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Tadalafil Once-a-day: Why, When, for Whom?

Tadalafil Once-a-day: Why, When, for Whom?. Contents. Modern management of erectile dysfunction Why the Once-Daily/Once-a-day (OAD) Alternative to On-Demand Dosing in Erectile Dysfunction (ED) Tadalafil OAD Efficacy in ED Tadalafil OAD Safety and Tolerability in ED

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Tadalafil Once-a-day: Why, When, for Whom?

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  1. Tadalafil Once-a-day: Why, When, for Whom?

  2. Contents • Modern management of erectile dysfunction • Why the Once-Daily/Once-a-day (OAD) Alternative to On-Demand Dosing in Erectile Dysfunction (ED) • Tadalafil OAD Efficacy in ED • Tadalafil OAD Safety and Tolerability in ED • Tadalafil OAD – Psychosocial Outcome and Partner Data

  3. ErectileDysfunction - Treatment algorithm Lifestyle changes andriskfactor modification Identifyandtreat ‘curable‘ causesof ED Hatzimouratidis K. et al.; EurUrol2010, 57: 804-814

  4. Link of ED andCardiovascularDisease Study population: 9.457 men (age>55 years), 85% (8.063) without CVD atstudystart (7 yearsoffollow-up) N= 4247 (number of men without ED at study start) Thompson I.M.; JAMA 2005;294:2996-3002

  5. Link of ED andCardiovascularDisease Time until cardiovascular event after initial report of ED (without any reports of ED or CV before) Thompson I.M.; JAMA 2005;294:2996-3002 At risk, n = 2495; number of cardiovascular events, 255; 5-year estimate of cardiovascular events, 11%.

  6. Link of ED andCardiovascularDisease Erectiledysfunctionis a strong predictorforseriouscardiovascularevents Böhm M. et al.; Circulation 2010; 121:1439-1446

  7. ReductionofAdipositasMay ImproveED • 110 obesemen, 35 – 55 years, BMI 30-49 kg/m2 – 2 yearsintervention: Reductiondietandincreasedphysicalactivity Weightloss: Intervention group – 15 kg Controlgroup – 2 kg CG IG CG IG IG CG CG IG CG IG p=0,01 p=0,02 p=0,02 p=0,02 p=0,008  Waist-to-hip ratio  Glucose (mg/dl)  IIEF-Score  Blood pressure (mmHg)  Platelet aggregation (%) Endothelian function: Response to L-Arginin CG: Control group (n=55) IG: Intervention group (n=55) ED defined as IIEF≤ 21 Esposito K et al.;JAMA 2004;291;2978-84

  8. PhysicalActivityand Maintenance ofErectileFunction The risk of severe erectile dysfunction was decreased by 82.9% for males with physical activity of at least 3000 kcal/wk compared with males with physical activity under 3000 kcal/wk (OR = 0.171, p = 0.018) PhysicalActivityCorrelateswith IIEF-5-Score Kratzik C. et al; EurUrol; 2009; 55, 509-517

  9. PhysicalActivityand PDE-5-Inhibitors Physicalactivitymaysupport PDE-5-Inhibitors in treatmentof ED Mild ED Normalised erections n= 27 n= 30 physicalactivity only **p= 0.003 IIEF-EF: 24.7** IIEF-EF: 26.7** *p= 0.004 Maio G. et al.: J Sex Med. 2010;7(6):2201-8

  10. ErectileDysfunction - Treatment Algorithm PDE-5Is arefirstlinetherapy 1a A Daily administrationof PDE5-Is mayimproveresultsandrestoreerectilefunction 1b A PDE-5Is arefirstlinetherapy1a A Daily administrationof PDE5-Is mayimproveresultsandrestoreerectilefunction1b A Longereffectivedaily Shorter effectiveon demand Longer effective(up to 36 h) on demand Sildenafil 25 – 100 mg Vardenafil 5 – 20 mg Tadalafil 5mg Tadalafil 10/20 mg Hatzimouratidis K. et al.; EurUrol2010,57: 804-814

  11. Introduction – Why the Once-Daily Option • Oral PDE5 inhibitors successfully treat ED1; however, • Ameliorating the full psychological impact of ED remains a challenge2 • One complication is the lack of a clear pattern of timing of sexual activity for many couples2 • Once-daily dosing would offer an alternative for couples who prefer spontaneous instead of scheduled sexual activities, or for those who anticipate frequent sexual activities ED=erectile dysfunction; PDE5=phosphodiesterase 5 1. Eardley I et al. J Sex Med 2010;7:524-40. 2. Fisher W et al. J Sex Med 2005;2:675-84.

