The efficacy and safety of inhaled salmeterol 50 microg bd in older patients with reversible airflow obstruction

Abstract

Twenty-eight patients aged 64-88 years with reversible airflow obstruction, showing a diurnal variation in peak expiratory flow rate (PEFR) of over 15% or symptoms of airflow obstruction on 4 days of the last week of the run-in period, were entered into a randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy of salmeterol 50 microg twice daily by metered-dose inhaler. Salmeterol or matching placebo were each given for 28 days. Mean morning PEFR was 258.71/min on slameterol and 242. 41/min on placebo (adjusted mean difference = 16.31/min; 95% CI = 7. 4, 25.21/min;p = 0.0011). Diurnal variation in PEFR was 7.31/min on salmeterol and 17.51/min on placebo (adjusted mean difference = 10. 31/min; 95% CI -2.0, 0.5 actuations/day; p = 0.0015). After 28 days of treatment the patients' assessment of efficacy was statistically significantly in favour of salmeterol (p = 0.05). Salmeterol was well tolerated as assessed by pulse, blood pressure, haematological and biochemical variables and number of adverse events. Salmeterol 50 microg bd is an effective and well-tolerated therapy for elderly patients with reversible airflow obstruction.