Literature Scan
Venous Thromboembolism ) trial , led by Jeffrey I . Weitz , MD , of the Thrombosis and Atherosclerosis Research Institute and McMaster University in Hamilton , Ontario , Canada , found that the use of rivaroxaban ( at either 10 or 20 mg ) reduced the risk of recurrent VTE more than aspirin , without significantly increasing bleeding rates . 1
“ Many patients with VTE benefit from extended anticoagulation but are reluctant to take it because of the fear of bleeding – opting to take aspirin instead ,” Dr . Weitz explained to ASH Clinical News . “ This study shows that rivaroxaban is superior to aspirin and is associated with a similar bleeding risk . Therefore , unless cost is the issue , rivaroxaban is a better choice than aspirin for extended treatment .”
The study , which was published in the New England Journal of Medicine , enrolled 3,396 patients from 244 sites in 31 countries ; 3,365 patients were included in the primary analysis . Adult patients were included if they had objectively confirmed symptomatic proximal deep vein thrombosis or pulmonary embolism and were treated for 6-12 months with an anticoagulant , including a vitamin K antagonist ( VKA ) or direct oral anticoagulant ( DOAC ; dabigatran , rivaroxaban , apixaban , or edoxaban ).
Patients were excluded from the study if they had a contraindication to continued anticoagulant therapy , required extended anticoagulant therapy at therapeutic doses or antiplatelet therapy , or had a creatinine clearance of < 30 mL / min or hepatic disease associated with a coagulopathy .
Patients were enrolled at least 24 hours after receiving their last dose of a DOAC or , if they were receiving a VKA , when the international normalized ratio was ≤2.5 . Patients were randomized 1:1:1 to receive :
• rivaroxaban 20 mg ( n = 1,107 ; median age = 59 years ; range = 48-69 years )
• rivaroxaban 10 mg ( n = 1,127 ; median age = 60 years ; range = 48-69 years )
• aspirin 100 mg ( n = 1,131 ; median age = 60 years ; range = 48-69 years )
Each agent was administered daily with food . Patients were treated for at least 6 months , with an intended duration of 12 months .
The primary efficacy endpoint of symptomatic , recurrent , fatal or nonfatal VTE occurred in 17 patients receiving rivaroxaban 20 mg ( 1.5 %), 13 receiving rivaroxaban 10 mg ( 1.2 %), and 50 patients receiving aspirin ( 4.4 %), which translated to hazard ratios ( HRs ) of :
• 0.34 for rivaroxaban 20 mg versus aspirin ( 95 % CI 0.20-0.59 ; p < 0.001 )
• 0.26 for rivaroxaban 10 mg versus aspirin ( 95 % CI 0.14-0.47 ; p < 0.001 )
• 1.34 for rivaroxaban 20 mg versus 10 mg ( 95 % CI 0.65-2.75 ; p = 0.42 )
Fatal VTE occurred in two patients each in the rivaroxaban 20 mg cohort and aspirin
INDICATIONS
Kogenate ® FS : His life . His treatment .
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■ Can be used as routine prophylaxis in adults and children with hemophilia A
■ For use as on-demand treatment in adults and children with hemophilia A
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* The Kogenate FS Free Trial Program is available to newly diagnosed patients and patients who are currently using other therapy . Patients currently using Kogenate FS are not eligible for the Free Trial Program . Participation in the Kogenate FS Free Trial Program is limited to 1 time only . The medication provided through this program is complimentary and is not an obligation to purchase or use Kogenate FS in the future . Reselling or billing any third party for the free product is prohibited by law .
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People with private , commercial health insurance may receive Kogenate FS co-pay or co-insurance assistance based on eligibility requirements . The program is on a first-come , first-served basis . Financial support is available for up to 12 months . Eligible patients can re-enroll for additional 12-month courses . The program is not for patients receiving prescription reimbursement under any federal- , state- , or government-funded insurance programs , or where prohibited by law . All people who meet these criteria are encouraged to apply . Bayer reserves the right to discontinue the program at any time .
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The program does not guarantee that patients will be successful in obtaining reimbursement . Support medication provided through Bayer ’ s assistance programs is complimentary and is not contingent on future Kogenate FS purchases . Reselling or billing any third party for free product provided by Bayer ’ s patient assistance programs is prohibited by law . Bayer reserves the right to determine eligibility , monitor participation , determine equitable distribution of product , and modify or discontinue the program at any time .
■ Kogenate ® FS is an Antihemophilic Factor ( Recombinant ) indicated for :
■ On-demand treatment and control of bleeding episodes in adults and children with hemophilia A .
■ Perioperative management of bleeding in adults and children with hemophilia A .
■ Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage .
■ Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A .
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IMPORTANT SAFETY INFORMATION
cohort ( 0.2 % each ) and zero patients in the rivaroxaban 10 mg cohort .
The authors reported that patients with VTE and ongoing risk factors “ have an appreciable risk of recurrence .” In the aspirin cohort , 3.6 percent of patients who experienced recurrent VTE had a provoked index event and were considered at a higher risk of recurrence , whereas 5.6 percent had an unprovoked index event . However , the authors noted , “ rates of recurrence in patients whose
Print-only content index events were provoked or unprovoked were lower in both the rivaroxaban 20 mg group ( 1.4 % and 1.8 %) and the rivaroxaban 10 mg group ( 0.9 % and 1.5 %).”
The incidence of major bleeding ( primary safety endpoint ) appeared to be similar among groups : 0.5 percent ( n = 6 ) of the rivaroxaban 20 mg cohort , 0.4 percent ( n = 5 ) of the rivaroxaban 10 mg cohort , and 0.3 percent ( n = 3 ) of the aspirin cohort . Clinically relevant but non-major bleed-
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■ Kogenate FS Antihemophilic Factor ( Recombinant ) is contraindicated in patients who have life-threatening hypersensitivity reactions , including anaphylaxis to mouse or hamster protein or other constituents of the product .
■ Hypersensitivity reactions , including anaphylaxis have been reported with Kogenate FS . Reported symptoms included facial swelling , flushing , hives , decrease in blood pressure , nausea , rash , restlessness , shortness of breath , tachycardia , tightness of the chest , tingling , urticaria , and vomiting . Discontinue Kogenate FS if symptoms occur and seek immediate emergency treatment .
40 ASH Clinical News