‡‡ The SmPC differs from the clinical trial. ‡ These patients received a dose reduction of LIXIANA ® (30 mg) if they had one or more of the following factors which put them at risk of bleeding on the 60 mg dose: moderate renal impairment: (CrCI 30–50 ml/min), low body weight (≤60 kg/132 lbs) or concomitant use of P-glycoprotein (P-gp) inhibitors verapamil, dronedarone or quinidine. †† Please refer to the SmPC for more information.
It is calculated by assigning 1 point each for a history of congestive heart failure, hypertension, age ≥75 years, or diabetes mellitus and by assigning 2 points for history of stroke or transient ischaemic attack. Ɨ CHADS2 SCORE: A validated measure for assessing stroke risk. ** Twenty-three patients in the LIXIANA ® 60/30 mg treatment arm and 24 patients in the warfarin arm did not receive study drug, resulting in 7012 patients included in each arm of the safety analysis, which reflects the modified intention-to-treat population in the on-treatment period. In patients taking LIXIANA ® and the following P-gp inhibitors dronedarone, erythromycin, ketoconazole or ciclosporin, the recommended dose is LIXIANA ® 30 mg once daily. Hence, no dose adjustment is required for concomitant use of verapamil, amiodarone and quinidine. The SmPC differs from the clinical trial. – Concomitant use of P-gp inhibitors verapamil, dronedarone or quinidine 1 – Renal impairment (CrCl 30 to 50 ml/min) * Patients were treated with the 30 mg reduced dose of LIXIANA ® if they had one or more of the following clinical factors: 1
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Subjects with the following diagnoses or situations: active malignancy (diagnosed within 5 years) except for adequately treated nonmelanoma skin cancer or other non invasive or in situ neoplasm.Women of childbearing potential including women with a history of tubal ligation and women Subjects previously randomised in a study of edoxaban.Subjects who received any investigational drug or device within 30 days before randomisation, or plan to recieve such therapy during the study period.Preplanned invasive procedures (other than routine endoscopy) or surgeries in which bleeding is anticipated during the study period.Any other clinically relevant laboratory abnormality.Haemoglobin Known positive test for HIV, hepatitis B antigen or hepatitis C antibody before randomisation.Active liver disease or persistent elevation of liver enzymes/bilirubin, alanine transaminase or aspartate transaminase ≥2 times the ULN, total bilirubin ≥1.5 times the ULN.Concomitant use of medications that increase the risk of bleeding.Intracardial mass or left ventricular thrombus subjects in whom chronic anticoagulation therapy will be discontinued if a planned pharmalogic, electrical, or surgical therapy were to be successful in converting and maintaining normal sinus rhythm contraindication for anticoagulant agents.History of left atrial appendage exclusion.Acute coronary syndromes, coronary revascularisation, or stroke within 30 days before randomisation.Other indications for anticoagulation therapy.Moderate-to-severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve.Atrial Fibrillation due to a reversible disorder.
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