Prostatic therapeutic efficacy of LENILUTS®, a novel and multi-2 active principles formulation

Lower Urinary Tract Symptoms (LUTs) in men are usually associated to benign prostatic 12 hyperplasia (BPH), a non-malignant prostate enlargement. Unfortunately, BPH etiology is still un-13 clear. Recent works highlighted a relevant inflammation role in BPH onset and development. Con-14 sequently, to complement the 5-α reductase (and α-adrenergic receptor agonists-based therapy, an 15 anti-inflammatory therapy should be devised. To reduce multi-drug treatment potential adverse 16 effects, plant extracts-based therapies are becoming increasingly common. Serenoa repens, the main 17 phytotherapic treatment for BPH, is not sufficient to front the multi-faceted BPH etiology. In re-18 sponse to that, a novel, multiple phytotherapic agents-based formulation, LENILUTS®, was devel-19 oped. In the present work, we compared, with an in vitro approach, the prostatic safety and efficacy 20 of LENILUTS® with a commercial formulation, based only on Serenoa repens, and a 5αR inhibitor, 21 Dutasteride. Furthermore, preliminary in vitro experiments to investigate LENILUTS® active prin-22 ciples bioaccessibility and bioavailability were performed. Our results showed a better prostatic 23 safety and therapeutic efficacy of LENILUTS®, compared to the commercial formulation and Dutas-24 teride, with an increased anti-inflammatory, and pro-apoptotic activity, and a stronger inhibitory 25 effect on the key enzyme 5αR and Prostatic-Specific Antigen (PSA) release. Limited bioaccessibility 26 and bioavailability of LENILUTS® active principles were highlighted. Considering the obtained re-27 sults, LENILUTS® formulation is more promising for BPH and LUTs therapy compared to Serenoa 28 repens only-based formulations, but further efforts should be devised to improve active principles 29 bioaccessibility and bioavailability.