|کد مقاله||کد نشریه||سال انتشار||مقاله انگلیسی||ترجمه فارسی||نسخه تمام متن|
|5688611||1409930||2017||6 صفحه PDF||ندارد||دانلود رایگان|
ObjectiveTo examine the safety of collagenase clostridium histolyticum (CCH) in adult men with penile curvature deformity <30Â°. CCH is indicated for treatment of Peyronie disease in adult men with palpable plaque and a penile curvature deformity â¥30Â° at start of therapy; however, during treatment, patients may receive CCH injections when penile curvature deformity is <30Â°.Materials and MethodsPatients who received â¥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 â¥30Â° 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 â¥30Â° and penile curvature <30Â°.ResultsThe number of CCH treatment cycles included in the current analysis totaled 1204 and 289 cycles in patients with penile curvature deformity â¥30Â° and <30Â°, respectively. The incidence of most TRAEs was similar between groups. Rates of penile swelling (21.1% vs 14.5%, Pâ=â.007), penile hemorrhage (12.8% vs 8.9%; Pâ=â.046), and skin hyperpigmentation (1.0% vs 0.1%; Pâ=â.025) were significantly higher in the <30Â° group. The occurrence of serious TRAEs was similar between groups.ConclusionNo clinically meaningful differences were observed with TRAE rates when CCH injections were administered at penile curvature deformity â¥30Â° vs CCH injections at penile curvature deformity <30Â°. These findings highlight the safety of continued CCH injections for patients who have achieved penile curvature deformity <30Â° after an initial treatment cycle of CCH.
Journal: Urology - Volume 106, August 2017, Pages 237.e9-237.e14