Adherence to asthma controller medication regimens.

BACKGROUND: Improved adherence to inhaled corticosteroids (ICS) is recognized as an important factor in reduced morbidity, mortality and consumption of health care resources. The present study was designed to replicate previous reports of patient adherence with fluticasone/salmeterol in a single inhaler (FSC), fluticasone and salmeterol in separate inhalers (FP+SAL), fluticasone and montelukast (FP+MON), fluticasone alone (FP) and montelukast alone (MON). METHODS: A 24-month observational retrospective study was conducted using administrative claims data. Subjects were 12 years old with 24 months of continuous enrollment; had 1 asthma claim (ICD-9: 493), 1 short-acting beta(2)-agonist claim, and 1 FSC, FP, SAL, or MON claim. Outcomes included asthma medication refill rates and persistence measured by treatment days. This study was designed with a unique population of patients with asthma from different health plans to validate previous findings. RESULTS: A total of 3,503 subjects were identified based on their index medication: FSC (996), FP+SAL (259), FP+MON (101), FP (1254) and MON (893). Mean number of prescription refills for FSC (3.98) was significantly higher than FP (2.29) and the FP component of FP+SAL (2.36), and FP+MON (2.15), P<0.05. No significant differences were observed between FSC and MON fill rates (4.33). Mean number of treatment days was greater for FSC compared to FP, FP+SAL, and FP+MON (P<0.0001). CONCLUSION: This study confirms a previous report that adherence profiles of fluticasone and salmeterol in a single inhaler are significantly better when compared to the controller regimens of fluticasone and salmeterol in separate inhalers, fluticasone and montelukast, or fluticasone alone and similar to montelukast alone.

Cost-efficacy comparison of inhaled fluticasone propionate and budesonide in the treatment of asthma.

BACKGROUND: The results of a recent meta-analysis comparing 2 inhaled corticosteroids, fluticasone propionate (FP) and budesonide, demonstrated that FP had an improved efficacy-to-safety ratio compared with budesonide. However, limited data are available on the relative economic benefits of these 2 regimens. OBJECTIVE: This pharmacoeconomic analysis used individual patient data from studies in the meta-analysis to compare the relative cost-efficacy of 2 asthma regimens from the perspective of a US third-party payer. METHODS: This analysis included all 7 studies in the meta-analysis that compared budesonide with FP dosed at approximately half the dose of budesonide and that included measurement of daily morning peak expiratory flow (PEF). RESULTS: The total daily per-person cost of asthma management was higher for patients treated with budesonide than with FP ($3.00 vs $2.25, respectively). Treatment with FP had greater cost-efficacy than treatment with budesonide, based on a range of outcome measures that included improvement in morning PEF, symptom-free days, and episode-free days. The daily cost per effectively treated patient (an increase in PEF of > or = 10%) was $5.62 with FP and $10.05 with budesonide. The cost per symptom-free day was $4.36 with FP, compared with $6.67 with budesonide. The cost per episode-free day was $5.60 with FP and $9.42 with budesonide. The pharmacoeconomic difference continued to favor FP as the criteria for success were made more stringent and the cost of budesonide was lowered. CONCLUSION: Based on data from the 7 randomized, controlled trials, treatment of asthma with FP was more effective and less expensive, using US health care assumptions and costs, than treatment with budesonide.

Respiratory infection and airway reactivity.

The data reviewed demonstrate that viral and mycoplasma infections induce a spectrum of functional abnormalities in airways. Acute virus infections cause wheezing illnesses in both children and adults. Changes in peripheral airway function during infection with similar organisms are observed in other subjects, usually normal adults. The pathogenesis of these responses is unclear. Pathologic data do show that infection with these pathogens damages the airway epithelium. These changes appear to increase permeability of the respiratory epithelium to protein antigens and consequently may contribute to increased frequency of attacks in asthmatic subjects. In addition, increased mucosal permeability may enhance delivery of inhaled drugs to effector sites in airway walls to induce exaggerated bronchoconstrictor responses in clinical challenge situations. Whether changes in the epithelium during infection, inducing greater antigen entry into the interstitium, results in subsequent development of specific allergy is not known and requires further study.

