Examinando por Materia "Safety"
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Publicación Acceso abierto BAX326 (RIXUBIS): a novel recombinant factor IX for the control and prevention of bleeding episodes in adults and children with hemophilia B(SAGE Publications Ltd, 2014) Solano Trujillo, María Helena; Windyga, Jerzy; Hafeman, Andrea E.Abstract: Hemophilia B management has improved considerably since the introduction of high-purity plasma-derived factor IX (pdFIX) products in the early 1990s. Recombinant FIX (rFIX) was introduced more recently and has potential safety advantages over the older bloodbased products. Until recently, only one such product, nonacog alfa (BeneFIX®, Pfizer, Inc.), has been available. However, a new rFIX product, BAX326 (RIXUBIS, Baxter Healthcare Corp.), has now been approved by the US Food and Drug Administration. BAX326 undergoes rigorous virus elimination and purification steps during manufacture, and has low activated FIX activity, which confers low thrombogenic potential in humans. Preclinical studies showed promising pharmacokinetic and safety profiles, and these early findings have since been expanded in a series of prospective, multicenter, clinical studies. Foremost among these is a pivotal phase I/ III study of BAX326 and its use in routine prophylaxis or on-demand treatment in patients aged 12–65 years with severe (FIX level <1%) or moderately severe (FIX level ⩽2%) hemophilia B. This study confirmed the pharmacokinetic equivalence of BAX326 and nonacog alfa, and showed a significant reduction in annualized bleeding rate with BAX326 prophylaxis compared with on-demand treatment (79% versus historic controls; p<0.001). The hemostatic efficacy of BAX326 was rated as ‘excellent’ or ‘good’ in 96% of bleeds. BAX326 was also associated with statistically significant and clinically meaningful improvements in physical health-related quality of life. Results are similarly encouraging in a pediatric study in children aged up to 12 years and in a study in hemophilia B patients undergoing surgery. A further study showed safe transition, with no inhibitor formation in any patient, from treatment with a pdFIX product to BAX326. Overall, the safety profile of BAX326 in clinical trials has been strong, with no inhibitor or specific antibody formation, thrombosis, or treatment-related serious adverse events or anaphylaxis.Publicación Acceso abierto Betahistine in the Treatment of Peripheral Vestibular Vertigo: Results of a Real-Life Study in Primary Care(SAGE Publications, 2019-03-28) Sánchez Vanegas, Guillermo; Castro Moreno, Carlos; Buitrago, DianaThe present research was carried out with the objective to establish the clinical effect and safety of betahistine (48 mg daily), for the management of peripheral vestibular vertigo, in patients treated by primary care physicians in Colombia. An observational prospective cohort study was conducted including patients older than 15 years with clinical diagnosis of peripheral vestibular vertigo who were candidates to be treated with betahistine (48 mg daily). A sample size of 150 individuals was calculated, and weekly follow-ups were planned for 12 weeks. Rotatory movement sensation, loss of balance, and global improvement scale from 0 to 100 points were evaluated. Complete improvement was defined when the patient reached a level of 100 points. We calculated average weekly improvement, cumulative incidence of complete improvement, incidence rate of complete improvement, and the probability of complete improvement as a function of time. After the first week, the average improvement was 56.6 points (95% confidence interval [CI]: 50.4-62.7). At the end of week 12, it was 89.3 points (95% CI: 86.5-92.2). Sixty-one percent of the patients had achieved complete improvement at the end of the second week. After the sixth week, the percentage of cumulative improvement was 72%, and after 12 weeks of follow-up, the cumulative incidence of complete improvement was 73% (95% CI: 65%-80%). Based on the follow-up times, a complete improvement incidence rate of 16 cases per 100 people/week was calculated (95% CI: 13-19). We concluded that Betahistine (48 mg daily) has a positive effect, controlling the symptoms associated with benign paroxysmal vertigo, with an adequate safety profile.