Danish medical journal
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Danish medical journal · Jan 2014
Randomized Controlled Trial Multicenter Study Comparative StudyHydroxyethyl starch in sepsis.
Hydroxyethyl starch (HES) is a colloid that has been widely used for fluid resuscitation for decades. The newest generation of HES, tetrastarch, was believed to provide an efficient volume expansion without causing the side effects observed with former HES solutions. However, this belief was based on physiological models and small studies rather than on firm clinical evidence. Our aim was to assess the safety and efficacy of tetrastarch in a randomised clinical trial and in a systematic review. ⋯ Our randomised clinical trial is one of several high-quality trials in critically ill patients with and without sepsis that now provide evidence that the use of tetrastarch impairs kidney function and haemostasis and may even increase mortality. Whether the results can be extrapolated to other types of patients is unclear, but so far no group of patients with an overall benefit of HES beyond surrogate markers has been identified. In line with this, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee now recommends that the marketing authorisations of all HES solutions are suspended in the European Union.
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Danish medical journal · Jan 2014
Multicenter StudyCrohn's disease and ulcerative colitis. Occurrence, course and prognosis during the first year of disease in a European population-based inception cohort.
Inflammatory bowel diseases (IBD), consisting of Crohn's disease (CD) and ulcerative colitis (UC), are chronic immune mediated diseases of unknown aetiology. Traditionally, the highest occurrence of both UC and CD is found in North America and Europe, including Scandinavia and the United Kingdom, while the diseases remain rare in Eastern Europe. Until recently, few population-based cohort data were available on the epidemiology of IBD in Eastern Europe. ⋯ Biological therapy accounted for one fourth costs in Western European CD patients. Long-term follow-up of the EpiCom cohort is needed in order to assess whether the earlier and more frequent treatment with immunomodulators and biologicals observed in this study will change the natural disease course and phenotypes over time or merely postpone outcomes such as surgery. Furthermore, the question of if and how differences in treatment choices between Eastern and Western Europe impact on the disease course requires long-term follow-up.