Jacqueline R. Carranza Rosenzweig

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.

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.

Resource utilization with fluticasone propionate and salmeterol in a single inhaler compared with other controller therapies in children with asthma

ABSTRACT Objective: To determine resource utilization in controller naïve children diagnosed with asthma receiving initial therapy with fluticasone propionate (FP) and salmeterol (SAL) in a single inhaler (FSC), FP alone, montelukast (MON), inhaled corticosteroid (ICS) + SAL from separate inhalers, or ICS + MON. Research design and methods: A retrospective, observational, 18‐month (6‐month pre-index and 12‐month follow-up) database study using medical and pharmacy claims from a 5 million member managed care organization. Multivariate modeling was used to evaluate post-index resource utilization and asthma-related costs. Refill rates during the 12‐month follow-up period were compared across cohorts. Results: The study included controller-naïve children (n = 9192) aged 4–17 years with an asthma diagnosis. Children treated with FSC were significantly less likely to receive additional prescriptions for short-acting beta-agonists compared with all other cohorts ( p ≤ 0.007) and oral corticosteroids compared with the MON, ICS + SAL, and ICS + MON cohorts ( p ≤ 0.009). Children receiving FSC were also significantly less likely to add another controller therapy compared with children started on FP alone, MON, or ICS + SAL ( p ≤ 0.001) and to receive care in an emergency department or hospital compared with children receiving ICS + MON ( p < 0.001). The number of prescriptions for FSC in the 12‐month post-index period was greater ( p < 0.05) than the number of ICS claims in the FP, ICS + SAL, and ICS + MON cohorts. Compared with FSC, the adjusted total asthma-related post-index costs were greater ( p ≤ 0.008) in the MON and ICS + MON cohorts. Although adherence was greater with MON compared with FSC, MON was associated with less favorable clinical outcomes and greater resource utilization and costs. Conclusion: FSC in children is associated with improved clinical outcomes and decreased resource utilization compared with other controller regimens.

The use of rhinitis medications in children receiving initial controller therapy for asthma

ABSTRACT Background: Due to common features of asthma and allergic rhinitis, a single therapeutic approach to treating both of these conditions has been proposed. Objective: To compare and contrast the use of rhinitis medications in a group of children initiating various controller therapies for asthma. Methods: A retrospective, observational study using an integrated managed care database of children aged 4–17 years with an initial medical claim for asthma and an initial pharmacy claim for fluticasone propionate (FP) and salmeterol in a single inhaler (FSC), FP alone, montelukast (MON), or combination FP + MON. Outcomes included the percentage of children initiating controller asthma therapy with prescriptions for non-sedating antihistamine (NSA) and intranasal corticosteroids (INCS) and the mean number of prescriptions for NSA and INCS. Results: A total of 5247 children were included. The percentage of children who filled prescriptions for NSA or INCS and the mean number of prescriptions dispensed was similar among children treated with FSC, FP, MON, and FP + MON. There were no significant differences in the relative risk of dispensing either a NSA or INCS across cohorts. Observational studies are limited by their use of administrative data and lack of access to patient records. Conclusions: Children started on common asthma controller therapy are frequent users of rhinitis medications. The quantity and frequency of these medications is not different between dispensed asthma regimens.