A new low molecular weight heparin in the treatment of peripheral arterial disease.

A double blind study was conducted on patients afflicted with obstructive arteriopathy of the lower limbs in order to verify the efficacy and tolerability, in long term treatment, of a new low molecular weight heparin (Alfa LMW1). Of the 55 patients studied, 28 were treated with Alfa LMW1 given subcutaneously in doses of 8,000 I.U. AXa daily for 6 months; the remainder 27 were treated with Placebo. Efficacy of Alfa LMW1 was evaluated by monitoring the lower limb segmental pressures and some pressure ratios (thigh/arm, ankle/arm). Moreover, by means of the treadmill test, also checked were: time of claudication; ankle/arm pressure ratio before and after exercise and time required to return to initial pressure. By means of the strain gauge plethysmography, basal flow and peak flow after ischemia were also evaluated. The results obtained indicated a significant difference in efficacy between the two therapies, most notable after the third month. While in the Alfa LMW1 group a significant (p less than 0.01) and progressive improvement by the third month of treatment was seen, in the Placebo group a slight improvement was registered only at the end of the study and this was significantly inferior with respect to the comparison group.

RCT Entities:   Population Interventions Outcomes