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Although studies have established that adding long-acting beta agonists (LABA) to inhaled corticosteroid (ICS) monotherapy among patients with inadequately controlled asthma is associated with better outcomes than increasing ICS dosage, outcomes with ICS versus fixed-dose ICS/LABA combination among patients with recent asthma exacerbation or frequent use of rescue medication are unavailable. This study was designed to compare health-care utilization/costs among patients with recent asthma exacerbation or frequent rescue medication use who received fluticasone propionate (FP) alone versus fixed-dose FP/salmeterol combination (FSC). A retrospective cohort study was conducted using a large health insurance data set. Patients with one or more claims with asthma diagnosis, two or more prescriptions for FSC (250/50- or 100/50-mg formulations) or FP (220- or 110-mg formulations), and one or more asthma exacerbations or five or more short-acting beta agonist (SABA) prescriptions within 1 year before initial receipt of study medications were included. Health-care utilization/costs and controller therapy compliance were compared for patients receiving FSC versus FP using multivariate regression analysis controlling for FP dose and baseline characteristics. A total of 7779 patients met inclusion criteria (5769, FSC, and 2010, FP) with comparable mean follow-up (FSC, 685 days; FP, 670 days; p = 0.151). Controlling for FP dosage and baseline characteristics, FSC patients had lower risks of asthma-related exacerbations, fewer SABAs and systemic corticosteroids, higher costs of asthma medications and total asthma-related health care, and lower total asthma-related health-care costs excluding study medication cost. In asthma patients with recent exacerbation or frequent SABA use, receipt of FSC reduced asthma-related exacerbation risks and rescue medication use versus receipt of FP.

Objective: National asthma treatment guidelines recommend low/medium-dose inhaled corticosteroids (ICSs) as initial therapy in mild asthma patients. However, low doses of a fixed-dose combination of ICS and long-acting β-agonists are sometimes used. This study compares asthma-related outcomes and health care utilization and costs in clinical practice in patients starting fluticasone propionate 100 μg and salmeterol 50 μg via Diskus (FSC) or mometasone furoate (MF)., Methods: A retrospective cohort study was conducted to compare asthma-related outcomes in asthma patients who received FSC or MF, using a large health insurance claims dataset spanning January 2004-December 2008. Patients with ≥1 claim with an asthma ICD-9-CM diagnosis code and ≥2 FSC or MF prescriptions were included, stratified into FSC or MF groups by study drug received first and matched using propensity score., Results: A total of 18,283 patients met inclusion criteria (14,044 FSC and 4239 MF); 3799 matched pairs were identified (mean follow-up: FSC 548 days, MF 537 days). FSC patients had lower risk of asthma-related exacerbation (Hazard ratio = 0.88, 95% CI 0.81-0.95, p = .002), defined as either asthma-related emergency department (ED) visits/hospitalizations or receipt of systemic corticosteroids (SCSs); fewer SCS claims (mean 0.28 vs. 0.33, p = .021); and fewer asthma-related physician office (PO) and hospital outpatient (HO) visits (mean 1.17 vs. 1.63, p < .001). However, asthma-related ED visits were higher with FSC (p = .004), and FSC patients had higher total costs of asthma-related health care ($953 vs. $862, p = .002)., Conclusions: In asthma patients initiating ICS therapy, MF had lower asthma-related ED visits. However, FSC may reduce the use of SCS and asthma-related PO/HO visits.

Background: The benefits of inhaled corticosteroids in asthma are well established. Early use of inhaled anti-inflammatories following and exacerbation could be beneficial., Methods: A retrospective observational cohort study compared the risk of asthma-related exacerbations [hospitalization, emergency department visit, and/or treatment with systemic corticosteroid] in patients receiving treatment with fluticasone propionate/salmeterol in a single inhaler (FSC) within 90 days following an initial asthma-related exacerbation (early treatment) versus patients receiving the treatment subsequently (late treatment). Data were from a large health insurance claims database spanning from January 1998 to April 2008. Subjects included patients with ≥1 prescription for FSC ≤ 1 year after first asthma-related exacerbation. Patients with early treatment were matched to those with late treatment by propensity score and compared in terms of healthcare utilization and costs after initiation of FSC., Results: A total of 14,861 patients met study inclusion criteria, including 10,793 early and 4068 late treatment patients. After matching, 3555 pairs were well matched on all pretreatment characteristics and duration of follow-up (mean 722 vs. 717 days, p = .634). Early versus late treatment was associated with longer time to first asthma-related exacerbation (hazard ratio = 0.82, 95% CI 0.75-0.88, p < .001), fewer short-acting β-agonists prescriptions (3.3 vs. 3.6, p = .031), higher outpatient yearly per patient pharmacy costs ($1320 vs. $1163, p = .008), and lower yearly per patient asthma-related emergency department visit costs ($80 vs. $105, p = .032). Total yearly per patient asthma-related costs were similar ($2197 vs. $2064, p = .203)., Conclusions: Earlier use of FSC following an asthma exacerbation was associated with reduced risk of future asthma-related exacerbation and lower use of rescue medications.

