title: Effects of Tadalafil Once-Daily or On-Demand vs Placebo on Return to Baseline Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy--Results from a Randomized Controlled Trial (REACTT).
abstract: OBJECTIVE
  The multicenter, randomized, double-blind, double-dummy, placebo-controlled REACTT trial suggested that treatment with tadalafil once daily (OaD) started early after bilateral nerve-sparing radical prostatectomy (nsRP) for prostate cancer may contribute to erectile function (EF)-recovery, which was predefined as achieving an International Index of Erectile Function (IIEF)-EF score ≥22. Here, we report descriptive post-hoc analyses, using the more strict definition for EF-recovery of returning back to the pre-surgery IIEF-EF-level ("back-to-baseline analysis").
  
  
  METHODS
  REACTT included 422 men <68 years with adenocarcinoma of the prostate and preoperative IIEF-EF ≥22 who underwent nsRP at 50 centers from 9 European countries and Canada. Patients were randomized post-nsRP 1:1:1 to 9-month double-blind treatment (DBT) with tadalafil 5 mg OaD (n = 139), tadalafil 20 mg on-demand (pro-re-nata, PRN; n = 142), or placebo (n = 141), followed by 6-week drug-free washout (DFW) and 3-month open-label tadalafil OaD treatment (OLT).
  
  
  METHODS
  Proportion of patients returning to their preoperative IIEF-EF category (22-25 or ≥26) at the end of DBT, DFW, and OLT.
  
  
  RESULTS
  Overall, 92.4% of patients had pre-surgery (baseline) IIEF-EF scores ≥26 (tadalafil OaD 94.2%, PRN 91.6%, placebo 91.5%), 7.4% had IIEF-EF 22-25. At the end of DBT, 22.3% of patients on tadalafil OaD had achieved "back-to-baseline" IIEF-EF, compared with 11.3% on tadalafil PRN and 7.8% on placebo. Of all 58 patients "back-to-baseline" at the end of DBT, only 1 PRN-group patient had started from a baseline IIEF-EF <26. The treatment-group difference at the end of DBT was not maintained after DFW. After 3 months of OLT with tadalafil OaD, the proportion of patients with "back-to-baseline" IIEF-EF had almost doubled in all 3 groups.
  
  
  CONCLUSIONS
  Changing the definition for EF-recovery from IIEF-EF ≥22 to the more strict definition of "returning back-to-baseline IIEF-EF" had no major impact. Tadalafil OaD started early after nsRP improved drug-assisted EF, but had no effect on unassisted EF following treatment cessation after 9 months.
authors.affiliation: Department of Urology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: John P
authors.initials: JP
authors.lastname: Mulhall
authors.affiliation: Division of Urology, Department of Surgery, University of Western Ontario, London, Ontario, Canada. Electronic address: gebrock@sympatico.ca.
authors.forename: Gerald
authors.initials: G
authors.lastname: Brock
authors.affiliation: Department of Urology and Urological Oncology, Hannover Medical School, Hannover, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Oelke
authors.affiliation: Department of Urology, Herlev and Gentofte Hospital, Herlev, Denmark.
authors.forename: Mikkel
authors.initials: M
authors.lastname: Fode
authors.affiliation: Department of Urology, Saarland University Medical Center, Homburg, Saar, Germany.
authors.forename: Kai A
authors.initials: KA
authors.lastname: Probst
authors.affiliation: Global Statistical Sciences, EU Statistics, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Henneges
authors.affiliation: Medical Department, Eli Lilly S.p.A., Florence, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: d'Anzeo
authors.affiliation: Medical Department, Eli Lilly S.p.A., Florence, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Rossi
authors.affiliation: Biomedicines BU, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Hartwig
authors.initials: H
authors.lastname: Büttner
mesh_terms: D000368:Aged; D002170:Canada / Q000453:epidemiology; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D005060:Europe / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D059351:Organ Sparing Treatments / Q000379:methods*; D010410:Penile Erection / Q000187:drug effects*; D010413:Penis / Q000294:innervation / Q000502:physiology; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage*; D011468:Prostatectomy / Q000009:adverse effects / Q000379:methods*; D011471:Prostatic Neoplasms / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D020127:Recovery of Function; D000068581:Tadalafil / Q000008:administration & dosage*
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil
keywords: Back to Baseline; Erectile Dysfunction; IIEF-EF; PDE5 Inhibitor; Prostate Cancer; REACTT; Radical Prostatectomy; Tadalafil