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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 randomized, 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 "

Becki

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