Angiol Sosud Khir. 2025 Mar 31;31(1):58-68. doi: 10.33029/1027-6661-2025-31-1-58-68.
ABSTRACT
Presented in the article are the results of an international, multicenter, randomized, doubleblind, two-stage, two-sequence cross-over comparative study of the efficacy and safety of arginine sodium succinate (Unifuzol®) and pentoxifylline in the form of intravenous infusions in patients with stage II PAD according to the classification of A.V. Pokrovsky.
OBJECTIVE: The study was planned to demonstrate superiority of treatment with arginine sodium succinate to pentoxifylline based on the absolute change in the maximum walking distance and pain-free walking distance on the day next to the end of the treatment compared to the baseline level.
PATIENTS AND METHODS: A total of 229 patients were randomized in a 1:1 ratio to each treatment sequence. The primary efficacy parameters were: absolute (in meters) and relative (in %) increase in maximal walking distance and pain-free walking distance in the treadmill test on the day next to completion of therapy with the study drugs compared with the baseline level.
RESULTS AND DISCUSSION: A comparative analysis revealed a significant difference in the increase of the maximum walking distance after a 12-day course of treatment with arginine sodium succinate and the comparative drug (29.4 and 19.6 m, respectively), with the absolute difference amounting to 9.8 m (95% CI 5.67-13.88). Thus, arginine sodium succinate turned out to be one and a half times more effective than pentoxifylline. The difference in pain-free walking distance, the average increase of which in the group treated with arginine sodium succinate was 23.9 m, and in the comparison group — 16.1 m, also showed higher efficacy of arginine sodium succinate.
CONCLUSION: According to the results of the analysis, for all parameters of effectiveness, a statistically significant superiority was shown in patients with stage II obliterating atherosclerosis of the vessels of the lower extremities treated with arginine sodium succinate compared to pentoxifylline.
PMID:41805668 | DOI:10.33029/1027-6661-2025-31-1-58-68
