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

UNLABELLED: 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.