Anti-hemophilic factor safely, effectively prevented bleeding during surgery in patients with von Willebrand’s disease

SAN DIEGO — Recombinant factor VIII proved safe and effective for the prevention of bleeding episodes during surgery or invasive procedures in patients with von Willebrand’s disease, according to findings presented at the ASH Annual Meeting and Exposition.

DDAPV – a synthetic derivative of the antidiuretic hormone vasopressin – also demonstrated excellent or good hemostasis outcomes in patients with the disease, according to researchers.

Chatree Chai-Adisaksopha, MD, of McMaster University in Ontario, and colleagues conducted a meta-analysis of 54 studies to evaluate the efficacy and safety of factor VIII, von Willebrand factor concentrates and DDAVP for the prevention of bleeding in patients with the disease undergoing surgery.

The researchers performed searches using MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials databases. Studies were excluded if they were either case reports or case series with fewer than five patients, patients had acquired disease or there were incomplete outcome reports.

The researchers calculated pooled incidence of patients who achieved good or excellent hemostatic control. Secondary outcomes included adverse events associated with the use of recombinant factors and DDAVP.

Forty-five studies analyzed the efficacy of von Willebrand factor and FVIII. Almost all (98.4%) patients treated with either FVIII or von Willebrand factor achieved good or excellent hemostasis, according to a pooled analysis. The majority of patients (99.4%) who underwent a major surgery and were administered one of the recombinant factors had either good or excellent hemostasis.

A minimal number of patients (0.2%) reported adverse events after receiving either FVIII or von Willebrand factor. Reported adverse events included phlebitis, shortness of breath, chest tightness, urticaria, pruritus, malaise, fever, nausea, vomiting and headache.

Thromboembolism occurred in 0.17% of patients who received either FVIII or von Willebrand factor.

Twenty-six studies investigated DDAVP during surgery. Hemostasis was good or excellent in 98% of patients. Subgroup analysis demonstrated that 96.9% of pediatric patients and 96.9% of adults reached good or excellent hemostasis.

Treatment-related adverse effects from DDAVP were reported in 1.2% of patients. Hyponatremia of any level was reported in 16.1% of cases. Patients also reported headache, fatigue, rash, seizure from hyponatremia, flushing, dizziness, nausea and vomiting. The researchers noted that no thromboembolic events occurred in patients treated with DDAVP. – by Ryan McDonald

For more information:

Chai-Adisaksopha C, et al. Abstract 1408. Presented at: ASH Annual Meeting and Exposition; Dec. 3-6, 2016; San Diego.

Disclosure: Chai-Adisaksopha reports no relevant financial disclosures.