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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
In an observational study of 32 patients, who had class B liver cirrhosis with venous thromboembolism (VTE), were treated between January 2014 and October 2020, 8 patients (3 men and 5 women; aged: 48−75 years) were described, who developed upper gastrointestinal bleeding, large posttraumatic haematoma, massive epistaxis, GI bleeding or exhibited lack of efficacy during anticoagulation treatment with apixaban, dabigatran etexilate or enoxaparin sodium for VTE [not all routes and times to reactions onsets stated, outcomes not stated].
A 61-year-old woman was described, who exhibited lack of efficacy during anticoagulation treatment with apixaban for VTE: The woman, who had a history of COVID-19, was diagnosed with Child-Pugh Scores (CPS) class B liver cirrhosis with VTE. Subsequently, she received anticoagulation treatment with apixaban 2.5mg twice daily. However, she had recurrent episodes of VTE (lack of efficacy).
A 75-year-old man was described, who exhibited lack of efficacy during anticoagulation treatment with enoxaparin sodium for VTE: The man, who was diagnosed with CPS class B liver cirrhosis with VTE, received anticoagulation treatment with apixaban. Later, his treatment was changed from apixaban to enoxaparin sodium [enoxaparin] for 2 months. However, he had recurrent episodes of VTE (lack of efficacy).
A 63-year-old man was described, who exhibited lack of efficacy during anticoagulation treatment with enoxaparin sodium for VTE: The man, who was diagnosed with CPS class B liver cirrhosis with VTE, received anticoagulation treatment with dabigatran etexilate [dabigatran] 110mg twice daily. Later, treatment was changed from dabigatran etexilate to SC enoxaparin sodium [enoxaparin] 40 mg/day for 3 months. However, he had recurrent episodes of VTE (lack of efficacy). Hence, treatment with dabigatran etexilate was re-started.
A 55-year-old woman was described, who developed upper GI bleeding during anticoagulation treatment with apixaban for VTE: The woman, who had a history of invasive therapy of oesophageal varices, was diagnosed with CPS class B liver cirrhosis with VTE. Subsequently, she received anticoagulation treatment with apixaban 2.5mg twice daily. However, after 7 months of apixaban therapy, she developed major upper GI bleeding, which was determined to be related to apixaban therapy.
A 68-year-old man was described, who developed upper GI bleeding during anticoagulation treatment with apixaban for VTE: The man, who had a history of invasive therapy of oesophageal varices, was diagnosed with CPS class B liver cirrhosis with VTE. Subsequently, he received anticoagulation treatment with apixaban 2.5mg twice daily. However, after 13 months of apixaban therapy, he developed major upper GI bleeding, which was determined to be related to apixaban therapy.
A 48-year-old woman was described, who developed large post-traumatic haematoma during anticoagulation treatment with apixaban: The woman, who was diagnosed with CPS class B liver cirrhosis with VTE, received anticoagulation treatment with apixaban 2.5mg twice daily. Subsequently, she developed large post-traumatic haematoma secondary to apixaban therapy.
A 65-year-old woman was described, who developed massive epistaxis during anticoagulation treatment with apixaban for VTE: The woman, who was diagnosed with CPS class B liver cirrhosis with VTE, received anticoagulation treatment with apixaban 2.5mg twice daily. Subsequently, she developed epistaxis secondary to apixaban therapy.
A 56-year-old woman was described, who developed GI bleeding during anticoagulation treatment with dabigatran etexilate for VTE: The woman, who was diagnosed with CPS class B liver cirrhosis with VTE, received anticoagulation treatment with dabigatran etexilate [dabigatran] 110mg twice daily. Subsequently, she developed GI bleeding at 21 month follow-up.