  12. Introduction – Why the Once-Daily Option • Dosing paradigms that eliminate coordinating dosing with sexual activity are desirable to accommodate individual patterns and spontaneity of sexual intimacy1-3 • Tadalafil is suited for use as a once-daily ED therapy, owing to its long half-life (17.5 hours)4 ED=erectile dysfunction; PDE5=phosphodiesterase 5 1. Carson C et al. BJU Int 2004;93:1276-81. 2. Rajfer J et al. Int J Impot Res 2007;19:95-103. 3. Dunn M et al. Int J Impot Res 2007;19:119-23. 4. Forgue S et al. Br J Clin Pharmacol 2006;61:280-8.

  13. Tadalafil Pharmacokinetics and Once-Daily Dosing • The mean half-life of tadalafil is 17.5 hours1,2 • Steady-state plasma concentrations are attained within5 days of daily dosing • Exposure is approximately 1.6-fold greater than after a single dose3: • Daily tadalafil 10 mg  16 mg at steady state • Daily tadalafil 5 mg  8 mg at steady state • This duration of efficacy may permit men with ED and their partners to disconnect sexual activity from dosing ED=erectile dysfunction 1. Cialis [US Package Insert] 2010. 2. Cialis [EU Summary of Product Characteristics] 2010. 3. Forgue S et al. Br J Clin Pharmacol 2006;61:280-8.

  14. Predicted Tadalafil Concentration-Versus-Time Profiles Tadalafil Plasma Concentrations Over 1 Week 400 350 Tadalafil 5 mg OAD 300 Tadalafil 20 mg single dose 250 200 Tadalafil Plasma Concentration (ng/mL) 150 100 50 0 0 24 48 72 96 120 144 168 Time (hours) OAD=Once-a-Day or Once-Daily Wrishko R et al. J Sex Med 2009;6:2039-48.

  15. Contents • Modern management of erectile dysfunction • Why the Once-Daily/Once-a-day (OAD) Alternative toOn-Demand Dosing in Erectile Dysfunction (ED) • Tadalafil OAD Efficacy in ED • Tadalafil OAD Safety and Tolerability in ED • Tadalafil OAD – Psychosocial Outcome and Partner Data

  16. Overview of Once-Daily Tadalafil Clinical (Registration) Studies ED=erectile dysfunction; OAD=Once-Daily/Once-a-Day 3. Hatzichristou D et al. Diabet Med 2008;25:138-146. 1. Porst H et al. Eur Urol 2006;50:351-359. 2. Rajfer J et al. Int J Impot Res 2007;19:95-103.

  17. Study 1 Secondary Endpoint: Percentage of Men With “No ED” at 12 Weeks(IIEF EF ≥26) Placebo 100 Tadalafil 5 mg OAD 90 Tadalafil 10 mg OAD 80 *p<0.001 vs placebo 70 * 52% * 51% 60 % of Patients 50 40 30 20 8% 10 0 Tadalafil10 mg OAD (n=101) Tadalafil 5 mg OAD (n=103) Placebo (n=48) Patients with IIEF EF <26 at Baseline IIEF EF=International Index of Erectile Function Erectile Function Domain Porst H et al. EurUrol 2006;50:351-359.

  18. Historical Comparison: IIEF EF DomainPooled Once-Daily and Integrated On-Demand Placebo Tadalafil 2.5 mg OAD Tadalafil 5 mg OAD Tadalafil 10 mg On-Demand Tadalafil 20 mg On-Demand *p<0.001 vs placebo *23.2 *21.9 *21.1 *19.2 15.3 14.9 Mean IIEF EF Domain Score Baseline (n=147) (n=93) (n=203) (n=638) (n=321) (n=1143) Once-Daily1 (12-week data from a 12-2 and 24-week3 study) On-Demand4 (11 pooled 12-week studies) IIEF EF=International Index of Erectile Function Erectile Function Domain; OAD = Once-Daily/Once-a-Day 1. Donatucci et al. Curr Med Res Opin 2008; 24:3383-3392. 2. Porst H et al. Eur Urol 2006;50:351-359 3. Rajfer J et al. Int J Impot Res 2007;19:95-103. 4. Carson et al. BJU Int 2004;93:1276-1281.

