Abstract
BackgroundIn Europe, administration of an inhaled corticosteroid (ICS) combined with a long-acting β2 agonist is approved in chronic obstructive pulmonary disease (COPD) patients with a pre-bronchodilator FEV1 < 60% predicted normal, a history of repeated exacerbations, and who have significant symptoms despite regular bronchodilator therapy. Minimal data are available on the use of the fluticasone propionate/salmeterol xinafoate combination (FSC) in the real-life COPD setting and prescription compliance with the licensed specifications.MethodsA French observational study was performed to describe the COPD population prescribed with FSC, prescription modalities, and the coherence of prescription practices with the market authorized population. Data were collected for patients initiating FSC treatment (500 μg fluticasone propionate, 50 μg salmeterol, dry powder inhaler) prescribed by a general practitioner (GP) or a pulmonologist, using physician and patient questionnaires.ResultsA total of 710 patients were included, 352 by GPs and 358 by pulmonologists. Mean age was over 60 years, and 70% of patients were male. More than half were retired, and overweight or obese. Approximately half were current smokers and one-third had cardiovascular comorbidities. According to both physician evaluation and GOLD 2006 classification, the majority of patients (>75%) had moderate to very severe COPD. Strict compliance by prescribing physicians with the market-approved population for dry powder inhaler SFC in COPD was low, notably in ICS-naïve patients; all three conditions were fulfilled in less than a quarter of patients with prior ICS and less than 7% of ICS-naïve patients.ConclusionsPrescription of dry powder inhaler SFC by GPs and pulmonologists has very low conformity with the three conditions defining the licensed COPD population. Prescription practices need to be improved and systematic FEV1 evaluation for COPD diagnosis and treatment management should be emphasized.
Highlights
In Europe, administration of an inhaled corticosteroid (ICS) combined with a long-acting β2 agonist is approved in chronic obstructive pulmonary disease (COPD) patients with a pre-bronchodilator forced expiratory volume in 1 second (FEV1) < 60% predicted normal, a history of repeated exacerbations, and who have significant symptoms despite regular bronchodilator therapy
Administration of the ICS fluticasone propionate with the Long-acting β2 agonists (LABA) salmeterol xinafoate with a dry powder inhaler was approved in Europe in 2003, at a dose of 500 μg fluticasone propionate with 50 μg salmeterol twice daily for treatment of COPD patients with a pre-bronchodilator FEV1 < 60% predicted normal, a history of repeated exacerbations, and who have significant symptoms despite regular bronchodilator therapy
Some differences in characteristics were apparent between the general practitioner (GP) and pulmonologist populations, with the latter having a higher proportion of patients who were retired, male, had hypertension or coronary heart disease, while fewer pulmonologist patients were current smokers
Summary
In Europe, administration of an inhaled corticosteroid (ICS) combined with a long-acting β2 agonist is approved in chronic obstructive pulmonary disease (COPD) patients with a pre-bronchodilator FEV1 < 60% predicted normal, a history of repeated exacerbations, and who have significant symptoms despite regular bronchodilator therapy. Administration of the ICS fluticasone propionate with the LABA salmeterol xinafoate (fluticasone /salmeterol combination, FSC) with a dry powder inhaler was approved in Europe in 2003, at a dose of 500 μg fluticasone propionate with 50 μg salmeterol twice daily for treatment of COPD patients with a pre-bronchodilator FEV1 < 60% predicted normal, a history of repeated exacerbations, and who have significant symptoms despite regular bronchodilator therapy. Data on FSC use in the real-life COPD setting are scarce and co-therapies in patients prescribed with this combination as long-term treatment have not been reported
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