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Bactrim dosing adjusted body weight and height, BMI, waist circumference, by time, and weight, height, waist circumference, after the start of therapy. Results and Discussion A total of 468 patients were randomized to receive daclizumab (n = 202; n 202), placebo (n = 195), or 1 mg methotrexate (n = 195). Demographic and baseline clinical data of the daclizumab group are provided in Table 1. The incidence of adverse events in all 4 groups were similar. The mean age of patients was 64.8±7.2 years, and the median age overall was 74.9±7.5 years (interquartile range [IQR], 72.4-78.9 years). Table 1. Demographic Characteristics of Patients by Group and Placebo Condition Table 1. Demographic Characteristics of Patients by Group and Daclizumab Condition The primary efficacy outcome was change in overall CD4 cell count, as a measure of disease activity. Overall CD4 cell count was reduced after 2 years of treatment with daclizumab compared placebo (P =.0001, time trend P.009, and dose-response analysis =.002). In patients receiving 1 mg methotrexate, the overall reduction from baseline was significantly greater than that in patients receiving placebo (P =.02), and the reduction from baseline in patients receiving 1 mg methotrexate plus daclizumab was much greater than that in patients receiving placebo (P <.0001), and significantly greater than the reduction from baseline in patients receiving daclizumab plus methotrexate (P =.067). The median difference in number of CD4 cells between the groups was 2.9 cells/mm 3 for the daclizumab-sodium salt regimen and 0.2 cells/mm 3 for the placebo regimen. As a secondary endpoint, the primary endpoint was time to treatment failure attain a target of 100-180-180 (Cordes et al, 1998). A total of 60% patients achieved 100% CD4 count. The mean time to treatment failure was 4.7 weeks for patients receiving daclizumab compared with a maximum target of 2 weeks (SD 3.4, range, 1-6), and 4.1 weeks for patients receiving combination therapy (both combined, 1 mg methotrexate plus daclizumab, combined, and placebo, Buy ventolin evohaler online respectively). At the end of treatment, safety profile Dx in the daclizumab-sodium salt regimen was similar in terms of adverse events. The most frequent events were anemia and skin reactions (e.g., urticaria, angioedemas, and pruritus), which occurred in 2.4% and 5.1% of the patients, respectively (P =.20 and.07, respectively). We noted no differences in adverse events between patients receiving daclizumab or combination therapy (P =.96). Comment Although daclizumab does not inhibit interferon-γ, in patients with CD4 positive disease this combination therapy appears to offer an additional benefit in slowing disease progression (Cordes et al, 1998). A similar effect seems to be the basis for other systemic therapies, such as doxarol, well (Wu et al, 2009). Our trial demonstrates the beneficial effect of combination therapy with daclizumab and methotrexate on overall CD4 cell count in a large cohort of treated patients. This trial was the first to investigate effect of daclizumab on overall CD4 cell level and time to treatment failure in patients with moderate to severe active rheumatoid arthritis. We did not demonstrate additional benefit of daclizumab in other immunologic parameters. This trial had the unique advantage of using a double-blind protocol as compared with the single-blind trial of Gao and colleagues Diflucan 24 Pills 100mg $90 - $3.75 Per pill in patients with moderate to severe active rheumatoid arthritis. In our design, 2 physicians randomly selected subjects per condition from the 2 groups, with no subject assigned to a group with the expectation that all patients would receive a treatment. The physician was instructed to assess the clinical improvement in any patient by assessing the target range of change CD4 count in each patient. Although we did not have this feature with Gao et al, we could not exclude the possibility that physicians would have been influenced or by their prior experience performing immunologic assessments in other patient populations. Because of the limitations our trial design, we were unable to determine whether the observed treatment effects are explained by baseline characteristics as well. We did demonstrate some difference between the different dosing conditions in terms of clinical response, but this difference was not clinically important. Thus, we cannot rule out the possibility of an independent effect on clinical outcomes related to changes in CD4 cell count.

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