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© 1996 Oxford University Press

research-article

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

I. D. STARKE and P. LUCE

Department of Medicine for the Elderly, Hither Green Hospital Hither Green Lane, London SE13 6RU

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 µg 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 242.4l/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 17.5l/min on placebo (adjusted mean difference = 10.3l/min; 95% CI = 2.4, 18.1 l/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 µg bd is an effective and well-tolerated therapy for elderly patients with reversible airflow obstruction.

Revision received June 26, 1995.
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