[Effect of salmeterol in obstructive sleep apnea syndrome].
The effect of inhaled long-acting beta 2-agonists on obstructive sleep apnoea syndrome (OSAS) is unknown, though from the pharmacological point of view both therapeutic and adverse effects might be discussed. The purpose of this study was to obtain data on the efficacy and safety of Salmeterol in patients with OSAS. In a randomised, double-blind, placebo-controlled, crossover study effects of Salmeterol were investigated in 20 patients with OSAS: 4 female, 16 male; age 53.0 +/- 7.8 years, body mass index (BMI) 28.0 +/- 3.0 kg.m-2; apnoea hypopnoea index (AHI) 35.6 +/- 17.8 h-1. Patients with asthma, chronic obstructive pulmonary disease (COPD), and left heart failure were excluded. Placebo or verum (50 micrograms Salmeterol) were administered at 7 p.m. by metered dose inhaler and spacer device. All patients underwent full polysomnography during baseline, placebo, and verum night. Statistical analysis was performed by Student's t-test (p < 0.05). Between placebo and verum there were no differences in total sleep time, sleep stages, apnoea index (AI), AHI, and nadir SaO2. There was, however, a significant deterioration of mean SaO2 (placebo 93.1 +/- 2.0 vs Salmeterol 92.5 +/- 2.2%) and of relative time spent with SaO2 < or = 90% (placebo 13.1 +/- 14.5 vs Salmeterol 19.5 +/- 20.8%), as well as a significant increase in heart rate (placebo 63.1 +/- 9.2 vs Salmeterol 65.6 +/- 9.3 h-1). Thus, in patients with OSAS Salmeterol had no adverse effect on quality of sleep, AI or AHI. The slight increase in heart rate and the deterioration of oxygen saturation are clinically irrelevant. The latter might be due to ventilation-perfusion-mismatch. This study demonstrates that Salmeterol has no influence on obstructive sleep apnoea and hypopnoea, but on the other hand provides an acceptable safety profile in OSAS. This might be of special importance in patients suffering from both OSAS and obstructive airway disease.
Rasche
K
K
Abteilung für Pneumologie, Allergologie und Schlafmedizin, Berufsgenossenschaftliche Kliniken Bergmannsheil, Universitäts-klinik/Ruhr-Universität Bochum.
Duchna
H W
HW
Orth
M
M
Bauer
T T
TT
Lauer
J
J
Podbregar
D
D
Schultze-Werninghaus
G
G
D000318:Adrenergic beta-Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000097:blood; D017286:Polysomnography / Q000187:drug effects; D000068299:Salmeterol Xinafoate; D012891:Sleep Apnea Syndromes / Q000188:drug therapy*; D016896:Treatment Outcome
D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D000420:Albuterol; D010100:Oxygen
Zur Wirkung von Salmeterol bei obstruktivem Schlafapnoesyndrom.