Liposomal Heparin Spray: A New Formula in Adjunctive Treatment of Superficial Venous Thrombosis

Abstract

The objective of this study was to assess the efficacy and safety of liposomal heparin spray-a new formula of topical heparin delivery. This was a randomized, multicenter, controlled open clinical trial with 2 parallel groups. Forty-six outpatients with clinical signs of superficial venous thrombosis (SVT) were treated with either topical liposomal heparin spraygel (LHSG) (Lipohep Forte Spraygel, 4 puffs of 458 IU tid (n = 22) or with low-molecular-weight heparin (LMWH) (Clexane 40 mg once a day (n = 24), administered subcutaneously (sc). Main outcome measures were efficacy parameters (improvement of local symptoms-pain control and planimetric evaluation of erythema size, duplex Doppler assessment of thrombus regression) and safety parameters (documentation of adverse events, with particular reference to deep vein thrombosis [DVT] by duplex sonography, and patients' and investigators' assessment of drug tolerance). Patients' and investigators' subjective assessment of efficacy of treatment and change in basic biochemical parameters were defined as secondary outcome measures. Statistical analysis was performed with use of Wilcoxon test, Mann-Whitney U-test and Chi-square test. Regression of SVT-related symptoms, including pain, erythema, and thrombus presence, was shown as comparable in LHSG and LMWH groups. These results were corroborated by efficacy assessment by investigators and patients. Three cases of deep venous thrombosis in heparin spraygel and 1 in heparin sc group were reported. No significant adverse reactions were observed in the spraygel group, but 1 serious allergic reaction was observed in the LMWH group. Tolerance of new formula heparin was assessed as good. Heparin spraygel-a new topical mode of heparin application, seems a promising method of heparin delivery. This initial study has demonstrated comparable efficacy and safety of LHSG and LMWH in local treatment of SVT. These findings should be confirmed by further extensive study that will reach appropriate statistical power to support such conclusion, for despite heparin treatment, significant risk of DVT was demonstrated in both groups.

Liposome‐based diclofenac for the treatment of inflammation in an acute synovitis model in horses

“…, 2007), cutaneous leishmaniasis (Ferreira et al. , 2004), varicose veins (Gorski et al. , 2005), ocular lesions (Danion et al.…”

“…This supports other research which has evaluated liposome-based formulations of drugs. In humans, liposomes have been investigated for use in numerous applications including treatment of rheumatoid arthritis (Cher-evatov et al, 1987), neoplastic conditions (Carvalho Junior et al, 2007), cutaneous leishmaniasis (Ferreira et al, 2004), varicose veins (Gorski et al, 2005), ocular lesions (Danion et al, 2007), hair loss (Mura et al, 2007), and for transcutaneous vaccination (Gupta et al, 2005). Therefore, it is plausible that liposome-based diclofenac has the potential to be an important alternative to parenteral NSAID therapy.…”

Inhalable Liposomes of Low Molecular Weight Heparin for the Treatment of Venous Thromboembolism

“…7,8 The safety and efficacy of a liposomal heparin spray in the treatment of superficial venous thrombosis has been studied in human subjects. 9 We have recently studied the safety and efficacy of pegylated cationic liposomal formulation of LMWH and demonstrated that the duration of action of cationic liposomal formulations of LMWH was longer than that of plain LMWH administered via the pulmonary route. Further, our study showed that liposomal formulations administered at a reduced dosing frequency produced thrombolytic effects similar to that produced by plain subcutaneous LMWH.…”

Topically applied heparin in venous thrombosis, why not using it: A review of literature

“…In 2003, and 2005 two studies of the same design [11,12] concluded that LMWH is equally effective in comparison with topically applied heparin regarding the reduction of erythema, swelling and pain. Another study [13], compared LMWH with topically applied heparin in alleviating the above mentioned symptoms.…”