Loracarbef, a member of the carbacephem class of
beta-lactam antibiotics, was tested in randomized, double-blind, parallel studies for the treatment of uncomplicated
urinary tract infections (UTIs). In one study conducted in the United States, a 7-day course of once-daily doses of
loracarbef (200 mg) was compared with a 7-day course of multiple daily doses of
cefaclor (250 mg three times a day). Analysis of data from a small, homogeneous patient population of 108 college-aged women showed that
loracarbef produced clinical and bacteriologic responses similar to those produced by
cefaclor. At 5-9 days posttherapy, bacteriologic cure was observed in 96% of patients in the
loracarbef group and 90% of patients in the
cefaclor group (p = 0.614); at 4-6 weeks post-
therapy, the same cure rate (81%) was observed in both groups. Analysis of the larger (333 patients) and more heterogeneous study population containing several male and elderly female patients showed that
loracarbef again produced responses similar to those produced by
cefaclor, with no statistically significant differences seen between the groups at 5-9 days or at 4-6 weeks posttherapy. The adverse events reported by the
loracarbef and
cefaclor groups were also comparable in both the small and large patient populations analyzed. Similarly favorable results were seen when a 7-day regimen of
loracarbef (200 mg once a day) was compared with a 7-day regimen of
norfloxacin (400 mg twice a day) in a large European study of approximately 300 patients with uncomplicated
cystitis. These studies demonstrate that the safety and efficacy of once-daily
loracarbef are comparable to the safety and efficacy of multiple-dose/day
therapy with other
antimicrobial agents commonly used in the treatment of uncomplicated UTIs.