A 1-YEAR COMMUNITY-BASED HEALTH ECONOMIC-STUDY OF CIPROFLOXACIN VS USUAL ANTIBIOTIC-TREATMENT IN ACUTE EXACERBATIONS OF CHRONIC-BRONCHITIS - THE CANADIAN CIPROFLOXACIN HEALTH ECONOMIC-STUDY GROUP

Objective: To evaluate the costs, consequences, effectiveness, and saf ety of ciprofloxacin vs standard antibiotic care in patients with an i nitial acute exacerbation of chronic bronchitis (AECB) as well as recu rrent AECBs over a 1-year period. Design: Randomized, multicenter, par allel-group, open-label study. Setting: Outpatient general practice. P atients: A total of 240 patients, 18 years or older with chronic bronc hitis, with a history of frequent exacerbations (three or more in the past year) presenting with a type 1 or 2 AECB (two or more of increase d dyspnea, increased sputum volume, or sputum purulence). Main outcome measures: The assessment included AECB symptoms, antibiotics prescrib ed, concomitant medications, adverse events, hospitalizations, emergen cy department visits, outpatient resources such as diagnostic tests, p rocedures, and patient and caregiver out-of-pocket expenses. Patients completed the Nottingham Health Profile, St. George's Respiratory Ques tionnaire, and the Health Utilities Index. The parameters were recorde d with each AECB and at regular quarterly intervals for 1 year. These variables were compared between the ciprofloxacin-treated group and th e usual-care-treated group. Results: Patients receiving ciprofloxacin experienced a median of two AECBs per patient compared to a median of three AECBs per patient receiving usual care. The mean annualized tota l number of AECB-symptom days was 42.9+/-2.8 in the ciprofloxacin arm compared to 45.6+/-3.0 days in the usual-care arm (p=0.50). The overal l duration of the average AECB was 15.2+/-0.6 days for the ciprofloxac in arm compared to 16.3+/-0.6 days for the usual-care arm. Treatment w ith ciprofloxacin tended to accelerate the resolution of all AECBs com pared to usual care (relative risk=1.20; 93% confidence interval [CI], 0.91 to 1.58; p=0.19). Treatment assignment did not affect the intere xacerbation period but a history of severe bronchitis, prolonged chron ic bronchitis, and an increased number of AECBs in the past year were associated with shorter exacerbations-free periods. There was a slight , but not statistically significant, improvement in all quality of lif e measures with ciprofloxacin over usual care. The only factors predic tive of hospitalization were duration of chronic bronchitis (odds rati o=4.6; 95% CI, 1.6, 13.0) and severity of chronic bronchitis (odds rat io=4.3; 95% CI, 0.8, 24.6). The incremental cost difference of $578 Ca nadian in favor of usual care was not significant (95% CI, -$778, $1,9 32). The cost for the ciprofloxacin arm over the usual care arm was $1 8,588 Canadian per quality-adjusted life year gained. When the simple base case analysis was expanded to examine the effect of risk stratifi cation, the presence of moderate or severe bronchitis and at least fou r AECBs in the previous year changed the economic and clinical analysi s to one favorable to ciprofloxacin with the ciprofloxacin-treated gro up having a better clinical outcome at lower cost (''win-win'' scenari o). Conclusions: Treatment with ciprofloxacin tended to accelerate the resolution of all AECBs compared to usual care; however, the differen ce was not statistically significant. Further, usual care was found to be more reflective of best available care rather than usual first-lin e agents such as amoxicillin, tetracycline, or trimethoprim-sulfametho xazole as originally expected. Despite the similar antimicrobial activ ities and broad-spectrum coverage of both ciprofloxacin and usual care , the trends in clinical outcomes and all quality of life measurements favor ciprofloxacin. In patients suffering from an AECB with a histor y of moderate to severe chronic bronchitis and at least four AECBs in the previous year, ciprofloxacin treatment offered substantial clinica l and economic benefits. In these patients, ciprofloxacin may be the p referred first antimicrobial choice.