SALMETEROL XINAFOATE AS MAINTENANCE THERAPY COMPARED WITH ALBUTEROL IN PATIENTS WITH ASTHMA

Objective.-To compare the efficacy and safety of inhaled salmeterol xinafoate, a long-acting beta(2)-adrenoceptor agonist, with that of albuterol, a short-acting inhaled beta(2)-agonist, in the treatment of asthma. Design.-Randomized, double-blind, placebo-controlled, parallel-group study. Setting.-Eleven outpatient clinical centers. Subjects.-A total of 322 male and female patients at least 12 years of age with chronic symptomatic asthma requiring daily therapy. Intervention.-Patients were treated with salmeterol xinafoate (42 mu g inhaled twice daily), albuterol (180 mu g inhaled four times daily), or placebo (four times a day) for 12 weeks; patients in all three groups could use inhaled albuterol as backup medication for breakthrough symptoms. Main Outcome Measures.-Serial 12-hour forced expiratory flow in 1 second (FEV(1)), peak expiratory flow (PEF), asthma symptoms, nocturnal awakenings due to asthma, episodes of asthma exacerbations, and electrocardiography. Results.-The mean area under the curve for FEV(1) throughout each 12-hour period was consistently greater after a single dose of salmeterol than after two doses of albuterol administered 6 hours apart (P<.001), with the difference ranging from 3.1 to 4.3 L.h. Salmeterol produced an average increase in morning and evening PEF of 26 and 29 L/min, respectively, over pretreatment values compared with decreases of -13 and -3 L/min, respectively, in the albuterol group and -2 L/min both in the morning and evening in the placebo group (P<.001). Patients in the salmeterol group had significantly fewer days and nights with symptoms than did either the albuterol or placebo group (P<.001). Responses to salmeterol were similar at day 1 and at week 12. Adverse events in all treatment groups were equally infrequent, and no clinically significant change in cardiac rhythm was observed with salmeterol treatment. Conclusion.-Salmeterol inhaled twice daily is more effective than albuterol inhaled four times a day (or as needed) in patients with asthma requiring maintenance therapy. No deterioration of asthma control was observed with the use of salmeterol over a 3-month period.