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High-Dose Salmeterol Effective In Mild To Moderate Cystic Fibrosis
A DGReview of :"Effectiveness and tolerability of high-dose salmeterol in cystic fibrosis"
Pediatric Pulmonology
10/08/2002
By Elda Hauschildt
Long-term, high-dose salmeterol appears to improve pulmonary function and reduce interventions in outpatients with mild to moderate cystic fibrosis.
The agent is also associated with fewer respiratory symptoms compared with standard albuterol therapy, report researchers from the University of Nebraska Medical Centre in Omaha, Nebraska, United States.
They enrolled 44 children with cystic fibrosis to test the efficacy and tolerability of high-dose salmeterol (100 µg BID) and albuterol (2.5 mg BID). The randomised, double-blind, double-dummy trial was placebo controlled.
A total of 36 patients finished the short-term crossover treatment period of four weeks each; 19 of 23 also finished the long-term crossover treatment period of 24 weeks each.
Investigators used the difference in mean change in forced expired volume in one second (FEV1) from baseline to the end of each treatment as the main outcome measure. They included five secondary outcome measures: changes in forced vital capacity (FVC), forced expiratory flow between 25 percent and 75 percent of FVC (FEF25-75), patient-rated weekly symptom scores, number of rescue albuterol treatments and number of antibiotic treatments.
They found no significant difference in mean percentage change in FEV1 to completion of short-term treatment with each drug. But after both 12 and 24 weeks of long-term treatment, they found a significant decrease from baseline in FEV1 with albuterol versus salmeterol. Salmeterol therapy was well tolerated.
The researchers also noted that rescue treatments were needed significantly more often during long-term treatment with albuterol than with salmeterol.
Patients receiving albuterol also required more antibiotic interventions in both the short- and long-term treatment phases. This was significant in the short-term treatment phase, however.
Pediatric Pulmonology, 2002; 34: 287-296.
"Effectiveness and tolerability of high-dose salmeterol in cystic fibrosis"
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