Effectiveness and tolerability of high-dose salmeterol in cystic fibrosis

TY - JOUR

T1 - Effectiveness and tolerability of high-dose salmeterol in cystic fibrosis

AU - Hordvik, Nancy L.

AU - Sammut, Paul Henry

AU - Gerald Judy, C.

AU - Colombo, John Louis

PY - 2002/10/1

Y1 - 2002/10/1

N2 - The efficacy and tolerability of high-dose salmeterol (100 mcg, BID) and albuterol (2.5 mg BID) were compared with those of albuterol (2.5 mg, BID) in outpatients with cystic fibrosis in a randomized, double-blind, double-dummy, placebo-controlled, crossover study with both short- (4 weeks of each) and long-term (24 weeks of each) treatment periods. The primary outcome measure was the difference in mean change in forced expired volume in 1 sec (FEV1) from baseline to the end of each treatment, and secondary measures included changes in forced vital capacity (FVC), forced expiratory flow between 25-75% of FVC (FEF25-75), patient-rated weekly symptom scores, number of extra (rescue) albuterol treatments, and number of antibiotic treatments. Tolerability was evaluated by changes in vital signs and adverse events. Thirty-six out of 44 patients enrolled finished the short-term treatment period, and 19 out of 23 who continued the study also finished the long-term treatment period. There was no significant difference in the mean % change in FEV1 from baseline to completion of 4 weeks with each drug in the short-term treatment period (0.1% vs. 0.06%, albuterol vs. salmeterol; respectively). In the long-term treatment period, there was a significant decrease from baseline in FEV1 with albuterol vs. salmeterol, as measured after both 12 and 24 weeks of each treatment (-6.2% vs. 1.8%, P = 0.013 after 12 weeks, and -6.5% vs. 1.7%, P = 0.002, after 24 weeks, respectively). In both treatment periods, salmeterol was well-tolerated. While there were more rescue treatments per patient per week with albuterol than with salmeterol treatment in both the short- and long-term periods (0.67 vs. 0.40 and 1.76 vs. 0.74, respectively), rescue treatments were needed significantly more often for only the long-term period with albuterol compared to salmeterol (P = 0.022). Also, there were more antibiotic interventions with albuterol than with salmeterol treatment in both the short- and long-term periods (25 vs. 10 and 56 vs. 42, respectively); however, antibiotics were needed significantly more often for only the short-term period (P = 0.011). In addition, there was a significantly higher symptom score with albuterol vs. salmeterol treatment during the second half of the long-term period (1.24 vs. 0.89, P = 0.001). In conclusion, long-term high-dose salmeterol was equally safe and was associated with better pulmonary function, fewer interventions, and fewer respiratory symptoms compared to standard therapy with albuterol in a population of outpatients with mild to moderate CF.

AB - The efficacy and tolerability of high-dose salmeterol (100 mcg, BID) and albuterol (2.5 mg BID) were compared with those of albuterol (2.5 mg, BID) in outpatients with cystic fibrosis in a randomized, double-blind, double-dummy, placebo-controlled, crossover study with both short- (4 weeks of each) and long-term (24 weeks of each) treatment periods. The primary outcome measure was the difference in mean change in forced expired volume in 1 sec (FEV1) from baseline to the end of each treatment, and secondary measures included changes in forced vital capacity (FVC), forced expiratory flow between 25-75% of FVC (FEF25-75), patient-rated weekly symptom scores, number of extra (rescue) albuterol treatments, and number of antibiotic treatments. Tolerability was evaluated by changes in vital signs and adverse events. Thirty-six out of 44 patients enrolled finished the short-term treatment period, and 19 out of 23 who continued the study also finished the long-term treatment period. There was no significant difference in the mean % change in FEV1 from baseline to completion of 4 weeks with each drug in the short-term treatment period (0.1% vs. 0.06%, albuterol vs. salmeterol; respectively). In the long-term treatment period, there was a significant decrease from baseline in FEV1 with albuterol vs. salmeterol, as measured after both 12 and 24 weeks of each treatment (-6.2% vs. 1.8%, P = 0.013 after 12 weeks, and -6.5% vs. 1.7%, P = 0.002, after 24 weeks, respectively). In both treatment periods, salmeterol was well-tolerated. While there were more rescue treatments per patient per week with albuterol than with salmeterol treatment in both the short- and long-term periods (0.67 vs. 0.40 and 1.76 vs. 0.74, respectively), rescue treatments were needed significantly more often for only the long-term period with albuterol compared to salmeterol (P = 0.022). Also, there were more antibiotic interventions with albuterol than with salmeterol treatment in both the short- and long-term periods (25 vs. 10 and 56 vs. 42, respectively); however, antibiotics were needed significantly more often for only the short-term period (P = 0.011). In addition, there was a significantly higher symptom score with albuterol vs. salmeterol treatment during the second half of the long-term period (1.24 vs. 0.89, P = 0.001). In conclusion, long-term high-dose salmeterol was equally safe and was associated with better pulmonary function, fewer interventions, and fewer respiratory symptoms compared to standard therapy with albuterol in a population of outpatients with mild to moderate CF.

KW - Albuterol

KW - Bronchodilators

KW - Cystic fibrosis

KW - Salmeterol

UR - http://www.scopus.com/inward/record.url?scp=0036785093&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036785093&partnerID=8YFLogxK

U2 - 10.1002/ppul.10162

DO - 10.1002/ppul.10162

M3 - Article

C2 - 12205570

AN - SCOPUS:0036785093

VL - 34

SP - 287

EP - 296

JO - Pediatric Pulmonology

JF - Pediatric Pulmonology

SN - 8755-6863

IS - 4

ER -