  19. Historical Comparison: SEP3Pooled Once-Daily and Integrated On-Demand Placebo Tadalafil 5 mg OAD Tadalafil 2.5 mg OAD Tadalafil 10 mg On-Demand Tadalafil 20 mg On-Demand *p<0.001 vs placebo *68% *62% *58% *50% Mean Per-Patient % SEP3 “Yes” 31% 33% Baseline (n=144) (n=92) (n=201) (n=638) (n=321) (n=1143) Once-Daily1 (one 12-2 and one 24-week3 study) On-Demand4 (11 pooled 12-week studies) SEP3=Sexual Encounter Profile Question 3: “Did your erection last long enough to have successful intercourse?” 1. Donatucci et al. Curr Med Res Opin 2008; 24:3383-3392. 2. Porst H et al. EurUrol 2006;50:351-359 3. Rajfer J et al. Int J Impot Res 2007;19:95-103. 4. Carson et al. BJU Int 2004;93:1276-1281.

  20. Once-Daily Tadalafil: Longterm Effectiveness

  21. Once-Daily Tadalafil Open-Label Extensions of OAD Studies (General ED Population) • 1-year, open-label extension (once-daily tadalafil 5 mg)3following Study 1 (12-week double-blind, placebo-controlled of once-daily tadalafil 5 mg or 10 mg (N=234)1 • 2-year, open-label extension (once-dailytadalafil 5 mg)3following Study 2 (24-week double-blind, placebo-controlled of once-daily tadalafil 2.5 mg or 5 mg (N=238)2 ED=erectile dysfunction; OAD=Once-Daily/Once-a-Day • Porst H et al. Eur Urol 2006;50:351-359. • Rajfer J et al. Int J Impot Res 2007;19:95-103. 3. Porst H et al. J Sex Med 2008;5:2160-2169.

  22. Once-Daily Tadalafil:Open-Label Extension Studies 1 and 2 Treatment Free Run-In Period Study 1 Open-Label Extension* *Extension primary endpoints: AEs, ECGs, labs †PAIRS and GAQ only measured in Study 22 AE=adverse event; ECG=Electrocardiogram; GAQ=Global Assessment Question; IIEF=International Index of Erectile Function; PAIRS=Psychological and Interpersonal Relationship Scales; SEP=Sexual Encounter Profile 12-Week Placebo- Controlled Tadalafil 5 mg OAD (N=234) Study 11 Treatment Free Week: -4 0 12 Month: 4 8 12 13 IIEF Labs ECG IIEF Labs ECG IIEF Labs ECG IIEF Labs ECG Randomization Treatment Free Run-In Period Study 2 Open-Label Extension* 24-Week Placebo- Controlled Study 22 Tadalafil 5 mg OAD (N=238) Week: -4 0 24 Month: 3 6 9 12 15 18 21 24 IIEF SEP IIEF GAQ† Labs ECG IIEF IIEF GAQ† Labs ECG IIEF GAQ† Labs ECG IIEF, SEP, PAIRS† Every 4 Weeks Every 3-4 Months: SEP and PAIRS • Porst H et al. Eur Urol 2006;50:351-359. • Rajfer J et al. Int J Impot Res 2007;19:95-103. 3. Porst H et al. J Sex Med 2008;5:2160-2169.

  23. Once-Daily Tadalafil 5 mg Longterm Effectiveness: IIEF EF 23 2-Year Extension 1-Year Extension Mean IIEF EF Domain Score 229 229 217 213 205 204 170 153 139 Baseline 4-mos 8-mos 12-mos Baseline 6-mos 12-mos 18-mos 24-mos In the 1-year extension, patients were washed out for 1 month following the open-label extension At the end of this washout period, the mean IIEF EF Domain score was 16.0 IIEF EF=International Index of Erectile Function Erectile Function Domain; mos = months’ study visit Porst H et al. J Sex Med 2008;5(9):2160-2169.

