G. Boyd, SALMETEROL XINAFOATE IN ASTHMATIC-PATIENTS UNDER CONSIDERATION FOR MAINTENANCE ORAL CORTICOSTEROID-THERAPY, The European respiratory journal, 8(9), 1995, pp. 1494-1498
In severe chronic asthma, long-term oral steroids may be necessary to
control symptoms. In patients in whom such treatment was under conside
ration, the efficacy and safety of salmeterol xinafoate 100 mu g b.i.d
was investigated in a randomized, double-blind, placebo-controlled pa
rallel-group, multicentre study.One hundred and nineteen chronic sympt
omatic asthmatics were randomized to receive either salmeterol, 100 mu
g b.id (n=55; baseline % predicted morning peak expiratory now (PEF)
59%; forced expiratory volume in one second (FEV1 66%) or placebo (n=6
4; baseline % predicted morning PEP 63%; FEV1 66%) both via the Diskha
ler, Morning and evening PEF and asthma symptoms were recorded in dail
y record booklets by the patient over a 12 week period. A significant
improvement in morning PEF was achieved after 1 month in the salmetero
l treated group; this persisted throughout the treatment period (estim
ated treatment difference 22 L . min(-1)). There was a significant inc
rease in the proportion of symptom-free nights experienced by the salm
eterol treated group (33 (so 32) %) compared with placebo (13 (26) %),
and a significant decrease in daily use of relief medication (mean de
crease 5.1 (4.7) doses per day with salmeterol, 2.5 (4.0) doses with p
lacebo). Both treatments were well-tolerated, with no evidence of any
difference in the side-effects associated with beta(2)-agonists. In co
nclusion, the addition of salmeterol (100 mu g daily) to the existing
treatment of chronic asthmatics under consideration for maintenance or
al corticosteroid therapy is well-tolerated, improves lung function an
d provides additional symptom control.