Prescription Status and Clinical Outcomes of Methylxanthines and Leukotriene Receptor Antagonists in Mild-to-Moderate Chronic Obstructive Pulmonary Disease.

Background: Methylxanthines and leukotriene receptor antagonists (LTRA) are not a first-line medical treatment for chronic obstructive pulmonary disease (COPD) but are frequently prescribed despite limited evidence. We aimed to elucidate the real prescribing status and clinical impacts of these agents in early COPD patients. Methods: Patients with mild-to-moderate COPD (FEV1>50%) were selected from the Korean National Health and Nutrition Examination Survey data between 2007 and 2012. Besides analyzing the prescription status of methylxanthines and LTRA and the contributing factors to the prescription, we evaluated the clinical impacts of these drugs on the exacerbation, hospitalization, and medical costs. Results: Of 2269 patients with mild-to-moderate COPD, 378 patients (16.7%) were under medical treatments, and the users of methylxanthines and/or LTRA were 279 patients (12.3%); however, only 139 patients (6.1%) were inhaler users. The contributing factors for the prescription of methylxanthines were a comorbidity of asthma or allergic disease, poor lung function, low quality of life, prescribing doctor from the specialty of internal medicine, and an institution type of private hospital. The prescription of LTRA was associated with the comorbidity of allergic disease. The methylxanthine and/or LTRA users had more hospital utilization but did not have significant differences in acute exacerbations and medical cost for hospital utilization, compared with the non-users. Conclusion: Methylxanthines and LTRA were used in a significant proportion of patients with mild-to-moderate COPD in real fields without favorable impacts on the exacerbations, hospitalizations, or medical costs. The use of more effective inhaled medications should be encouraged.

Economic Burden Associated with Receiving Inhaled Corticosteroids with Leukotriene Receptor Antagonists or Long-Acting Beta Agonists as Combination Therapy in Older Adults.

BACKGROUND: There is a paucity of literature on the health care expenditures associated with different pharmacologic treatments in older adults with asthma that is not well controlled on inhaled corticosteroids (ICS). OBJECTIVE: To compare asthma-related and all-cause health care expenditures associated with leukotriene receptor antagonists (LTRA) versus long-acting beta agonists (LABA) when added to ICS in older adults with asthma. METHODS: A retrospective cohort was constructed using 2009-2010 Medicare fee-for-service medical and pharmacy claims from a 10% random sample of beneficiaries continuously enrolled in Parts A, B, and D in 2009. The sample comprised patients who were aged 65 years and older, diagnosed with asthma, and treated exclusively with ICS + LABA or ICS + LTRA. Outcomes assessed were asthma-related expenditures (medical, pharmacy, and total) and all-cause health care expenditures (medical, pharmacy, and total). Outcomes were measured from the date of the first prescription for the add-on treatment (LABA or LTRA in combination with ICS) after having at least a 4-month "wash-in" period in which patients were receiving no controller, ICS alone, or ICS plus the add-on treatment of the follow-up period. Patients were followed until death, switching to or adding the other add-on treatment, or the end of the study (December 31, 2010). Multivariable regression models with nonparametric bootstrapped standard errors were used to compare all-cause and asthma-related expenditures per patient per month (PPPM) between ICS + LABA and ICS + LTRA users. All models were adjusted for demographics, comorbidities, and county-level health care access variables. RESULTS: The primary analysis included 14,702 patients, of whom 12,940 were treated with ICS + LABA and 1,762 were treated with ICS + LTRA. The mean (SD) follow-up periods were 12.3 (± 5.7) months for the ICS + LABA group and 15.3 (± 5.1) months for the ICS + LTRA group. Adjusted asthma-related expenditures PPPM were $400 for the ICS + LTRA group compared with $286 for the ICS + LABA group (P < 0.001). However, adjusted total all-cause expenditure PPPM was significantly lower for patients treated with ICS + LTRA ($6,087 for ICS + LTRA compared with $6,975 for ICS + LABA, P = 0.029). CONCLUSIONS: Older adults with asthma often experience economic burden from asthma and other chronic illnesses. Compared with ICS + LTRA, ICS + LABA was associated with lower asthma-related expenditures but with higher all-cause expenditures in older adults. DISCLOSURES: Support for this study was provided by the University of Pittsburgh School of Pharmacy and the Pittsburgh Claude D. Pepper Older Americans Independence Center (NIA P30 AGAG024827). C. Thorpe reports grants from the National Institute of Aging during the conduct of this study. The other authors have nothing to disclose.

