342 research outputs found
Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients: A US. Perspective
No full textVenous thromboembolism (VTE) remains a major cause of morbidity and mortality in hospitalized medically ill patients. These patients constitute a heterogeneous population, whose VTE risk is dependent upon the acute medical illness, immobility status, and patient-specific risk factors that have been incorporated into individualized VTE risk assessment models. Randomized placebo-controlled trials (RCTs) have shown both efficacy and net clinical benefit of in-hospital thromboprophylaxis, which is supported by guideline recommendations. The data for extended posthospital discharge thromboprophylaxis are more nuanced. RCTs comparing standardized duration low-molecular weight heparin versus extended duration direct oral anticoagulants, such as betrixaban and rivaroxaban, have shown efficacy and net clinical benefit in select groups of high VTE and low-bleed risk populations of hospitalized medically ill patients. These oral agents are now approved for both in-hospital and extended thromboprophylaxis. However, the most recent guidelines do not recommend routine use of these agents for extended thromboprophylaxis. Longitudinal studies in medically ill patients have shown that the majority of VTE events occur in the posthospital discharge setting within 6 weeks of hospitalization. This, coupled with the short hospital length-of-stay and lack of routine postdischarge thromboprophylaxis in U.S. health care settings, has dampened quality improvement efforts aimed at reducing hospital-acquired VTE. The aim of this multidisciplinary document is to provide an evidence-based framework to guide clinicians in assessing VTE and bleeding risk in hospitalized medically ill patients using an individualized, risk-adapted, and patient-centered approach, with the aim of providing clinical pathways toward the use of appropriate type and duration of available thromboprophylactic agents
The Non-Vitamin K Antagonist Oral Anticoagulants in Heart Disease: Section V - Special Situations
No full textNon-vitamin K antagonist oral anticoagulants (NOACs) include dabigatran, which inhibits thrombin, and apixaban, betrixaban, edoxaban and rivaroxaban, which inhibit factor Xa. In large clinical trials comparing the NOACs with the vitamin K antagonist (VKA) warfarin, dabigatran, apixaban, rivaroxaban and edoxaban were at least as effective for stroke prevention in atrial fibrillation and for treatment of venous thromboembolism, but were associated with less intracranial bleeding. In addition, the NOACs are more convenient to administer than VKAs because they can be given in fixed doses without routine coagulation monitoring. Consequently, the NOACs are now replacing VKAs for these indications, and their use is increasing. Although, as a class, the NOACs have a favourable benefit-risk profile compared with VKAs, choosing among them is complicated because they have not been compared in head-to-head trials. Therefore, selection depends on the results of the individual trials, renal function, the potential for drug-drug interactions and preference for once- or twice-daily dosing. In addition, several 'special situations' were not adequately studied in the dedicated clinical trials. For these situations, knowledge of the unique pharmacological features of the various NOACs and judicious cross-trial comparison can help inform prescription choices. The purpose of this position article is therefore to help clinicians choose the right anticoagulant for the right patient at the right dose by reviewing a variety of special situations not widely studied in clinical trials
The PREPARE project
No full textThe 3-year PREPARE project that started in February 2013 aims to close gaps that have
been identified in nuclear and radiological preparedness in Europe following the first
evaluation of the Fukushima disaster. Among other issues, the project will address the
review of existing emergency preparedness and response procedures for dealing with
long-lasting releases, cross-border problems in monitoring and food safety, and further
develop missing functionalities in decision support systems ranging from improved source
term estimation and dispersion modelling to the inclusion of hydrological pathways for
European water bodies. In addition, as the management of the Fukushima event in Europe was
far from optimal, a so-called Analytical Platform will be developed exploring the
scientific and operational means to improve information collection, information exchange
and the evaluation of such types of disasters. This will be achieved through a
collaboration of industry, research and governmental organisations in Europe, taking into
account the networking activities carried out under the NERIS-TP project. Furthermore, the
NERIS Platform member organisations (so far 50 partners) will be actively involved in the
development of the new tools
Oral Apixaban for the Treatment of Acute Venous Thromboembolism.
