Vol.67 No.1 January 2019
Review of safety and efficacy of garenoxacin based on data from postmarketing surveillance
1)Scientific Information Department, Toyama Chemical Co., Ltd., 4-1 Shimookui 2-chome, Toyama, Japan
2)Scientific Information Department, Toyama Chemical Co., Ltd.
3)Department of Infection Diasese and Infection Control, Jikei University School of Medicine
4)Institute of Development, Aging and Cancer, Tohoku University Research Division for Development of Anti-Infective Agents
5)President, Nagasaki University; Emeritus Professor of the Second Department of Internal Medicine, Nagasaki University School of Medicine
Abstract
The safety and efficacy of garenoxacin (GRNX) was evaluated by combined analysis of the data collected from four postmarketing surveillance studies. Especially the safety and efficacy of the drug in elderly patients were evaluated.
The incidence of adverse drug reactions (ADRs), including of abnormal laboratory values, in elderly patients was 4.75% (130/2,739). The patient demographic characteristics affecting the incidence of ADRs were the inpatient/outpatient status of the patient, diagnosis, presence/absence of liver function impairment, presence/absence of renal function impairment, presence/absence of drug allergy, use/non-use of antimicrobials in advance, and concomitant use/non-use of antimicrobials. However, no specific ADRs were associated with any demographic characteristics in the elderly patients Neither the types nor the incidence of ADRs differed between elderly patients and non-elderly patients.
The efficacy rate at the end of treatment in elderly patients was 93.9% (2,345/2,498), and exceeded 90% in all cases where the indications were respiratory tract infections or otorhinolaryngological infections. The efficacy rate was 90.5% (363/401) in elderly patients with chronic respiratory tract disease as an underlying disease/complication, and 90.1% (173/192) in patients with the risk of aspiration. The adult pneumonia clinical practice guideline published in 2017 recommends use of respiratory quinolones as the drugs of first choice for the treatment of pneumonia.
These results indicate that GRNX, a respiratory quinolone, can be a useful antimicrobial drug for the treatment of elderly patients with respiratory tract infections and otorhinolaryngological infections.
Key word
garenoxacin, postmarketing surveillance study, elder patients, safety, efficacy
Received
December 25, 2017
Accepted
July 13, 2018
Jpn. J. Chemother. 67 (1): 57-75, 2019
