To examine the safety of collagenase clostridium histolyticum (CCH) in adult males with penile curvature deformity <30°. Collagenase clostridium histolyticum is indicated for treatment of Peyronie's disease (PD) in adult males with palpable plaque and a penile curvature deformity ≥30° at start of therapy; however, during treatment, patients may receive CCH injections when penile curvature deformity is <30°.
Patients who received ≥2 CCH treatment cycles in 2 phase 3 studies (IMPRESS I and II) were included. All patients had penile curvature ≥30° at the beginning of treatment and could receive up to 4 treatment cycles. The rate and number of treatment-related adverse events (TRAEs) with CCH treatment were compared between patients with penile curvature deformity ≥30° and penile curvature <30°.
The number of CCH treatment cycles included in the current analysis totaled 1204 and 289 cycles in patients with penile curvature deformity ≥30° and <30°, respectively. The incidence of most TRAEs was similar between groups. Rates of penile swelling (21.1% vs 14.5%, P=0.007), penile hemorrhage (12.8% vs 8.9%; P=0.046), and skin hyperpigmentation (1.0% vs 0.1%; P=0.025) were significantly higher in the <30° group. The occurrence of serious TRAEs was similar between groups.
No clinically meaningful differences were observed with TRAE rates when CCH injections were administered at penile curvature deformity ≥30° versus CCH injections at penile curvature deformity <30°. These findings highlight the safety of continued CCH injections for patients who have achieved penile curvature deformity <30° after an initial treatment cycle of CCH.
Urology. 2017 May 10 [Epub ahead of print]
Wayne J G Hellstrom, Ronny B W Tan, Genzhou Liu
Tulane University Health Sciences Center, New Orleans, LA, USA; Department of Urology, Tan Tock Seng Hospital, Singapore; Endo Pharmaceuticals Inc., Malvern, PA, USA. Electronic address: ., Tulane University Health Sciences Center, New Orleans, LA, USA; Department of Urology, Tan Tock Seng Hospital, Singapore; Endo Pharmaceuticals Inc., Malvern, PA, USA.