  24. Once-Daily Tadalafil 5 mg Longterm Effectiveness: Percentage of Men Achieving IIEF EF ≥26 24 1-Year Extension Study 2-Year Extension Study % of Patients with NormalIIEF EF Domain Score N=202 N=135 Patients with IIEF EF <26 at Baseline IIEF EF=International Index of Erectile Function Erectile Function Domain Porst H et al. J Sex Med 2008;5(9):2160-2169.

  25. Once-Daily Tadalafil Longterm Effectiveness: IIEF EF in 1- and 2-yr Open-Label Extensions 1-Year Open-Label Extension 2-Year Open-Label Extension 30 24.8 24.1 25 20 14.0 15 Mean IIEF EF Domain Score 16.0 13.7 10 5 N= N= 229 205 229 --- --- 204 213 170 206 --- --- 153 --- 139 217 --- 0 Baseline 4 8 12 16 20 24 Month of Open-Label Extension IEF EF=International Index of Erectile Function Erectile Function Domain; N=number of evaluable patients Porst H et al. J Sex Med 2008;5(9):2160-2169.

  26. OAD Longterm Effectiveness: Conclusions Efficacy improvements observed after 12 and 24 weeks in the placebo-controlled study periods1,2 were maintained as effectiveness improvements after 1 and 2 years ofopen-label treatment3 There was no evidence of tolerance or treatment resistance (tachyphylaxis) after up to 2 years of tadalafil 5 mgonce-daily dosing3 Longterm, once-daily tadalafil treatment provides a viable treatment alternative to on-demand dosing of tadalafil for men with ED3 26 ED=erectile dysfunction; OAD=once-daily/once-a-day 1. Porst H et al. Eur Urol 2006;50:351-359. 2. Rajfer J et al. Int J Impot Res 2007;19:95-103. 3. Porst H et al. J Sex Med 2008;5(9):2160-2169.

  27. Tadalafil OAD Onset of Efficacy: 2-Study1,2 Retrospective Sub-Analysis3 and Prospective Study3 • Porst H et al. EurUrol2006;50(2):351-359. • Rajfer J et al. Int J Impot Res 2007;19(1):95-103. • SeftelA et al. J Urol. 2011 ;185(1):243-8

  28. ErectileDysfunction - Treatment Algorithm Hatzimouratidis K. et al.; EurUrol2010, 57 : 804-814

  29. Tadalafil 5 mg OAD Onset of Efficacy: Retrospective 2-Trial1,2 Subanalysis3 Successful IntercourseDuring First 10 Days of Therapy3 100 80 * * * * * * * * * 60 Tadalafil 5 mg OAD % Patients w/Successful Attempt Placebo 40 20 0 10 6 4 2 8 Day of Therapy *p<0.05 by Chi-square test. Plot is percentage of patients having successful intercourse by Day 1, by Day 2, etc. 1. Porst H et al. Eur Urol 2006;50:351-359. 2. Rajfer J et al. Int J Impot Res 2007;19:95-103. 3. Seftel A et al. J Urol. 2011 ;185(1):243-8 .

  30. Tadalafil 2.5 mg and 5 mg OAD Onset of Efficacy Prospective Study: Percentage Successful Attempts by SEP3 (Secondary Analysis) Cumulative Percentage of Successful Intercourse Attempts by SEP3During 14-Day Double-Blind Period 50 * * 45 * † * Tadalafil 5 mg OAD † 40 * * Tadalafil 2.5 mg OAD † 35 † Placebo † 30 % of Successful Attempts 25 20 15 *p<0.025 tadalafil 5 mg OAD versus placebo (Day 2 to Day 14) †p<0.025 tadalafil 2.5 mg OAD versus placebo (Day 3 to Day 14) 10 5 0 Baseline 7 11 2 3 4 Day 1 14 SEP3=Sexual Encounter Profile Question 3: “Did your erection last long enough to have successful intercourse?” Seftel A et al. J Urol. 2011 ;185(1):243-8

  31. Tadalafil 5 mg OAD Onset of Efficacy: Conclusions Onset of efficacy of once-daily tadalafil 2.5 mg or 5 mg within a few days (Day 2 or Day 3) of initiating therapy was demonstrated by the following: A 2-study (general ED population)1,2 retrospective analysis3 A prospective trial (N=372)3comprised of a 2-week double-blind placebo-controlled period with instructions for multiple attempts followed by a 2-week open-label period (tadalafil 5 mg only;no attempt requirements) ED=erectile dysfunction 1. Porst H et al. Eur Urol 2006;50:351-359. 2. Rajfer J et al. Int J Impot Res 2007;19:95-103. 3. Seftel A et al. J Urol. 2011 ;185(1):243-8.

