The Efficacy and Safety of Inhaled Salmeterol 50 μg bd in Older Patients with Reversible Airflow Obstruction

Summary 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/zg twice daily by metered-dose inhaler. Salmeterol or matching placebo were each given for 28 days. Mean morning PEFR was 258.71/min on salmeterol and 242.41/min on placebo (adjusted mean difference = 16.3 1/min; 95% CI = 7.4, 25.21/min; p =0.0011). Diurnal variation in PEFR was 7.3 1/min on salmeterol and 17.5 1/min on placebo (adjusted mean difference = 10.3 1/min; 95% CI = 2.4, 18.11/min; p = 0.013). The median number of actuations of 'rescue' salbutamol during the day was significantly less for those receiving salmeterol than for placebo (adjusted median difference —1.5 actuations/day; 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 /ig bd is an effective and well-tolerated therapy for elderly patients with reversible airflow obstruction.