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Treatment comparison of budesonide/formoterol with salmeterol/fluticasone propionate in adults aged > or =16 years with asthma: post hoc analysis of a randomized, double-blind study.
Clin Drug Investig. 2010; 30(9):565-79.CD

Abstract

BACKGROUND

Three fixed maintenance-dose inhaled corticosteroid/long-acting beta(2)-agonist (ICS/LABA) combinations for the treatment of asthma are currently available: salmeterol/fluticasone propionate (Seretide/Advair/Adoair) budesonide/formoterol (Symbicort) and beclometasone/formoterol (Foster). All of these combinations have proven efficacy in terms of controlling symptoms, improving lung function and reducing the rate of exacerbations compared with ICSs and LABAs administered separately. Budesonide/formoterol is also approved for use as maintenance and reliever therapy in a number of countries (Symbicort SMART). Many of the studies supporting the use of budesonide/formoterol combination therapies have included populations of adolescents and adults aged >11 years.

OBJECTIVE

This post hoc analysis compared the efficacy of ICS/LABA fixed maintenance-dose treatment with budesonide/formoterol and salmeterol/fluticasone propionate versus budesonide/formoterol maintenance and reliever therapy in patients with persistent asthma aged > or =16 years.

METHODS

Following 2-weeks' run-in, 2866 adults aged > or =16 years were randomized to: fixed maintenance-dose budesonide/formoterol 640 microg/18 microg per day, salmeterol/fluticasone propionate 100 microg/500 microg per day plus terbutaline as needed, or budesonide/formoterol 320 microg/9 microg per day plus additional inhalations as needed (budesonide/formoterol maintenance and reliever therapy). Outcome measures included time to first severe asthma exacerbation (primary outcome) and number of severe asthma exacerbations.

RESULTS

Budesonide/formoterol maintenance and reliever therapy prolonged time to first severe exacerbation versus budesonide/formoterol and salmeterol/fluticasone propionate fixed maintenance dose (p = 0.037 and p = 0.0089, respectively). Compared with salmeterol/fluticasone propionate fixed maintenance-dose treatment, fixed maintenance-dose budesonide/formoterol reduced the risk of hospitalizations/emergency-room visits by 28% (relative rate [RR] 0.72; 95% CI 0.53, 0.98; p = 0.034) and budesonide/formoterol maintenance and reliever therapy by 37% (RR 0.63; 95% CI 0.46, 0.87; p = 0.0043). All treatments provided similar improvements in lung function, asthma control days and asthma-related quality of life.

CONCLUSIONS

Budesonide/formoterol fixed maintenance dose or maintenance and reliever therapy provides similar improvements in current asthma control and reduces the future risk of hospitalizations/emergency-room treatments versus salmeterol/fluticasone propionate fixed maintenance-dose treatment, providing additional clinical benefit to asthma patients aged > or =16 years.

Authors+Show Affiliations

Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland. piotr.kuna@umed.lodz.pl

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20593912

Citation

Kuna, Piotr. "Treatment Comparison of Budesonide/formoterol With Salmeterol/fluticasone Propionate in Adults Aged > or =16 Years With Asthma: Post Hoc Analysis of a Randomized, Double-blind Study." Clinical Drug Investigation, vol. 30, no. 9, 2010, pp. 565-79.
Kuna P. Treatment comparison of budesonide/formoterol with salmeterol/fluticasone propionate in adults aged > or =16 years with asthma: post hoc analysis of a randomized, double-blind study. Clin Drug Investig. 2010;30(9):565-79.
Kuna, P. (2010). Treatment comparison of budesonide/formoterol with salmeterol/fluticasone propionate in adults aged > or =16 years with asthma: post hoc analysis of a randomized, double-blind study. Clinical Drug Investigation, 30(9), 565-79. https://doi.org/10.2165/11533450-000000000-00000
Kuna P. Treatment Comparison of Budesonide/formoterol With Salmeterol/fluticasone Propionate in Adults Aged > or =16 Years With Asthma: Post Hoc Analysis of a Randomized, Double-blind Study. Clin Drug Investig. 2010;30(9):565-79. PubMed PMID: 20593912.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment comparison of budesonide/formoterol with salmeterol/fluticasone propionate in adults aged > or =16 years with asthma: post hoc analysis of a randomized, double-blind study. A1 - Kuna,Piotr, PY - 2010/7/3/entrez PY - 2010/7/3/pubmed PY - 2010/10/13/medline SP - 565 EP - 79 JF - Clinical drug investigation JO - Clin Drug Investig VL - 30 IS - 9 N2 - BACKGROUND: Three fixed maintenance-dose inhaled corticosteroid/long-acting beta(2)-agonist (ICS/LABA) combinations for the treatment of asthma are currently available: salmeterol/fluticasone propionate (Seretide/Advair/Adoair) budesonide/formoterol (Symbicort) and beclometasone/formoterol (Foster). All of these combinations have proven efficacy in terms of controlling symptoms, improving lung function and reducing the rate of exacerbations compared with ICSs and LABAs administered separately. Budesonide/formoterol is also approved for use as maintenance and reliever therapy in a number of countries (Symbicort SMART). Many of the studies supporting the use of budesonide/formoterol combination therapies have included populations of adolescents and adults aged >11 years. OBJECTIVE: This post hoc analysis compared the efficacy of ICS/LABA fixed maintenance-dose treatment with budesonide/formoterol and salmeterol/fluticasone propionate versus budesonide/formoterol maintenance and reliever therapy in patients with persistent asthma aged > or =16 years. METHODS: Following 2-weeks' run-in, 2866 adults aged > or =16 years were randomized to: fixed maintenance-dose budesonide/formoterol 640 microg/18 microg per day, salmeterol/fluticasone propionate 100 microg/500 microg per day plus terbutaline as needed, or budesonide/formoterol 320 microg/9 microg per day plus additional inhalations as needed (budesonide/formoterol maintenance and reliever therapy). Outcome measures included time to first severe asthma exacerbation (primary outcome) and number of severe asthma exacerbations. RESULTS: Budesonide/formoterol maintenance and reliever therapy prolonged time to first severe exacerbation versus budesonide/formoterol and salmeterol/fluticasone propionate fixed maintenance dose (p = 0.037 and p = 0.0089, respectively). Compared with salmeterol/fluticasone propionate fixed maintenance-dose treatment, fixed maintenance-dose budesonide/formoterol reduced the risk of hospitalizations/emergency-room visits by 28% (relative rate [RR] 0.72; 95% CI 0.53, 0.98; p = 0.034) and budesonide/formoterol maintenance and reliever therapy by 37% (RR 0.63; 95% CI 0.46, 0.87; p = 0.0043). All treatments provided similar improvements in lung function, asthma control days and asthma-related quality of life. CONCLUSIONS: Budesonide/formoterol fixed maintenance dose or maintenance and reliever therapy provides similar improvements in current asthma control and reduces the future risk of hospitalizations/emergency-room treatments versus salmeterol/fluticasone propionate fixed maintenance-dose treatment, providing additional clinical benefit to asthma patients aged > or =16 years. SN - 1173-2563 UR - https://www.unboundmedicine.com/medline/citation/20593912/Treatment_comparison_of_budesonide/formoterol_with_salmeterol/fluticasone_propionate_in_adults_aged_>_or_=16_years_with_asthma:_post_hoc_analysis_of_a_randomized_double_blind_study_ L2 - https://dx.doi.org/10.2165/11533450-000000000-00000 DB - PRIME DP - Unbound Medicine ER -