title: Continuation and effectiveness of tadalafil once daily during a 6-month observational study in erectile dysfunction: the EDATE study.
abstract: OBJECTIVE
  This was the first observational study evaluating treatment continuation, effectiveness and tolerability of tadalafil 5 mg once daily (TAD-OaD) in patients who chose and paid for treatment of erectile dysfunction (ED) in routine clinical practice.
  
  
  METHODS
  Men ≥ 18 years with ED, treated previously with phosphodiesterase type 5 (PDE5)-inhibitor on-demand (PRN) or treatment-naïve, were enrolled at 59 sites. For patients prescribed TAD-OaD at baseline (T1), change in erectile function (IIEF-EF and GAQ) was documented after 1-3 (T2) and 4-6 (T3) months. The primary outcome was the probability to switch/discontinue from TAD-OaD, estimated by Kaplan-Meier (KM) product-limit method. Changes in IIEF-EF were evaluated using a mixed model for repeated measures adjusting for patient baseline characteristics.
  
  
  RESULTS
  Of 975 men enrolled (median age 56.8 years, 33.7% with previous PDE5-inhibitor use), 778 were prescribed TAD-OaD, 135 TAD-PRN and 62 sildenafil or vardenafil PRN. During the 6-month longitudinal observation, 107 patients (13.8% of 778) switched or discontinued TAD-OaD-treatment. KM-rates (95%CI) for continuing TAD-OaD at 2, 4 and 6 months were 94.0% (92.3, 95.7), 88.3% (85.9, 90.6) and 86.3% (83.7, 88.9), respectively. The 25th percentile of time to switch/discontinuation of TAD-OaD was estimated as 31.1 weeks (lower 95%CI 30.3 weeks). At T3, IIEF-EF scores had increased by 7.1 (LSmean; 95%CI 5.8, 8.5) points; 91.3% of patients reported improved erections. The most frequently reported AE was headache (10 patients; 1.3%); no new/unexpected safety signals were observed.
  
  
  CONCLUSIONS
  Under routine conditions, and when patients were involved in treatment decision-making, more than 86% of men starting/switching to tadalafil once daily (OaD) at baseline continued tadalafil OaD treatment for ≥ 6 months.
authors.affiliation: Centre d'Etude et de Traitement de la Pathologie de l'Appareil Reproducteur et de la Psychosomatique (ETPARP), Lille, France.
authors.forename: J
authors.initials: J
authors.lastname: Buvat
authors.forename: D
authors.initials: D
authors.lastname: Hatzichristou
authors.forename: F G
authors.initials: FG
authors.lastname: Boess
authors.forename: H
authors.initials: H
authors.lastname: Büttner
authors.forename: N
authors.initials: N
authors.lastname: Gehchan
authors.forename: C
authors.initials: C
authors.lastname: Henneges
authors.forename: H
authors.initials: H
authors.lastname: Porst
mesh_terms: D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D004311:Double-Blind Method; D016903:Drug Monitoring / Q000379:methods; D007172:Erectile Dysfunction / Q000188:drug therapy; D053208:Kaplan-Meier Estimate; D064887:Observational Studies as Topic; D017060:Patient Satisfaction; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D000068581:Tadalafil / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil