Vol.54 No.1 January 2006
Evaluation of efficacy and safety of gatifloxacin for secondary infection in patients with chronic respiratory disease
Second Department of Internal Medicine, Nagasaki University, School of Medicine, 1-7-1 Sakamoto, Nagasaki, Japan
Abstract
The new quinolone antimicrobial drug gatifloxacin (GFLX) was reported to cause adverse effects in patients with abnormal blood sugar levels after it had been placed on the market (in Japan) in June 2002, and GFLX became counterindicated in diabetic patients in March 2003. Nevertheless, it is still recommended by the Japanese Respiratory Society guidelines as a "respiratory quinolone" because of its excellent antimicrobial activity and expectoration. Moreover, the AUC/MIC of GFLX for pneumococcus is 74.4 at 200 mg b.i.d. (400 mg/day) and 35.9 (age< 65years) and 97.2 (age>65 years) at 100 mg b.i.d. (200 mg/day). Based on these results, the treatment of senior citizens at a dose of 200 mg/day was thought to be feasible.
Subsequently, a clinical study was undertaken to establish the efficacy of a GFLX dose of 200 mg/day for the treatment of secondary infections in senior citizens (age>65 years) chronic respiratory illnesses to determine if the effectiveness was equal to treat of 400 mg/day in non-senior citizens.
Fifty-two patients were enrolled in this study, and 32 of these patients were evaluated between November 2004 and March 2005 at our university hospital or surrounding clinics. The clinical efficacy of GFLX was 87.0% (20/23) in senior citizens and 88.9% (8/9) non-senior citizens, for an overall efficacy of 87.5% (28/32). The bacteriological clinical efficacy of GFLX was concluded to be equivalent in both groups. Moreover, only three adverse events occurred: one in the senior citizen and two in the non-senior citizen group. These adverse events were generally mild in nature. Abnormal lab results were also seen in four patients: two in the senior citizen group and two in the non-senior citizen group.
The present study suggests that GFLX at a dose of 200 mg/day is equally safe and effective as a dose of 400 mg/day for the treatment of secondary infections resulting from chronic respiratory disease in both senior citizens and non-senior citizens.
Key word
gatifloxacin, chronic respiratory tract infection, elderly patient or senior citizen
Received
October 11, 2005
Accepted
December 6, 2005
Jpn. J. Chemother. 54 (1): 31-38, 2006