Access to affordable medicines and diagnostic tests for asthma and COPD in sub Saharan Africa: the Ugandan perspective.

BACKGROUND: Equitable access to affordable medicines and diagnostic tests is an integral component of optimal clinical care of patients with asthma and chronic obstructive pulmonary disease (COPD). In Uganda, we lack contemporary data about the availability, cost and affordability of medicines and diagnostic tests essential in asthma and COPD management. METHODS: Data on the availability, cost and affordability of 17 medicines and 2 diagnostic tests essential in asthma and COPD management were collected from 22 public hospitals, 23 private and 85 private pharmacies. The percentage of the available medicines and diagnostic tests, the median retail price of the lowest priced generic brand and affordability in terms of the number of days' wages it would cost the least paid public servant were analysed. RESULTS: The availability of inhaled short acting beta agonists (SABA), oral leukotriene receptor antagonists (LTRA), inhaled LABA-ICS combinations and inhaled corticosteroids (ICS) in all the study sites was 75%, 60.8%, 46.9% and 45.4% respectively. None of the study sites had inhaled long acting anti muscarinic agents (LAMA) and inhaled long acting beta agonist (LABA)-LAMA combinations. Spirometry and peak flow-metry as diagnostic tests were available in 24.4% and 6.7% of the study sites respectively. Affordability ranged from 2.2 days' wages for inhaled salbutamol to 17.1 days' wages for formoterol/budesonide inhalers and 27.8 days' wages for spirometry. CONCLUSION: Medicines and diagnostic tests essential in asthma and COPD care are not widely available in Uganda and remain largely unaffordable. Strategies to improve access to affordable asthma and COPD medicines and diagnostic tests should be implemented in Uganda.

Cost-Utility Analysis of Long-Acting Beta Agonists versus Leukotriene Receptor Antagonists in Older Adults with Persistent Asthma Receiving Concomitant Inhaled Corticosteroid Therapy.

BACKGROUND: Long-acting beta agonists (LABA) and leukotriene receptor antagonists (LTRA) are the major add-on treatments in older adults with persistent asthma when inhaled corticosteroids (ICS) fail to achieve adequate asthma control. OBJECTIVES: To evaluate the cost-utility of ICS + LABA treatment compared with ICS + LTRA treatment in older adults with asthma. METHODS: A Markov model was used to estimate the incremental costs and quality-adjusted life expectancy associated with ICS + LABA treatment versus ICS + LTRA treatment in older adults with asthma in the United States from the health system perspective. The HCUPnet 2010 national statistics were used to extract the costs associated with asthma and cardiovascular hospitalizations, and inpatient mortality associated with these events. Event probabilities were predicted using Medicare 2009-2010 claims for older adults with asthma. Treatment costs were estimated on the basis of average wholesale drug price listings, and utility estimates were extracted from the literature. To account for uncertainty, one-way sensitivity analysis and probabilistic sensitivity analysis were performed. RESULTS: The model predicted that, compared with ICS + LTRA treatment, ICS + LABA treatment costs $5,823 more while gaining 0.03 quality-adjusted life-years (QALYs), resulting in an incremental cost-effectiveness ratio of $209,090 per QALY. Hospitalization probabilities and posthospitalization utilities were the most influential parameters in the one-way sensitivity analysis. Probabilistic uncertainty analysis using Monte-Carlo simulations showed that the probabilities that ICS + LTRA treatment is cost-effective compared with ICS + LABA treatment are 77% and 62% at $50,000 and $100,000 per QALY gained willingness-to-pay thresholds, respectively. CONCLUSIONS: The cost-effectiveness of ICS + LABA treatment is economically unfavorable in older adults when compared with LTRA as add-on treatment.

Comparative safety and costs of stepping down asthma medications in patients with controlled asthma.

