The use of corticosteroids in patients with chronic obstructive pulmonary disease: epidemiological and economic aspects

Objective: this study aimed at assessing the level of compliance to GOLD guidelines regarding the use of ICS containing drugs for the treatment of patients with COPD in the GPs setting in Italy and at evaluating the economic consequences that the use of corticosteroids may have, specifically in mild and moderate COPD patients where it is inappropriate. Methods: the retrospective GPs database study has analyzed patients with at least one diagnosis of COPD during the period January 2005 – December 2008 who had a report of VEMS and at least one prescription of a drug from ATC R03 class within two months from the date of spirometric exam, who were 40 years or older and that have been followed for at least 9 months. Patients were classified in four disease severity groups according to GOLD (2008). Compliance to GOLD guidelines regarding the use of corticosteroids was evaluated on the basis of the first treatment prescribed after spirometric exam. The analysis evaluated exacerbations as well, assuming their occurrence when one prescription of either antibiotic, oxygen or systemic corticosteroid was found. The cost of the first prescription of treatments containing ICS in mild and moderate patients was calculated. Then the “Hypothetic cost” was built for those patients in order to estimate the cost that would have been created in case the considered treatments had been ICS free. The difference between these two costs represents inappropriate cost that could have been avoided by using an ICS free treatment, more appropriate according to GOLD. Results: a cohort of 2,103 Italian patients with the diagnosis of COPD, followed by 700 GPs all over Italy was analyzed. An ICS-containing treatment was prescribed to more than 50% of patients within each disease severity group. The percentage of patients who experienced an exacerbation within 6 months from the first prescription was not found to be different among patients prescribed with an ICS-free treatment and those treated with an ICS-containing treatment and was independent of the disease severity. In mild and moderate COPD patients respectively, 53% and 48% of the cost generated by the ICS containing prescriptions represent the inappropriate cost for the Health Care System. Moreover, patients are unnecessarily exposed to the risk of inadequate therapy.