Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 259

Posts Tagged ‘persistent’

Inclisiran Results in Persistent Lowering of LDL Cholesterol with No Material Safety Observations Out to Three Years

Posted by fidest press agency su lunedì, 20 maggio 2019

The Medicines Company (NASDAQ: MDCO) today announced interim results from the ongoing ORION-3 open-label extension study (Group 1, n=290) which showed that twice-a-year dosing with inclisiran sodium 300 mg resulted in consistent lowering of low density lipoprotein cholesterol (LDL-C) by more than 50 percent with overall follow-up of up to three years. Inclisiran was well tolerated, and no material safety issues were observed in the study. These results were presented today during a late-breaking clinical trial session at the National Lipid Association (NLA) Scientific Sessions in Miami.Inclisiran, the first cholesterol-lowering therapy in the siRNA class, is in Phase 3 clinical development to evaluate its ability to lower LDL-C through twice-a-year dosing. Pivotal Phase 3 readouts for inclisiran are expected in the third quarter. ORION-3 (n=382) is an open-label extension study of the Phase 2 ORION-1 trial to assess the efficacy, safety and tolerability of long-term dosing of inclisiran.“The cumulative effects of elevated LDL-C over time continue to place millions of people with atherosclerosis at increased cardiovascular risk, despite the widespread use of LDL cholesterol-lowering treatments,” said John J.P. Kastelein, M.D., Ph.D., ORION-3 study chair and Professor of Medicine at the Department of Vascular Medicine at the Academic Medical Center of the University of Amsterdam, The Netherlands. “These new data from ORION-3 provide further evidence of inclisiran’s unprecedented ability to deliver persistent LDL-C reductions over a prolonged period, which can help more patients reliably achieve LDL-C goals. Inclisiran also demonstrated a favorable safety profile, an important consideration given the long duration of LDL-C treatment.” In this interim analysis of ORION-3, inclisiran demonstrated a 51 percent (64.0 mg/dL, p<0.001) reduction in LDL-C levels through day 210, which was the study’s primary endpoint. The time-averaged absolute LDL-C reduction with inclisiran was 59.4 mg/dL (p<0.001). These effects were independent of dose level and number of doses of inclisiran previously given in the ORION-1 study.With overall follow-up of approximately three years from the first dose in ORION-1, no change in the overall safety profile was observed in this interim analysis of ORION-3 compared to the one-year follow-up in ORION-1. Inclisiran was well tolerated and no material safety issues were observed, including no elevations of liver enzymes or changes in renal function considered related to study medication. Clinically relevant injection site reactions were infrequent, mild or moderate, and transient, in line with observations in ORION-1. More than 3,000 patient-years of inclisiran safety data have been accumulated to date in the ORION program. The data from ORION-3, as well as ongoing review of blinded data to date from the Phase 3 trials, show no material safety issues; data are at least as favorable as those generated and published from the ORION-1 Phase 2 trial.

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More than just remembrance is needed to tackle persistent antisemitism

Posted by fidest press agency su martedì, 27 gennaio 2015

olocaustoInternational Holocaust Remembrance Day, on 27 January, is a chance to honour the memory of the victims of the Holocaust and to remind us of the persistent problem of antisemitism. This year FRA will join senior politicians, diplomats, global figures and experts from around the world to discuss how to deal more effectively with antisemitism, racism and xenophobia in Europe as they mark 70 years to the day on which the concentration camp at Auschwitz-Birkenau was liberated.“Recent tragic events across Europe are poignant reminders of the pressing need to counter antisemitism that continues to haunt Europe today. We need to more than just remember the Holocaust to honour the countless victims that were brutally slain under the Nazi regime,” said FRA Director Morten Kjaerum. “We must stamp out all forms of antisemitism; from the blatant acts of vandalism of Jewish sites to the quiet acceptance of stereotypes and subtle forms of hate speech online and off. We must address anti-Jewish prejudice at every level of society and we should condemn antisemitism wherever we meet it, if we are to counter the fear that Jews continue to feel in Europe today.”FRA’s 2013 report on the first-ever comparable figures on Jewish people’s experiences of antisemitic harassment, discrimination and hate crime in the EU revealed how 66% of respondents consider antisemitism to be a major problem in their countries. 76% said the situation had become more acute over the last five years, underlining the need for urgent action by EU and its Member States to find effective ways of combating this pervasive and persistent problem.
On 27 January, FRA will launch its online training toolkit ‘Fundamental Rights and Holocaust Remembrance’ accompanied by a training workshop for European Commission officials in Brussels. The workshop objective is to reflect on remembrance and how EU officials should address contemporary fundamental rights challenges in their daily work. Participants will be led through a series of interactive working groups where they can discuss with trainers the responsibilities of civil servants. The seminar was co-developed between FRA and the Wannsee-Memorial and is the latest in a series of Holocaust and human rights education activities that have been developed by FRA.

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