其 他 安 全 警 示
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| Canada: XARELTO (rivaroxaban) - Increase in all-cause mortality, thromboembolic and bleeding events in patients after transcatheter aortic valve replacement (English Only) |
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Health Canada announces that, in August 2018, the Data Safety Monitoring Board (DSMB), while monitoring patient safety independently in the phase III clinical study (GALILEO) in patients after transcatheter aortic valve replacement (TAVR), recommended stopping the study based on preliminary results showing an increase in all-cause mortality, thromboembolic and bleeding events in XARELTO-treated patients.
GALILEO is a randomized, open label, active-controlled, multicentre phase III trial to evaluate clinical outcomes after successful TAVR in subjects randomized to either a XARELTO-based anticoagulation strategy or an antiplatelet-based strategy. The first group received XARELTO 10 mg once daily and acetylsalicylic acid (ASA) 75-100 mg once daily for 90 days, followed by maintenance with XARELTO 10 mg once daily. The comparator group was given clopidogrel 75 mg and ASA 75-100 mg once daily for 90 days, followed by ASA 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 and major bleeding events. Patients with atrial fibrillation were excluded from this trial.
In August 2018, the independent DSMB recommended stopping the trial, as a preliminary analysis of available data suggested a numerical imbalance between the two study groups in all-cause mortality, thromboembolic and bleeding events. The incidences in the XARELTO group (826 patients) and the antiplatelet group (818 patients), respectively, were 11.4% versus 8.8% for death or first thromboembolic events, 6.8% versus 3.3% for all-cause death and 4.2% versus 2.4% for primary bleeding events. These results are preliminary and based on incomplete data collection. The final study data will be assessed as soon as they are available, including an assessment of any implications for approved indications.
TAVR is performed in patients who need an aortic valve replacement but who are at too high a risk for a standard open heart valve surgery. Patients undergoing TAVR present with multiple clinical risk factors pertinent to the background disease of aortic valve stenosis.
Healthcare professionals are reminded that:
- XARELTO is not approved for thromboprophylaxis in patients with prosthetic heart valves, including patients who have undergone TAVR, and should not be used in such patients.
- XARELTO treatment should be stopped in patients who undergo TAVR, and they should be switched to standard of care.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../68616a-eng.php
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 has received 15 cases of adverse drug reaction related to rivaroxaban, and these cases include bleeding. Related news was previously issued by Medicines and Healthcare products Regulatory Agency (MHRA) and was posted on the Drug Office website on 12 Oct 2018. Letters to inform local healthcare professionals were also issued on the same day. The DH will remain vigilant on safety update of the drug, including the final results of the study, issued by MHRA, Health Canada and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Friday, December 21, 2018
Issued at HKT 17:30
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