title: Loracarbef (LY163892) versus amoxicillin/clavulanate in the treatment of acute bacterial exacerbations of chronic bronchitis.
abstract: In this single-blind study, 579 patients with chronic bronchitis were randomly assigned to receive 400 mg of loracarbef twice daily or 500/125 mg of amoxicillin/clavulanate thrice daily for seven days. Treatment efficacy was evaluated in 129 of the loracarbef-treated patients and 120 amoxicillin/clavulanate-treated patients in whom pretreatment positive cultures of pathogens susceptible to both antibiotics were isolated. Three organisms predominated in either pure or mixed cultures in 57.0% of the evaluable patients: Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella (Branhamella) catarrhalis; H influenzae was isolated in 25.0% of the patients with single pathogens. Among the evaluable patients, favorable clinical responses (cure or improvement) were noted in 93.8% of the loracarbef-treated patients and in 95.0% of the amoxicillin/clavulanate-treated patients. A favorable bacteriologic response (pathogen eliminated or presumed eliminated) was found in 82.2% of loracarbef-treated patients and 90.0% of amoxicillin/clavulanate-treated patients. Six patients in the loracarbef group and 14 in the amoxicillin/clavulanate group discontinued treatment because of adverse events. The events were judged to be drug related in four loracarbef-treated patients and in 11 amoxicillin/clavulanate-treated patients. The incidence of diarrhea and other gastrointestinal symptoms was significantly more frequent in the amoxicillin/clavulanate group (13.5% and 5.6%) than in the loracarbef group (4.5% and 1.7%), while the incidence of severe headaches was significantly more frequent in the loracarbef than the amoxicillin/clavulanate group (7.2% vs 3.1%). It is concluded that loracarbef and amoxicillin/clavulanate are safe and effective in the treatment of acute bacterial exacerbations of chronic bronchitis.
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: M L
authors.initials: ML
authors.lastname: Zeckel
authors.forename: K D
authors.initials: KD
authors.lastname: Jacobson
authors.forename: F J
authors.initials: FJ
authors.lastname: Guerra
authors.forename: D G
authors.initials: DG
authors.lastname: Therasse
authors.forename: D
authors.initials: D
authors.lastname: Farlow
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D001424:Bacterial Infections / Q000188:drug therapy*; D001991:Bronchitis / Q000188:drug therapy*; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D002969:Clavulanic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006192:Haemophilus Infections / Q000188:drug therapy; D006193:Haemophilus influenzae; D006801:Humans; D008297:Male; D008875:Middle Aged; D001936:Moraxella catarrhalis; D016870:Neisseriaceae Infections / Q000188:drug therapy; D011008:Pneumococcal Infections / Q000188:drug therapy; D016037:Single-Blind Method
chemical_list: D002511:Cephalosporins; D002969:Clavulanic Acids; C054920:loracarbef; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin