The efficacy and safety of sitafloxacin and garenoxacin for the treatment of pneumonia in elderly patients: A randomized, multicenter, open-label trial
2019
Abstract Oral treatment for elderly outpatients with pneumonia is becoming increasingly important in this super-aged society from the perspective of cost-effectiveness and limited hospital capacities. We evaluated the efficacy and safety of two oral respiratory quinolones,
sitafloxacinand
garenoxacin, in elderly patients with pneumonia. This randomized, multicenter, open-label trial was conducted among patients aged ≥65 years with clinically and radiographically confirmed pneumonia in Japan. Patients were randomly assigned (1:1) to receive either
sitafloxacin(100 mg/day) or
garenoxacin(400 mg/day) for 3–10 days. The primary efficacy endpoint was the clinical cure rate at 5–10 days after the end of treatment. From December 2013 to November 2017, we enrolled 120 patients at 11 hospitals and randomly assigned 59 patients to the
sitafloxacingroup (1 patient withdrew) and 61 patients to the
garenoxacingroup. These included 30 patients with nursing and healthcare-associated pneumonia (NHCAP) (18 receiving
sitafloxacin, 12 receiving
garenoxacin) and 37 patients with
aspiration pneumonia(16 receiving
sitafloxacin, 21 receiving
garenoxacin). The clinical cure rates in the
sitafloxacinand
garenoxacingroups were 88.5% (95% confidence interval: 76.6–95.6) and 88.9% (95% confidence interval: 77.4–95.8), respectively. No significant differences were observed in the incidence rates of drug-related adverse events between the
sitafloxacin(20.7%; 12/58 patients) and
garenoxacin(27.9%; 17/61 patients) groups. The most common adverse event was
hepatic dysfunction, which occurred in seven patients in each group. We conclude that
sitafloxacinand
garenoxacinare comparably effective and safe for the treatment of pneumonia, including NHCAP and
aspiration pneumonia, in elderly patients.
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