Ten-day, double-blind, randomized, parallel treatment regimens of
loracarbef (200 mg
capsule twice daily or 15 mg/kg/day oral
suspension in two divided doses up to a maximum of 375 mg/day; n = 169) and
penicillin V (250 mg
capsule four times daily or 20 mg/kg/day
suspension in four divided doses up to a maximum of 500 mg/day; n = 175) were compared in the treatment of group A beta-haemolytic streptococcal (GABHS)
pharyngitis and
tonsillitis. Post-
therapy clinical responses were similar for evaluable patients in both treatment groups: 97.4% of the
loracarbef group (101/115 patients cured and 11/115 improved) and 96.0% of the
penicillin group (101/124 patients cured and 18/124 improved). A statistically significant difference in the pathogen elimination rate was noted between treatment groups: post-
therapy throat cultures were negative for GABHS in 94.8% (109/115) of
loracarbef-treated patients compared with 87.1% (108/124) of
penicillin-treated patients (p = 0.040).
Loracarbef and
penicillin V were comparable in terms of safety.
Headache and
nausea/
vomiting were the most common events reported during
therapy (
nausea/
vomiting were slightly less common in the
loracarbef group). Three patients in each group were discontinued from the study due to
drug-related adverse events; one due to
rash in the
loracarbef group and one due to
rash and one due to
vomiting in the
penicillin group. These data support the conclusion that
loracarbef twice daily is more effective in eradicating GABHS than
penicillin V four times daily, and the two drugs are comparable in safety and clinical efficacy in the treatment of GABHS
pharyngitis and
tonsillitis.