The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey.

AIMS: To evaluate whether the Asthma Control Test (ACT) score is predictive of Global Initiative for Asthma (GINA) guideline-defined classification levels of asthma control. The ACT is a validated, 5-item, patient-completed measure of asthma control with a recall period of four weeks. METHODS: Cross-sectional survey comparing ACT score and GINA classification of asthma control among 2949 patients attending primary care physicians and specialists in France, Germany, Italy, Spain, the UK, and the USA. RESULTS: The area under the receiver operating characteristics curve for ACT score predicting GINA control was 0.84 (95% CI 0.82-0.85). An ACT score of <19 (not well-controlled asthma) correctly predicted GINA-defined partly controlled/uncontrolled asthma 94% of the time, while an ACT score of >20 predicted GINA-defined controlled asthma 51% of the time, with kappa statistic of 0.42, representing moderate agreement. CONCLUSIONS: An ACT score <19 is useful for identifying patients with poorly controlled asthma as defined by GINA.

The economic impact of children dispensed asthma medications without an asthma diagnosis.

OBJECTIVE: To compare the resource utilization and healthcare costs of children with a diagnosis of asthma, children dispensed asthma medications but without a diagnosis of asthma, and control children. STUDY DESIGN: Children 0 to 17 years old were identified from an integrated managed-care database during calendar year 2001. They were compared on the basis of the presence of a medical claim for asthma (Dx cohort); a prescription for an asthma controller or reliever medication (excluding oral corticosteroids) but without an asthma diagnosis (Rx cohort), and control children. Using medical and pharmacy claims, resource utilization and costs were compared across cohorts. RESULTS: Children in both the Dx and Rx cohorts had significantly greater nonasthma and total all-cause annual healthcare costs compared with control children. The Dx and Rx cohorts had higher rates of nonasthma emergency department visits and hospitalizations. The risk of an oral corticosteroid dispensed was 14-fold and 7-fold greater for the Dx and Rx cohorts, respectively, compared with the control children. These findings were consistent in infant, toddler, school-age, and adolescent groups. CONCLUSIONS: Children dispensed asthma medications but lacking an asthma diagnosis have considerable morbidity and incur high healthcare resource utilization. This study suggests that better recognition of pediatric asthma is warranted.

Asthma-related exacerbations, therapy switching, and therapy discontinuation: a comparison of 3 commonly used controller regimens.

BACKGROUND: Asthma control is the goal of therapeutic interventions. In observational studies, the use of short-acting beta-agonists (SABAs) is a surrogate for symptoms and emergency department or hospital events for exacerbations. OBJECTIVE: To compare asthma exacerbations, medication switch, and use of SABAs among 3 treatment cohorts: fluticasone propionate and salmeterol as a single inhaler (FSC), fluticasone and salmeterol as separate inhalers (FP + SAL), and fluticasone propionate alone (FP). METHODS: Administrative claims data from approximately 10 million individuals from April 2000 to December 2002 were examined. Patients 15 years or older with claims for asthma, SABAs, and study medications were included in the study. Asthma-related medical and pharmacy claims were evaluated. Multivariate regression techniques were used to model the outcomes of interest, controlling for patient characteristics. RESULTS: The odds of a hospitalization or emergency department event were significantly lower for the patients receiving FSC (n=1013) compared with those receiving FP (n=1130) (odds ratio, 0.75; 95% confidence interval, 0.61-0.93) and those receiving FP + SAL (n=271) (odds ratio, 0.69; 95% confidence interval, 0.51-0.95). Patients receiving FSC also had a significantly lower risk of switch or discontinuation of index medication and lower rates of postindex SABA use. CONCLUSION: In this analysis, patients receiving FSC had lower rates of asthma-related symptoms and exacerbations as measured by SABA refills and hospitalization, respectively, when compared with patients receiving either FP or FP + SAL. This observational examination of medical and pharmacy claims data adds to the clinical reports that demonstrate the increased effectiveness of FSC when compared with FP or FP + SAL.

Improved ability to perform strenuous activities after treatment with fluticasone propionate/salmeterol combination in patients with persistent asthma.

Patients with asthma experience disruptions in usual activities that can impair their quality of life, and in patients whose daily routine involves an active lifestyle, these disruptions can be severe. We assessed the patient-perceived effect of treatment with fluticasone propionate/salmeterol combination (FSC), compared with fluticasone propionate (FP) or salmeterol (SAL) alone, on activity limitations, particularly strenuous physical activities. The Asthma Quality of Life Questionnaire (AQLQ) was administered in two 12-week, randomized, double-blind, placebo-controlled trials comparing FSC 100/50 or 250/50 microg twice daily vs. the individual components alone in 686 adults and adolescents with asthma. In one study, patients were stratified by prior treatment [low to medium doses of inhaled corticosteroids (ICS) or SAL], and in the other study, all patients were previously treated with medium to high doses of ICS. Patients prospectively identified five activities they performed regularly and were asked how these activities were limited by their asthma. The effect of randomized treatment on strenuous activities (e.g., aerobics, cycling, hiking, and basketball) was assessed. In both studies, treatment with FSC resulted in clinically meaningful improvements (i.e., change in AQLQ of > or = 0.5) and was statistically significantly better than SAL in both studies and FP in one study. Treatment of the two main components of asthma--inflammation and bronchoconstriction--with FSC results in clinically meaningful improvements in the ability of patients with persistent asthma to perform not only their usual activities but also strenuous activities.

Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment.

Prison inmates with human immunodeficiency virus (HIV) infection can be difficult to treat because of the complexity and intrusiveness of many combination antiretroviral therapy regimens. NZTA4007, a 24-week open-label, single-arm clinical trial involving 108 antiretroviral therapy-naive, incarcerated, HIV-infected persons, was conducted to evaluate a compact regimen (4 tablets per day) consisting of 1 lamivudine-zidovudine (150 mg/300 mg) combination tablet (COM) and one 300-mg abacavir tablet administered twice daily under directly observed treatment conditions. In the intent-to-treat observed analysis, the plasma HIV type 1 (HIV-1) RNA level remained at < or =400 copies/mL in 85% of the patients and at < 50 copies/mL in 75% of the patients. Median change from baseline was -2.41 log(10) copies/mL for the HIV-1 RNA level and +111 cells/mm(3) for the CD4 cell count. The overall adherence to prescribed doses was 94% for patients who remained enrolled in the study. COM-abacavir given twice daily was generally well tolerated, and adverse events prompted only 4 patients to withdraw from the study.