In an attempt to confirm the appropriateness of the expected clinical dose of telithromycin (TEL), a ketolide antibiotic, in Japan, the clinical efficacy and safety of TEL 600 mg once daily (600 mg group) and TEL 800 mg once daily (800 mg group) against community-acquired pneumonia were investigated in a double-blind, randomized, two-arm parallel-group, non-inferiority, comparative study. Obtained results were as follows. 1. Clinical efficacy. The number of subjects in population for analysis was 91 cases. The efficacy rate excluding 1 indeterminate case was respectively 92.9% (39/42) in 600 mg group and 95.8% (46/48) in 800 mg group, and there was no significant difference between groups. The ratio of "not-relapsed/not reinfected" who did not receive a subsequent antibiotic after completion of study drug treatment to 87 cases who did undergo "relapse/infection" investigation was respectively 85.0% (34/40) in 600 mg group and 85.1% (40/47) in 800 mg group, and no significant difference was observed between groups. 2. Bacteriological efficacy. The number of subjects in population for analysis of bacteriological efficacy was 90 cases. The eradication rate excluding 53 indeterminate cases was 92.9% (13/14) in 600 mg group and 95.7% (22/23) in 800 mg group. Streptococcus pneumoniae including penicillin- or erythromycin-resistant strains were all eradicated in either treatment group. 3. Safety. The number of subjects in population for safety analysis was 103 cases. The incidence rate of adverse events (including abnormal changes in clinical laboratory variables) was 41.3% (19/46) in 600 mg group and 57.4% (27/47) in 800 mg group. The incidence for which a causal relationship to study medication could not be ruled out (excluding indeterminate 10 cases) was 34.8% (16/46) in 600 mg group and 50.0 % (23/46) in 800 mg group. The clinical and bacteriological efficacy in pneumonia was nearly comparable between both groups and no significant difference was not observed between groups. In the "non-relapse/non-reinfection" rate after the confirmation of final cure assessment, no significant difference was observed between groups. On the other hand, the incidence rate of adverse events (including abnormal change of clinical laboratory variables) was 41.3% (19/46) in 600 mg group and 57.4% (27/47) in 800 mg group, and there was no significant difference between groups. However, the incidence rate of side effects in 800 mg group was higher than that of 600 mg group by 15% or more, and so 600 mg was to be recommended from the aspect of safety. In conclusion, based on the efficacy and safety results, it was suggested that the appropriate recommended optimum clinical dose of TEL in Japan was 600 mg once daily.
|Number of pages||15|
|Journal||Japanese Journal of Chemotherapy|
|Issue number||SUPPL. 1|
|Publication status||Published - 2003|
ASJC Scopus subject areas
- Pharmacology (medical)