부산대학교 도서관

Asthma therapy including inhaled corticosteroids (ICS) has been shown to be effective in many parts of the world, but its use is still limited in Japan. A 6-week, randomized, placebo-controlled, clinical trial was therefore undertaken to assess the efficacy of the ICS budesonide Turbuhaler (budesonide administered via the dry-powder inhaler Turbuhaler) in patients in Japan with mild-to-moderate asthma. Prior to, and during, the study, all concomitant medications, except corticosteroid preparations, were allowed (i.e. all pre-study medication was to be maintained throughout the study). In total, 218 patients randomized to receive budesonide Turbuhaler 200 μg/day (n = 53), 400 μg/day (n = 55), 800 μg/day (n = 57) or placebo (n = 53) were included in the analysis. Due to the increased demand and interest for health economic data in Japan, this retrospective cost-effectiveness analysis reports on the economic impact of budesonide Turbuhaler compared with placebo (i.e. usual care), based on this clinical trial. At each dosage, budesonide Turbuhaler was significantly more effective than the placebo, according to the number of symptom-free and episode-free days. The number of emergency visits, days of lost production and days of hospitalization were all lower in the budesonide Turbuhaler groups, leading to significantly (P < 0.05) reduced total health-care and productivity costs compared with placebo. These findings were generally stable to sensitivity analysis. However, this reduction in costs will obviously have to be compared with the acquisition cost of budesonide Turbuhaler (which was excluded in the analysis as a price had not been determined) when it becomes available on the market. Budesonide Turbuhaler, while improving the health of patients, could thus have a considerable impact on the costs of treating asthma in Japan, by shifting large hospital care costs towards relatively small out-patient medication costs.