Levofloxacin 750-mg for 5 days for the treatment of hospitalized Fine Risk Class III/IV community-acquired pneumonia patients

• Published in: Respiratory medicine 2006-12, Vol.100 (12), p.2129-2136
• Main Authors: Shorr, Andrew F., Khashab, Mohammed M., Xiang, Jim X., Tennenberg, Alan M., Kahn, James B.
• Format: Article
• Language: English
• Subjects: Aged; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antimicrobial; Bacteremia - drug therapy; Biological and medical sciences; Community-Acquired Infections - drug therapy; Community-Acquired Infections - microbiology; Community-acquired pneumonia; Costs; Drug Administration Schedule; Drug dosages; Drug therapy; Efficacy; Hospitalization; Humans; Levofloxacin; Medical sciences; Middle Aged; Mortality; Ofloxacin - administration & dosage; Ofloxacin - adverse effects; Pharmacology. Drug treatments; Pneumology; Pneumonia; Pneumonia, Bacterial - drug therapy; Pneumonia, Bacterial - microbiology; Retrospective Studies; Safety; Severity of Illness Index; Streptococcus infections; Streptococcus pneumoniae - isolation & purification; Studies; Success; Symptom resolution; Treatment Outcome
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2006.03.019

The efficacy and safety of 750-mg, 5-day levofloxacin was recently shown to be comparable to 500-mg, 10-day levofloxacin in a randomized, double-blind, multicentre clinical trial for mild-to-severe community-acquired pneumonia (CAP). This subgroup analysis attempted to compare the safety and efficacy of a short-course levofloxacin regimen with traditional levofloxacin dosing for PSI Class III/IV patients. This retrospective, subgroup analysis focused on Pneumonia Severity Index Class III and IV patients enrolled in the study. Measurements included clinical and microbiological success rates, adverse events, and symptom resolution by day 3 of therapy. Of the 528 patients in the ITT population, 219 (41.5%) were categorized as PSI Class III/IV and included in this analysis. Among the clinically evaluable patients, 90.8% (69/76) of patients treated with the 750-mg regimen achieved clinical success, compared with 85.5% (71/83) treated with 500-mg levofloxacin (95% CI,−15.9 to 5.4). Eradication rates in the microbiologically evaluable population were comparable for the 750- and 500-mg regimens (88.9% vs 87.5%, respectively; 95% CI,−18.3 to 15.6). Both regimens were well tolerated and had comparable safety profiles. A greater proportion of patients in the 750-mg treatment group experienced resolution of fever (48.4% vs 34.0%; P=.046) and purulent sputum (48.4% vs 27.5%; P=.007) by day 3 of therapy. The 750-mg, 5-day levofloxacin course achieved comparable clinical and microbiologic efficacy to the 500-mg, 10-day regimen. By day 3 of therapy, a greater proportion of patients in the 750-mg group had objective and subjective resolution of fever. Further research is needed to determine the economic significance of short-course levofloxacin therapy.