Inhaled Salmeterol/Fluticasone Propionate Combination in Chronic Obstructive Pulmonary Disease
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Am J Respir Med 2002; 1 (4): 283-284 1175-6365/02/0004-0283/$25.00/0 © Adis International Limited. All rights reserved.
Inhaled Salmeterol/Fluticasone Propionate Combination in Chronic Obstructive Pulmonary Disease A Viewpoint by Donald A. Mahler Section of Pulmonary and Critical Care Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
The Global Obstructive Lung Disease (GOLD) initiative published in April 2001 states that the airflow limitation in chronic obstructive pulmonary disease (COPD) is ‘associated with an abnormal inflammatory response of the lungs to noxious particles and gases’. This statement provides a strong rationale for considering anti-inflammatory therapy in patients with COPD. What is the evidence that adding fluticasone propionate, a high potency inhaled corticosteroid, to salmeterol, a long-acting β2adrenoceptor agonist, makes a difference in patients with COPD? Figure 1 in the accompanying article illustrates that the combination of salmeterol/fluticasone propionate 50/250 or 50/500μg augmented the pre-dose forced expiratory volume in 1 second (FEV1) by ≈70 or 50ml above that observed with salmeterol alone. The presumed mechanism for this additional bronchodilation with an inhaled corticosteroid is a reduction in the inflammation and edema of the bronchial wall.
Does combination therapy with salmeterol/fluticasone propionate provide clinical benefits? It is certainly important to consider clinical outcomes beyond FEV1 because changes in lung function correlate only modestly with improvements in dyspnea and health status. Both doses of the salmeterol/fluticasone propionate combination showed substantial reductions in the severity of breathlessness during activities of daily living as measured on the Transition Dyspnea Index (TDI) [i.e. patients were less breathless] compared with placebo. Moreover, salmeterol/fluticasone propionate 50/500μg provided clinically important changes in TDI (predefined as a treatment difference ≥ 1 unit) when compared with placebo (difference of 1.7 units) or salmeterol (difference of 1.2 units). Moreover, both doses of the salmeterol/fluticasone propionate combination enhanced health status (health-related quality of life for the individual patient) by approximately 10 units on the Chronic Respiratory Disease Questionnaire; this magnitude is considered to represent a clinically meaningful change. Thus, the addition of fluticasone propionate provided important clinical benefits beyond bronchodilation. It is possible, even likely, that reduced dynamic hyperinflation (better position of the diaphragm and decreased elastic recoil of the lung) and decreased airway reactivity (as demonstrated with triamcinolone in Lung Health Study II) are the mechanisms for these improvements. ▲
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