Home Therapy With LMWH in Deep Vein Thrombosis: Randomized Study Comparing Single and Double Daily Administrations

Abstract

The aim of this study was to assess the effectiveness of low-molecular-weight heparin (LMWH) treatment of deep vein thrombosis (DVT) in terms of the evolution of thrombosis, the incidence of adverse events, and compliance with heparin treatment using 2 types of LMWH available on the market administered in therapeutic doses throughout the period of treatment (Nadroparin) or at therapeutic doses only during the first month of treatment followed by a prophylactic phase at half dose (Parnaparin). A randomized prospective study was carried out on patients under observation with a recent diagnosis of DVT. The objectives of the study were to confirm the effectiveness of therapy with LMWH in terms of prevention of the risk of thromboembolism, of relapse of DVT, and of hemorrhagic complications, and to complete an evaluation of venous recanalization and residual valve competence in the 2 groups of patients. From December 2002 to June 2005, we randomized a total of 91 patients (51 in the Parnaparin group and 40 in the Nadroparin group). Overall, there was 1 case of nonfatal pulmonary embolism (1.1%) at 7 days into therapy with LMWH. There were 3 cases (3.3%) of progression of thrombosis despite therapy with LMWH, 2 cases (5%) in the Nadroparin group, and 1 case (2%) in the Parnaparin group (P = NS), and after suspension of the therapy, there was 1 case of relapse of thrombosis. Three of the 4 thrombotic events occurred in patients with active neoplasia. Moreover, only 1 major hemorrhagic event (1.1%) required blood transfusion. The Doppler ultrasound in the follow-up showed a complete resolution of 56% of the vein thromboses at an average of 6.1 +/- 4.6 (mean +/- SD) months. Valve competence recovered in 65.9% of cases with no significant difference between the 2 heparin groups. Home treatment of sural and femoral-popliteal DVT using LMWH represents a safe and effective method in the prevention of pulmonary embolism and encourages the process of recanalization of the thrombosed vessel, especially in cases of sural and/or popliteal DVT. Administration can be carried out with the same degree of safety at the therapeutic dose throughout the period of treatment or can be halved after the first month of treatment. In patients with active neoplasia, treatment with oral anticoagulant therapy must be considered.

Update on the clinical use of the low-molecular-weight heparin, parnaparin

“…Subcutaneous parnaparin, administered once or twice daily at 6400 or 12,800 IuaXa, was compared with intravenous46 or subcutaneous47,48 UFH, or with nadroparin49 in 4 randomized trials of adult patients with objectively proven DVT. In all studies parnaparin was at least as effective as the comparator in preventing recurrent extending DVT and PE, with a similar safety profile.…”

Clinical use of parnaparin in major and minor orthopedic sugery: a review

“…Bellosta et al (2007) have compared the effectiveness of nadroparin and parnaparin in the non-prophylactic treatment of DVT in terms of the evolution of thrombosis, in a randomized prospective study in 91 patients. Overall, there were 3 cases (3.3%) of progression of thrombosis despite therapy with LMWH, 2 cases (5%) in the nadroparin group, and 1 case (2%) in the parnaparin group (not significant).…”

“…At a local level, the tolerability of parnaparin seems better than that of UFH, with a lower rate of hematomas, pain, and burning in the injection site (Corrado et al 1989; Verardi et al 1989; Mangialardi et al 1991; Della Marchina et al 1993; Bandiera et al 2003; Bellosta et al 2007). …”

Parnaparin: review of the literature

“…Lorenzo Pradelli (1) Farmeconomia e percorsi terapeutici 2008; 9(1): [27][28][29][30][31][32][33][34][35][36][37][38][39][40] composta da piastrine e da fibrina, nella quale restano inglobate cellule ematiche.…”

“…L'analisi dei dati aggregati ha confermato la sicurezza e l'efficacia della continuazione del trattamento a dosi dimezzate dopo il primo mese di terapia, con la possibile eccezione dei pazienti con neoplasia attiva. La Tabella IV riassume i principali risultati in termini di efficacia e sicurezza della casistica completa [31].…”