Real-life use of fluticasone propionate/salmeterol in patients with chronic obstructive pulmonary disease: a French observational study.

BACKGROUND: In Europe, administration of an inhaled corticosteroid (ICS) combined with a long-acting ß2 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. METHODS: A 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. RESULTS: A 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. CONCLUSIONS: Prescription 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.

[Control of asthma by treatment with inhaled corticosteroids and prolonged action beta 2-agonists in free or fixed combination. Results of the ALISE study]. / Contrôle de l'asthme sous traitement par corticostéroïdes inhalés et beta 2-agonistes à longue durée d'action en association libre ou fixe. Résultats de l'enquête ALISE.

CONTEXT: The basics of asthma treatment are well defined in the guidelines, however the criteria for the choice between fixed and free combinations of inhaled corticosteroids and long acting beta 2-agonist have not been clearly established. METHOD: A modified Juniper questionnaire (using peak expiratory flow rather than maximal expiratory volume per second) was used by 421 general practitioners to assess asthma control in 861 adult patients (aged 47 +/- 17 years) having received inhaled corticosteroids and long-acting beta 2-agonist in a fixed (n = 413) or free (n = 448) combination for at least 6 weeks. RESULTS: Treatment groups were comparable for demographics, asthma history and severity as assessed by the physician. Despite better compliance to treatment in the fixed combination group and a mean daily dose of corticosteroids around two-fold greater compared with free combination group (913 +/- 450 micrograms/d vs 401 +/- 178 micrograms/d), the mean Juniper score was lower in the free combination group (1.60 +/- 0.94 vs 1.73 +/- 0.96) with a greater percentage of patients controlled (Juniper score < 2): 67.6% vs 60.8%. Other treatments for asthma were significantly less frequent with the free combination (14.2% vs 22.3%), as were local side effects and notably voice changes (3.3% vs 9.5%. COMMENTS: The apparently greater efficacy/safety ratio of the free combination was probably due to the greater severity of asthma in the patients treated with a fixed combination. This highlights the interest of free combinations as first-line therapy for patient with mild to moderate asthma.

[Difficulties in the assessment of dyspnea and respiratory function in general practice]. / Difficultés de l'évaluation de la dyspnée et de la fonction respiratoire en médecine générale.

BACKGROUND: Dyspnea is one of the principal signs of chronic respiratory diseases. OBJECTIVE AND METHODS: To determine the appropriate questions and tests for recognizing dyspnea, 295 general practitioners questioned 1991 patients with or at risk of COPD in this cross-sectional study. After a brief training session, the physicians were asked to assess respiratory function with a small electronic spirometer. RESULTS: A questionnaire with a six-point semi-quantitative scale of dyspnea detected more dyspneic patients (78.1%) than the single question "Are you usually short of breath?" (68.6%), which in turn detected this symptom more often than simply listening for spontaneous complaints (33.7%). Even when dyspnea was reported only for substantial exertion, it was associated with impairment of all domains of quality of life. Only half the spirometry results met the minimal criteria of validity and reproducibility. DISCUSSION AND CONCLUSIONS: These results underline the importance of a specific, systematic assessment of dyspnea in patients at risk, and the need for sufficient training and practice before the use of electronic spirometers in general practice.