Cost analysis of the use of inhaled corticosteroids in the treatment of asthma: a 1-year follow-up.

A retrospective cohort using pharmacy and medical claims was analysed to determine whether the differences in efficacy of various inhaled corticosteroids demonstrated in clinical trials lead to differences in costs of care observed in clinical practice. Subjects that had an ICD-9 (493.XX) code for asthma and a new pharmacy claim for inhaled fluticasone propionate 44 mcg (FP), beclomethasone dipropionate (BDP), triamcinolone acetonide (TAA), budesonide (BUD) or flunisolide (FLU) were identified and followed for 12 months. Annual asthma care charges (pharmacy and medical) over the 12-month observation period were significantly (P < 0.03) higher in patients treated with BDPTAA, BUD and FLU compared to FP, 24%, 27%, 34% and 45% respectively In addition, patients treated with BDPTAA, and FLU were associated with significantly (P < 0.005) higher total healthcare (asthma + non-asthma) charges compared to patients on FP, 53%, 46% and 39% respectively Asthma care and total healthcare charges remained lower for FP after including FP110 mcg and excluding patients who were extreme cost outliers (+/- 2 SD from the mean) in a univariate sensitivity analysis. This analysis supports recent randomized control trials that FP offers a superior efficacy profile at lower asthma care as well as total healthcare charges compared to other inhaled corticosteroids.

Comparison of asthma costs in patients starting fluticasone propionate compared to patients starting montelukast.

An observational study using pharmacy and medical claims was used to determine whether there are differences in asthma care cost between patients that are newly started on montelukast and low-dose fluticasone propionate. Patients were identified who had at least one ICD-9 (493.XX) claim for asthma and were newly prescribed inhaled fluticasone propionate 44 microg (FP) or montelukast 5 or 10 mg (MON). Subjects could not have had a claim for any inhaled corticosteroid or oral leukotriene modifier in 9 months prior to the first prescription claim for either FP or MON. They were subsequently followed for 9 months. Multi-variate regression analysis was used to determine the influence of these single-controller therapies on post-index asthma related costs. Positively skewed cost variables were log-transformed prior to their inclusion into the multi-variate model. Asthma-related costs were adjusted for age, gender, health plan, co-morbidities, pre-index asthma medication use and pre-index asthma care costs. Multivariate regression analysis, adjusting for baseline covariates, indicated that compared to treatment with montelukast, treatment with FP had significantly (P<0.001) lower post-index total asthma related costs. Adjusted least squares mean total asthma care costs for the 9-month post-index period were $US649 for FP 44 microg compared to $US1028 for montelukast.

Using health outcomes data to inform decision-making: healthcare payer perspective.

Healthcare payers are charged with the responsibility of achieving maximum profits or output within their limited budget. As the demands are always greater than the budget, there is growing interest in tools that can inform decisions on the allocation of limited resources. Healthcare payers are using health outcomes data to assist the decision-making process, although the way in which such information is being used may differ between payers. From the perspective of the French sickness fund, there is a need for real-world information to supplement the results of clinical trials and inform negotiations on pricing. In the US, the large databases of healthcare insurers are being examined in order to carry out retrospective cohort studies that go some way towards providing such real-world information on outcomes with alternative treatments. Another approach to health outcomes information has been taken by an Israeli healthcare organisation, Maccabi Healthcare Services, which introduced a disease management programme in order to improve outcomes of asthma management. Clearly, healthcare payers are using health outcomes information in a variety of ways to inform decision-making. The extensive databases available to payers may be used to good effect, to obtain real-life information that supplements clinical trial data and economic models of outcomes and costs, and to enable the targeting of interventions.

Economic analysis of asthma practices.

