Daily Tadalafil May Be Effective for Peyronie's Disease
In a study, men with Peyronie's disease who tadalafil 5 mg per day had decreased pain on erection and degree of penile curvature.
Daily tadalafil has the potential to be a treatment option for Peyronie's disease (PD), according to data presented at the Sexual Medicine Society of North America 18th Annual Fall Scientific Meeting in San Antonio, Texas.
In a small study of PD patients, treatment with the drug, a phosphodiesterase type 5 (PDE5) inhibitor that is FDA approved for treating erectile dysfunction, was associated with decreased pain on erection and degree of penile curvature and improved erectile function.
Hyun Jun Park, MD, PhD, and Nam Cheol Park, MD, PhD, from Pusan National University School of Medicine in Busan, Korea, divided 66 PD patients into 3 groups: Group 1, which included 20 patients treated with an intralesional injection of verapamil (IVI); group 2, which included 23 patients treated with tadalafil 5 mg once daily for 12 weeks; and group 3, which included 23 patients who received IVI and tadalafil 5 mg once daily for 12 weeks. Groups 1, 2, and 3 had means ages of 53.2, 56.1, and 55.3 years, respectively. At baseline, the groups had no significant differences in age, erectile function, or duration and characteristics of PD, according to the researchers.
Pain resolution was achieved in 55%, 70%, and 78.3% of groups 1, 2, and 3, respectively, after 12 weeks, the researchers reported in a poster presentation. The changes in the mean degree of penile curvature were -4.6, -6.2, and -7.2 degrees, respectively. The changes in mean plaque size were 0.2, 0.2, and 0.3 cm2. Further, groups 2 and 3 showed a greater increase in International Index of Erectile Function (IIEF)-Erectile Function domain score compared with group 1 (3.8 and 3.8 vs 0.4, respectively). Commonly reported adverse events (AEs) included hematoma at the injection site (4 cases), myalgia (3 cases), and dyspepsia, headache, and flushing (1 case each). No patient discontinued treatment due to AEs, the investigators reported.
The researchers said it has been speculated the PDE5 inhibitors may have an effect on PD by inhibiting tissue remodeling after acute injury and decreasing the oxidative stress responsible for inflammation and fibrosis.
The new study is not the first investigation to demonstrate the potential usefulness of tadalafil in treating PD. In a paper published in Urology Annals (2015;7:345-349) Lucio Dell'Atti, MD, of University Hospital S. Anna, Ferrara, Italy, reported that combined treatment with tadalafil and IVI was associated with better pain control and reduced penile curvature and improved erectile function than IVI or tadalafil alone. The study included 59 PD patients, who were divided into 3 groups. Group A had 23 patients treated with IVI, group B had 19 patients treated with tadalafil 5 mg once daily for 12 weeks, and group C had 17 patients treated with IVI and tadalafil 5 mg once daily for 12 weeks. At baseline, groups A, B, and C had mean IIEF-5 scores of 12.90, 12.51, and 11.58, respectively.
At 12 weeks, pain resolved completely in 57%, 61%, and 76% of groups A, B, and C, respectively. The final mean curvature degree decreased in all groups, with not significant difference among the groups. Mean plaque size did not decrease significantly in group A (1.57 vs 1.59 cm2 at baseline) and group B (1.51 vs 1.52 cm2 at baseline), but decreased significantly in group C (1.46 vs 1.58 cm2 at baseline). The mean IIEF-5 score improved significantly in group C compared with groups A and B (23.1 vs 14.4 and 18.2, respectively).
Park HJ, Park NC. Daily tadalafil therapy: A new treatment option for Peyronie's disease? Presented in poster format at the Sexual Medical Society of North American 18th Annual Fall Scientific Meeting in San Antonio, Texas. Poster 134.