Effect of fluticasone propionate and salmeterol in a single device, fluticasone propionate, and montelukast on overall asthma control, exacerbations, and costs.
BACKGROUND
Inhaled corticosteroids are the most effective class of anti-inflammatory agents and are recommended for patients with persistent asthma.


OBJECTIVE
To compare the effectiveness of (1) fluticasone propionate, 100 microg, and salmeterol, 50 microg; (2) fluticasone propionate, 100 microg; and (3) montelukast, 10 mg, as first-line maintenance treatment for persistent asthma.


METHODS
Combined analysis of 4 clinical trials, 2 that compared fluticasone propionate-salmeterol with montelukast and 2 that compared fluticasone propionate with montelukast as initial asthma therapy.


RESULTS
The 4 studies had a total of 1,910 patients 15 years or older with symptomatic asthma previously treated with inhaled short-acting beta2-agonists alone. At the end point, there were significantly greater increases in forced expiratory volume in 1 second with fluticasone propionate-salmeterol (0.57 L; P < or = .004) vs fluticasone propionate (0.48 L) and montelukast (0.31 L) and significantly greater increases in morning peak expiratory flow rate (84.9 L/min; P < .001) vs fluticasone propionate (56.0 L/min) and montelukast (36.1 L/min). Fluticasone propionate-salmeterol significantly increased the percentage of symptom- and rescue-free days and significantly reduced albuterol use vs fluticasone propionate and montelukast (P < or = .04 for both). Patients treated with fluticasone propionate and montelukast had 2.6 and 3.6 greater risk, respectively, of having an asthma-related exacerbation vs fluticasone propionate-salmeterol users. In addition, mean daily exacerbation costs per treated patient were dollars 0.41 for fluticasone propionate-salmeterol, dollars 4.60 for fluticasone propionate, and dollars 7.57 for montelukast, whereas mean daily costs per patient exacerbation for fluticasone propionate-salmeterol, fluticasone propionate, and montelukast were dollars 29, dollars 128, and dollars 154, respectively.


CONCLUSIONS
Patients with symptomatic asthma previously treated with short-acting beta2-agonists only who require maintenance therapy are likely to have greater clinical benefits, lower risk of an asthma exacerbation, and reduced exacerbation-related costs when initiating therapy with fluticasone propionate-salmeterol vs fluticasone propionate or montelukast.
O'Connor
Richard D
RD
Sharp Rees-Stealy Medical Group, San Diego, California 92101, USA. Richard.oconnor@sharp.com
Stanford
Richard
R
Crim
Courtney
C
Yancey
Steven W
SW
Edwards
Lisa
L
Rickard
Kathleen A
KA
Dorinsky
Paul
P
D000085:Acetates / Q000008:administration & dosage* / Q000191:economics; D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000191:economics; D000730:Androstadienes / Q000008:administration & dosage* / Q000191:economics; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000191:economics; D001249:Asthma / Q000188:drug therapy* / Q000191:economics*; D002986:Clinical Trials as Topic; D017281:Cost of Illness; D003521:Cyclopropanes; D004338:Drug Combinations; D000068298:Fluticasone; D006801:Humans; D008875:Middle Aged; D011804:Quinolines / Q000008:administration & dosage* / Q000191:economics; D000068299:Salmeterol Xinafoate; D013440:Sulfides
D000085:Acetates; D000305:Adrenal Cortex Hormones; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D004338:Drug Combinations; D011804:Quinolines; D013440:Sulfides; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; C093875:montelukast; D000420:Albuterol