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: M L Zeckel, K D Jacobson, F J Guerra, D G Therasse, D Farlow
• Journal: Clinical therapeutics (Clin Ther) 1992 Mar-Apr Vol. 14 Issue 2 Pg. 214-29 ISSN: 0149-2918 [Print] United States
• PMID: 1611645 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Cephalosporins
• Clavulanic Acids
• loracarbef
• Amoxicillin-Potassium Clavulanate Combination
• Amoxicillin

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Amoxicillin (adverse effects, therapeutic use)
• Amoxicillin-Potassium Clavulanate Combination
• Bacterial Infections (drug therapy)
• Bronchitis (drug therapy)
• Cephalosporins (adverse effects, therapeutic use)
• Chronic Disease
• Clavulanic Acids (adverse effects, therapeutic use)
• Drug Therapy, Combination (adverse effects, therapeutic use)
• Female
• Haemophilus Infections (drug therapy)
• Haemophilus influenzae
• Humans
• Male
• Middle Aged
• Moraxella catarrhalis
• Neisseriaceae Infections (drug therapy)
• Pneumococcal Infections (drug therapy)
• Single-Blind Method