The Best Way To Identify A Genuine Ixazomib

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Версія від 18:02, 15 грудня 2016, створена Mittenedge34 (обговореннявнесок) (Створена сторінка: 56,65 Furthermore, formation of antibodies to therapeutic peptides is common, even when the peptide is identical to the endogenous human form. In a study by Fin...)

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56,65 Furthermore, formation of antibodies to therapeutic peptides is common, even when the peptide is identical to the endogenous human form. In a study by Fineman et al,32 37% of exenatide-treated patients developed antibodies to exenatide after 30 weeks of treatment; this rate fell to 17% after 3 years. In a study of liraglutide QD, antibodies find more developed in approximately 8% of patients who received liraglutide QD for up to 26 weeks.66 Analysis of cross-reactivity in a subset of antibody-positive patients in the Buse et al study showed that treatment-emergent antibodies to exenatide did not cross-react with human GLP-1 or glucagon. Similarly, in the LEAD-6 trial of liraglutide QD, 4.4% (n=5/113) of antibody-positive samples cross-reacted with GLP-1; however, it was unknown whether the cross-reactivity was pre-existing or treatment-emergent.67 A low antibody titer does not appear to be predictive of safety or efficacy issues as there was no difference between groups in potentially immune-related AEs overall, and only a slight Thalidomide increase in the occurrence of some injection site-related AEs in patients with a positive antibody titer to exenatide.32 There were no reports of systemic hypersensitivity or immune-related respiratory reactions such as anaphylaxis with exenatide QW treatment. In open-label extension periods up to 3 years, exenatide QW maintained improvements in glycemic control and weight loss when compared with exenatide BID or insulin glargine.68,69 The AEs reported in these longer trials are similar to those observed in this integrated safety analysis. Moreover, the AEs were mostly mild in intensity Ixazomib and decreased over time. Strengths and limitations There are several strengths of this analysis: a large number of patients were included in the pooled data set; the trials were randomized and controlled with centralized monitoring and laboratory analyses; and results were derived from individual patient data. Limitations of this analysis are that AEs were not independently adjudicated and the post hoc design of this analysis was not adequately powered to detect very rare AEs (incidence