Clinical studies of gatifloxacin for infections in internal medicine
Keywords:
gatifloxacin
2002 Volume 50 Issue 10 Pages 646-673
Details
2002 Volume 50 Issue 10 Pages 646-673
We conducted3open label clinical studies, a randomized, double-blinded dose-finding study, and 2 randomized, double-blinded clinical studies of gatifloxacin (GFLX), from January1992to October1998, for the treatment of infections in the field of internal medicine, and published results of individual studies in earlier issues of this journal.Recollation of case reports with source data has shown the necessity of some corrections in published papers. We therefore report collectively results based on our reanalysis of all data.
1. 3open label clinical studies Clinical effectiveness of GFLX for pneumonia, chronic bronchitis (acute exacerbation), bronchiectasis with infection, and chronic respiratory diseases with secondary infection was 91.8%(78/85), 93.8%(61/65), 92.1%(35/38), and97.0%(32/33).
2.Randomized, double-blinded dose-finding study
Clinical effectiveness in groups L (100mgb.i.d), M (150mgb.i.d), and H (200mgb.i.d) was97.1%(33/34), 86.7%(26/30), and 94.3%(33/35).No significant difference was seen among groups.A daily dosage of 200mg b.i.d. of GFLX was considered optimal for treatment of chronic respiratory tract infections.
3. 2 double-blinded comparative studies
1) GFLX and levofloxacin (LVFX) in pneumonia Clinical effectiveness was 98.0%(97/99) in the GFLX group and 94.9%(94/99) in the LVFX group. The clinical equivalency of GFLX to LVFX was confirmed at Δ=10% in effectiveness.
2) GFLX and LVFX in chronic respiratory tract infections Clinical effectiveness was 98.9%(91/92) in the GFLX group and 78.7%(70/89) in the LVFX group. The clinical equivalency of GFLX to LVFX was confirmed at Δ=10%in effectiveness, and the difference in effectiveness between groups was significant.
4.Clinical pharmacokinetics and penetration into sputum
Individual maximum concentrations of GFLX in sputum ranged from 1.45 to 7.11, ug/mL in patients with chronic respiratory tract infection.Penetration into sputum ranged from 1.09 to 6.25 against the concentration in serum.
In conclusion, results were consistent with those published, and indicate that GFLX is one of the most highly effective drugs for the treatment of respiratory tract infections.
