Urology · 2017
Safety Profile of Collagenase Clostridium Histolyticum Stratified by Degree of Penile Curvature in Patients With Peyronie Disease.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Hellstrom Wayne J G, Tan Ronny B W, Liu Genzhou
Аннотация
OBJECTIVE: To examine the safety of collagenase clostridium histolyticum (CCH) in adult men with penile curvature deformity <30°. CCH is indicated for treatment of Peyronie disease in adult men 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°.
MATERIALS AND METHODS: Patients who received ≥2 CCH treatment cycles in 2 phase 3 studies (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies 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°.
RESULTS: 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 = .007), penile hemorrhage (12.8% vs 8.9%; P = .046), and skin hyperpigmentation (1.0% vs 0.1%; P = .025) were significantly higher in the <30° group. The occurrence of serious TRAEs was similar between groups.
CONCLUSION: No clinically meaningful differences were observed with TRAE rates when CCH injections were administered at penile curvature deformity ≥30° vs 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.
MATERIALS AND METHODS: Patients who received ≥2 CCH treatment cycles in 2 phase 3 studies (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies 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°.
RESULTS: 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 = .007), penile hemorrhage (12.8% vs 8.9%; P = .046), and skin hyperpigmentation (1.0% vs 0.1%; P = .025) were significantly higher in the <30° group. The occurrence of serious TRAEs was similar between groups.
CONCLUSION: No clinically meaningful differences were observed with TRAE rates when CCH injections were administered at penile curvature deformity ≥30° vs 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.