Effects of tadalafil once daily or on demand versus placebo on time to recovery of erectile function in patients after bilateral nerve-sparing radical prostatectomy

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• 作者：Ignacio Moncada ; Fermín R. de Bethencourt ; Enrique Lledó-García…
• 关键词：Nerve ; sparing prostatectomy ; Penile function ; Phosphodiesterase 5 inhibitors ; Prostate cancer ; Rehabilitation ; Tadalafil once a day
• 刊名：World Journal of Urology
• 出版年：2015
• 出版时间：July 2015
• 年：2015
• 卷：33
• 期：7
• 页码：1031-1038
• 全文大小：557 KB
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  8.Montorsi F, Nathan PH, McCullough A et al (2004) Tadalafil in the treatment of erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy: a randomized, double-blind, placebo controlled trial. J Urol 172:1036-041PubMed View Article
  9.Hatzimouratidis K, Burnett AL, Hatzichristou D, McCullough AR, Montorsi F, Mulhall JP (2009) Phosphodiesterase type 5 inhibitors in postprostatectomy erectile dysfunction: a critical analysis of the basic science rationale and clinical application. Eur Urol 55:334-47PubMed View Article
  10.Nathan PH, McCullough AR, Levine LA et al (2008) Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy. Int J Impot Res 20:479-86View Article
  11.Montorsi F, Brock G, Lee J et al (2008) Effect of nightly versus on demand vardenafil on recovery of erectile function in men following bilateral nervesparing radical prostatectomy. Eur Urol 54:924-31PubMed View Article
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  14.Seo YE, Kim SD, Kim TH, Sung GT (2014) The efficacy and safety of tadalafil 5 mg once daily in the treatment of erectile dysfunction after robot-assisted laparoscopic radical prostatectomy: 1-year follow-up. Korean J Urol 55:112-19PubMed Central PubMed View Article
  15.Montorsi F, Brock G, Stolzenburg JU et al (2014) Effects of tadalafil treatment on erectile function recovery post bilateral nerve-sparing radical prostatectomy: a randomized placebo-controlled study. Eur Urol 65:587-96PubMed View Article
  16.Mulhall JP, Goldstein I, Bushmakin AG et al (2007) Validation of the erection hardness score. J Sex Med 4:1626-634PubMed View Article
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• 作者单位：Ignacio Moncada (1)
  Fermín R. de Bethencourt (2)
  Enrique Lledó-García (3)
  Javier Romero-Otero (4)
  Carmen Turbi (5)
  Hartwig Büttner (6)
  Carsten Henneges (6)
  Juan I. Martinez Salamanca (7)
  
  1. Department of Urology, Hospital La Zarzuela, Madrid, Spain
  2. Department of Urology, Hospital “La Paz- Madrid, Spain
  3. Departament of Urology, Hospital General Universitario Gregorio Mara?ón, Madrid, Spain
  4. Department of Urology, Hospital Universitario 12 Octubre, Madrid, Spain
  5. Eli Lilly and Company, Madrid, Spain
  6. Lilly Deutschland GmbH, Bad Homburg, Germany
  7. Department of Urology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Urology and Andrology
  Nephrology
  Oncology
  
• 出版者：Springer Berlin / Heidelberg
• ISSN：1433-8726

文摘

Purpose We report time to erectile function (EF)-recovery data from a multicenter, randomized, double-blind, double-dummy, placebo-controlled trial evaluating tadalafil started after bilateral nerve-sparing radical prostatectomy (nsRP). Methods Patients ?8?years were randomized post-nsRP 1:1:1 to 9-month double-blind treatment (DBT) with tadalafil 5?mg once daily (OaD), 20?mg tadalafil on demand (“pro-re-nata- PRN), or placebo, followed by 6-week drug-free washout (DFW) and 3-month open-label OaD treatment. Secondary outcome measures included Kaplan–Meier estimates of time to EF-recovery (IIEF-EF?≥?2) during DBT (Cox proportional hazard model adjusting for treatment, age, and country). Results A total of 423 patients were randomized to tadalafil OaD (N?=?139), PRN (N?=?143), and placebo (N?=?141); 114/122/155 completed DBT. The proportion of patients achieving IIEF-EF ?2 at some point during DBT with OaD, PRN, and placebo was 29.5, 23.9, and 18.4?%, respectively. DBT was too short to achieve EF-recovery (IIEF-EF?≥?2) in >50?% of patients; median time to EF-recovery was non-estimable. Time for 25?% of patients to achieve EF-recovery (95?% CI) was 5.8 (4.9, 9.2) months for OaD versus 9.0 (5.5, 9.2) and 9.3 (9.0, 9.9)?months for PRN and placebo, respectively. Showing a significant overall treatment effect (p?=?0.038), the probability for EF-recovery was significantly higher for OaD versus placebo [hazard ratio (HR); 95?% CI 1.9; 1.2, 3.1; p?=?0.011], but not for PRN versus placebo (p?=?0.140). Of 57 OaD patients (41.0?%) with ED improved (by ? IIEF-EF severity grade) at the end of DBT, 16 (28.1?% of 57) maintained this improvement through DFW and 27 (47.4?%) declined but maintained improvement from baseline after DFW. Conclusions Data suggest that the use of tadalafil OaD can significantly shorten the time to EF-recovery post-nsRP compared with placebo.