Combining two widely prescribed drug classes, phosphodiesterase type 5 (PDE5) inhibitors like sildenafil (Viagra) and tadalafil (Cialis), with selective estrogen receptor modulators (SERMs) such as tamoxifen, may provide the first effective treatment for early-stage Peyronie's disease according to a new study published in The Journal of Sexual Medicine. Peyronie's disease is caused by fibrotic scar tissue within the penis leading to pain, curvature, sexual dysfunction and psychological distress affecting an estimated 10% of men during their lifetime.
The clinical study conducted by Anglia Ruskin University (ARU) and University College London Hospital (UCLH), evaluated outcomes in 133 men diagnosed with acute Peyronie's disease who were treated with the drug combination for three months. Their results were compared to a smaller group of patients receiving standard care, which included vitamin E or no treatment at all.
The study found that 43% of patients on the combination experienced an improvement in penile curvature, almost three times higher than in the standard-care group (15%). At the start of treatment, 65% of patients in the combination group reported pain during erections. After three months, this figure had fallen to just 1.5%. By comparison, pain prevalence in the standard-care group fell from 50% to 27%.
The clinical findings build on earlier laboratory work led by Professor Selim Cellek at ARU's Fibrosis Research Group. Over several years, his team screened FDA-approved drugs and identified compounds capable of blocking the transformation of fibroblasts into myofibroblasts, responsible for fibrosis.
Professor Cellek stated, "Positive findings from this pilot clinical study validate our drug-screening approach in the lab. It shows how repurposing well-known medicines can accelerate progress in areas of unmet clinical need." He because both PDE5 inhibitors and SERMs are already widely used in clinical practice with established safety profiles, the approach could be readily adoptable if confirmed in larger studies.
Professor David Ralph from UCLH noted, "This paper confirms the basic science research with regards to halting the progression of Peyronie's disease. In previous papers we have tamoxifen and PDE5 inhibitors inhibit the transformation of fibroblasts into myofibroblasts and therefore contraction of the plaque."
These results suggest early intervention targeting fibrosis could change how we treat Peyronie's disease, moving from managing symptoms to modifying the disease itself. The study highlights the potential for repurposing existing drugs to address unmet clinical needs in treating this condition.