[Heparan sulfate in the therapy of postphlebitic syndrome. Evaluation of the efficacy and tolerability as compared to mesoglycan].
BACKGROUND
Antithrombotics and profibrinolytics are indicated in several clinical thrombophilic conditions such as postphlebitic syndrome. Heparansulphate, a glycosaminoglycan, shows an antithrombotic activity with low anticoagulant effect. The aim of the study was to evaluate the efficacy and the safety of heparansulphate (100 mg b.i.d.) versus mesoglycan (50 mg b.i.d.), both administered for three months in patients with postphlebitic syndrome.


METHODS
The trial was performed in an open-label, controlled, with parallel and randomized groups, design. Thirty patients, with chronic venous insufficiency and a history of venous thrombosis were enrolled. Coagulative and fibrinolytic parameters (PT, aPTT, euglobulin lysis time, fibrinogen, D-dimer, t-PA, PAI-1) and signs and symptoms (cramps, paresthesia, itch, edema, local pain, skin trophism) were assessed at enrollment, 15 days later after the pharmacological washout period and after 1, 2, 3 months of treatment. Safety was evaluated by monitoring any adverse event during the study and performing clinical laboratory tests at the beginning and at the end of treatment.


RESULTS
The two drugs showed a superimposable efficacy and very good tolerability. Coagulative and fibrinolytic parameters were positively affected by both treatments and the clinical benefit was particularly evident in the heparansulphate group with a significant decrease "between times" of local pain, edema, paresthesia and itching.


CONCLUSIONS
These data support the use of heparansulphate, and in general of glycosaminoglycans, in the postflebitic syndrome.
Giorgetti
P L
PL
IRCCS Ospedale Maggiore, Università degli Studi, Milano.
Marenghi
M C
MC
Bianciardi
P
P
D004341:Drug Evaluation; D004361:Drug Tolerance; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006025:Glycosaminoglycans / Q000627:therapeutic use*; D019812:Heparan Sulfate Proteoglycans / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011186:Postphlebitic Syndrome / Q000188:drug therapy*; D013923:Thromboembolism / Q000517:prevention & control*
D005343:Fibrinolytic Agents; D006025:Glycosaminoglycans; D019812:Heparan Sulfate Proteoglycans; C040617:mesoglycan