An observational study of fixed dose combination fluticasone propionate/salmeterol or fluticasone propionate alone on asthma-related outcomes .
OBJECTIVE
To identify the relationship between resource utilization and treatment of asthma in subjects who were first time users of controller therapies, either fluticasone propionate (FP) and salmeterol delivered in a single Diskus device (FSC) or FP monotherapy.


METHODS
A retrospective, observational cohort analysis evaluated pharmacy and medical claims from subjects from a commercial managed-care database, which is similar in makeup to the US privately insured population, with a diagnosis of asthma and ≥1 prescription for FSC or FP dispensed from 1/1/2001 to 4/30/2005. Outcomes of interest were asthma-related emergency department (ED) visits, inpatient (IP) visits, and a combined outcome (IP or ED visits). Predicted rates of asthma-related and all-cause intubations were also reported for each cohort. Multivariate analysis of events was conducted using logistic regression and Cox proportional hazard regression. All outcomes were adjusted for differences in baseline characteristics.


RESULTS
There were 58 270 subjects identified (FSC, n = 42 466; FP, n = 15 804). Mean age was 37.65 years and 35.75% was female. The use of FSC was associated with lower risk of having an asthma-related ED visit (adjusted OR 0.79; 95% CI, 0.72-0.87) and an asthma-related ED/IP visit (OR 0.80; 95% CI, 0.73-0.88). Asthma-related ED and ED/IP rates were also significantly lower for FSC than for FP. There were no differences observed in post-index asthma-related intubations rates.


CONCLUSIONS
In this observational study using a large managed-care database, subjects treated with FSC were at significantly less risk for developing serious asthma exacerbations and had lower resource utilization than a cohort of subjects treated with FP. This is clinically meaningful despite the inherent limitations of these types of observational studies.
GlaxoSmithKline, Research Triangle Park, NC, USA. richard.h.stanford@gsk.com
Richard H
RH
Stanford
Anne
A
Fuhlbrigge
Aylin
A
Riedel
Gabriel Gomez
GG
Rey
David A
DA
Stempel
D000293:Adolescent; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage*; D018926:Anti-Allergic Agents / Q000008:administration & dosage; D001249:Asthma / Q000150:complications / Q000188:drug therapy*; D015331:Cohort Studies; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D000068298:Fluticasone; D000068297:Fluticasone-Salmeterol Drug Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D019370:Observation; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000730:Androstadienes; D018926:Anti-Allergic Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D000068298:Fluticasone; D000420:Albuterol