[Clinical study of Unifuzol® in patients with intermittent claudication]

Presented herein are the results of a multicenter double-blind placebo-controlled randomized clinical trial of the safety and efficacy of 'Unifuzol®' (arginine sodium succinate, 1.4% solution for infusion) in 40-to-65-year-old patients with obliterating atherosclerosis of lower limb arteries stage II A according to the classification of A.V. Pokrovsky.

This study was undertaken to investigate the efficacy and safety of Unifuzol® at a daily dose of 500 ml during 1 course of 10 days and during 2 courses of 10 days each with an interval of 14 days between them.

The study included a total of 460 patients randomized in a 1:1:1:1 ratio into each treatment group. The primary efficacy parameters were as follows: absolute (in meters) and relative (in %) gain in the pain-free walking distance and maximal walking distance in the treadmill test compared with the baseline measures (the mean value of 2 treadmill tests performed at the screening visit).

After the 10-day course of therapy, the comparative between-group analysis demonstrated the most pronounced difference for the maximal walking distance measure, which averaged 25 meters (95% CI, p=0.036) 30 days after completion of therapy. The 20-day therapy cohort showed a difference in the pain-free walking distance, amounting to 23 meters immediately after completion of the 2nd course of therapy and 29 meters 30 days after completion of therapy (p=0.039 and p=0.01, respectively). Analyzing the significance of intergroup differences for each efficacy variable, the change in the pain-free walking distance was 10 (4%) meters immediately upon completion of the course and 17.8 (8.3%) meters 30 days after completion of therapy, and the change in the maximum walking distance was 13 meters and 22 meters in absolute terms and 4% and 7.6% in relative terms, respectively.

The obtained findings confirmed efficacy of infusion therapy with Unifuzol® in patients with stage II A obliterating atherosclerosis of lower limb arteries in course administration during both 10 and 20 days (10 and 20 infusions, respectively).