PMID- 30616912
OWN - NLM
STAT- MEDLINE
DCOM- 20200121
LR  - 20200121
IS  - 1995-9133 (Electronic)
IS  - 1684-1182 (Linking)
VI  - 52
IP  - 5
DP  - 2019 Oct
TI  - Integrated safety summary of phase II and III studies comparing oral nemonoxacin 
      and levofloxacin in community-acquired pneumonia.
PG  - 743-751
LID - S1684-1182(18)30279-2 [pii]
LID - 10.1016/j.jmii.2018.11.006 [doi]
AB  - BACKGROUND: Nemonoxacin, a novel nonfluorinated quinolone, has broad-spectrum 
      antibacterial activity, including activity against antibiotic-resistant strains, 
      and was developed for treating community-acquired pneumonia (CAP). This report 
      provides an integrated safety summary of oral nemonoxacin from two phase II and 
      one phase III clinical studies. METHODS: Patients with mild CAP were randomized 
      for treatment with nemonoxacin 500 mg (NEMO-500MG), nemonoxacin 750 mg 
      (NEMO-750MG), or levofloxacin 500 mg (LEVO), orally, once daily, for 7-10 days. 
      Hematological, gastrointestinal, and hepatic disorders; electrocardiography 
      abnormalities; and reported quinolone-associated clinical concerns were included 
      in this analysis. RESULTS: A total of 520, 155, and 320 subjects were assigned to 
      receive NEMO-500MG, NEMO-750MG, and LEVO, respectively. The incidence of adverse 
      events (AEs) was the highest (54.8%) in the NEMO-750MG group (NEMO-500MG, 36.9%; 
      NEMO-750MG, 54.8%; LEVO, 39.7%) and that of drug-related AEs was comparable 
      between the three groups (NEMO-500MG, 22.9%; NEMO-750MG, 31.0%; LEVO, 22.5%). The 
      majority (>80%) of the patients showed mild drug-related AEs and the distribution 
      based on severity was similar between the groups. The most commonly reported 
      drug-related AEs included neutropenia (NEMO-500MG, 2.5%; NEMO-750MG, 8.4%; LEVO, 
      4.4%), nausea (NEMO-500MG, 2.5%; NEMO-750MG, 7.1%; LEVO, 2.5%), leukopenia 
      (NEMO-500MG, 2.3%; NEMO-750MG, 4.5%; LEVO, 3.1%), and increased alanine 
      aminotransferase level (NEMO-500MG, 4.4%; NEMO-750MG, 0%; LEVO, 2.5%). 
      CONCLUSION: Nemonoxacin was well tolerated and no clinically significant safety 
      concerns were identified, suggesting that it possesses a desirable safety and 
      tolerability profile similar to that of levofloxacin, and may be a suitable 
      alternative to fluoroquinolones for treating patients with CAP.
CI  - Copyright (c) 2019. Published by Elsevier B.V.
FAU - Cheng, Shih-Lung
AU  - Cheng SL
AD  - Department of Internal Medicine, Far-Eastern Memorial Hospital, Taipei, Taiwan; 
      Department of Chemical Engineering and Materials Science, Yuan Ze University, 
      Taoyuan, Taiwan.
FAU - Wu, Ren-Guang
AU  - Wu RG
AD  - Department of Chest Medicine, Cheng-Ching General Hospital, Taichung, Taiwan.
FAU - Chuang, Yin-Ching
AU  - Chuang YC
AD  - Department of Medical Research, Chi-Mei Medical Center, Tainan, Taiwan.
FAU - Perng, Wann-Cherng
AU  - Perng WC
AD  - Division of Pulmonary Medicine, Department of Internal Medicine, Tri-Service 
      General Hospital, Taipei, Taiwan.
FAU - Tsao, Shih-Ming
AU  - Tsao SM
AD  - Division of Chest Medicine, Department of Internal Medicine, Chung-Shan Medical 
      University Hospital, Taichung, Taiwan.
FAU - Chang, Yu-Ting
AU  - Chang YT
AD  - TaiGen Biotechnology Co., Ltd., Taipei, Taiwan.
FAU - Chang, Li-Wen
AU  - Chang LW
AD  - TaiGen Biotechnology Co., Ltd., Taipei, Taiwan.
FAU - Hsu, Ming-Chu
AU  - Hsu MC
AD  - TaiGen Biotechnology Co., Ltd., Taipei, Taiwan. Electronic address: 
      jennychang@taigenbiotech.com.tw.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20181221
PL  - England
TA  - J Microbiol Immunol Infect
JT  - Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi
JID - 100956211
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Fluoroquinolones)
RN  - 0 (Quinolones)
RN  - 6GNT3Y5LMF (Levofloxacin)
RN  - P94L0PVO94 (nemonoxacin)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/administration & dosage/therapeutic use
MH  - China
MH  - Community-Acquired Infections/*drug therapy
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Fluoroquinolones/therapeutic use
MH  - Humans
MH  - Levofloxacin/administration & dosage/*therapeutic use
MH  - Lung Diseases/drug therapy
MH  - Male
MH  - Middle Aged
MH  - Pneumonia/*drug therapy
MH  - Quinolones/administration & dosage/*therapeutic use
MH  - *Safety
MH  - South Africa
MH  - Taiwan
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Community-acquired pneumonia
OT  - Fluoroquinolone
OT  - Levofloxacin
OT  - Nemonoxacin
OT  - Safety
EDAT- 2019/01/09 06:00
MHDA- 2020/01/22 06:00
CRDT- 2019/01/09 06:00
PHST- 2018/08/20 00:00 [received]
PHST- 2018/10/19 00:00 [revised]
PHST- 2018/11/14 00:00 [accepted]
PHST- 2019/01/09 06:00 [pubmed]
PHST- 2020/01/22 06:00 [medline]
PHST- 2019/01/09 06:00 [entrez]
AID - S1684-1182(18)30279-2 [pii]
AID - 10.1016/j.jmii.2018.11.006 [doi]
PST - ppublish
SO  - J Microbiol Immunol Infect. 2019 Oct;52(5):743-751. doi: 
      10.1016/j.jmii.2018.11.006. Epub 2018 Dec 21.