New follow-up phase III data reinforce the long-term benefit of Roche ’s Hemlibra for people with haemophilia A
Basel, 7 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a new analysis of pooled, three-year follow-up data of 401 people with haemophilia A from the pivotal HAVEN 1-4 studies, which reinforce the long-term efficacy and safety profile of Hemlibra ® (emicizumab).These data, from adults, adolescents and children with haemophilia A with and without factor VIII inhibitors, were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 5-8 December 2020.“The long-term benefit of Hemlibra, with a consistent safety profile and durably effective control of bleeding, underscores its potential to redefine the standard of care for people living with haemophilia A,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Pr oduct Development. “As the first new class of medicine in nearly 20 years, Hemlibra continues to show a positive impact on disease burden and quality of life for people with haemophilia A, regardless of their inhibitor status or age.” The analysis included pooled data from 401 people with haemophilia A with and without factor VIII inhibitors, from across the four pivotal HAVEN studies (HAVEN 1, n=113; HAVEN 2, n=88; HAVEN 3, n=152; HAVEN 4, n=48) with a median duration efficacy period of 120.4 weeks.Hemlibra maintained low treated bleed rates across the study period, with model based annualised bleed rates (ABR) remaining...
CONCLUSIONS: Gaps in memory and various memory types were common after ICU admission, whose prevalence waned over time. Compared with nightmares and fearful memories, gaps in memories were most strongly associated with poor mental health and quality of life. Identifying patients with gaps in memories might be an objective way of planning interventions to improve their long-term outcomes.
CONCLUSIONS: Currently, available evidence does not unequivocally support the clinical effectiveness of andexanet alfa or prothrombin complex concentrate to reverse factor Xa inhibitor-associated acute major bleeding, nor does it permit conventional meta-analysis of potential superiority. Neither reversal agent was significantly associated with increased effectiveness or a higher rate of venous thromboembolic event. These results underscore the importance of randomized controlled trials comparing the two reversal agents and may provide guidance in designing institutional guidelines.
CONCLUSIONS: These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.
We examined the incidence and impact of early multiple organ dysfunction syndrome on clinical, functional, and disability outcomes over the year following traumatic brain injury. DESIGN: Retrospective cohort study. SETTING: Patients enrolled in the Transforming Clinical Research and Knowledge in Traumatic Brain Injury study, an 18-center prospective cohort study of traumatic brain injury patients evaluated in participating level 1 trauma centers. SUBJECTS: Adult (age> 17 yr) patients with moderate-severe traumatic brain injury (Glasgow Coma Scale
If it hurts – take notice, and avoid it. Learn from it. If there are other people around, make sure your behaviour is noticeable so they take care of you and don’t do what you just did. If they look after you, you’ll probably do the same thing again when you hurt, if they don’t you probably won’t. This is one description of pain behaviour and how it works. It’s the only part of our pain experience that we can share directly with one another (actions and words). The “doing” part is also the part that is most affected by pain – even distress is signalled to others &nd...
Last week, I became involved in two situations of pain between the eyes that seemed to potentially be presentations of very serious medical conditions. Autumn took a call from her sister late on Friday afternoon. Her sister had been tested for COVID the day before and told Autumn she instantly felt a severe pain betweenRead more …The art and uncertainty of triage originally appeared inKevinMD.com.
Hi, I was wondering if anyone knows of any pain management docs in Scranton, PA or surrounding area (private practice or hospital employed). I'm looking to learn more about local market and network. Thank you.
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