  32. Tadalafil OAD Reliability of Efficacy: 2-Study1,2 Retrospective Analysis3 1. Porst H et al. Eur Urol 2006;50(2):351-359. 2. Rajfer J et al. Int J Impot Res 2007;19(1):95-103. 3. Shabsigh R et al. Int J Impot Res 2010;22(1):1-8.

  33. Tadalafil OAD: Reliability of Efficacy • A pooled retrospective analysis of the two general ED OAD registration studies1,2 for the initial 12 weeks of either study examined first-attempt success rate and the reliability of response* in men treated with tadalafil 2.5 mg OAD (n=96) or 5 mg OAD (n=206) versus placebo (n=148)3 • Cumulative proportion of men with intercourse success (“Yes” to SEP3) at any time (to Week 12) by number of attempts was also calculated *Defined as rate of intercourse success (following successful attempt) per Sexual Encounter Profile Question 3 (SEP3): “Did your erection last long enough for you to have successful intercourse?” after a successful attempt ED=erectile dysfunction; OAD=Once-a-Day or Once-Daily 1. Porst H et al. Eur Urol 2006;50(2):351-359. 2. Rajfer J et al. Int J Impot Res 2007;19(1):95-103. 3. Shabsigh R et al. Int J Impot Res 2010;22(1):1-8.

  34. Once-Daily Tadalafil: 2-Study1,2 Retrospective Analysis3 Success (SEP3) By Number of Attempts Cumulative Proportion of Patients With Intercourse Success (“Yes” to SEP3) by Number of Attempts During the Initial 12-Weeks of 2 Studies1,2 90 Tadalafil 5 mg OAD 80 Tadalafil 2.5 mg OAD 70 Placebo 60 % Who Recorded Successful Intercourse 50 40 30 20 10 0 0 2 4 6 8 10 12 Number of Intercourse Attempts SEP3=Sexual Encounter Profile Question 3: “Did your erection last long enough to have successful intercourse?” 1. Porst H et al. Eur Urol 2006;50(2):351-359. 2. Rajfer J et al. Int J Impot Res 2007;19(1):95-103. 3. Shabsigh R et al. Int J Impot Res 2010;22(1):1-8.

  35. Tadalafil 5 mg OAD Reliability of Efficacy: Conclusions Reliability of efficacy of tadalafil OAD over 12 weeks ─“rate of intercourse success (SEP3) after successful attempt”─ by a 2-study1,2 retrospective analysis3 (2.5 mg or 5 mg doses only) revealed the following: Following initial success, a greater proportion of men (85.9%; p<0.001) taking tadalafil 5 mg had subsequent success compared to placebo (70.2%) Men who may not be initially successful under treatment with once-daily tadalafil for ED may have increased success on subsequent intercourse attempts (up to 10 attempts)3 SEP3=Sexual Encounter Profile Question 3: “Did your erection last long enough to have successful intercourse?” 1. Porst H et al. Eur Urol 2006;50(2):351-359. 2. Rajfer J et al. Int J Impot Res 2007;19(1):95-103. 3. Shabsigh R et al. Int J Impot Res 2010;22(1):1-8.

  36. Tadalafil Once-Daily Efficacy Summary • Once-daily tadalafil improved erectile function by IIEF EF domain in general ED placebo-controlled studies (2.5 mg or 5 mg)1,2as well as in 1- and 2-year open-label studies (5-mg only)3 • Onset of efficacy of tadalafil 2.5 mg or 5 mg OAD within a few days (Day 2 or Day 3) of initiating therapy has been demonstrated1-2,4 • Reliability: Over 12 weeks and post initial success, more men on tadalafil 5 mg OAD (85.9%; p<0.001) had subsequent success than placebo (70.2%)5 ED=erectile dysfunction; IIEF EF=International Index of Erectile Function Erectile Function Domain; OAD=Once-a-Day or Once-Daily 1. Porst H et al. EurUrol2006;50(2):351-359. 2. Rajfer J et al. Int J Impot Res 2007;19(1):95-103. 3. Porst H et al. J Sex Med 2008;5(9):2160-2169. 4. Seftel A et al. J Urol. 2011 ;185(1):243-8 5. Shabsigh R et al. Int J Impot Res 2010;22(1):1-8.

