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The phase II ARES trial (EudraCT 2016–002885-30) assessed the long-term pharmacodynamic superiority and safety of a twice-daily 100 mg aspirin regimen vs the standard once-daily regimen in 242 adult patients with essential thrombocythemia (ET).1 Results from this trial were published in the American Journal of Hematology by Rocca et al.1
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Key learnings1 |
The primary endpoint was met; during a 20-month follow-up, patients who were treated with the twice-daily low-dose aspirin regimen showed significantly lower levels of serum thromboxane B2 compared with once-daily dosing (median, 3.9 vs 19.2 ng/ml; p < 0.001), suggesting enhanced antithrombotic efficacy. |
Twice-daily low-dose aspirin dosing was associated with a reduction in disease-specific symptoms vs standard once-daily dosing (no reported symptoms, 17.3% vs 14.3%; p < 0.05; ≥8 reported symptoms; 7.9% vs 13.0%; p = 0.0001) and significant relief from severe hand and foot microvascular pain, without an increase in upper gastrointestinal discomfort. |
Bleeding risks were similar between the twice-daily and once-daily aspirin regimens, although there was a trend towards more clinically relevant non-major bleeding in the twice-daily group (8 vs 2). |
This study supports consideration of twice-daily low-dose aspirin as a well-tolerated and potentially more effective option for managing patients with ET, particularly in those with high symptom burden and risk of thrombotic events. |
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