AI Article Synopsis

  • Limited data exists on the safety and effectiveness of 4-factor prothrombin complex concentrate (4F-PCC) in patients facing major bleeding or needing urgent surgery, particularly in Japan.
  • A post-marketing study was conducted involving 1,381 patients who received 4F-PCC for the first time, with a follow-up period of 4 weeks, finding a high percentage (92%) of patients were on vitamin K antagonists and a notable incidence of intracranial hemorrhage.
  • Results showed that 85.8% of patients achieved hemostatic effectiveness, with a low incidence of adverse drug reactions (3.9%) and thromboembolic events (1.5%), indicating that

Article Abstract

Introduction: Limited data are available regarding the safety and effectiveness of 4-factor prothrombin complex concentrate (4F-PCC) in patients experiencing major hemorrhage or requiring expeditious surgical intervention, both globally and within Japan.

Methods: We executed a prospective, observational post-marketing surveillance study of patients receiving 4F-PCC for the first time between September 19, 2017 and August 15, 2018 in Japan. Patients were subjected to a comprehensive follow-up for a duration of 4 weeks.

Results: Of 1381 eligible patients, 1271 (92%) received a vitamin K antagonist. Among these, 58% were aged ≥ 75 years, 49% manifested atrial fibrillation, 17% presented with valvular heart disease, and 6% exhibited venous thromboembolism. The median (range) international normalized ratio was 2.67 (0.96-27.11) at baseline and 1.21 (0.45-6.61) at first measurement post-administration of 4F-PCC. The most common reason for 4F-PCC administration was intracranial hemorrhage (59.6%), followed by gastrointestinal bleeding (6.6%). Hemostatic effectiveness was achieved in 85.8% of patients. The incidences of adverse drug reactions (ADRs) and serious ADRs were 3.9% and 2.8%, respectively. Thromboembolic events (TEEs) occurred in 20 (1.5%) patients, with a mean onset of 10 days. The majority of TEEs were classified as nervous system disorders (55%). At the time of TEE, only 13% of patients resumed anticoagulant therapy.

Conclusion: The incidence of TEEs following treatment with 4F-PCC did not surpass those observed in phase 3 trials. No novel safety signals were identified. The safety and effectiveness of 4F-PCC in Japanese real-world practice were in harmony with the observations of prior studies.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10899136PMC
http://dx.doi.org/10.1007/s40119-024-00357-6DOI Listing

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