The National Asthma Education and Prevention Program guidelines recommend two options for patients uncontrolled on inhaled corticosteroid (ICS) alone: add a long-acting bronchodilator or increase the dose of the ICS. The purpose of this study was to compare asthma-related exacerbations and asthma control in asthma patients receiving fluticasone propionate (FP) monotherapy with an increased dose of FP compared with maintaining the dose and adding salmeterol (SAL) via a single device (FP/SAL combination [FSC]). A retrospective observational study was performed using health insurance claims spanning from January 2001 to August 2006 ("study period"). Subjects were > or =12 years of age, with asthma (International Classification of Diseases [ICD] 493.xx), and were stepped up from FP 44 microg to either FP 110 microg (FP110) or FP 100 microg/SAL 50 microg (FSC), or from FP110 to either FP 220 microg or FP 250 microg/SAL 50 microg (FSC). There were 1744 subjects identified, 557 (32%) increased FP and 1187 (68%) added SAL. The cohorts were relatively similar, and after adjusting for baseline characteristics, patients who added SAL to their same dose of FP had 41% lower odds of an asthma exacerbation (odds ratio = 0.59; 95% confidence interval [CI] = 0.46-0.76; p < 0.001), 36% fewer prescriptions for a short-acting beta-agonist (rate ratio = 0.64; 95% CI = 0.58-0.70; p < 0.001), and a 32% increase in ICS refill persistence compared with increasing the dose of FP. In asthma patients who are not adequately controlled with ICS (FP), adding SAL as FSC is associated with lower risk of an asthma-related exacerbation and better asthma control compared with increasing the dose of ICS (FP).

Clinical guidelines recommend add-on therapy with long-acting beta2-agonists (LABA) in patients with mild-to-moderate persistent asthma whose disease is not adequately controlled with inhaled corticosteroids (ICSs) alone. For those achieving control with add-on therapy, careful reduction in ICS dose followed by withdrawal of LABA is recommended. This study was designed to compare asthma-related outcomes in patients receiving fluticasone propionate/salmeterol combination (FSC) who stepped down to a lower dose of FSC versus those who stepped down to fluticasone propionate (FP) at the same dose of FP. A retrospective observational cohort study was performed using two large health insurance claims databases spanning from January 2000 to June 2007. Subjects were age > or =12 and <65 years, had a diagnosis of asthma (International Classification of Diseases [ICD-493.xx]), and who within 1 year of initiating FSC either stepped down to a lower dose of FSC ("FSC patients") or to FP only at the same dose of FP ("FP patients"). FSC and FP patients were matched based on propensity scores to control for potential differences in baseline demographic and clinical characteristics and preindex asthma-related and costs. Of 4350 subjects identified, 3881 stepped down to a lower dose of FSC and 469 stepped down to FP. After matching, there were 447 pairs of FSC and FP patients. FSC patients had 30% fewer prescriptions for short-acting beta-agonists, a 26% lower risk of receiving systemic corticosteroids, and a 48% lower risk of asthma-related hospitalization or Emergency Department visit during follow-up. Stepping down to FP monotherapy is associated with worsening asthma symptoms and greater risk of severe asthma-related exacerbations compared with staying on FSC at a lower ICS dose.

Background: Clinical trials suggest that in patients with asthma inadequately controlled on low- to medium- dose inhaled corticosteroids (ICSs), the addition of a long-acting beta-agonist such as salmeterol (SAL is more effective than the addition of montelukast (MON) or a higher-dose ICS., Objective: This study was designed to expand on these earlier findings by comparing asthma-related health care resource utilization and costs, as well as adherence to ICSs, in children and adults with asthma receiving ICS monotherapy who either were switched to fluticasone propionate plus SAL from a single inhaler (FSC) or initiated add-on therapy with SAL from a separate inhaler or MON., Methods: This retrospective study used an integrated managed-care database from >30 health plans. Patients were >or=5 years of age with a diagnosis of asthma (International Classification of Diseases, Ninth Revision, Clinical Modification 493.xx) and >or=2 claims for FSC, SAL, or MON. The date of first claim for the medication of interest was the index date. Patients were also required to have >or=1 claim for an ICS during the 12 months preindex and 12 months postindex. Utilization and costs of asthma-related care and adherence to ICS treatment postindex were compared using multivariate methods., Results: After adjusting for preindex characteristics, patients receiving FSC (n=1287) had fewer claims for short-acting beta-agonists, oral corticosteroids, and lower adjusted asthma-related costs postindex compared with ICS + SAL (n=562) and ICS + MON (n=420). FSC patients also had greater adherence to ICS therapy. Those who received FSC had lower risks for treatment failure (defined as asthma-related emergency department visits or hospitalization or receipt of alternative study medication or oral corticosteroids during the postindex period)., Conclusion: In this health insurance claims-based study of patients with asthma inadequately controlled with an ICS alone, those who received stepped-up therapy with FSC used fewer rescue medications and had greater persistence with ICSs compared with those in whom SAL or MON was added to ICS monotherapy.