Effectiveness of mesoglycan in patients with previous deep venous thrombosis and chronic venous insufficiency.
OBJECTIVE
Retrospective analysis of mesoglycan therapeutic activity in venous disorders. The clinical data have been selected from the outpatient database of the Chair of Angiology of the University of Catania (from 1988 to 1997) through a cross survey between the prescription commercial name of mesoglycan and the key words varicose veins, deep venous thrombosis (DVT), chronic venous insufficiency (CVI), post-thrombotic syndrome (PTS), venous thrombosis, venous ulcer.


METHODS
Patients have been selected on the basis of definite data relative to principal diagnosis, clinical history, clinical and instrumental objective phlebological picture, posology and duration of treatment, follow-up visits in the first three years following the first observation. Group 1: 56 patients with first episode DVT; Group 2: 27 patients with recurrent DVT; Group 3: 182 patients with CVI (107 with primitive CVI and 75 with secondary CVI). The selected patients data have been included in new databases. DVT patients were evaluated for recurrence prevalence during the follow-up period (6, 12, 18, 24, 30 and 36 months). In Group 2 the recurrence prevalence in the normal follow-up period was evaluated and, in addition, the clinical chronology of the recurrence previous to observation was drawn, in order to find out the recurrence prevalence of the thrombotic episode preceding our observation. The two prevalence trends ( mesoglycan treatment and episode preceding our observation) have been compared with the Student t test. CVI patients (Group 3) were classified according to CEAP classification criteria. The effectiveness of treatment was assessed according to the changes in the scores of venous dysfunction of CEAP classification (disability score; pain; oedema; skin color change; cutaneous ulcer). The mean and standard deviation of the considered scores have been evaluated with the Student t test comparing each series with the immediately previous series and with the T0 series. The mean dose of mesoglycan was 50 mg twice per day.


RESULTS
Group 1 (1(st) episode DVT): the recurrence prevalence was 3.5% at 6 months, 9% at 12 months, 12.5% at 18 months, 14.28% at 24, 30 and 36 months. At the end of the 3 follow-up years the PTS diagnosis could be performed in 10 patients (17.85%). Group 2 (recurrent DVT): the recurrence prevalence was 3.7% at 6 months, 11.11% at 12 months, 14.81% at 24 months, 18.51% at 36 months during mesoglycan treatment. In the preceding period the prevalence was 11.11% at 6 months from the preceding episode, 16.66% at 12 months, 33.33% at 24 months and 37.03% at 36 months. In the remaining 62.96% the recurrence occurred at 36 and 48 months. The comparison between the two series showed a significant difference with P < 0.0004. PTS prevalence at the end of the 3 follow-up years was 17.85% in patients with a first episode of DVT and 81.41% in patients with recurrent DVT. Group 3 (CVI): all the venous dysfunction scores showed a significant improvement during the follow-up period, both in comparison with the beginning of treatment and with the immediately preceding control visit.


CONCLUSIONS
The results obtained in groups 1 and 2 show that mesoglycan is effective in preventing thrombotic recurrence in patients with previous DVT. The recurrence prevalence in patients with DVT at 1(st) episode was lower than the prevalence reported by the literature data (17.5% within 2 years and 24.6% within 5 years). The positive trend was also confirmed in the recurrent DVT group, although with a major prevalence (18.51%) due to a higher thrombotic risk. However, the prevalence in the treatment period is significantly lower than the previous thrombotic episode. Mesoglycan was also effective in CVI patients, with a progressive and significant improvement of disability, pain and edema, which are the pathophysiologic elements responsible for the impairment of quality of life. At the various follow-up points the mean score value significantly reduced compared to T0 and to the values of the preceding control. In conclusion mesoglycan is a useful and effective medication in the treatment of venous disorders, both in the subacute phase of DVT and in the long-term therapy for CVI, and is worth more extensive documentation, in accordance with the criteria of evidence-based medicine.
Andreozzi
G M
GM
Angiology Care Unit, University Hospital of Padua, Padua, Italy. gm.andreozzi@angio-pd.it
D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006025:Glycosaminoglycans / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010045:Outpatients; D018579:Patient Selection; D011186:Postphlebitic Syndrome / Q000188:drug therapy; D012008:Recurrence; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000188:drug therapy*; D014689:Venous Insufficiency / Q000188:drug therapy*; D020246:Venous Thrombosis / Q000188:drug therapy*
D006025:Glycosaminoglycans; C040617:mesoglycan