ly-163892 and Urinary-Tract-Infections

The efficacy and safety of the antibiotic loracarbef have been demonstrated in a series of 22 clinical trials involving over 9,000 patients. The data compiled from these trials indicate that loracarbef is well tolerated by the majority of patients, including children and elderly patients. Most adverse events in patients receiving loracarbef were mild and transient in nature; only 1.5% of patients discontinued therapy because of drug-related adverse events. The frequency of adverse events associated with this agent compares favorably with that reported for the other antibiotics in these trials. The most commonly reported adverse reaction in the loracarbef study group was diarrhea, but this condition occurred less frequently in patients who received loracarbef than in those treated with the comparative agents. Other gastrointestinal events, such as nausea and vomiting, were reported infrequently. Headache was the second most common adverse event reported and occurred at a slightly higher frequency in the loracarbef-treated group than in patients receiving comparative antibiotics. No clinically significant alterations in laboratory parameters or gastrointestinal flora were observed following loracarbef administration. The compiled data indicate that loracarbef is a safe therapeutic option for the treatment of a wide spectrum of bacterial infections.

Topics: Adult; Adverse Drug Reaction Reporting Systems; Aged; Cephalosporins; Child; Diarrhea; Headache; Humans; Incidence; Intestines; Respiratory Tract Infections; Skin Diseases, Infectious; Urinary Tract Infections

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.

Topics: Cefaclor; Cephalosporins; Clinical Trials as Topic; Europe; Female; Humans; Male; Norfloxacin; United States; Urinary Tract Infections

In a double-blind, prospective, randomized study, 108 college women with acute urinary tract infections were treated for 7 days with either loracarbef (LY163892) at 200 mg once daily (n = 53) or cefaclor at 250 mg three times daily (n = 55). The cure rates at 5 to 9 days after treatment in the loracarbef and cefaclor groups were 96 and 90%, respectively. Both loracarbef and cefaclor are safe, well tolerated, and effective in the treatment of urinary tract infections in women.

Topics: Cefaclor; Cephalosporins; Double-Blind Method; Female; Humans; Urinary Tract Infections

Topics: Adult; Cephalosporins; Child; Clinical Trials as Topic; Costs and Cost Analysis; Humans; Microbial Sensitivity Tests; Respiratory Tract Infections; Skin Diseases, Infectious; Urinary Tract Infections

Minimum inhibitory concentrations of cefixime, cefaclor and loracarbef have been determined against 200 strains of bacteria, representing a wide selection of species causing urinary infections. Cefixime was poorly active against Gram-positive species, but was active (MIC90 less than 2 mg/l) against almost all the Gram-negative pathogens tested (except Pseudomonas aeruginosa), and particularly so against Klebsiella pneumoniae and members of the tribe Proteae. Cefaclor and loracarbef were more active against the Gram-positive species than was cefixime, but had a less broad spectrum against the Gram-negative species. Cefixime use seems more appropriate in nosocomial than in domiciliary urinary infections.

Topics: Anti-Infective Agents, Urinary; Bacteria; Cefaclor; Cefixime; Cefotaxime; Cephalosporins; Humans; Microbial Sensitivity Tests; Urinary Tract Infections