Effects on Resource Utilization of Adding Salmeterol in Combination or Separately to Inhaled Corticosteroids

Abstract

BACKGROUND: The addition of a long-acting beta-agonist (LABA) to an inhaled corticosteroid (ICS) for patients with moderate or severe persistent asthma improves outcomes such as pulmonary function, reduces exacerbations requiring oral steroids, and reduces use of rescue beta-agonists.OBJECTIVE: To assess the key resource utilization outcomes of adding salmeterol, a LABA, to fluticasone, an ICS, either as a fixed-combination inhaler (fluticasone-salmeterol [FSA] or as a separate inhaler used concomitantly with the ICS beclomethasone (BSA).METHODS: This is a retrospective, observational database study that extracted data from electronic medical and prescription records in which the prescription written was identical to the prescription dispensed. The sample included asthmatic patients aged 12 to 55 years who received a medium dose of an ICS (240-480 mcg of beclomethasone, 264-660 mcg of fluticasone, 600-1,200 mcg of budesonide, or 1,000-2,000 mcg of triamcinolone acetonide) between July 2001 and December 2002 and had salmeterol added to the regimen (index date). From this population of patients, the analytical cohort was derived to include 1,213 patients who received FSA and a matched cohort of 1,213 patients who received BSA. The primary endpoint was an asthmarelated event (ARE), which was defined as (1) an emergency department (ED) visit or (2) hospital admission with a primary asthma diagnosis code (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 493.xx). The secondary endpoints were the (1) use of short-acting beta-agonist (SABA) equivalents, (2) percentage of patients who received 1 or more oral steroid prescriptions, (3) patterns of ICS use, and (4) refill rates of salmeterol. All data were collected for 6 months before and 6 months after the index date, defined as the first prescription dispensed to the patient that included salmeterol as an ingredient.RESULTS: Outcomes were improved in both cohorts with no significant difference in the likelihood of an ARE, 60 patients (4.9%) for FSA and 90 patients (8.1%) for BSA (odds ratio [OR], 0.668; 95% confidence interval [CI], 0.443-1.008); P = 0.055). FSA was associated with a reduction in AREs of 55% (10.9%-4.9%; P <0.001), and BSA with a reduction in AREs of 39% (13.3%-8.1%; P <0.001). FSA compared with BSA was associated with a greater reduction in SABA use (-0.66 canister equivalents over 6 months, P <0.001) and a lower likelihood of filling an oral steroid prescription, 35.8% of FSA patients compared with 38.0% of BSA patients (OR, 0.801; 95% CI, 0.662-0.970; P = 0.023). For the 132 FSA patients (10.9%) and 162 BSA patients (13.4%) who had an ARE in the preperiod, those who received FSA in the postperiod had a 47% lower likelihood of a subsequent ARE, 17.4% of 132 patients compared with 27.8% of 162 BSA patients (OR, 0.527; 95% CI, 0.291-0.954; P = 0.034). No ARE differences in subgroup analyses were noted for patients without an ARE in the preperiod or for patients using more than 6 canisters of SABA. More pat...

The relationship between combination inhaled corticosteroid and long-acting β-agonist use and severe asthma exacerbations in a diverse population

“…29 In another retrospective study using administrative data, the addition of LABA therapy to existing ICS treatment appeared to improve asthma outcomes. 30 These authors also found adherence to be significantly better for the ICS/LABA combination preparation when compared to separate inhalers for ICS and LABA. Importantly, our study accounts for patient use or adherence such that we calculate the effect of therapy in only those with apparently consistent use.…”

<p>Impact of Single Combination Inhaler versus Multiple Inhalers to Deliver the Same Medications for Patients with Asthma or COPD: A Systematic Literature Review</p>

“…Data on adherence (including compliance and persistence) were reported in non-randomized observational and RCTs in asthma (n=8 [17][18][19][20][21][22][23][24] and n=4, [25][26][27][28] respectively) and COPD (n=2 29,30 and n=2, 31,32 respectively; Table 1). Adherence was assessed as medication usage (including self-reported), [25][26][27]32 prescription/refill rates, [17][18][19]21 MPR, 18,20 treatment days, 17,18 treatment persistence/ interruptions, 19,[22][23][24][28][29][30] and residual treatment. 31…”

“…Prescription/Refill Rates Results from four retrospective studies in asthma (patient numbers ranging from 2426 to 5118) indicated that users of single inhalers filled significantly more prescriptions than users of multiple inhalers over time periods of 6 21 and 12 months [17][18][19] (all P<0.05; Table 1). Using medical and pharmacy claims data from the Ingenix database collected between April 2001 and July 2001, prescriptions for single inhalers were significantly higher than the number of requests for ICS in the multiple-inhalers group (4.06 versus 2.35; P<0.001).…”

A retrospective observational study comparing rescue medication use in children on combined versus separate long-acting -agonists and corticosteroids

“…The reasons for the increased use of fixed-dose combination of LABA and ICS are said to be the ease of use and better adherence14 30–33 and better asthma control 21 32–35…”