Efficacy and safety of oral porcine relaxin (pRLX) in adjunct to physical exercise in the treatment of peripheral arterial disease (PAD)

Abstract

Introduction: PAD medical therapy has a number of limitations. RLX showed promises in experimental model mainly through NO release. Our study is the first to evaluate the efficacy and safety of RLX in PAD.

Materials-methods: Eligible PAD La fontaine IIa-IIb patients were randomized in 2 groups. Group A was treated with physical therapy plus oral pRLX, 20 ug b.i.d for 12 weeks, group B received physical therapy alone. Pain Free Walking Distance (PFWD) and Maximum Walking Distance (MWD) at 3 and 12 wks and at follow up 3 months after treatment interruption were performed.

Results: The percentage increases of PFWD in group B were 23 +/- 9, 65 +/- 17, and 35 +/- 4 respectively at 3 and at 12 weeks, and 3 months after termination. In Group A showed significantly higher percentage increases: 74 +/- 16 p < 0.01, 168 +/- 28 p < 0.001, and 122 +/- 15 p < 0.001 at the corresponding time points. The percentage increases of MWD in the B group were 29 +/- 7, 55 +/- 10 and 54 +/- 8 at the above time points, while in the A group were 55 +/- 10 p < 0.001, and 99 +/- 12 p < 0.001. The RLX patients referred a better physical and mental status. No adverse events during or after the treatment were recorded.

Comment: RLX resulted very effective in PAD. Our results may suggest that the observed functional benefits should come not only from hemodynamic improvement but also from positive vascular remodeling.