[Efficacy of 1.4% solution for infusion arginine sodium succinate in patients with obliterating atherosclerosis of lower limbs (international clinical study)].

Arginine sodium succinate produced a significantly greater increase in maximum walking distance compared to pentoxifylline after a 12-day treatment course.

• The absolute increase in maximum walking distance was 29.4 m for arginine sodium succinate versus 19.6 m for pentoxifylline.
• The absolute difference between treatments was 9.8 m (95% CI 5.67–13.88).
• Arginine sodium succinate was described as 'one and a half times more effective than pentoxifylline' based on this comparison.
• Treatment duration was 12 days of intravenous infusion for each study drug.

Arginine sodium succinate produced a greater increase in pain-free walking distance compared to pentoxifylline.

• The average increase in pain-free walking distance was 23.9 m in the arginine sodium succinate group versus 16.1 m in the pentoxifylline comparison group.
• The difference in pain-free walking distance also showed higher efficacy of arginine sodium succinate.
• Pain-free walking distance was measured via treadmill test on the day following completion of therapy compared to baseline.

For all parameters of effectiveness, arginine sodium succinate demonstrated statistically significant superiority over pentoxifylline in patients with stage II obliterating atherosclerosis of lower limb vessels.

• Primary efficacy parameters included absolute (in meters) and relative (in %) increases in maximal walking distance and pain-free walking distance.
• Assessments were made on the day following completion of therapy compared to baseline level.
• The study was specifically planned to demonstrate superiority of arginine sodium succinate over pentoxifylline based on absolute change in these walking distance measures.

The study was an international, multicenter, randomized, double-blind, two-stage, two-sequence cross-over trial enrolling 229 patients.

• A total of 229 patients were randomized in a 1:1 ratio to each treatment sequence.
• Patients had stage II peripheral arterial disease (PAD) according to the classification of A.V. Pokrovsky.
• The study compared arginine sodium succinate (Unifuzol) to pentoxifylline, both administered as intravenous infusions.
• The cross-over design used two stages and two sequences.