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Is platelet monitoring during 7-day lusutrombopag treatment necessary in chronic liver disease patients with thrombocytopenia undergoing planned invasive procedures? A phase IIIb open-label study. | LitMetric

AI Article Synopsis

  • Lusutrombopag is a treatment for low platelet counts in chronic liver disease patients and was studied to see how monitoring platelets affected treatment outcomes.
  • An open-label study involved three patient groups that differed in monitoring and discontinuation practices, ultimately measuring how many patients managed to avoid platelet transfusions before invasive procedures.
  • Results showed similar success rates and safety profiles across groups, suggesting that lusutrombopag can be given without strict platelet monitoring.

Article Abstract

Aim: Lusutrombopag is approved for thrombocytopenia in chronic liver disease patients planned to undergo invasive procedures. In previous clinical studies, lusutrombopag treatment was stopped in patients with an increase in platelet count (PC) of ≥20 × 10 /L from baseline and whose PC was ≥50 × 10 /L (discontinuation criteria). We assessed the influence of platelet monitoring during lusutrombopag treatment in lusutrombopag-naïve patients.

Methods: In this open-label study, Child-Pugh class A and B (A/B) patients were enrolled and treated with lusutrombopag (3 mg/day) for 7 days. In the treatment-naïve A/B-1 group, the discontinuation criteria were applied on day 6. In the treatment-naïve A/B-2 group, the criteria were not applied. In a non-naïve A/B group, the criteria were applied on days 3 and 5-7. The main efficacy end-point was the proportion of patients without platelet transfusion (PT) before the primary invasive procedure.

Results: In the A/B-1, A/B-2, and non-naïve A/B groups, the proportions of patients without PT were 80.9% (38/47), 83.0% (39/47), and 75.0% (6/8), respectively. The mean durations of PC ≥ 50 × 10 /L without PT were 20.7, 20.3, and 22.8 days, respectively. Excessive PC increases (≥200 × 10 /L) were not detected in any group. Treatment-related adverse events occurred in 4.3%, 6.4%, and 0% of A/B-1, A/B-2, and non-naïve A/B patients, respectively. Severe portal vein thrombosis occurred in one A/B-2 patient (PC 75 × 10 /L at onset).

Conclusions: No meaningful efficacy and safety differences were observed among the groups with or without discontinuation criteria and the non-naïve group. These findings support lusutrombopag treatment without platelet monitoring and retreatment with lusutrombopag.

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Source
http://dx.doi.org/10.1111/hepr.13544DOI Listing

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