Efficacy of relaxin on functional recovery of post stroke patients.

BACKGROUND: Relaxin is a peptide hormone that exerts specific effects on cardiovascular system and human brain, leading to the hypothesis that this hormone may play a protective role against CVD and integration and modulation of behavioral activation. We aimed to demonstrate the efficacy of Relaxin on functional recovery of post-stroke patients. METHODS: Patients admitted within a Rehabilitation Unit suffering from stroke have been evaluated. Patients have been randomized to RLX (40 mcg/d) plus rehabilitation vs a control group that underwent only rehabilitation. A preliminary analysis of 36 patients at 20 and 40 days was made using the mRS for global function, the Functional Independent Measure (FIM) for daily activity and Trail Making Test (TMT) for cognitive function. RESULTS: Eighteen patients (age 72 (64-79), M 56%) randomized to RLX plus rehabilitation were compared to 18 patients (age 68 (64-78), M 50%) that underwent only rehabilitation. There was no difference between the two groups in terms of risk factors, stroke syndromes and etiology. At admission the two groups showed the same characteristics in terms of functional aspects (mRS, FIM; p ns) and cognitive function (TMT; p ns). After 20 days (T1) the treatment group (RLX+rehabilitation) showed no differences between the two groups (FIM 78 vs 69; p ns), while after 40 days (T2) patients treated with RLX+R showed an excellent recovery (FIM 96 vs 75; p0.001). In terms of cognitive function patients RLX+R revealed a better performance at T1 (TMT 3.5 vs 2; p 0.002) and still better at T2 (TMT 4 vs 2; p 0.001). These results have been confirmed in terms of global function both at T1 (mRS 2.5 vs 3; p0.001) and T2 (mRS 2 vs 3; p < 0.001). CONCLUSION: Relaxin showed in this analysis a positive effects on stroke patient's recovery, thus offering the broad therapeutic potential role of RLX as new drug in post-stroke patients.

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

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.