BACKGROUND: Limited data exist regarding outcomes after stepping down asthma medication. OBJECTIVE: We sought to compare the safety and costs of stepping down asthma controller medications with maintaining current treatment levels in patients with controlled asthma. METHODS: Patients with persistent asthma were identified from the US Medical Expenditure Panel Survey years 2000-2010. Each patient had Medical Expenditure Panel Survey data for 2 years, and measurement was divided into 5 periods of 4 to 5 months each. Eligibility for stepping down asthma controller medications included no hospitalizations or emergency department visits for asthma in periods 1 to 3 and no systemic corticosteroid and 3 or less rescue inhalers dispensed in periods 2 and 3. Steps were defined by type and dose of chronic asthma medication based on current guidelines when comparing period 4 with period 3. The primary outcome of complete asthma control in period 5 was defined as no asthma hospitalizations, emergency department visits, and dispensed systemic corticosteroids and 2 or fewer dispensed rescue inhalers. Multivariable analyses were conducted to assess safety and costs after step down compared with those who maintained the treatment level. RESULTS: Overall, 29.9% of patients meeting the inclusion criteria (n = 4235) were eligible for step down; 89.4% (95% CI, 86.4% to 92.4%) of those who stepped down had preserved asthma control compared with 83.5% (95% CI, 79.9% to 87.0%) of those who were similarly eligible for step down but maintained their treatment level. The average monthly asthma-related cost savings was $34.02/mo (95% CI, $5.42/mo to $61.24/mo) with step down compared with maintenance of the treatment level. CONCLUSION: Stepping down asthma medications in those whose symptoms were controlled led to similar clinical outcomes at reduced cost compared with those who maintained their current treatment level.

A randomized trial examining the effect of pretreatment point-of-care computed tomography imaging on the management of patients with chronic rhinosinusitis symptoms.

BACKGROUND: Recent consensus statements on the diagnosis of chronic rhinosinusitis (CRS) now require endoscopic or radiographic evidence of paranasal sinus inflammation. The timing of point-of-care (POC) computed tomography (CT) scan in the workup of these patients remains to be elucidated, particularly when endoscopy is negative. The objective of this research was to prospectively evaluate 2 algorithms for the initial management of patients with symptoms of CRS who manifest a normal nasal endoscopic examination. METHODS: A total of 40 such patients were randomized to 1 of 2 pathways: POC-CT at the initial visit followed by medical therapy based upon CT results (pre-CT group; n = 20), or empiric medical therapy (EMT) followed by POC posttreatment CT if symptoms persisted (EMT group; n = 20). RESULTS: The 2 groups were demographically and symptomatically similar with regard to 2003 Task Force major criteria. Otolaryngology follow-up was recommended in 11 of 20 pre-CT patients, all of whom (100%) returned. In contrast, only 10 of 20 EMT patients (50%) followed up as instructed (p < 0.05). Radiographic confirmation of CRS was found in 8 of 20 pre-CT patients, and only 2 of 9 patients after EMT (p = 0.61). EMT patients received more antibiotic prescriptions (relative ratio [RR], 2.50; 95% CI, 1.46-4.27), while pre-CT patients received more CT scans (RR, 2.22; 95% CI, 1.37-3.61). Overall prescriptions costs were similar to the EMT group ($253 vs $218; p = 0.37) and the overall number of otolaryngology visits was similar. CONCLUSION: In patients with symptoms of CRS but negative endoscopy, POC at initial presentation results in substantially less unnecessary antibiotic prescriptions and significantly greater compliance with otolaryngology care but does result in a higher utilization of radiographic imaging.

[Cost-effectiveness analysis of pre-seasonal medication for cedar pollinosis in Japan].

Pre-seasonal medication is recommended for cases of cedar pollinosis that are expected to manifest severe symptoms during the season, according to the standard clinical guideline in Japan. This study aims to appraise the value for money of additional costs that accompany the choice of pre-seasonal medication from payer's perspective. Based on the 12 reports of controlled clinical trials with Symptom Score (SS) and Medication Score (MS) comparing pre-seasonal medication with intra-seasonal symptomatic medication, 15 incremental cost-effectiveness ratios (ICERs) and 4 integrated ICERs of each group of targeted agents are estimated. Incremental effects are estimated by reading SS charts, and incremental costs are estimated by reading MS charts and using National Health Insurance Medical Fee Schedule and National Health Insurance Drug Price Standard. Estimated ICERs range from ¥322,195 per quality-adjusted life-year (QALY) to ¥57,088,063 per QALY. Integrated ICERs are: ¥1,128,286 per QALY for 2nd generation histamine H(1) receptor antagonists, ¥2,248,018 per QALY for leukotriene receptor antagonists, ¥2,692,911 per QALY for prostaglandin D(2) and thromboxane A(2) receptor antagonists, ¥1,150,943 per QALY for Th2 cytokine suppressors, and ¥1,291,341 per QALY for all agents. Pre-seasonal medication for cedar pollinosis is cost-effective regardless of the choice of the prophylactic agent among 2nd generation histamine H(1) receptor antagonists, leukotriene receptor antagonists, prostaglandin D(2) and thromboxane A(2) receptor antagonists, or Th2 cytokine suppressors, taking the suggested threshold of ¥5,000,000 per 1 QALY gain in Japan. The use of 2nd generation histamine H(1) receptor antagonists and Th2 cytokine suppressors are found more favourable.

