title: A 6-month, prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Middle Eastern and North African men with erectile dysfunction.
abstract: BACKGROUND
  Erectile dysfunction (ED) negatively impacts quality of life. Phosphodiesterase type 5 inhibitors (PDE5Is) are effective in treating ED; however, rates of discontinuation remain high.
  
  
  OBJECTIVE
  To assess on-demand PDE5I treatment persistence and adherence through 6 months in Middle Eastern and North African (MENA) men with ED in a prospective, non-interventional, observational trial.
  
  
  METHODS
  Enrolled men were ≥18 years old from Saudi Arabia, Egypt, and the United Arab Emirates, PDE5I naïve, and sexually active. PDE5Is were selected per routine clinical practice. Persistence was defined as use of ≥1 dose during the prior 4 weeks, adherence as compliance with dosing instructions during the most recent dose. Logistic regression models were used to identify factors associated with persistence and adherence.
  
  
  METHODS
  Persistence and Adherence Questionnaire; Partner Relationship Questionnaire; Self-Esteem and Relationship Questionnaire; International Index of Erectile Function (IIEF); Erectile Dysfunction Inventory of Treatment Satisfaction.
  
  
  RESULTS
  Patients' (n = 493) mean age was 49.8 years, mean BMI was 29.3, and the majority (n = 354, 71.8%) were from Saudi Arabia. Tadalafil was the most prescribed PDE5I (69.6%), versus sildenafil (15.4%), or vardenafil (15.0%). Patients' mean IIEF-Erectile Function scores improved from moderate to mild and Erection Hardness Scores (SD) improved from 1.8 (1.0) at baseline to 3.5 (0.7) at 6 months. At 6 months, 64.9% of patients were treatment persistent (tadalafil, 68.8%, sildenafil, 65.8%, and vardenafil, 45.9%) and 59.6% were adherent. Factors significantly predictive (p < 0.05) of persistence at 6 months included age, employment status, and ED severity. Factors significantly predictive of adherence were age, employment status, and duration of ED. Interpretation of differences between drugs was limited by substantial differences in prescription rates between countries.
  
  
  CONCLUSIONS
  At 6 months, 64.9% of men were treatment persistent. In this study, age, employment status, ED severity, and duration of ED were associated with persistence and/or adherence.
authors.affiliation: Soliman Fakeeh Hospital, Jeddah, Saudi Arabia.
authors.forename: Amr
authors.initials: A
authors.lastname: El-Meliegy
authors.forename: Danny
authors.initials: D
authors.lastname: Rabah
authors.forename: Kutaiba
authors.initials: K
authors.lastname: Al-Mitwalli
authors.forename: Taymour
authors.initials: T
authors.lastname: Mostafa
authors.forename: Tarek
authors.initials: T
authors.lastname: Hussein
authors.forename: Mohamed
authors.initials: M
authors.lastname: Istarabadi
authors.forename: Yao
authors.initials: Y
authors.lastname: Lei
authors.forename: Sirel
authors.initials: S
authors.lastname: Gurbuz
mesh_terms: D002243:Carbolines / Q000627:therapeutic use; D004534:Egypt; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use; D011446:Prospective Studies; D011687:Purines / Q000627:therapeutic use; D012529:Saudi Arabia; D012649:Self Concept; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D000068581:Tadalafil; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use; D014479:United Arab Emirates; D000069058:Vardenafil Dihydrochloride
chemical_list: D002243:Carbolines; D007093:Imidazoles; D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride; D000068581:Tadalafil; D000068677:Sildenafil Citrate