  37. Contents Modern management of erectile dysfunction Why the Once-Daily/ Once-a-Day (OAD) Alternative to On-Demand Dosing in Erectile Dysfunction (ED) Tadalafil OAD Efficacy in ED Tadalafil OAD Safety and Tolerability in ED Tadalafil OAD – Psychosocial Outcome and Partner Data

  38. Historical Comparison: Adverse Events – Once-Daily (Studies 1 and 2) vs. On-Demand Randomized Trials *All once-daily and on-demand trials were randomized and placebo-controlled AE=Adverse Event; OAD=Once-A-Day; TEAE=Treatment-Emergent Adverse Events 1. Porst H et al. Eur Urol 2006;50:351-9. 2. Rajfer J et al. Int J Impot Res 2007;19:95-103. 3. Donatucci et al. Curr Med Res Opin 2008; 24:3383-92. 4. Carson CC et al. BJU Int2004;93:1276-81.

  39. Long-Term Safety: Most Common Adverse Events at 12 Months (Extension Studies 1 and 2) AE=Adverse Event; OAD=Once-A-Day; OL=Open-Label; Treatment-Emergent Adverse Events 1. Porst H et al. J Sex Med 2008;5:2160–9. 2. Rajfer J et al. Int J Impot Res 2007;19:95-103.

  40. Cardiovascular Safety: Tadalafil Once-Daily Dosing, 3x/Weekly Dosing, All Studies Combined *Framingham study: MI incidence rates of 0.61/100 PYs (45-54 y) and 2.25/100 PYs (75-84 y) †Combined studies – sample sizes not additive: some received tadalafil in placebo-controlled as well as open-label trials ‡One patient who had a MI had been randomized to tadalafil, but had not taken drug CVTEAE=Cardiovascular Treatment-Emergent Adverse Event; CI=Confidence Interval; MI=Myocardial Infarction Kloner R et al. Am J Cardiol 2006;97:1778-84.

  41. Tadalafil Once-Daily Safety and Tolerability Summary • Most patients completed open-label extensions of the two once-daily studies in the general erectile dysfunction population (208/234 [1-year extension]; 139/238 [2-year extension]) • Incidence and type of adverse events was similar for tadalafil once-daily 5 mg (24 months) and on-demand 5/10/20 mg (24 months) • No events suggestive of drug-related toxicity on tests of visual function were evident with 6 months’ daily treatment • Incidence of cardiovascular adverse events was low, and comparable for tadalafil- and placebo-treated patients

  42. Contents • Modern management of erectile dysfunction • Why the Once-Daily / Once-a-Day (OAD) Alternative to On-Demand Dosing in Erectile Dysfunction (ED) • Tadalafil OAD Efficacy in ED • Tadalafil OAD Safety and Tolerability in ED • Tadalafil OAD – Psychosocial Outcome and Partner Data

  43. Once-Daily Tadalafil for ED: Partner and Psychosocial Outcome Data Introduction • Erectile dysfunction (ED) is a condition that can affect more than male erectile functioning; it also has an impact on patient and partner sexual quality of life (SQoL) and other psychosocial outcomes1,2 • Biopsychosocial considerations that include the partner and the relationship are important in the treatment of ED3-5 1. Althof SE Int J Impot Res 2002;14 Suppl 1:S99-S104. 2. Althof SE. Urology 2002;59(6):803-10. 3. McCabe M et al. J Sex Med 2010;7(1 Pt 2):327-36 4. Hackett G et al. J Sex Med 2008;5(8):1841-65. 5. Fisher WA et al. J Sex Med 2009;6(10):2746-60.

