title: Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies.
abstract: BACKGROUND
  This analysis explores tadalafil once-daily treatment for 12 wk in clinical subpopulations of men with erectile dysfunction (ED).
  
  
  OBJECTIVE
  Assess the efficacy and safety of once-daily tadalafil 2.5mg and 5mg in patients with different ED characteristics and comorbidities.
  
  
  METHODS
  This analysis integrated data from six randomized, double-blind, placebo-controlled studies that assigned 1913 men with ≥3-mo history of ED either to once-daily placebo (n=596), tadalafil 2.5mg (n=394), or tadalafil 5mg (n=923). Clinical factors examined included: ethnicity, age, obesity, alcohol consumption, smoking, comorbidities, concomitant medication, and ED characteristics (etiology, duration, severity).
  
  
  METHODS
  Descriptive statistics were reported for efficacy and safety, including International Index of Erectile Function Erectile Function Domain (IIEF-EF) scores and Sexual Encounter Profile question 3 (SEP3) responses. Clinical factors were included in analysis of covariance models using last observation carried forward for SEP3 and IIEF-EF scores.
  
  
  CONCLUSIONS
  Both tadalafil doses significantly improved SEP3 responses (least-squares [LS] mean change: 17.8% and 23.6%, respectively) and IIEF-EF scores (LS mean change: 4.2; 5.4) compared with placebo (p<0.01). Treatment with 2.5mg and 5mg tadalafil resulted in IIEF-EF LS mean improvements ≥4 (minimal clinically important difference [MCID]) in patients with hypertension (4.3 [95% confidence interval (CI), 2.9-5.7]; 4.7 [95% CI, 3.5-5.8]), cardiac disorder (7.0 [95% CI, 4.7-9.3]; 6.3 [95% CI, 4.4-8.2]), or hyperlipidemia (5.3 [95% CI, 3.4-7.1]; 5.8 [95% CI, 4.3-7.4]). Obese patients (4.7 [95% CI, 3.4-6.0]), smokers (4.8 [95% CI, 3.0-6.7]), and psychogenic ED (7.3 [95% CI, 5.0-9.6]) reached MCID only after treatment with 5mg tadalafil. Severity-specific MCID (IIEF-EF change ≥7) was achieved by 44.5% of patients with severe baseline ED treated with tadalafil 5mg, compared with 11.6% of placebo-treated patients. No unexpected safety findings were observed. These analyses were performed on integrated data and can only provide descriptive results to guide further investigations.
  
  
  CONCLUSIONS
  Treatment with tadalafil 2.5mg or 5mg once daily was well tolerated and resulted in clinically important improvements in patients with mild (54.3% and 74.8%, respectively), moderate (51.3% and 63.1%, respectively), or severe (33.7% and 44.5%, respectively) ED.
authors.affiliation: Private Practice of Urology/Andrology, Hamburg, Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Porst
authors.affiliation: Department of Urology, University of Florence, Careggi Hospital, Florence, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Gacci
authors.affiliation: Eli Lilly Biomedicines BU - Men's Health Therapeutic Area Europe, c/o Lilly Deutschland, GmbH, Bad Homburg, Germany.
authors.forename: Hartwig
authors.initials: H
authors.lastname: Büttner
authors.affiliation: Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Henneges
authors.affiliation: Lilly Deutschland GmbH, Medical Department, Bad Homburg, Germany. Electronic address: boess_frank@lilly.com.
authors.forename: Frank
authors.initials: F
authors.lastname: Boess
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002243:Carbolines / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects*; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D020127:Recovery of Function; D012189:Retrospective Studies; D012720:Severity of Illness Index; D000068581:Tadalafil; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil
keywords: Comorbidities; Diabetes; Erectile dysfunction; Metabolic syndrome; Once daily; Phosphodiesterase type 5 inhibitors; Tadalafil