All patients received background therapy with a P2Y12 inhibitor (clopidogrel: 90.3%) prescribed per local standard of care.Patients were randomized up to 14 days after the ACS and/or PCI to either apixaban 5 mg twice daily (2.5 mg twice daily if two or more of the dose-reduction criteria were met; 10% received lower dose) or VKA and to either ASA (81 mg once daily) or placebo.
No systemic embolism events were reported.Major bleeding and CRNM bleeding events occurred in 3 (0.41%) and 11 (1.50%) patients, respectively, in the apixaban group, compared to 6 (0.83%) and 13 (1.80%) patients in the heparin and/or VKA group.This exploratory study showed comparable efficacy and safety between apixaban and heparin and/or VKA treatment groups in the setting of cardioversion.The clinical program (AMPLIFY: apixaban versus enoxaparin/warfarin, AMPLIFY-EXT: apixaban versus placebo) was designed to demonstrate the efficacy and safety of apixaban for the treatment of DVT and/or PE (AMPLIFY), and extended therapy for the prevention of recurrent DVT and/or PE following 6 to 12 months of anticoagulant treatment for DVT and/or PE (AMPLIFY-EXT). Preclinical studies of apixaban in animal models have demonstrated antithrombotic efficacy in the prevention of arterial and venous thrombosis at doses that preserved haemostasis.The pharmacodynamic effects of apixaban are reflective of the mechanism of action (FXa inhibition). Eliquis should be used with caution when coadministered with SSRIs/SNRIs, NSAIDs, ASA and/or P2Y12 inhibitors because these medicinal products typically increase the bleeding risk (see section 4.4).There is limited experience of co-administration with other platelet aggregation inhibitors (such as GPIIb/IIIa receptor antagonists, dipyridamole, dextran or sulfinpyrazone) or thrombolytic agents.
Renal impairment had no evident effect on the relationship between apixaban plasma concentration and anti-FXa activity.In subjects with end-stage renal disease (ESRD), the AUC of apixaban was increased by 36% when a single dose of apixaban 5 mg was administered immediately after haemodialysis, compared to that seen in subjects with normal renal function. There was an increase in apixaban exposure correlated to decrease in renal function, as assessed via measured creatinine clearance. Decisions on initiation and duration of treatment should take established guideline recommendations for anticoagulant treatment in patients undergoing cardioversion into account.There is limited experience of treatment with apixaban at the recommended dose for NVAF patients when used in combination with antiplatelet agents in patients with ACS and/or undergoing PCI after haemostasis is achieved (see sections 4.4, 5.1).The safety and efficacy of Eliquis in children and adolescents below age 18 have not been established. * Noninferior compared to enoxaparin/warfarin (p-value <0.0001)Apixaban efficacy in initial treatment of VTE was consistent between patients who were treated for a PE [Relative Risk 0.9; 95% CI (0.5, 1.6)] or DVT [Relative Risk 0.8; 95% CI (0.5, 1.3)]. • Some injections can be given After 2 days of coadministration of Eliquis with VKA therapy, an INR should be obtained prior to the next scheduled dose of Eliquis. Cartons of 10, 20, 60, 168 and 200 film-coated tablets.Alu PVC/PVdC perforated unit dose blisters of 60x1 and 100x1 film-coated tablets.Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.euBristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH, UKTo bookmark a medicine you must sign up and log in.To view the changes to a medicine you must sign up and log in. atony of the intestine and bladder,intestine atony,bladder atony,hf,asymptomatic left ventricular dysfunction,lvd,left ventricular dysfunction,coronary ischemic,anaphylactic shock,reduce diffusion of local anesthetic,mycoplasma pneumonia,mycoplasma pneumonia infection,legionnaires’ disease,chlamydia infections,pertusis,streptococcal infections,staphylococcal infections,campylobacter infections,helicobacter 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inhibitors,lipid regulator,aminoglycoside.,second-generation antidiabetic (long-acting),oral hypoglycemic agent,sulfonylurea.,second-generation antidiabetic,glucose elevating agnet,antianginal agent,vasodilator,organic nitrate,gonadotropin-releasing hormone,lutenizing hormone-releasing hormone (lh-rh agonist),5-ht3 antagonist,antiemetic.,anticoagulant,thiazide,glucocorticosteroid,water soluble vitamine,vitamine,anti-malarial,chloroquine,atropine-like substance,acetylcholine antagonist. The service maker disclaim all liability in connection with the use. Array indices run from 0 to 47. Additional contributions from biliary and direct intestinal excretion were observed in clinical and nonclinical studies, respectively.Apixaban has a total clearance of about 3.3 L/h and a half-life of approximately 12 hours.O-demethylation and hydroxylation at the 3-oxopiperidinyl moiety are the major sites of biotransformation. As with all new anticoagulant medicinal products, experience with neuraxial blockade is limited and extreme caution is therefore recommended when using apixaban in the presence of neuraxial blockade.Eliquis is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of apixaban have not been established in these clinical situations.Efficacy and safety of apixaban in the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) in patients with active cancer have not been established.Limited clinical data indicate that apixaban plasma concentrations are increased in patients with severe renal impairment (creatinine clearance 15-29 mL/min) which may lead to an increased bleeding risk.
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