang |
| author_facet | Jinyi Yuan Xiaoping Zhang Jing Chen Yueyuan Zhang Fengjia Zhu Haihui Huang |
| author_sort | Jinyi Yuan |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T06:17:25Z |
| format | Article |
| id | doaj.art-6431efeb6be241ab993cabeb738815ad |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-11T06:17:25Z |
| publishDate | 2022-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-6431efeb6be241ab993cabeb738815ad2022-12-22T04:41:01ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-12-011310.3389/fphar.2022.10676861067686Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillanceJinyi Yuan0Xiaoping Zhang1Jing Chen2Yueyuan Zhang3Fengjia Zhu4Haihui Huang5Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, ChinaResearchand Development Center, Zhejiang Medicine Co., Ltd., Zhejiang, ChinaResearchand Development Center, Zhejiang Medicine Co., Ltd., Zhejiang, ChinaResearchand Development Center, Zhejiang Medicine Co., Ltd., Zhejiang, ChinaResearchand Development Center, Zhejiang Medicine Co., Ltd., Zhejiang, ChinaInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, ChinaBackground: 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.https://www.frontiersin.org/articles/10.3389/fphar.2022.1067686/fullnemonoxacinnon-fluorinated quinolonesafetypostmarketing surveillancesystematic review |
| spellingShingle | Jinyi Yuan Xiaoping Zhang Jing Chen Yueyuan Zhang Fengjia Zhu Haihui Huang Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance Frontiers in Pharmacology nemonoxacin non-fluorinated quinolone safety postmarketing surveillance systematic review |
| title | Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance |
| title_full | Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance |
| title_fullStr | Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance |
| title_full_unstemmed | Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance |
| title_short | Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance |
| title_sort | safety of oral nemonoxacin a systematic review of clinical trials and postmarketing surveillance |
| topic | nemonoxacin non-fluorinated quinolone safety postmarketing surveillance systematic review |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.1067686/full |
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