143 resultados para Aviation safety
Resumo:
BACKGROUND: Anemia is considered a negative prognostic risk factor for survival in patients with myelofibrosis. Most patients with myelofibrosis are anemic, and 35-54 % present with anemia at diagnosis. Ruxolitinib, a potent inhibitor of Janus kinase (JAK) 1 and JAK2, was associated with an overall survival benefit and improvements in splenomegaly and patient-reported outcomes in patients with myelofibrosis in the two phase 3 COMFORT studies. Consistent with the ruxolitinib mechanism of action, anemia was a frequently reported adverse event. In clinical practice, anemia is sometimes managed with erythropoiesis-stimulating agents (ESAs). This post hoc analysis evaluated the safety and efficacy of concomitant ruxolitinib and ESA administration in patients enrolled in COMFORT-II, an open-label, phase 3 study comparing the efficacy and safety of ruxolitinib with best available therapy for treatment of myelofibrosis. Patients were randomized (2:1) to receive ruxolitinib 15 or 20 mg twice daily or best available therapy. Spleen volume was assessed by magnetic resonance imaging or computed tomography scan.
RESULTS: Thirteen of 146 ruxolitinib-treated patients had concomitant ESA administration (+ESA). The median exposure to ruxolitinib was 114 weeks in the +ESA group and 111 weeks in the overall ruxolitinib arm; the median ruxolitinib dose intensity was 33 mg/day for each group. Six weeks before the first ESA administration, 10 of the 13 patients had grade 3/4 hemoglobin abnormalities. These had improved to grade 2 in 7 of the 13 patients by 6 weeks after the first ESA administration. The rate of packed red blood cell transfusions per month within 12 weeks before and after first ESA administration remained the same in 1 patient, decreased in 2 patients, and increased in 3 patients; 7 patients remained transfusion independent. Reductions in splenomegaly were observed in 69 % of evaluable patients (9/13) following first ESA administration.
CONCLUSIONS: Concomitant use of an ESA with ruxolitinib was well tolerated and did not affect the efficacy of ruxolitinib. Further investigations evaluating the effects of ESAs to alleviate anemia in ruxolitinib-treated patients are warranted (ClinicalTrials.gov identifier, NCT00934544; July 6, 2009).
Resumo:
The recent ‘horse meat scandal’ in Europe has sparked huge concerns among consumers, as horse meat was found in beef lasagne ready to be consumed. Within STARTEC, a European funded project, this study investigates consumers’ preferences, attitudes and willingness to pay (WTP) towards characteristics of ready to heat (RTH) fresh lasagne, including origin of the meat, tested for meat authenticity, safety of the lasagne, and nutritional value, using Discrete Choice Experiments in six countries - Republic of Ireland, France, Italy, Spain, Germany and Norway. Our representative sample of 4,598 European consumers makes this the largest cross country study of this kind. The questionnaire was administered online in January 2014. Results from models in WTP-space show that, on average, consumers are willing to pay considerable amount (about €4-9) for food authenticity; on this Irish and Italian are the least concerned while Spanish are the most concerned. As expected from discussing with stakeholders, food safety claims and nutritional value of the RTH lasagne are relatively less important. Consumers also value knowing the origin of ingredients preferring locally sourced meat. Primarily, the results of this study present strong evidence that consumers in Europe are highly concerned about authenticity of the meat in ready meals and strongly prefer to know that the meat is national. This evidence suggests that there is great value in providing information on these attributes, both from a consumer perspective and where this leads to an increased consumer confidence has benefits for the food industry.