When deciding on treatment for patients with asthma, clinicians should consider the following: basic science that supports the therapeutic agent, randomized clinical trials that demonstrate clinical efficacy, and "real world" economic evidence that confirms the basic science and clinical study findings. When selecting first-line controller therapy for persistent asthma, clinicians should look for the single agent that produces the greatest improvement in lung function and patient outcomes, has minimal adverse effects, and is cost effective. To determine whether there is one first-line controller that achieves all of these goals, physicians should evaluate findings of randomized controlled trials that assess a drug's effect on asthma symptoms, lung function, and albuterol use compared with placebo or a comparator. They should also consider findings from retrospective claims analyses. This combination of data provides a truer picture and more robust evidence of a drug's clinical and economic performance. Similar evaluations need to be undertaken when deciding on the most cost-effective add-on therapy.

Treatment of allergic rhinitis: an evidence-based evaluation of nasal corticosteroids versus nonsedating antihistamines.

Allergic rhinitis is a high-cost, high-prevalence disease. In the 12 months ending March 31, 1997 $3.1 billion was spent in the United States for medications to manage this illness. Allergic rhinitis affects quality of life and interferes with work productivity. Nonsedating antihistamines are the most common and most expensive therapy for this condition. This study reviewed 13 randomized studies in which blinded investigators compared management of allergic rhinitis by means of intranasal steroids to management by means of nonsedating antihistamine. Evidence tables demonstrated that in all studies in which total nasal symptoms and nasal obstruction were recorded, the nasal steroid was statistically superior to the nonsedating antihistamine. For nasal blockage the nonsedating antihistamines did not perform better than placebo. For all other nasal symptoms the intranasal steroid was statistically superior in most reports and equal or numerically better in the remaining papers. When these data are linked to those from cost analysis and quality-of-life studies, the evidence strongly suggests that nasal steroids should be first-line therapy for allergic rhinitis. In four reports on the combination of a nonsedating antihistamine compared to a nasal steroid alone, there was no significant difference between these two treatments. Like asthma, allergic rhinitis is an inflammatory disease and should be managed with anti-inflammatory medication. Making such a change in the management of allergic rhinitis should increase efficacy and decrease costs.

Patterns of anti-inflammatory therapy in the post-guidelines era: a retrospective claims analysis of managed care members.

Published and widely disseminated guidelines for the care and management of asthma characterize asthma as a chronic, inflammatory disease and propose specific recommendations for therapy with inhaled anti-inflammatory medications. In a retrospective analysis of medical and pharmacy claims data of approximately 28,000 asthmatic members from five managed care settings, the dominant pattern of pharmacologic therapy that emerged was the use of bronchodilators without inhaled anti-inflammatory drug therapy. In addition, a significant proportion of asthmatic patients received no prescription drug therapy for asthma. Less than one third of asthmatic patients received any anti-inflammatory therapy and the majority of these received one or two prescriptions per year. Specialist physicians were two to three times more likely than non-specialists during a study period of 1 year to prescribe an anti-inflammatory medication, and were half as likely to have their asthmatic patients experience an emergency department or hospital event. This database analysis suggests that greater conformity with guidelines and/or access to specialist physician care for asthmatic members will lead to improved patient outcomes.

Risk factors associated with the development of chronic lung disease in children.

By better understanding the intrinsic and extrinsic factors that predispose children to chronic lung disease, strategies to prevent its development can be proposed. This article addresses conditions, such as bronchiolitis, croup, hyaline membrane disease, hydrocarbon ingestion, and near-drowning, that have been found to result in long-term changes in lung physiology. Also considered are the possible relationships of common respiratory infection, asthma, smoking, and air pollution to the development of chronic respiratory infection.

Management of acute asthma.

Patients with acute asthma experience increased airway obstruction, increased work of breathing, and ventilation-perfusion mismatch. Careful observation and assessment of the patient are fundamental for successful treatment. Therapy is dictated by the severity of the acute episode. Prevention of subsequent flares of asthma needs to be initiated as the patient convalesces.

Management of acute severe asthma.

Discussed in this article are the pathophysiology of acute asthma and its differential diagnosis and management, placing special emphasis on rapid assessment, prompt and decisive therapeutic intervention, and on recognition of the severity of the disease.

