[Effectiveness of mesoglycan therapy in patients with ischemia of the lower limbs. Preliminary results of a new therapeutic protocol].

Background: Mesoglycan is a natural glycosaminoglycans preparation, with antithrombotic and pro-fibrinolytic activities, which has been shown to be clinically effective in a number of vascular atherosclerotic disorders with thrombotic risk.

Methods: In the present investigation we studied the effect of mesoglycan in patients with acute episodes of relative lower limb ischemia (Stage IIb according to Leriche-Fontaine classification) coming to our observation. Mesoglycan was administered according to the following schedule: a 10-days period of endovenous mesoglycan (90 mg/day), given in day-hospital regimen, followed by a 20-days period of oral mesoglycan (100 mg/day). The treatment schedule was repeated for two months and then patient continued with oral mesoglycan. We present the preliminary results obtained on 36 patients which were followed for a mean period of 12 months.

Results: From February 1995 thirty-six patients, 24 males and 12 females, aged between 45 and 83 years (mean +/- SD: 69.8 +/- 7.5) coming to our observation for acute relative lower limb ischemia were enrolled. At baseline, the diagnosis was Fontaine's IIb stage (walking distance < or = 200 m) in all patients, 17 patients presenting walking distance < 100 m. After 3 and 6 months of mesoglycan treatment a significant improvement of symptoms and signs was observed in all patients but one. At the end of the 6-months period, 29 patients (81% of the study population) became to a Fontaine's IIa degree, with a significant increase in walking distance (in 70% three times their basal value) and improvement of symptoms and recovery time. After treatment, Winsor Index was not significantly modified. Similar results were obtained after 12 months of follow-up. During the study period only one patient included in the trial needed surgical revascularisation. The administration of mesoglycan was well tolerated, with only minor complaints in two patients (one case of headache and one of diarrhea). During the endovenous administration of mesoglycan most patients (81%) presented values of aPTT almost double than baseline, which returned to normal values at the end of the administration.

Conclusions: The present preliminary results show that, in patients with acute episodes of relative lower limb ischemia, mesoglycan (administered according to the described protocol) is an effective and safe agent able to improve symptoms (walking distance, pain, leg appearance) and to possibly delay the need of surgical interventions.