SAFETY AND TOLERABILITY OF LOCAL TREATMENT WITH ILOPROST, A PROSTACYCLIN ANALOGUE, IN PATIENTS WITH PEYRONIE'S DISEASE. A PHASE I STUDY

Objective. To assess the possibility of intralesional therapy for the treatment ofPeyronie's disease, we have verified the safety and tolerability ofintralesional injections of Iloprost ( an I 2 Prostacyclin analogue) for itsproperty to suppress the production of CTFG in fibroblasts. CTFG is aconnective tissue growth factor that acts in concert with TGF-β to stimulatethe fibrotic process.Materials and methods. 38 patients with Peyronie’s disease were preliminarily evaluated byconsidering the symptoms, the degree of penile curvature, and the size ofthe plaque. Each patient received weekly intralesional injections of 200 ngof Iloprost in 1 ml normal saline for 5 weeks. If tolerated, the single dosewas increased weekly to the maximum of 400 ng (2ml). All patientstolerated well a Iloprost dose of 200 ng; 19 of them reached a 300 ng doseand 14 tolerated a 400 ng dose without showing side effects. There was noplacebo control group in this phase I study.Results. To evaluate the efficacy of the treatment, all the patients werepreliminarily evaluated by an at-home photography. Two months after theend of the treatment they were re-evaluated. Almost all patients showed mild side effects (burning or pain) during the treatment at the site ofinjection. 29% of the patients showed an improvement in curvature.Conclusion. According to the results, therapy with intralesional Iloprost (prostacyclindrug with antifibrotic properties) in Peyronie’s disease seems to be anencouraging alternative to surgery.