1. Integrated safety summary of phase II and III studies comparing oral nemonoxacin and levofloxacin in community-acquired pneumonia
- Author
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Yin-Ching Chuang, Ren-Guang Wu, Yu-Ting Chang, Wann-Cherng Perng, Shih-Ming Tsao, Shih-Lung Cheng, Li-Wen Chang, and Ming-Chu Hsu
- Subjects
0301 basic medicine ,Lung Diseases ,Male ,lcsh:QR1-502 ,Administration, Oral ,Levofloxacin ,Quinolones ,Gastroenterology ,lcsh:Microbiology ,chemistry.chemical_compound ,South Africa ,0302 clinical medicine ,Community-acquired pneumonia ,Immunology and Allergy ,030212 general & internal medicine ,skin and connective tissue diseases ,Aged, 80 and over ,Leukopenia ,General Medicine ,Middle Aged ,Anti-Bacterial Agents ,Community-Acquired Infections ,Drug Combinations ,Infectious Diseases ,Treatment Outcome ,Tolerability ,Female ,medicine.symptom ,Safety ,medicine.drug ,Fluoroquinolones ,Microbiology (medical) ,Adult ,medicine.medical_specialty ,congenital, hereditary, and neonatal diseases and abnormalities ,China ,Adolescent ,Nausea ,030106 microbiology ,Taiwan ,Neutropenia ,03 medical and health sciences ,Young Adult ,Double-Blind Method ,Internal medicine ,medicine ,Humans ,Adverse effect ,Aged ,General Immunology and Microbiology ,business.industry ,Pneumonia ,medicine.disease ,chemistry ,business ,Nemonoxacin - Abstract
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. Keywords: Community-acquired pneumonia, Fluoroquinolone, Levofloxacin, Nemonoxacin, Safety
- Published
- 2018