To evaluate the costs, consequences, effectiveness, and safety of ciprofloxacin vs standard antibiotic care in patients with an initial acute exacerbation of chronic bronchitis (AECB) as well as recurrent AECBs over a 1-year period.
A total of 240 patients, 18 years or older with chronic bronchitis, 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 increased dyspnea, increased sputum volume, or sputum purulence).
The assessment included AECB symptoms, antibiotics prescribed, concomitant medications, adverse events, hospitalizations, emergency department visits, outpatient resources such as diagnostic tests, procedures, and patient and caregiver out-of-pocket expenses. Patients completed the Nottingham Health Profile, St. George's Respiratory Questionnaire, and the Health Utilities Index. The parameters were recorded with each AECB and at regular quarterly intervals for 1 year. These variables were compared between the ciprofloxacin-treated group and the usual-care-treated group.
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 total 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 overall duration of the average AECB was 15.2+/-0.6 days for the ciprofloxacin arm compared to 16.3+/-0.6 days for the usual-care arm. Treatment with ciprofloxacin tended to accelerate the resolution of all AECBs compared to usual care (relative risk=1.20; 95% confidence interval [CI], 0.91 to 1.58; p=0.19). Treatment assignment did not affect the interexacerbation period but a history of severe bronchitis, prolonged chronic 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 life measures with ciprofloxacin over usual care. The only factors predictive of hospitalization were duration of chronic bronchitis (odds ratio=4.6; 95% CI, 1.6, 13.0) and severity of chronic bronchitis (odds ratio=4.3; 95% CI, 0.8, 24.6). The incremental cost difference of $578 Canadian in favor of usual care was not significant (95% CI, -$778, $1,932). The cost for the ciprofloxacin arm over the usual care arm was $18,588 Canadian per quality-adjusted life year gained. When the simple base case analysis was expanded to examine the effect of risk stratification, the presence of moderate or severe bronchitis and at least four AECBs in the previous year changed the economic and clinical analysis to one favorable to ciprofloxacin with the ciprofloxacin-treated group having a better clinical outcome at lower cost ("win-win" scenario).
Treatment with ciprofloxacin tended to accelerate the resolution of all AECBs compared to usual care; however, the difference was not statistically significant. Further, usual care was found to be more reflective of best available care rather than usual first-line agents such as amoxicillin, tetracycline, or trimethoprim-sulfamethoxazole as originally expected. Despite the similar antimicrobial activities 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 history of moderate to severe chronic bronchitis and at least four AECBs in the previous year, ciprofloxacin treatment offered substantial clinical and economic benefits. In these patients, ciprofloxacin may be the preferred first antimicrobial choice.
To undertake a 1-year prospective economic evaluation of ciprofloxacin compared with usual antibacterial care (any antibacterial other than a quinolone) for the treatment of acute exacerbations of chronic bronchitis (AECB) in adults presenting with a type I or type II AECB.
Patients entered the study with an initial AECB and were randomised to the ciprofloxacin group or the usual care group. The following measurements were taken at the end of each AECB and every 3 months: resource utilisation, St. George's Respiratory Questionnaire, Nottingham Health Profile and Health Utilities Index (HUI). The following additional measurements were taken after each AECB: AECB-symptom days and willingness to pay to avoid the AECB. Economic evaluations were performed from the societal viewpoint and the viewpoint of a major third-party payer. Cost-effectiveness analysis was based on cost per AECB-symptom day averted; cost-utility analysis (CUA) was based on cost per quality-adjusted life-year (QALY) gained using the HUI as the basis for calculating QALYs. Cost-benefit analysis was based on the willingness-to-pay (WTP) data.
This was a study of outpatients enrolled from 46 family physicians and 2 respirologists in Ontario (29 sites) and Qu?bec (19 sites), Canada, between November 1993 and June 1994.
240 adult male and female patients aged > or = 18 years with chronic bronchitis.
WTP data did not pass scope tests for reasonableness. Ciprofloxacin was more costly and provided better outcomes compared with usual antibacterial care. The base-case results are as follows (1994/1995 values): the incremental annual cost was 578 Canadian dollars ($Can) from the societal viewpoint and $Can840 for the third-party payer; the cost-effectiveness ratio per AECB-symptom day averted was $Can209 from the societal viewpoint and $Can304 for the third-party payer; the cost-utility ratio per QALY gained was $Can18,600 from the societal viewpoint and $Can27,000 for the third-party payer. According to Laupacis criteria, these CUA results are strong evidence in favour of adoption from the societal viewpoint and moderate evidence in favour from the viewpoint of the third-party payer. A subgroup analysis suggests that ciprofloxacin may be particularly cost effective, even 'win-win', in patients with more severe disease.
The sensitivity analyses indicate that the results are relatively robust. Nevertheless, the statistical uncertainty in the results is sufficient that the findings cannot be accepted unequivocally. A further study with a larger sample size would be useful to confirm (or deny) the findings of this study.