No full textBackground Apixaban, an oral factor Xa inhibitor administered in fixed doses, may
simplify the treatment of venous thromboembolism. Methods In this randomized,
double-blind study, we compared apixaban (at a dose of 10 mg twice daily for 7
days, followed by 5 mg twice daily for 6 months) with conventional therapy
(subcutaneous enoxaparin, followed by warfarin) in 5395 patients with acute
venous thromboembolism. The primary efficacy outcome was recurrent symptomatic
venous thromboembolism or death related to venous thromboembolism. The principal
safety outcomes were major bleeding alone and major bleeding plus clinically
relevant nonmajor bleeding. Results The primary efficacy outcome occurred in 59
of 2609 patients (2.3%) in the apixaban group, as compared with 71 of 2635 (2.7%)
in the conventional-therapy group (relative risk, 0.84; 95% confidence interval
[CI], 0.60 to 1.18; difference in risk [apixaban minus conventional therapy],
-0.4 percentage points; 95% CI, -1.3 to 0.4). Apixaban was noninferior to
conventional therapy (P<0.001) for predefined upper limits of the 95% confidence
intervals for both relative risk (<1.80) and difference in risk (<3.5 percentage
points). Major bleeding occurred in 0.6% of patients who received apixaban and in
1.8% of those who received conventional therapy (relative risk, 0.31; 95% CI,
0.17 to 0.55; P<0.001 for superiority). The composite outcome of major bleeding
and clinically relevant nonmajor bleeding occurred in 4.3% of the patients in the
apixaban group, as compared with 9.7% of those in the conventional-therapy group
(relative risk, 0.44; 95% CI, 0.36 to 0.55; P<0.001). Rates of other adverse
events were similar in the two groups. Conclusions A fixed-dose regimen of
apixaban alone was noninferior to conventional therapy for the treatment of acute
venous thromboembolism and was associated with significantly less bleeding
(Funded by Pfizer and Bristol-Myers Squibb; ClinicalTrials.gov number,
NCT00643201 )
Apixaban for extended treatment of venous thromboembolism.
No full textBackground
Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose
regimen, may be an option for the extended treatment of venous thromboembolism.
Methods
In this randomized, double-blind study, we compared two doses of apixaban (2.5 mg
and 5 mg, twice daily) with placebo in patients with venous thromboembolism who
had completed 6 to 12 months of anticoagulation therapy and for whom there was
clinical equipoise regarding the continuation or cessation of anticoagulation therapy.
The study drugs were administered for 12 months.
Results
A total of 2486 patients underwent randomization, of whom 2482 were included in
the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism
or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%)
who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who
were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence
interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving
5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1)
(P<0.001 for both comparisons). The rates of major bleeding were 0.5% in the placebo
group, 0.2% in the 2.5-mg apixaban group, and 0.1% in the 5-mg apixaban
group. The rates of clinically relevant nonmajor bleeding were 2.3% in the placebo
group, 3.0% in the 2.5-mg apixaban group, and 4.2% in the 5-mg apixaban group.
The rate of death from any cause was 1.7% in the placebo group, as compared with
0.8% in the 2.5-mg apixaban group and 0.5% in the 5-mg apixaban group.
Conclusions
Extended anticoagulation with apixaban at either a treatment dose (5 mg) or a
thromboprophylactic dose (2.5 mg) reduced the risk of recurrent venous thromboembolism
without increasing the rate of major bleeding. (Funded by Bristol-Myers
Squibb and Pfizer; AMPLIFY-EXT ClinicalTrials.gov number, NCT00633893.
Pat Harrison and [John J.] Raskob playing golf.
No full texthttps://egrove.olemiss.edu/harrison/1012/thumbnail.jp
Test and validation studies performed with UFOTRI and NORMTRI. TW5-TSS/SEP2 - deliverable 4
No full textAssessment of the Environmental Impact from Tritium Releases under Normal Operation Conditions and after Accidents
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