Potaba™
Potaba™ (potassium paraaminobenzoate) may exert its effects through antiinflammatory and antifibrotic mechanisms. Several observational studies have demonstrated its effectiveness in treating PD. In the lone clinical trial conducted, men randomized to the Potaba™ arm, all of whom had early-stage PD, had a greater reduction in plaque size. Despite the limited data, Potaba™ holds promise in terms of stabilizing preexisting lesions and preventing new plaques from forming; however, frequent dosing, significant gastrointestinal side effects and its relatively high cost limit its use.
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Pentoxifylline
Pentoxifylline is a nonspecific PDE-5 inhibitor with anti-inflammatory properties used to treat claudication and symptomatic cerebral atherosclerosis, kidney transplants, open heart surgery, dermatologic conditions, and radiation-induced fibrosis as a means of decreasing inflammation and fibrosis. The potential benefit of pentoxifylline for the treatment of PD is based upon data from in vitro and in vivo models. Pentoxifylline added to fibroblast culture resulted in an upregulation of cAMP and decreased collagen I production. These researchers also demonstrated decreased levels of profibrotic factors and decreased size of fibrotic plaques after the treatment with pentoxifylline in a rat model of Peyronie’s disease. Additional in vitro evidence revealed an upregulation of osteoclastic activity after the treatment with pentoxifylline.
From a clinical standpoint, case reports suggest that pentoxifylline may prevent corporal fibrosis after priapism and decrease calcifications in new-onset Peyronie’s disease. The reduction in tunica albuginea calcifications may derive from pentoxifylline’s ability to promote osteoclastic activity. In general, side effects are mild and consist of nausea (14%), dizziness (9%), and headache (3.5%). Despite the potential for benefit based upon its mechanism of action and early clinical data, higher quality data is needed to support the use of pentoxifylline for the routine treatment of PD.
Vitamin E
Although numerous in vitro studies have demonstrated the potent antioxidant properties of Vitamin E (alpha-tocopherol), these properties may not translate into improved clinical outcomes for men with PD. Several randomized studies have shown no benefit; however, when vitamin E was combined with colchicine, a single-blind, small randomized controlled trial in men with mild, early PD demonstrated significantly decreased plaque size in the intervention arm. Despite this lack of efficacy, vitamin E is often prescribed because of its ease of use and the perception of few side effects. Unfortunately, a growing body of literature suggests a possible link between chronic, high dose vitamin E ingestion and significant side effects such as increased heart failure, blood pressure, and all-cause mortality; however, these findings were confined to patients being treated for chronic medical conditions, such as diabetes, cardiovascular disease, and hypertension.
Tamoxifen
Tamoxifen, a nonsteroidal antiestrogen, may reduce the production of TGF-b by fibroblasts in the tunica albuginea. Observational studies have demonstrated modest treatment benefits. One clinical trial revealed no significant difference between tamoxifen and placebo, while another found that tamoxifen was inferior to l-carnitine in terms of reducing penile curvature and pain, and plaque size during the early stage of PD.
Colchicine
Colchicine is often used for the treatment of gout and a variety of malignancies and has been used for the treatment of PD because of its anti-inflammatory properties. One randomized study has shown decreased plaque size in the acute phase of PD; however, these findings could not be repeated in a subsequent, larger clinical trial. Because of the potential for significant bone marrow suppression, a complete blood count should be obtained quarterly. More commonly, gastrointestinal side effects (i.e., diarrhea, nausea, and anorexia) are reported.