[efficacy and safety of salmeterol in long-term therapy in patients with chronic obstructive airway diseases].
BACKGROUND
Salmeterol is a long-acting inhaled beta 2-agonist with a bronchodilating effect lasting over 10 to 12 hours.


METHODS
A prospective, open, multi-centre study was performed to evaluate the efficacy and safety of inhaled salmeterol (50 micrograms BID) over a mean treatment period of 29 months (range: 4-1145 days) in 634 patients (54% male, age 45 +/- 15 years) with mild to moderate asthma or chronic obstructive pulmonary disease (COPD). Peak expiratory flow rates, rescue use of short acting beta 2-agonists and safety were study objectives. Patients were critically monitored for a possible loss of bronchodilator efficacy of salmeterol during long-term treatment.


RESULTS
During the first month of salmeterol therapy, morning peak flow improved from 384 +/- 104 l/min to 413 +/- 112 l/min (p < 0.001), and use of rescue salbutamol was significantly reduced (21 +/- 21 to 8 +/- 14 puffs/week during daytime and 9 +/- 12 to 4.5 +/- 9 puffs/week during nighttime, p < 0.001 both comparisons). Peak flow improvement and reduction of short-acting beta 2-agonist use was maintained during the whole study period. Frequent adverse events were exacerbations of the underlying airway disease (24%) and infections (12%), while typical pharmacological side-effects like tremor or tachycardia where reported in less than 1% of all patients.


CONCLUSIONS
These results confirm the persistent efficacy and favourable safety profile of salmeterol during long-term therapy over more than two years. No clinical signs of a decreasing bronchodilator potency indicating tachyphylaxis were observed. Salmeterol treatment provides a therapeutic option to further improve the management and care of patients with moderate obstructive airway diseases.
Schwerpunkt Pneumologie, III. Medizinische Klinik und Poliklinik, Klinikum der Johannes Gutenberg-Universität, Mainz. k.beeh@3-med.klinik.uni-mainz.de
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Beeh
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Wiewrodt
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Salem
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Buhl
D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008173:Lung Diseases, Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012129:Respiratory Function Tests; D012449:Safety; D000068299:Salmeterol Xinafoate
D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D000420:Albuterol