title: Budesonide/formoterol maintenance and reliever therapy versus conventional best practice.
abstract: Budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) reduces asthma exacerbations and symptoms versus fixed-dose regimens plus short-acting beta(2)-agonists (SABA) in double-blind trials. Information is lacking regarding its effectiveness versus conventional best practice (CBP). This pooled analysis of six 6-month, randomized, open-label studies examined asthma control and exacerbation risk in asthmatics (aged> or =12 years). Patients (N=7855) symptomatic on inhaled corticosteroids (ICS) or stable/symptomatic on ICS/long-acting beta(2)-agonists (LABA) received budesonide/formoterol maintenance and reliever therapy (160/4.5microg bid and as needed) or CBP (ICS or ICS/LABA+/-other agents at an approved dose plus as-needed SABA). Overall asthma control was assessed comparing the incidence of exacerbations and levels of asthma control using the asthma control questionnaire (ACQ). Budesonide/formoterol maintenance and reliever therapy did not significantly reduce time to first severe exacerbation (primary variable) versus CBP (P=0.062). However, patients in this group experienced 15% fewer exacerbations (0.20 versus 0.24/patient/year; P=0.021) and used 27% less ICS (P<0.0001). Odds of remaining well controlled (ACQ< or =0.75) over 6 months were higher with budesonide/formoterol maintenance and reliever therapy versus CBP (45% versus 41%, odds ratio [OR] 1.29; P<0.01) while risk of remaining uncontrolled decreased (25% versus 29%, OR 0.81; P<0.01). Budesonide/formoterol maintenance and reliever therapy improves key aspects of asthma control versus physicians' choice of CBP.
authors.affiliation: University Hospital of Montpellier and INSERM U, Hôpital Arnaud de Villeneuve, France. pascal.demoly@inserm.fr
authors.forename: Pascal
authors.initials: P
authors.lastname: Demoly
authors.forename: Renaud
authors.initials: R
authors.lastname: Louis
authors.forename: Ulrik
authors.initials: U
authors.lastname: Søes-Petersen
authors.forename: Ian
authors.initials: I
authors.lastname: Naya
authors.forename: Asa
authors.initials: A
authors.lastname: Carlsheimer
authors.forename: Heinrich
authors.initials: H
authors.lastname: Worth
authors.forename: Joao
authors.initials: J
authors.lastname: Almeida
authors.forename: Malcolm R
authors.initials: MR
authors.lastname: Sears
mesh_terms: D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D019819:Budesonide / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate