Sulodexide: implicazioni cliniche ed economiche

Abstract

INTRODUZIONESulodexide è un farmaco antitrombotico eparinico costituito da una miscela di glicosaminoglicani (GAGs) estratti da mucosa intestinale suina, costituita da una frazione eparinica a medio peso molecolare e da dermatan solfato (DS), un glicosaminoglicano chimicamente distinto dall'eparina e derivati per la presenza di galattosamina.Scopo di questo lavoro è delineare un profilo farmacologico clinico e farmacoeconomico del farmaco, analizzando in modo particolare la sua efficacia nel trattamento di pazienti affetti da forme croniche di Insufficienza Venosa (ulcere venose croniche), nella prevenzione delle recidive di trombosi venosa profonda e nella cura dell'arteriopatia ostruttiva periferica. Sulodexide: implicazioni cliniche ed economicheOrietta Zaniolo*, Mario Eandi § ABSTRACTSulodexide is a highly purified glycosaminoglycan approved for leg ulcers treatment. It contains two principal components: heparan sulfate, a fast-moving heparin fraction, (80%) and dermatan sulfate (20%). Sulodexide is available as an oral agent and as an injectable preparation. Its pharmacological action is obtained by dose-dependent coagulation factors inhibition: dermatan sulfate upgrades the physiological action of a selective thrombin inhibitor, heparin cofactor II, and heparan sulfate depresses activated factor X, via an increase of antithrombin III action. The antithrombotic action is enhanced by platelet aggregation inhibition and by the activation of the fibrinolytic system. This paper summarizes the results of some of the main trials that evaluated sulodexide in the treatment of peripheral occlusive arterial disease and venous leg ulcers; a trial on prevention of recurrent deep venous thrombosis with sulodexide is also reviewed. We analyzed data about the clinical and economical impact of chronic venous insufficiency with a particular attention to the cost of medication, hospitalization and management of leg ulcers. The hypothetical savings correlated to the reduction of leg ulcers incidence and healing time attainable with sulodexide have been estimated. A comparison between the different acquisition costs of the drugs frequently used to treat leg ulcers is also provided.Finally we reviewed some quality of life trials in which the psychological and sociological influence of the disease and its treatments on the patient are assessed. Keywords FARMACOLOGIA FarmacodinamicaIn caso di lesione della parete di un vaso le cellule endoteliali espongono il tessuto connettivo sottoendoteliale altamente trombogenico, al quale le piastrine aderiscono entrando in uno stato di "attivazione" che induce in loro un cambiamento morfologico-strutturale e una reazione di esocitosi.I fattori che si liberano dai granuli piastrinici (ADP, TXA 2 , serotonina e altri) stimolano il meccanismo di auto-amplificazione della risposta piastrinica così da formare il tappo piastrinico. Tale reazione avviene entro pochi minuti dalla lesione e, insieme alla vasocostrizione, costituisce la cosiddetta emostasi primaria.

Effects of sulodexide on stability of sclerosing foams

“…14 SUL is a known mixture of GAGs, which is already used clinically for vascular treatments. 22 It has specific pharmacological features, and the anticoagulant ability is one of them. SUL, in fact, interferes with the mechanisms that control the platelet aggregation and, therefore, the coagulation of the corpuscle components in the circulating blood.…”

“…SUL is a vasoactive substance with antithrombotic activity that is related to the ability of inhibiting some coagulative factors during the process of hemostasis at the site of a vascular injury. 22 This drug performs, therefore, a protection activity of the vascular microcirculation without significant hemorrhagic risks, and it is used for the treatment of vascular conditions including venous ulcers. 23,24 SUL has reported to be safe and well tolerated when injected intravenously.…”