OBJECTIVES: To characterize the formation of anti-vatreptacog alfa ADAs in hemophilia patients with inhibitors.
METHODS/PATIENTS: This was a post hoc analysis of adept(™) 2. Immunoglobulin isotype determination, specificity analysis of rFVIIa cross-reactive antibodies, epitope mapping of rFVIIa single mutant analogs and pharmacokinetic (PK) profiling were performed to characterize the ADAs.
RESULTS: Immunoglobulin isotyping indicated that the ADAs were of the immunoglobulin G subtype. In epitope mapping, none of the rFVIIa single mutant analogs (V158D, E296V or M298Q) contained the complete antibody epitope, confirming that the antibodies were specific for vatreptacog alfa. In two patients, for whom PK profiling was performed both before and after the development of ADAs, vatreptacog alfa showed a prolonged elimination phase following ADA development. During the follow-up evaluation, the rFVIIa cross-reactivity disappeared after the last vatreptacog alfa exposure, despite continued exposure to rFVIIa as part of standard care.
CONCLUSIONS: Results from the vatreptacog alfa phase III trial demonstrate that the specific changes made, albeit relatively small, to the FVIIa molecule alter its clinical immunogenicity.
METHODS: Extensive research was conducted using the Scopus database, which is the most authoritative database of research publications and citations, to focus on CKD research between 2003 and 2022, as indicated by title and author keywords. Then, within this vast collection of academic publications, a notable subset of articles was exclusively dedicated to investigating the relationship between CKD and malnutrition. Finally, we performed bibliometric analysis and visualization using VOSviewer 1.6.19 and Microsoft Excel 2013.
RESULTS: Large global research between 2003 and 2022 resulted in 50,588 documents focused on CKD, as indicated by title and author keywords. In this extensive collection of scientific publications, a staggering portion of 823 articles is devoted exclusively to investigating the link between CKD and malnutrition. Further analysis reveals that this body of work consists of 565 articles (68.65%), 221 reviews (26.85%), and 37 miscellaneous entries (4.50%), which encompass letters and editorials. The USA was found to be the most productive country (n = 173; 21.02%), followed by Italy (n = 83; 10.09%), Sweden (n = 56; 6.80%), Brazil (n = 54; 6.56%) and China (n = 51; 6.20%). The most common terms on the map include those related to the topic of (a) malnutrition in hemodialysis patients and predicting factors; terms associated with the (b) impact of malnutrition on cardiovascular risk and complications in CKD patients; and terms related to the (c) dietary protein intake and malnutrition in CKD.
CONCLUSIONS: This study is the first of its kind to analyze CKD and malnutrition research using data from Scopus for visualization and network mapping. Recent trends indicate an increasing focus on protein-energy wasting/malnutrition in hemodialysis patients and predicting factors, dietary protein intake, and malnutrition in CKD. These topics have gained significant attention and reflect the latest scientific advances. Intervention studies are crucial to examining diet therapy's impact on patients with stages 1 to 5 CKD. We hope this study will offer researchers, dietitians and nephrologists valuable information.
OBJECTIVES: The aim of the current study is to investigate and examine the oxidation status of dietary supplements containing fish oils and to identify important factors related to the oxidation status of such supplements available in the United Arab Emirates (UAE).
METHODS: A total of 44 fish oil supplements were analysed in this study. For each product, the oxidative parameters peroxide value (PV), anisidine value (AV), and total oxidation (TOTOX) were calculated, and comparisons were made with the guidelines supplied by the Global Organization for EPA and DHA Omega-3s (GOED). Median values for each of the above oxidative parameters were tested using the Kruskal-Wallis and Mann-Whitney U tests. P values < 0.05 were chosen as the statistically significant boundary.
RESULTS: The estimate for the average PV value was 6.4 with a 95% confidence interval (CI) [4.2-8.7] compared to the maximum allowable limit of 5 meq/kg. The estimate for the average P-AV was 11 with a 95% CI [7.8-14.2] compared to the maximum allowable limit of 20. The estimate for the average TOTOX value was 23.8 meq/kg with a 95% CI [17.4-30.3] compared to the maximum allowable limit of 26 according to the GOED standards.
CONCLUSION: This research shows that most, although not all, of the fish oil supplements tested are compliant with the GOED oxidative quality standards. Nevertheless, it is clear that there should be a high level of inspection and control regarding authenticity, purity, quality, and safety in the processes of production and supply of dietary supplements containing fish oils.