Clinical evaluation of roxithromycin 300 mg once daily as an alternative to 150 mg twice daily.
A multicenter, double-blind, randomized, two-arm study was conducted to compare two dosage regimens of roxithromycin--150 mg b.i.d. and 300 mg once daily--in 1588 patients with infectious disease, 1573 of whom were evaluable for safety and 1391 for efficacy. There were no significant differences in demographic or disease characteristics at presentation. Treatment duration averaged 10 days in both groups. Clinical response rates (% satisfactory response) were similar in both arms (b.i.d. versus once daily, respectively): upper respiratory tract, 95.3 and 95.0; lower respiratory tract, 93.1 and 93.6; and skin and soft tissue, 93.1 and 93.0. Bacteriologic response was also similar. The overall incidences of adverse events were 8.5% for daily dosing and 7.2% for b.i.d. dosing, but there was a slightly greater frequency of gastrointestinal events (p less than 0.03) was observed with the once-daily regimen. Thus roxithromycin 300 mg once daily can be recommended as an effective and well-tolerated alternative to the conventional b.i.d. regimen.
Pechère
J C
JC
Faculty of Medicine, Department of Microbiology, CMU Geneva, Switzerland.
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D015575:Roxithromycin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012874:Skin Diseases, Infectious / Q000188:drug therapy*
D015575:Roxithromycin