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| Home > Publications database > Experimental and numerical investigations of heat transport and crystallization kinetics in laser-induced modification of barium strontium titanate thin films |
| Journal Article | PreJuSER-49726 |
;
2005
Springer
Berlin
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Please use a persistent id in citations: doi:10.1007/s00339-004-2904-7
Abstract: Venous thromboembolism is treated with unfractionated heparin or low-molecular-weight heparin, followed by a vitamin K antagonist. We investigated the potential use of idraparinux, a long-acting inhibitor of activated factor X, as a substitute for standard therapy.We conducted two randomized, open-label noninferiority trials involving 2904 patients with deep-vein thrombosis and 2215 patients with pulmonary embolism to compare the efficacy and safety of idraparinux versus standard therapy. Patients received either subcutaneous idraparinux (2.5 mg once weekly) or a heparin followed by an adjusted-dose vitamin K antagonist for either 3 or 6 months. The primary efficacy outcome was the 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal).In the study of patients with deep venous thrombosis, the incidence of recurrence at day 92 was 2.9% in the idraparinux group as compared with 3.0% in the standard-therapy group (odds ratio, 0.98; 95% confidence interval [CI], 0.63 to 1.50), a result that satisfied the prespecified noninferiority requirement. At 6 months, the hazard ratio for idraparinux was 1.01. The rates of clinically relevant bleeding at day 92 were 4.5% in the idraparinux group and 7.0% in the standard-therapy group (P=0.004). At 6 months, bleeding rates were similar. In the study of patients with pulmonary embolism, the incidence of recurrence at day 92 was 3.4% in the idraparinux group and 1.6% in the standard-therapy group (odds ratio, 2.14; 95% CI, 1.21 to 3.78), a finding that did not meet the noninferiority requirement.In patients with deep venous thrombosis, once-weekly subcutaneous idraparinux for 3 or 6 months had an efficacy similar to that of heparin plus a vitamin K antagonist. However, in patients with pulmonary embolism, idraparinux was less efficacious than standard therapy. (ClinicalTrials.gov numbers, NCT00067093 [ClinicalTrials.gov] and NCT00062803 [ClinicalTrials.gov].).
Keyword(s): Anticoagulants: adverse effects (MeSH) ; Anticoagulants: therapeutic use (MeSH) ; Female (MeSH) ; Follow-Up Studies (MeSH) ; Hemorrhage: chemically induced (MeSH) ; Heparin: adverse effects (MeSH) ; Heparin: therapeutic use (MeSH) ; Humans (MeSH) ; Incidence (MeSH) ; Male (MeSH) ; Middle Aged (MeSH) ; Oligosaccharides: adverse effects (MeSH) ; Oligosaccharides: therapeutic use (MeSH) ; Pulmonary Embolism: drug therapy (MeSH) ; Pulmonary Embolism: mortality (MeSH) ; Recurrence (MeSH) ; Treatment Outcome (MeSH) ; Venous Thrombosis: drug therapy (MeSH) ; Venous Thrombosis: mortality (MeSH) ; Vitamin K: antagonists & inhibitors (MeSH) ; Anticoagulants ; Oligosaccharides ; idraparinux ; Vitamin K ; Heparin ; J
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