How far is real life from COPD therapy guidelines? An Italian observational study

Background: According to the GOLD international guidelines, the treatment of chronic obstructive pulmonary disease (COPD) should be proportional to the severity of airflow obstruction graded according to FEV1% predicted. Regular treatment with long-acting bronchodilators should be prescribed for symptomatic patients with FEV1 <80%. Inhaled corticosteroids should be added in patients with FEV1 < 50% predicted and frequent exacerbations. Aim: To investigate whether pulmonologists follow the GOLD guidelines when prescribing treatment for COPD. Methods: A multicenter, cross-sectional, observational study was carried out in 49 Pulmonary Units evenly distributed throughout the country. For each patient the demographic, clinical data and the current therapies were registered in an electronic database. Results: 4094 patients (mean age: 70.9 +/- 9.4; males 72.4%, female 27.6%) were enrolled. Disease severity was classified as: mild (745), moderate (1722), severe (923), very severe (704). Irrespective of disease severity, inhaled corticosteroids alone or in combination with long-acting bronchodilators were used in 15.2% and 66.8% of patients, respectively. The appropriateness of the pharmacological treatment of the COPD patients was defined in accordance with the GOLD recommendations. The treatment was appropriate in 37.9% of patients and inappropriate in 62.1%, p < 0.0001. The inappropriateness was due to under-prescription in 7.2% and to over-prescription in 54.9% of patients. The presence and the number of exacerbations represented an important trigger for over-prescription at stages I and II. Conclusions: This study shows that there is a poor relationship between the recommendations of the GOLD international guidelines and current clinical practice, and that exacerbations may play a role in over-prescription. (C) 2012 Elsevier Ltd. All rights reserved.