Safety and Efficacy of Lomefloxaciri Versus Cefaclor in the Treatment of Acute Exacerbations of Chronic Bronchitis MARK
H.
GOTFRIED,
M.D.,
Phoenix, Arizona,
W. TRAVIS
ELLISON,
M.D.,
In two multicenter trials, lomefloxacin and cefaclor were compared as treatments for acute bacterial exacerbations of chronic bronchitis. In total, 522 adult outpatients were enrolled at 50 centers in the United States. Patients were randomized to treatment groups receiving either 400 mg lomefloxacin orally once daily (n = 259) or 260 mg cefaclor every 8 hours (n = 263) for 7-10 days. Both groups were comparable in terms of age, severity of exacerbation, smoking history, theophylline use, and baseline pathogens. The most common baseline pathogens were Haemophilus influenzae, found in 32% of patients in the lomefloxacin group and in 29% in the cefaclor group, Pseudomonas aeruginosa (13% and 16%, respectively), Moraxella (Branhamella) catarrhalis (12% and 13%), and Streptococcus pneumoniae (10% in both groups). Bacterial eradication rates l-4 days after the completion of treatment for all patients with baseline pathogens were 81.8% in the lomefloxacin group and 62.7% in the cefaclor group (p , and within 4 days after completing treatment (visit 3). A medical history and chest radiograph were performed at visit 1, and complete physical examinations were performed at visits 1 and 3. Clinical evaluations, clinical laboratory testing (hematology, chemistry, and urinalysis), and sputum specimens for culture and susceptibility testing were collected at all visits. Sputum Gram stains were optional. Serum theophylline levels were monitored in those patients who took theophylline compounds. Bacteriologic and clinical outcomes were computed by comparing the data obtained at the pretreatment visit to that obtained at the final visit. Bacteriologic “eradication” was subcategorized and defined as “cure” (eradication of the pathogens isolated at baseline), or “cure with superinfection” (eradication of the baseline pathogen with a new pathogen isolated at the final visit). If a sputum specimen could not be obtained at visit 3 because of amelioration of symptoms, this was considered a cure. “Persistence” indicated that the pretreatment pathogen was not eradicated at the final visit. Clinical “cure” was defined as the disappearance of all relevant signs and symptoms associated with an acute exacerbation of chronic bronchitis at the final visit. “Improvement” was defined as a decrease in severity of at least one grade in at least one pretreatment sign or symptom with none increasing in severity. “Success” was defined as either clinical cure or improvement, and “failure” indicated that there was no change in relevant pretreatment signs or symptoms or a worsening of at least one sign or symptom at visit 3. Statistical analyses were performed using SAS versions 6.06 and 5.18 (SAS Institute, Cary, North Carolina) and BMDP 1988 and 1990 versions (BMDP, Los Angeles, California). Reported p-values are two-sided with a 0.05 nominal significance level.
RESULTS A total of 285 patients were enrolled at 21 centers participating in the single-blind study; 237 were enrolled at 29 centers participating in the doubleblind study. A total of 259 patients were randomized to lomefloxacin treatment, and 263 were randomized to cefaclor treatment. Of these, 170 patients receiving lomefloxacin treatment, and 153 receiving cefaclor were considered eligible for analysis of clinical and bacteriologic efficacy (reasons for exclusion of patients from evaluability are listed in Table I). There were no clinically significant differences between the two groups in terms of demographics or in the severity of pretreatment signs and symptoms (Table II).
April 6, 1992
The American Journal of Medicine
Volume 92 (suppl 4A)
4A-109s
SYMPOSIUMON ONCE-A.DAYQUINOLONE/ GOTFRIEDand ELLISON
riologic eradication was noted in 139 of 170 patients (81.8%) treated with lomefloxacin and in 96 of 153 patients (62.7%) treated with cefaclor (p
H.
GOTFRIED,
M.D.,
Phoenix, Arizona,
W. TRAVIS
ELLISON,
M.D.,
In two multicenter trials, lomefloxacin and cefaclor were compared as treatments for acute bacterial exacerbations of chronic bronchitis. In total, 522 adult outpatients were enrolled at 50 centers in the United States. Patients were randomized to treatment groups receiving either 400 mg lomefloxacin orally once daily (n = 259) or 260 mg cefaclor every 8 hours (n = 263) for 7-10 days. Both groups were comparable in terms of age, severity of exacerbation, smoking history, theophylline use, and baseline pathogens. The most common baseline pathogens were Haemophilus influenzae, found in 32% of patients in the lomefloxacin group and in 29% in the cefaclor group, Pseudomonas aeruginosa (13% and 16%, respectively), Moraxella (Branhamella) catarrhalis (12% and 13%), and Streptococcus pneumoniae (10% in both groups). Bacterial eradication rates l-4 days after the completion of treatment for all patients with baseline pathogens were 81.8% in the lomefloxacin group and 62.7% in the cefaclor group (p , and within 4 days after completing treatment (visit 3). A medical history and chest radiograph were performed at visit 1, and complete physical examinations were performed at visits 1 and 3. Clinical evaluations, clinical laboratory testing (hematology, chemistry, and urinalysis), and sputum specimens for culture and susceptibility testing were collected at all visits. Sputum Gram stains were optional. Serum theophylline levels were monitored in those patients who took theophylline compounds. Bacteriologic and clinical outcomes were computed by comparing the data obtained at the pretreatment visit to that obtained at the final visit. Bacteriologic “eradication” was subcategorized and defined as “cure” (eradication of the pathogens isolated at baseline), or “cure with superinfection” (eradication of the baseline pathogen with a new pathogen isolated at the final visit). If a sputum specimen could not be obtained at visit 3 because of amelioration of symptoms, this was considered a cure. “Persistence” indicated that the pretreatment pathogen was not eradicated at the final visit. Clinical “cure” was defined as the disappearance of all relevant signs and symptoms associated with an acute exacerbation of chronic bronchitis at the final visit. “Improvement” was defined as a decrease in severity of at least one grade in at least one pretreatment sign or symptom with none increasing in severity. “Success” was defined as either clinical cure or improvement, and “failure” indicated that there was no change in relevant pretreatment signs or symptoms or a worsening of at least one sign or symptom at visit 3. Statistical analyses were performed using SAS versions 6.06 and 5.18 (SAS Institute, Cary, North Carolina) and BMDP 1988 and 1990 versions (BMDP, Los Angeles, California). Reported p-values are two-sided with a 0.05 nominal significance level.
RESULTS A total of 285 patients were enrolled at 21 centers participating in the single-blind study; 237 were enrolled at 29 centers participating in the doubleblind study. A total of 259 patients were randomized to lomefloxacin treatment, and 263 were randomized to cefaclor treatment. Of these, 170 patients receiving lomefloxacin treatment, and 153 receiving cefaclor were considered eligible for analysis of clinical and bacteriologic efficacy (reasons for exclusion of patients from evaluability are listed in Table I). There were no clinically significant differences between the two groups in terms of demographics or in the severity of pretreatment signs and symptoms (Table II).
April 6, 1992
The American Journal of Medicine
Volume 92 (suppl 4A)
4A-109s
SYMPOSIUMON ONCE-A.DAYQUINOLONE/ GOTFRIEDand ELLISON
riologic eradication was noted in 139 of 170 patients (81.8%) treated with lomefloxacin and in 96 of 153 patients (62.7%) treated with cefaclor (p