Cost effectiveness of leukotriene receptor antagonists versus inhaled corticosteroids for initial asthma controller therapy: a pragmatic trial.

BACKGROUND: Information is lacking on the relative effectiveness and cost effectiveness--in a primary-care setting--of leukotriene receptor antagonists (LTRAs) as an alternative to inhaled corticosteroids (ICS) for initial asthma controller therapy. OBJECTIVE: To compare the cost effectiveness of LTRAs versus ICS for patients initiating asthma controller therapy. METHODS: An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 12-80 years with asthma and symptoms requiring regular anti-inflammatory therapy (n = 326) were randomly assigned to LTRAs (n = 162) or ICS (n = 164). The main outcome measures were the incremental costs per point improvement in the Mini Asthma Quality of Life Questionnaire, per point improvement in the Asthma Control Questionnaire and per QALY gained from the UK NHS and societal perspectives. RESULTS: Over 2 years, resource use was similar between the two treatment groups, but the cost to society per patient was significantly higher for the LTRA group, at pounds sterling 711 versus pounds sterling 433 for the ICS group (adjusted difference pounds sterling 204; 95% CI 74, 308) [year 2005 values]. Cost differences were driven primarily by differences in prescription drug costs, particularly study drug costs. There was a nonsignificant (imputed, adjusted) difference between treatment groups, favouring ICS, in QALYs gained at 2 years of -0.073 (95% CI -0.143, 0.010). Therapy with LTRAs was, on average, a dominated strategy, and, at a threshold for willingness to pay of pounds sterling 30,000 per QALY gained, the probability of LTRAs being cost effective compared with ICS was approximately 3% from both societal and NHS perspectives. CONCLUSIONS: There is a very low probability of LTRAs being cost effective in the UK, at 2005 values, compared with ICS for initial asthma controller therapy. TRIAL REGISTRATION: UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.

Cost effectiveness of leukotriene receptor antagonists versus long-acting beta-2 agonists as add-on therapy to inhaled corticosteroids for asthma: a pragmatic trial.

BACKGROUND: Information is lacking on the relative effectiveness and cost effectiveness--in a real-life primary-care setting--of leukotriene receptor antagonists (LTRAs) and long-acting beta2 adrenergic receptor agonists (beta2 agonists) as add-on therapy for patients whose asthma symptoms are not controlled on low-dose inhaled corticosteroids (ICS). OBJECTIVE: To estimate the cost effectiveness of LTRAs compared with long-acting beta2 agonists as add-on therapy for patients whose asthma symptoms are not controlled on low-dose ICS. METHODS: An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 12-80 years with asthma insufficiently controlled with ICS (n = 361) were randomly assigned to add-on LTRAs (n = 176) or long-acting beta2 agonists (n = 185). The main outcome measures were the incremental cost per point improvement in the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), per point improvement in the Asthma Control Questionnaire (ACQ) and per QALY gained from perspectives of the UK NHS and society. RESULTS: Over 2 years, the societal cost per patient receiving LTRAs was pounds sterling 1157 versus pounds sterling 952 for long-acting beta2 agonists, a (significant, adjusted) increase of pounds sterling 214 (95% CI 2, 411) [year 2005 values]. Patients receiving LTRAs experienced a non-significant incremental gain of 0.009 QALYs (95% CI -0.077, 0.103). The incremental cost per QALY gained from the societal (NHS) perspective was pounds sterling 22,589 (pounds sterling 11,919). Uncertainty around this point estimate suggested that, given a maximum willingness to pay of pounds sterling 30,000 per QALY gained, the probability that LTRAs are a cost-effective alternative to long-acting beta2 agonists as add-on therapy was approximately 52% from both societal and NHS perspectives. CONCLUSIONS: On balance, these results marginally favour the repositioning of LTRAs as a cost-effective alternative to long-acting beta2 agonists as add-on therapy to ICS for asthma. However, there is much uncertainty surrounding the incremental cost effectiveness because of similarity of clinical benefit and broad confidence intervals for differences in healthcare costs. TRIAL REGISTRATION: UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.