  44. Tadalafil Once Daily and Sexual Quality of Life in Patient and Partner

  45. Tadalafil 5 mg OAD: Patient and Partner Scores on the SLQQ–SQoL Items 1-5 100 *p<0.001 change from baseline vs placebo Placebo Partners of Placebo-Treated Baseline Tadalafil 5 mg OAD Partners of TAD 5 mg OAD-Treated 80 * * * * * * Better * * * * 60 Same as prior to ED (range 0–100) Mean Per Item SLQQ-SQoL Score 40 20 Worse 0 Item 1 Item 2 Item 3 Item 4 Item 5 Freq of Sex Duration of Sex Ease of Insertion Ease of Orgasm Ease Initiating Female Partners SLQQ-SQoL Individual Items (1→ 5) ED Patients SLQQ-SQoL Individual Items (1→ 5) Item 1 Item 2 Item 3 Item 4 Item 5 Freq of Sex Duration of Sex Ease of Insertion Ease of Orgasm Ease Initiating Freq=Frequency; SLQQ=Sexual Life Quality Questionnaire; SQoL=Sexual Quality of Life; TAD=tadalafil Rubio-Aurioles et al. J Sex Med 2009;6(5):1314-23.

  46. Tadalafil 5 mg OAD: Patient and Partner Scores on the SLQQ–SQoL Items 6-10 100 *p<0.001 change from baseline vs placebo Placebo Partners of Placebo-Treated Baseline Tadalafil 5 mg OAD Partners of TAD 5 mg OAD-Treated 80 * * * * * * * * * * Better 60 Same as prior to ED Mean Per Item SLQQ-SQoL Score 40 ( range 0–100 ) 20 Worse 0 Item 6 Item 7 Item 8 Item 9 Item 10 Item 6 Item 7 Item 8 Item 9 Item 10 Carefree Feelings Pleasure of Anticipation Carefree Feelings Pleasure Orgasm Pleasure Overall Partner Pleasure Pleasure of Anticipation Pleasure Orgasm Pleasure Overall Partner Pleasure Female Partners SLQQ-SQoL Individual Items (6→ 10) ED Patients SLQQ-SQoL Individual Items (6→ 10) SLQQ=Sexual Life Quality Questionnaire; SQoL=Sexual Quality of Life; TAD=tadalafil Rubio-Aurioles et al. J Sex Med 2009;6(5):1314-23.

  47. Once-Daily Tadalafil 5 mg and Treatment Satisfaction (Secondary Endpoint) *p<0.001 vs placebo Placebo Partners of Placebo-Treated 100 Tadalafil 5 mg OAD Partners of TAD 5 mg OAD-Treated 80 75* 73* 60 55 51 Mean SLQQ-THX Domain Score(6 items; range 0 – 100) 40 20 0 (n=238) (n=72) (n=244) (n=70) ED Patients Female Partners SLQQ-THX SLQQ=Sexual Life Quality Questionnaire; TAD=tadalafil; –THX=Treatment Satisfaction Domain Seftel AD et al. Int J Impot Res 2009;21(4):240-8.

  48. Once-Daily Tadalafil 5 mg and Psychosocial Outcomes by SEAR Scale (Secondary Endpoints) *p<0.001 change from baseline vs placebo Placebo Tadalafil 5 mg OAD Baseline 100 81* 80* 79* 80 73* † SEAR score change from baseline was minus 0.7 points 58† 60 65 54 52 59 Mean SEAR Score 55 43 51 50 46 40 39 38 20 0 n= 72 72 72 244 244 244 244 72 Sexual Relationship Domain Confidence Domain Self–Esteem SS Overall Relationship SS ED Patients OAD=Once-Daily/Once-a-Day; SEAR=Self-Esteem and Relationship Questionnaire; SS=Subscale Seftel AD et al. Int J Impot Res 2009;21:240-8.

  49. Tadalafil Once-a-day: Why, When, for Whom? • Modern management of erectile dysfunction • Careful assessment (silent CAD!), modify risk-factors, PDE5-I’s first-line treatment, involve partner • Why the Once-Daily/Once-a-day (OAD) Alternative to On-Demand Dosing in Erectile Dysfunction (ED) • Daily dosing has been included into EAU-Guidelines – offer this treatment-option to your patients • Tadalafil OAD Efficacy in ED • Tadalafil OAD shows comparable efficacy as on-demand treatment-options (IIEF, SEP)

  50. Tadalafil Once-a-day: Why, When, for Whom? • Tadalafil OAD Safety and Tolerability in ED • Less adverse events (historically) compared with on-demand therapy-regimens • Tadalafil OAD – Psychosocial Outcome and Partner Data • Majority of patients’ and partners’ sexual quality of life improves to scores comparable to those in couples without ED

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