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

• Yuriy V. Lukyanov
• German Yu. Sokurenko
• Andrey Yu. Petrov
• Alexey L. Kovalenko
• Vyacheslav V. Lukyanchikov
• Yuri P. Didenko
• Mikhail S. Bogomolov

Abstract

Presented in the article are the results of an international, multicenter, randomized, double-blind, 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.

Funding. The study was sponsored by the LLC “NTFF POLISAN”, Russia.

Conflict of interest. The authors have no conflicts of interest to declare.

Authors’ contribution. Study conception and design – Lukyanchikov V.V., Kovalenko A.L., Petrov A.Yu.; data collection and handling – Lukyanchikov V.V., Lukyanov Yu.V.; statistical processing – Lukyanchikov V.V.; draft manuscript preparation – Lukyanov Yu.V., Lukyanchikov V.V., Petrov A.Yu.; manuscript revision – Sokurenko G.Yu., Lukyanchikov V.V., Didenko Yu.P., Bogomolov M.S.

Acknowledgements. The authors would like to express their sincere thanks to the following employees of research centers participating in the study: MD, Professor I.A.Suchkov (Ryazan State Medical University of the RF Ministry of Health, Ryazan), F.Yu. Kopylov (First Moscow State Medical University named after I.M. Sechenov, Moscow), PhD in Medical Sciences A.S. Agafyina (“City Polyclinic № 40”, St. Petersburg), L.Ya. Odnopolozova (LLC “Alliance Biomedical – Ural Group”, Izhevsk), O.V. Orlikova (“Regional Clinical Cardiological Dispensary”, Saratov), D.V. Saenko (LLC “4D Ultrasound Clinic”, Pyatigorsk), A.T. Umbetzhanova (LLP “Medical Center of the Astana Medical University”, Astana, Kazakhstan), A.A. Seitkaliev (Republican State Enterprise “Medical Center Hospital” of the Administrative Directorate of the President of the Republic of Kazakhstan, Astana, Kazakhstan).

For citation: Lukyanov Yu.V., Sokurenko G.Yu., Petrov A.Yu., Kovalenko A.L., Lukyanchikov V.V., Didenko Yu.P., Bogomolov M.S. Efficacy of 1.4% solution for infusion arginine sodium succinate in patients with obliterating atherosclerosis of lower limbs (international clinical study). Angiology and Vascular Surgery. Journal named after Academician A.V. Pokrovsky. 2025; 31 (1): 58–68. DOI: https://doi.org/10.33029/1027-6661-2025-31-58-68

Keywords: arginine sodium succinate; Unifuzol; pentoxifylline; obliterating atherosclerosis of the vessels of the lower extremities; infusion therapy; maximum walking distance; endothelium