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KMID : 0378019970400060037
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New Medical Journal
1997 Volume.40 No. 6 p.37 ~ p.43
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Clinical Efficacy and Safety of Inhaled Salmeterol in Adult Asthmatic Patients
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Abstract
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B 2-agonists are the first line of drugs for bronchial asthma but currently available B 2-agonists have a short duration of action for 4-6hours and are used in combi-nation with slow released bronchodilator to prevent nocturnal asthma. But salmeterol is a new B 2-adrenoceptor agonist with long action duration of at least 12 hours. We conducted this study to assess the clinical efficacy and safety of 50mcg inhaled salmeterol(Serevent) twice daily in adult patients with mild to moderate asthma.
Method : Our study was an open trial composed of a run-in period of 2 weeks, a treat-ment period 10 weeks and a follow-up period 2 weeks. Patients were recruited after the demonstration of airway reversibility in forced expiratory volume in one second(FEV1) of at least 15% to 200mcg salbutamol or efficacy and safety of salmeterol in 23 patients with mild to moderate asthma. The efficacy was assessed by symptom scores and pulmonary functions. Each of the parameters during first five weeks and 2nd five weeks treatment were compared with those of the run-in period.
Results
1. During first and 2nd five weeks treatment of salmeterol, morning and evening PEFRs increased significantly in comparison with that of the run-in period(p<0.05).
2. There was an increase in FEV I and FVC after first and second 5 weeks salmeterol treatment, but there were significant differences.
3. There were significant differences in day-time and night-time symptom scores, the percentage of days with symptom score 0 and the percentage of days required for additional inhalation of short acting bronchodilator during salmeterol treatment peri-ods(p<0.05).
4. Neither significant side effects of salmeterol, no(significant changes in body weight, heart rate, blood pressure, EKG, and other laboratory profiles were noted.
Conclusion : In conclusion, salmeterol inhalation at a dose of 50mcg bid has been shown to be effective and safe in the treatment of patients with mild to moderate bronchial asthma.
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