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KMID : 0378019940370080079
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New Medical Journal
1994 Volume.37 No. 8 p.79 ~ p.89
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Clinical Efficacy & Safety of Salmeterol in the Treatment of Patients with Mild to Moderate Asthma
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Abstract
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Background : Salmeterol is a novel ?2-adrenoceptor agonist with a long duration of at least 12 hours. We conducted this study to assess the clinical efficacy & safety of Salmeterol (Serevent®), a new long acting inhaled ?2-adrenoceptor agonist, in the treatment of mild to moderate bronchial asthmatic patients. Method : Ten patients with stable asthma were included after the demonstration of airways reversibility in forced expiratory volume in one second(FEVi) of at least 15% to 200?g salbutamol or 20% to 400?g salbutamol and whose FEV1 was greater than 50% predicted. And then the patients were treated for 10week period with inhaled salmeterol 50?g twice a day. We compared daily symptom score, Peak expiratory flow rate(PEFR) & its diurnal variability, the number of puffs & days of additional bronchodilator required to relieve asthma symptoms, and FEV1 between run-in & period of treatment. Results
1. Salmeterol produced a significant higher morning PEFR during 10-week salmeterol treatment period compared with run-in period (87.20±20.59% pred. in treatment period vs 74.73±21.51% pred. in run-in period, p<0.01) and night PEFR(97.42±18.67% pred. vs 86.31±19.43% pred., p<0.001). And Diurnal variability of PEFR showed tendency to reduce during treatment period (13.66±8.54%) compared with run-in period (18.22±9.49%) (p=0.07) .
2. FEV1 was improved after 10-week salmeterol treatment compared with runin period (83.22±17.28% pred. after treatment vs 70.86±14.72% pred. before treatment, p<0.01).
3. Day-time symptom scores were more significantly reduced after treatment (0.26±0.30) than run-in period(1. 27±0.97): (p<0.05) and night-time symptom scores appeared to be reduced but it was not significant statistically (0.16±0.23 treatment period vs 0.49±0.39 run-in period, p=0.14).
4. The number of puffs for additional bronchodilator inhalation during daytime was significantly decreased in treatment period (1.00±1.64 puffs per week) compared with run-in period (5.50±3.46 puffs per week) (p<0.05). The number of puffs for additional brondchodialtor inhalation during night-time showed reducing tendency but it was not significant statistically(0.89±1.35 puffs per week in treatment period vs 3.43±2.62 puffs per week in run-in period, p= 0.07).
5. The number of days required for additional bronchodialtor use during daytime was significant in treatment period (0.77±1.24 days per week) compared to run-in period (3.79±2.08 days per week) (p<0.05). The number of days required for additional bronchodialtor use during night-time showed reducing tendency but it was not significant statistically (0.7 ±1.20 days per week in treatment period vs 3.36±2.21 days per week in run-in period, p=0.06).
6. There were no significant. differences in the blood pressure, pulse rate, ECG & other laboratory examinations between run-in period and- the end of treatment period. And there was no adverse reactions enough to discontinue the salmeterol during the entire treatment period.
Conclusion As a results, we concluded that salmeterol given twice daily would be effective & safe treatment in the management of the mild to moderate bronchial asthmatic patients.
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KEYWORD
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