AN EVALUATION OF SALMETEROL IN THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY-DISEASE (COPD)

The objectives of this study were to compare the efficacy and safety o f salmeterol xinafoate (50 and 100 mu g b.i.d.) with that of placebo, when added to existing therapy, in the treatment of patients with chro nic obstructive pulmonary disease (COPD). Six hundred and seventy four patients were randomized to receive either salmeterol 50 mu g b.i.d., salmeterol 100 mu g b.i.d., or placebo treatment for a period of 16 w eeks. The results showed a significant improvement in daily symptom sc ores noted for patients taking either 50 mu g (p = 0.043) or 100 mu g b.i.d. salmeterol (p = 0.01) compared with placebo, with a correspondi ng decrease in additional daytime salbutamol requirements for both sal meterol groups, The same pattern was reflected for night-time symptoms and additional salbutamol use. During treatment, forced expiratory vo lume in one second (FEV1) measurements improved significantly in each salmeterol group, with up to a 7% improvement observed at the end of t he study, Although no difference was observed between treatment groups for the distance walked in 6 min, patients treated with salmeterol 50 mu g b.i.d. were significantly less breathless than those treated wit h placebo after their 6 min walk, after 8 weeks (p = 0.024) and 16 wee ks (p = 0.004) of therapy, Adverse events were similar in all three gr oups except for tremor, which was significantly higher in the 100 mu g b.i.d. salmeterol group (p = 0.005) compared both with 50 mu g b.i.d. salmeterol and placebo. Salmeterol offered further positive improveme nt to the effect of therapy in patients with chronic obstructive pulmo nary disease when added to their existing regimens, This clinical impr ovement was similar both with 50 and 100 mu g b.i.d. dosage, although the group receiving 50 mu g b.i.d. tolerated the drug better than thos e receiving 100 mu g bid, salmeterol.