Management of chronic asthma.

The treatment of asthma is changing to reflect the importance of inflammation in the disease pathogenesis. Medicines that alter the inflammatory response are the cornerstone of therapy for patients with persistent symptoms. Bronchodilators are important in acute care, but in chronic illness they are adjuvant therapy. Patient education is essential for successful outcome.

Tobramycin elimination rate change from first to later doses in older cystic fibrosis patients.

Adults with cystic fibrosis frequently require larger than usual tobramycin dosages in order to achieve desired serum concentrations. The application of dosing methods utilizing first-dose pharmacokinetics has been advocated as a means for rapidly attaining therapeutic serum concentrations. Review of ten cystic fibrosis patients between ages 13 and 33 years admitted for exacerbation of pulmonary disease caused primarily by Pseudomonas aeruginosa (Staphylococcus aureus in two patients) was conducted. Elimination rate constant (ke, h-1) was calculated from two concentration-time pairs obtained following the first dose. Two concentration-time pairs were again measured between cumulative doses (n) 7 to 19, and ke was calculated. First dose ke varied significantly from nth dose ke (p = 0.018). First-dose pharmacokinetic analysis may not be a reliable predictor of maintenance tobramycin dosage requirements due to apparent changes in ke over time.

Asthma: benchmarking for quality improvement.

BACKGROUND: Linked medical and pharmacy claims can be used to identify patients with asthma and benchmark current practice standards. METHOD: This was a 3-year study of five independent practice association style health maintenance organizations with an annual enrollment of 870,000. More than 28,000 members were identified with claims for asthma. OBJECTIVE: The intent of this study was to benchmark current asthma practice. Before quality improvement projects can be implemented baseline data are required. RESULTS: The prevalence of asthma varied by geographic regions. Specialty care was associated with greater use of anti-inflammatory medications and more refills of these drugs. Refill rates for inhaled corticosteroids for all patients was low. Specialty care of asthmatic members was associated with a lower rate of emergency service events and hospitalizations. CONCLUSIONS: Linked medical and pharmacy claims' databases can be used to benchmark current practice performance and serve as a reference for quality improvement programs. Appropriate use of specialty care may improve asthma outcomes.

Anemia in patients with juvenile rheumatoid arthritis.

Patients with juvenile rheumatoid arthritis may have an anemia attributable to the chronic disease, to iron deficiency, or to a combination of the two. The contribution of iron deficiency is often difficult to determine by routine laboratory studies. We studied 51 patients with pauciarticular and polyarticular juvenile rheumatoid arthritis with red blood cell counts, indices, free erythrocyte protoporphyrin, and serum ferritin. Fifteen of the 18 who were anemic were restudied after a 3 to 6-month period of iron therapy. Thirteen of the 15 responded by these criteria: a rise in hemoglobin of 1.0 gm/dl or more and an increase in mean corpuscular volume of 3 fl or more; in 11 of these 13, hemoglobin values returned to the normal range for age. These findings indicate that iron deficiency can be a major component of the anemia that is commonly found in patients with active juvenile rheumatoid arthritis.

Sleeping bradycardia during recovery from childhood status asthmaticus.

Seventeen of 67 children recovering from status asthmaticus developed sleeping bradycardia. They were compared to a control population of asthmatic children who did not develop sleeping bradycardia and differed only in the low heart rate. The authors speculate that this phenomenon is due to a combination of withdrawal of sympathomimetic stimulation and catch-up in REM (rapid eye movement) sleep.

Proportional hazards life table models: an illustrative analysis of socio-demographic influences on marriage dissolution in the United States.

The proportional hazards life table is a recently developed approach to the analysis of survival data when mortality risks vary among individuals. It assumes that at a given age (or duration since the start of a life) the force of mortality is a constant (specific to that age) multiplied by a proportionality factor which is determined by the characteristics of the individual and does not change unless these covariates do. In this paper, the method is reviewed for the case where the covariates are fixed at the start of the lifetime and illustrated by an application to marital dissolution in the United States.