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Inhaled salmeterol in the treatment of patients with moderate to severe reversible obstructive airways disease — a 3-month comparison of the efficacy and safety of twice-daily salmeterol (100 μg) with salmeterol (50 μg)

1992; Elsevier BV; Volume: 86; Issue: 5 Linguagem: Inglês

10.1016/s0954-6111(06)80008-9

1532-3064

Jamie Palmer, Alice Stuart, G.L. Shepherd, K Viskum,

Respiratory and Cough-Related Research

Three-hundred and fifty patients with moderate to severe reversible obstructive airways disease (forced expiratory volume in 1 s or peak expiratory flow rate ⩽ 50% predicted, a 15% reversibility to inhaled salbutamol and symptomatic) were recruited into a multi-centre, multinational, double-blind, parallel-group randomized study. Two-hundred and eighty-three patients were randomized to receive 50 μg salmeterol twice daily or 100 μg salmeterol twice daily administered from a metered-dose inhaler for 3 months. Salbutamol (100μg per metered actuation) was provided for symptomatic relief. Morning and evening peak expiratory flow rate (PEFR), daytime and night-time asthma symptoms and additional bronchodilator usage were recorded by the patient on a daily basis. Lung function and patient/physician assessment of treatment efficacy were recorded at scheduled clinic visits. Safety was determined by monitoring adverse events and standard biochemical, haematological and cardiovascular parameters. Salmeterol 100 μg twice daily was consistently superior to salmeterol 50 μg twice daily in morning and evening PEFR measurements (mean differences between the treatments: 10–14 l min−1 for morning, 95% CI-0, 22 l min−1, P = 0·047; and 10–15 l min−1 for evening, 95% CI 2, 22l min−1, P = 0·023). The improvement in PEFR was independent of concurrent steroid usage, with the most marked improvement being seen in the more severe asthmatics requiring concurrent oral corticosteroids (mean differences between the treatments: 27–31 l min−1, 95% CI: 3,55 l m−1, P = 0·027). The 1 s forced expiratory volume (FEV1) increased from 1·48 l to 1·89 l in the salmeterol 50 μg b.d. group and from 1·46 l to 1·89 l in the salmeterol 100 μg b.d group over the treatment period. Both treatments were highly effective in improving night-time symptoms. Salmeterol 100 μg produced a significantly greater improvement in median day-time asthma score, percentage of days with no additional salbutamol and the need for additional actuations of salbutamol during the day than did salmeterol 50 μg. Both treatments were well tolerated with a similar incidence of adverse events reported in both groups, although there were slightly more respiratory events reported by the 50 μg salmeterol group, and a slightly higher incidence of pharmacologically predictable adverse events (tremor) in the 100 μg salmeterol group. This study shows that salmeterol at both dose levels, 50 μg and 100 μg twice daily, is an effective treatment in the management of moderate to severe reversible obstructive airways disease; however, in more severe asthmatics, using 100 μg twice daily provides better control of the disease. Three-hundred and fifty patients with moderate to severe reversible obstructive airways disease (forced expiratory volume in 1 s or peak expiratory flow rate ⩽ 50% predicted, a 15% reversibility to inhaled salbutamol and symptomatic) were recruited into a multi-centre, multinational, double-blind, parallel-group randomized study. Two-hundred and eighty-three patients were randomized to receive 50 μg salmeterol twice daily or 100 μg salmeterol twice daily administered from a metered-dose inhaler for 3 months. Salbutamol (100μg per metered actuation) was provided for symptomatic relief. Morning and evening peak expiratory flow rate (PEFR), daytime and night-time asthma symptoms and additional bronchodilator usage were recorded by the patient on a daily basis. Lung function and patient/physician assessment of treatment efficacy were recorded at scheduled clinic visits. Safety was determined by monitoring adverse events and standard biochemical, haematological and cardiovascular parameters. Salmeterol 100 μg twice daily was consistently superior to salmeterol 50 μg twice daily in morning and evening PEFR measurements (mean differences between the treatments: 10–14 l min−1 for morning, 95% CI-0, 22 l min−1, P = 0·047; and 10–15 l min−1 for evening, 95% CI 2, 22l min−1, P = 0·023). The improvement in PEFR was independent of concurrent steroid usage, with the most marked improvement being seen in the more severe asthmatics requiring concurrent oral corticosteroids (mean differences between the treatments: 27–31 l min−1, 95% CI: 3,55 l m−1, P = 0·027). The 1 s forced expiratory volume (FEV1) increased from 1·48 l to 1·89 l in the salmeterol 50 μg b.d. group and from 1·46 l to 1·89 l in the salmeterol 100 μg b.d group over the treatment period. Both treatments were highly effective in improving night-time symptoms. Salmeterol 100 μg produced a significantly greater improvement in median day-time asthma score, percentage of days with no additional salbutamol and the need for additional actuations of salbutamol during the day than did salmeterol 50 μg. Both treatments were well tolerated with a similar incidence of adverse events reported in both groups, although there were slightly more respiratory events reported by the 50 μg salmeterol group, and a slightly higher incidence of pharmacologically predictable adverse events (tremor) in the 100 μg salmeterol group. This study shows that salmeterol at both dose levels, 50 μg and 100 μg twice daily, is an effective treatment in the management of moderate to severe reversible obstructive airways disease; however, in more severe asthmatics, using 100 μg twice daily provides better control of the disease.