Costs and resource use of mild persistent asthma patients initiated on controller therapy.

BACKGROUND: The treatment of mild persistent asthma is controversial. OBJECTIVES: A retrospective database approach was used to evaluate different alternatives to treating mild persistent asthma. We hypothesized that treatment with inhaled corticosteroids (ICS) would result in lowest costs than treatment with leukotriene modifiers (LM) and combination therapy with ICS long-acting inhaled beta(2)-agonists (LABA) because it would be associated with fewer acute care visits and hospitalizations than LM and it would have lower drug acquisition costs than both ICS+LABA and LM. METHODS: Costs and resource utilization were compared in 1,283 mild persistent asthma patients initiating regular use of either ICS, ICS+LABA, or LM. Mild persistent asthma patients were identified from a privately insured claims database (1999-2005) using an established algorithm. Wilcoxon rank-sum tests and generalized linear models were used to compare costs. RESULTS: Of the total patients who met study criteria, 319 patients (24.9%) initiated regular ICS use, 414 (32.3%) ICS+LABA use, and 550 (42.9%) LM use. Over the 1 year after controller therapy initiation, asthma-related direct costs were significantly lower with ICS compared with ICS+LABA or LM ($819 for ICS, $1,094 for ICS+LABA, and $869 for LM, p < 0.001 for all comparisons). There were no significant differences in resource use. CONCLUSION: In this analysis, physicians, despite guideline recommendations, chose to treat patients with mild persistent asthma more often with LM and ICS+LABA than with ICS. However, therapy with ICS was less costly than treatment with either LM or ICS+LABA, primarily due to differences in drug costs, and provided similar outcomes.

Cost effectiveness of leukotriene modifiers in adults with asthma.

Asthma is the most common chronic disorder in industrialised nations, with over 100 million people worldwide affected. Leukotrienes are chemical mediators released from mast cells, eosinophils and basophils. They cause bronchoconstriction, an increase in mucous secretions and activation of inflammatory cells. Leukotriene modifiers are a long-term controller medication used to treat asthma. They function by selectively competing for the leukotriene receptor sites, thereby blocking their action, or by inhibiting 5-lipoxygenase and thus preventing leukotriene formation. Both current US and Global Initiative for Asthma treatment guidelines have clarified the role of leukotriene modifiers in the management of asthma in adults and children. Leukotriene modifiers have two distinct roles: to replace inhaled corticosteroids in milder asthma and as an add-on therapy to inhaled corticosteroids in more severe asthma. While efficacy is certainly an important issue, economic considerations are also important in a disease such as asthma where there are a variety of treatment options and the severity of the disease varies widely. This review examined published studies to better understand the cost effectiveness of leukotriene modifiers in adults with asthma. Fifteen articles were found that analysed the cost effectiveness of leukotriene modifiers, with almost all performed in the US. The vast majority of the studies were retrospective claims analyses, but three randomised controlled trials incorporating economic outcomes have been reported. The majority of the articles found that for both monotherapy in mild persistent asthma and add-on therapy in moderate persistent asthma, leukotriene modifiers were less cost effective than inhaled corticosteroids with or without a long-acting beta2-adrenoceptor agonist. However, these results must be viewed cautiously as in several studies there were methodological issues such as comparisons of unequal treatment groups or inappropriate use of leukotriene modifiers in stepwise treatment.

Inhaled corticosteroids vs leukotriene receptor antagonists: health care costs across varying asthma severities.

BACKGROUND: The burden of asthma is substantial, and the overall cost of its management is growing. OBJECTIVE: To compare asthma-related charges and resource utilization across disease severity levels in the year after initial asthma treatment with any inhaled corticosteroid (ICS) or leukotriene receptor antagonist (LTRA). METHODS: This was a longitudinal, retrospective cohort study of claims data from managed care plans in the United States. All patients had a new prescription for an ICS or an LTRA between January 1999 and December 2000 and were enrolled in a managed care plan for at least 12 months before (preindex) and 12 months after (postindex) the initial claim. Asthma-related charges, hospitalizations, emergency department (ED) visits, physician visits, and asthma medication use were compared between the 2 cohorts. Propensity scores were calculated to control for baseline differences in patient characteristics and types of health care coverage. RESULTS: Claims from 31,860 patients were evaluated. Total postindex asthma-related charges were significantly lower in the ICS cohort than in the LTRA cohort (dollars 613 vs dollars 902, respectively; P < .001), as were asthma-related pharmacy charges (dollars 305 vs dollars 564, respectively; P < .001). Results were consistent for all propensity subclasses and all age groups. CONCLUSIONS: Results from this cohort study suggest that, across varying disease severities, treating asthma with an ICS as initial controller therapy leads to less health care resource utilization than does using an LTRA as initial therapy.

