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Agnelli, G; Buller, HR; Cohen, A; Curto, M; Gallus, AS; Johnson, M; Porcari, A; Raskob, GE; Weitz, JI; PLIFY-EXT Investigators.
Apixaban for extended treatment of venous thromboembolism.
N Engl J Med. 2013; 368(8):699-708 Doi: 10.1056/NEJMoa1207541 [OPEN ACCESS]
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Study Group Members Med Uni Graz:: Pilger Ernst
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Abstract:: BACKGROUND 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.)
Find related publications in this database (using NLM MeSH Indexing): Adult -; Aged -; Creatinine - metabolism; Double-Blind Method -; Factor Xa - antagonists & inhibitors; Female -; Fibrinolytic Agents - administration & dosage Fibrinolytic Agents - adverse effects Fibrinolytic Agents - therapeutic use; Follow-Up Studies -; Hemorrhage - etiology; Humans -; Intention to Treat Analysis -; Kaplan-Meier Estimate -; Male -; Middle Aged -; Pyrazoles - administration & dosage Pyrazoles - adverse effects Pyrazoles - therapeutic use; Pyridones - administration & dosage Pyridones - adverse effects Pyridones - therapeutic use; Recurrence -; Treatment Outcome -; Venous Thromboembolism - drug therapy Venous Thromboembolism - mortality