Other safety alerts
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| The United Kingdom: Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that preliminary analysis of a phase 3 clinical trial show risks of all-cause death and bleeding post-transcatheter aortic valve replacement (TAVR) were approximately doubled in patients assigned to a rivaroxaban-based anticoagulation strategy compared with those assigned to receive an antiplatelet-based strategy (clopidogrel and aspirin).
Study 17938 (GALILEO) is a randomised, open label, active-controlled, multicentre, phase 3 trial that aimed to assess clinical outcomes after successful TAVR in patients randomly assigned to receive either a rivaroxaban-based anticoagulation strategy or an antiplatelet-based strategy. The first group was assigned to receive rivaroxaban 10 mg once a day and acetylsalicylic acid (aspirin) 75–100 mg once a day for 90 days followed by maintenance with rivaroxaban 10 mg once a day. The comparator group was assigned to receive clopidogrel 75 mg and acetylsalicylic acid 75–100 mg once a day for 90 days, followed by acetylsalicylic acid alone. The primary efficacy endpoint is a composite of all-cause death, stroke, systemic embolism, myocardial infarction, pulmonary embolism, deep vein thrombosis, and symptomatic valve thrombosis. The primary safety endpoint is a composite of life-threatening or disabling (BARC types 5 and 3b/3c) and major (BARC type 3a) bleeding events. Patients with atrial fibrillation at randomisation were excluded.
The trial was stopped in Aug 2018, on recommendation of the independent Data Safety Monitoring Board (DSMB), following a preliminary analysis of available data. The trial findings suggested an imbalance between the two study groups in all-cause mortality, thromboembolic, and bleeding events. These results are preliminary and based on incomplete data collection. The final study data will be assessed by regulatory authorities as soon as they are available, including an assessment of any implications for approved indications. MHRA will promptly communicate any relevant updates.
Healthcare professionals are advised:
- Rivaroxaban is not authorised for thromboprophylaxis in patients with prosthetic heart valves, including patients who have undergone TAVR, and should not be used in such patients.
- Rivaroxaban treatment in patients who undergo TAVR should be stopped and switched to standard of care.
- The direct-acting oral anticoagulants apixaban and edoxaban have not been studied in patients with prosthetic heart valves and their use is also not recommended in these patients; the use of dabigatran is contraindicated in patients with prosthetic heart valves requiring anticoagulant treatment.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/rivaroxaban-xarelto-after-transcatheter-aortic-valve-replacement-increase-in-all-cause-mortality-thromboembolic-and-bleeding-events-in-a-clinical-trial
In Hong Kong, there are 6 registered pharmaceutical products containing rivaroxaban, namely Xarelto Tab 10mg (HK-57861), Xarelto Tab 15mg (HK-61396), Xarelto Tab 20mg (HK-61395), Xarelto Tablets 10mg (Italy) (HK-65786), Xarelto Tablets 15mg (Italy) (HK-65787) and Xarelto Tablets 20mg (Italy) (HK-65785). All products are registered by Bayer Healthcare Limited, and are prescription-only medicines.
So far, the Department of Health (DH) has received 14 cases of adverse drug reaction related to rivaroxaban, and these cases include stroke and bleeding. In light of the above MHRA’s announcement, letters to inform local healthcare professionals will be issued. The DH will remain vigilant on safety update of the drug, including the final results of the study, issued by MHRA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Friday, Oct 12, 2018
Issued at HKT 17:00
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