Determining economic feasibility of fluticasone propionate-salmeterol vs montelukast in the treatment of persistent asthma using a net benefit approach and cost-effectiveness acceptability curves.

BACKGROUND: The choice of treatment can have a major impact on the total costs associated with asthma care. OBJECTIVE: To determine the relative cost-effectiveness of twice-daily treatment with inhaled fluticasone propionate-salmeterol via Diskus, 100/50 microg, with that of once-daily treatment with oral montelukast as initial maintenance therapy in patients with persistent asthma uncontrolled with a short-acting beta2-agonist alone. METHODS: Data from a randomized, double-blind, double-dummy, 12-week clinical trial were analyzed. Efficacy end points included (1) symptom-free days (SFDs) during the 12-week period and (2) a 12% or greater increase in forced expiratory volume in 1 second (FEV1) from baseline. The economic analysis was performed from a payer's perspective, and hence only direct costs were included in the analysis. The incremental cost-effectiveness ratio (ICER), which is the mean difference in average costs divided by the mean difference in average effectiveness, was calculated for both effectiveness outcomes (SFDs and FEV1). RESULTS: For the SFDs end point, the ICER for fluticasone propionate-salmeterol vs montelukast was $2.87 (95% confidence interval, -$1.08 to $6.65), indicating that it costs, on average, an extra $2.87 per day for an additional SFD with fluticasone propionate-salmeterol than with montelukast. With regard to FEV1, the ICER was $1.79 (95% confidence interval, -$0.72 to $3.86), indicating that it costs, on average, an extra $1.79 per day to achieve a lung function improvement of 12% or greater from baseline with fluticasone propionate-salmeterol than with montelukast. At a widely acceptable ceiling ratio of $9.95 per day, the probability of fluticasone propionate-salmeterol being more cost-effective than montelukast was 99.8% for SFDs and was almost 100% for an FEV1 improvement of 12% of greater. CONCLUSIONS: Treating 2 main components of asthma, inflammation and smooth muscle dysfunction, using fluticasone propionate-salmeterol is more cost-effective than using a single mediator antagonist alone, such as montelukast, as initial maintenance therapy for persistent asthma in patients treated with a short-acting beta2-agonist only.

[Cost and management of asthma exacerbations in Spanish hospitals (COAX study in hospital services)]. / Coste y manejo de una crisis asmática en el ámbito hospitalario de nuestro medio (estudio COAX en servicios hospitalarios).

OBJECTIVE: The prevalence and associated health cost of asthma have been increasing in developed countries, and 70% of the overall disease cost is due to exacerbations. The primary objective of this study was to determine the hospital cost of an asthma exacerbation in Spain. The secondary objective was to determine what maintenance treatments patients were using to control asthma before the exacerbation and how the exacerbation was treated. The study formed part of a broader study (COAX II), with the same objectives in each of the 8 participating European countries. PATIENTS AND METHODS: Prospective observational study that enrolled 126 patients with an asthma exacerbation treated in the usual way in 6 Spanish hospitals over a 3-month period (from January 1 to March 31, 2000). RESULTS: According to the criteria of the Global Initiative for Asthma, 33.3% of the exacerbations were mild, 38.9% moderate, 26.2% severe, and 1.6% were associated with risk of imminent respiratory arrest. Use of corticosteroids was widespread among patients with moderate and severe asthma, but only 68% of the patients with severe asthma used long-acting beta2 agonists. The mean cost was 1555.70 Euros (95% confidence interval [CI], 1237.60 Euros-1907.00 Euros), of which 93.8% (1460.60 Euros; 95% CI, 1152.50 Euros-1779.40 Euros) was due to direct costs, and 6.2% (95.10 Euros; 95% CI, 35.50 Euros-177.00 Euros) to indirect costs. Cost rose with increasing severity of the exacerbation--292.60 Euros for a mild exacerbation, 1230.50 Euros for a moderate exacerbation, and 3543.10 Euros for a severe exacerbation. CONCLUSIONS: The mean cost was 1555.70 Euros. The costs of moderate and severe exacerbations were 4 and 12 times that of a mild exacerbation, respectively. Long-acting beta2 agonists were less widely used than recommended by the guidelines for treatment of moderate and severe persistent asthma leading to asthma exacerbations.

