[Efficacy and safety of salmeterol (50 microgram) and fluticasone (250 microgram) in a single inhaler device (diskus) in patients with mild to moderate asthma].
BACKGROUND
Inhaled corticosteroids and long-acting beta-agonists are first-line agents for the treatment of patients with persisting bronchial asthma. Several lines of evidence have shown, that inhaled corticosteroids and long-acting beta-agonist have multiple synergisms both in vivo and in vitro, leading to improved clinical asthma control.


METHODS
A prospective, open, multi-centre study was performed to evaluate the efficacy and safety of a fixed combination of inhaled Fluticasone (250 microgram BID) and Salmeterol (50 microgram BID) in a single inhaler device (Diskus). 3345 patients (48 % male, mean age 52 years, range 17 - 90 years) with mild to moderate asthma were treated over a period of 8 weeks. Lung function, quality of life and adverse events were evaluated as primary outcome variables.


RESULTS
After 8 weeks of treatment, forced expiratory volume in one second (FEV1) improved from 2.37 +/- 0.86 l to 2.7 +/- 0.96 l (p < 0.001). Accordingly, morning peak expiratory flow (PEF) increased from 4.9 +/- 2.1 l/s to 5.6 +/- 2.2 l/s (p < 0.001). Quality of life improved in 90 % of all patients, with an overall increase of 1.1. points. Frequent adverse events included symptoms of asthma (5.3 % of all adverse events) and infections (2.7 %). Typical side-effects of the study medication, e. g. oral candidiasis or tachycardia were observed in less than 2 % of all patients.


CONCLUSIONS
These results confirm the efficacy and tolerability of a fixed combination of salmeterol and fluticasone in a single inhaler device (Diskus). Lung function and quality of life were significantly improved in mild to moderate asthmatics. A fixed combination of long-acting beta-agonists and inhaled corticosteroids is therefore considered as a valuable therapeutic option for the treatment of patients with asthma.
Beeh
K M
KM
Schwerpunkt Pneumologie, III. Medizinische Klinik und Poliklinik, Klinikum der Johannes Gutenberg-Universität, Mainz. k.beeh@3-med.klinik.uni-mainz.de
Beier
J
J
Kornmann
O
O
Wiewrodt
R
R
Buhl
R
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D011446:Prospective Studies; D000068299:Salmeterol Xinafoate; D016896:Treatment Outcome
D000730:Androstadienes; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol