ABSTRACT
Unlike granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) is not approved for reducing the incidence or duration of chemotherapy-induced febrile neutropenia. However, some studies have been conducted in this setting. A systematic review assessing the efficacy of GM-CSF versus placebo or G-CSF in reducing chemotherapy-induced febrile neutropenia and related complications was performed. Medline was reviewed for articles published between January 1987 and March 2003 that contained specific search terms. Explicit inclusion/exclusion criteria were developed for titles, abstracts, and articles. Two researchers reviewed (kappa>/= 0.7) and divided studies according to their evaluation of GM-CSF versus placebo or versus G-CSF. Nine studies were accepted: 6 randomized controlled trials compared GM-CSF versus placebo and 3 studies compared GM-CSF versus GCSF. Three placebo-controlled trials showed that GM-CSF was ineffective in reducing the risk of chemotherapy-induced febrile neutropenia. The remaining 3 trials reported incidence of fever and not febrile neutropenia: 2 reported a significantly increased incidence of fever in the GM-CSF group, and 1 reported that more patients receiving placebo experienced fever compared with patients in the GMCSF group (P > 0.05). The 3 studies comparing GM-CSF versus G-CSF reported fever as a primary outcome also. All 3 reported higher incidence of fever in the GM-CSF group (P < 0.05). Head-to-head trials of G-CSF and GM-CSF in reducing chemotherapy-induced complications are lacking. Identified GM-CSF studies did not show significant reduction in febrile neutropenia and fever.
ABSTRACT
OBJECTIVE: To compare asthma-related health-care utilization and expenditures for patients prescribed one of three dual-controller therapies: fluticasone plus salmeterol, inhaled corticosteroids (ICS) [excluding fluticasone] plus salmeterol, and ICS plus a leukotriene modifier (LTM). MATERIALS AND METHODS: Asthma-related medical claims from two major health plans were obtained for the 12 months before and after the initiation of dual therapy. A total of 1,325 patients > or = 12 years old with no claims for COPD or respiratory tract cancer were selected from the approximately 3.5 million lives covered. Multivariable regression was used to assess differences in asthma-related expenditures. To compensate for positive skew, all cost variables were log-transformed. RESULTS: Risk-adjusted total asthma-related costs for the fluticasone-plus-salmeterol cohort (n = 121), the ICS-plus-salmeterol cohort (n = 844), and the ICS-plus-LTM cohort (n = 360) [corrected] were $975, $1,089, and $1,268, respectively. Risk-adjusted pharmacy costs were $813, $841, and $996, respectively. Generalized linear modeling, controlling for baseline covariates, indicated that compared to ICS-plus-LTM therapy, fluticasone-plus-salmeterol therapy was associated with a significant reduction in asthma-related total (p = 0.0014) and pharmacy (p = 0.001) costs. Similar results were found when the ICS-plus-salmeterol group and the ICS-plus-LTM group were compared (p = 0.0001). The number of inpatient, outpatient, and emergency department visits and their corresponding costs were lower for the fluticasone-plus-salmeterol cohort, but were not statistically significant (p > 0.05). CONCLUSION: Results from managed-care practice suggest that treatment with fluticasone plus salmeterol, and more broadly ICS plus salmeterol, yield important cost savings when compared to treatment with ICS plus LTM.