Outcomes associated with initiation of different controller therapies in a Medicaid asthmatic population: a retrospective data analysis.

BACKGROUND: Outcomes in asthmatic patients may vary depending on the controller medication used. Observational studies of outcomes of asthma therapy are needed to understand the implications of choice of controller in different populations. OBJECTIVES: To determine whether there are differences in health care use and costs of asthma treatment in asthma patients treated with montelukast compared with fluticasone proponiate 44 microg. METHOD: Using data from the North Carolina Medicaid program, we compared continuously enrolled asthmatic patients starting either fluticasone propionate 44 microg (FP44), an inhaled corticosteroid (ICS) (n = 312), or montelukast 5 and 10 mg, an oral leukotriene modifier (LM) (n = 398) between the years 1998 and 1999. A secondary analysis compared continuously enrolled asthmatic patients already using ICS as controller therapy initiating either salmeterol (long-acting beta-agonist) (n = 97) or montelukast (n = 101) in the year 1998. Patients were followed for 1 year pre- and postcontroller or additional controller initiation for health care service use, medication refill patterns, and costs. RESULTS: There were no significant differences in the adjusted asthma-related health care costs between the montelukast and FP44 groups. In both groups, physician visits were significantly higher in year 2 (p < 0.01) than in year 1. We found montelukast users to be more adherent with prescription refills (using measures of medication possession) even after allowing for a wider adherence range for FP (RR = 2.53; 95% CI = 1.50-4.26), although patients using montelukast were more likely than patients with fluticasone to switch controller pharmacotherapy (RR = 1.53; 95% CI = 1.12-2.09). Similarly, there were no differences in health care service use and costs between the montelukast and salmeterol groups, with the exception of a 33% reduction (p < 0.01) in number of inhaled corticosteroid refills in the second year in the salmeterol group. CONCLUSION: There were no cost and major health care use differences between the two primary or secondary controller therapies in the postinitiation year. Although FP was associated with lower rate of controller switch, montelukast use was associated with significantly better treatment adherence in patients with treatment persistence in this population of Medicaid-enrolled asthmatic patients. The addition of salmeterol as additional controller was associated with a significant decrease in inhaled corticosteroid use, suggesting decreased adherence in patients on the two-drug regimen.

Asthma: resource use and costs for inhaled corticosteroid vs leukotriene modifier treatment--a meta-analysis.

OBJECTIVE: To compare the effects of inhaled corticosteroid treatment with leukotriene modifier treatment on medical resource use and costs for asthma patients. STUDY DESIGN: Meta-analysis combining results from published and unpublished studies. DATA SOURCES: Studies were identified from the MEDLINE and EMBASE databases and the GlaxoSmithKline internal database study registers. Two independent reviewers evaluated the identified studies; studies meeting specified inclusion criteria were abstracted and summarized by meta-analysis with a random effects model. OUTCOMES MEASURED: Hospitalization rate, emergency department visit rate, emergency department costs, drug costs, total asthma-related costs, and total medical care costs. RESULTS: Patients taking inhaled corticosteroids had: a significantly lower annual rate of hospitalization than those taking leukotriene modifiers (2.2% vs 4.3%, respectively; P<.05); a greater decline in hospitalization rate (before vs after therapy initiation) than those taking leukotriene modifiers (decline of 2.4% vs 0.55%; P<.01); a lower annual rate of emergency department visits than those taking leukotriene modifiers (6.2% vs 7.7%; P<.005); lower total asthma-related medical costs than those taking leukotriene modifiers (P<.05) and a 17% reduction in overall total medical care costs (P not significant). CONCLUSIONS: Patients with asthma treated with inhaled corticosteroids have significantly fewer asthma-related hospitalizations and emergency department visits and lower total asthma-related health care costs than patients treated with leukotriene modifiers. These meta-analysis findings are consistent with results from randomized controlled trials showing improvements in lung function for patients taking inhaled corticosteroids as opposed to leukotriene modifiers.