Indobufen in the prevention of complications in orthopaedic surgery: A pharmacoeconomic assessment

This Italian prospective multicentre trial was conducted between 1992 and 1994 to assess how antithrombotic prophylaxis influences the need for homologous blood transfusion, and the incidence of deep venous thrombosis (DVT) and pulmonary thromboembolism in patients undergoing major orthopaedic surgery. The patients (n = 980; 321 males and 659 females) received antithrombotic prophylaxis comprising haemodilution together with one of the following pharmacological regimens: indobufen (INDO) (n = 688); calcium heparin (CaH) (n = 200); low molecular weight heparin (LMWH) (n = 112). Patients who received prophylaxis with INDO experienced less frequent postoperative complications (haematomas and DVT) compared with those who received CaH or LMWH (p = 0.0001), as well as requiring a significantly shorter postoperative hospital stay (p = 0.04) and a significantly reduced need for homologous transfusion (p = 0.03). A cost-effectiveness analysis carried out using this clinical evidence has shown INDO to be a 'cost-saving' drug when compared with CaH and LMWH in the prophylaxis and treatment of orthopaedic postoperative complications. A sensitivity analysis performed by varying the hospitalisation cost according to two different hypotheses confirmed these findings. These data may have important implications for the management of patients with venous thromboembolism.