408 The 3 PDE 5 inhibitors sildenafil, tadalafil and vardenafil: Results of an independent intraindividual comparative study

405 VARDENAFIL ACHIEVEMENT: VARDENAFIL

ALLOWS RESULTS IN SILDENAFIL

RAPID AND RELIABLE ERECTION OF THE PATIENT RESPONSE WITH NONRESPONDERS (PROVEN) TRIAL

Hatzichristou D.‘, Carson C.2, Lording D.3, Lyngdorf P.4,Aliotta P.j, Vardenafil Study Group, Philadelphm, Pennsylvania, United States ‘Universitv of Thessaloniki. Deoartment of Uroloev. Thessaloniki. Greece. Wniversitv of North Carolina. Departme& of Urologic Surge& Chapel Hill, Ul&d States, ?Alfred Hospital, Dep&ment of Medicine, Melbourne, Australia, 4Klinik for Seksuelle Dysfunktioner, Department of Sexual Dysfunction, Gent& Denmark, 5Mau~Urology Associates, Department of Urology, Buffalo, United States INTRODUCTION & OBJECTIVES: Vardenafil, a potent, highly selective PDE-5 inhibitor, is efficacious in the treatment of a broad range of erectile dysfunction (ED) patients, including those nonresponsive to sildenatil by history. To assess the rapidity and reliability of erection achievement in this patient populatmn, an ad-hoc analysis of the success of subjects attempting sex at various times since vardenafil dosing was conducted. MATERIAL & METHODS: In this multxentre, double-blind study, 463 men with moderate to severe ED (identified by six rigorous criteria as sildenafil nonresponders, including no response to 1OOmg sildenatil) were randomized to receive olacebo or 10 me vardenafil for 4 weeks. with the ootion to stw on lOme. or titrate to 5mg or 20mg after kach of two cons&tive, 4.week intervals (total of 15 weeks). data on v&al penetration (SEPZ) from subject diaries were recorded in 15.minute increments post-dosing with vardenafil. For each time interval, per-subject success rates were based on the total number of attempts made m that time interval. RESULTS: On average, vardenafi-treated sub]ects had greater success rates for achieving erections sufficient for penetration than those recewing placebo at all time intervals (ITT population=454). This was seen as early as in the first 15 minutes post-dose (62% vardenatil, n=57; 30% placebo, N=55) and the next 15 minutes (63% vardenafil, n-103; 38% placebo, N=lOO). The trend continued through to >5.0-6.0 hours post-dose (79% vardenafil, n=l5; 46% placebo, n=l2) and beyond 6 hours post-dose (77% vardenafil, n=3Q 50% placebo, ,,=18). vardenatil \rw well-tolerated: the most common drug-related adverse events (vardenafdiplacebo %) were headache(6,511.X);flushing (6.911.3); nasal congestion (4.810.4); dyspepsm (4,8/O). Overall Per-Subject Success Rates by Time from Intake of Study Medication to Start of Sexual Activity

406 EFFICACY TADALAFIL FROM THE

Mirone V.‘, Van Ahlen E Study Investigators ‘Federico II for Urology, Department Canada 5Eli

H.“, Moncada

I.j, Chan M.“,

University, Department of Andrology Department of Urology, Osnabruck, of Urology, Madrid, Spain, 4Eli Lilly, Lilly, Cialis Product Team; Erl Wood,

Varanese

Mlrane.‘,

IN SURE

Damber J.E.2,WespesE.‘, Chan M.4, Corde,, W.5, “aranese L.“, for the S ” R E Study Investig~ttors

‘Fed&co II Universey, Andrology Surgery, Naples. Italy, 2SahlgrenskaUniversity Hospital, Urology, Goteborg, Sweden,‘CHU de Charleroi, Hopital Civil, Urology, Charleroi, Belgium, 4Eli Lilly Canada,Cubs Product Team, Toronto. Canada,5Eli Lilly and Company,Cialis Product Team,Indlanapalis,United States,“Eli Ldly andCompany. Cialis Product Team,Erl Wood, Umted Kingdom INTRODUCTION Br OBJECTIVES: To examinethe preferencefor 2 dasmg regimens(3 tmxeslweekor on demand) for tad&&l, a phosphodiesterase5 mhlbitor thar provides a duraimnof effectivenessup to 36 hours in men with erecrile dysfunctmn (ED). MATERIAL & METHODS: The SURE study is a 14 Europeancountry, multicenter,crossover. and open-labelstudy. Men wth ED (N=4262) were randomizedto tadalatil 20 mg treatment3 times/week or on demand(maximum onedose per day) before sexual actiwty for a period of S-6 weeks. After a l-week washoutperiod. patientswere crossed over to the alternateregunenfor another5-6 weeks. The mnient’sreswnse to a TreatmenrPreferenceQnestmn(TPQI was used to detenmnethe preferredtreatmentregimen RESULTS: The mean ageof the randomzed patientswas 55 years, 85.2% of the patlentsreported a history of more than oneyear ofED, and 79 6% hadat leastone comorbidity. Overall, the responsesof3861 men to theTPQ assessment showedthat 42.2%ofthe patxnrs treatedwith tadalafil20 mg preferred the 3 times/weekdosing while 57.8%preferred the on-demandregimen.The preferenceacross the subgroups analyzed(age,ED etialagy,and severity) was consistent for each regimen. Commonly reported adverse events (>5%) were headacheand dyspepsia, which had a similar incidencein both regm~ens. Summary of Patient Responseto TPQ Assessment Evaluable(Respondedto the TPQ) N=3861 3 timesiweek

AS I 8.<=65 >65 ED Etmlogy Psychogenic organic Mined ED Severity” Mild Moderate severe

On demand %

All Randomized n N = 4262 1628

0% 42.2%

” 2233

3568 694

,401 227

43.0% 37.8%

I860 373

57.0% 62.2%

770 1469 2023

322 533 773,

45.2% 40.3% 42.3%

390 788 1055

54.8% 59.7% 57.7%

1653 1179 1389

666 455 489

43 7% 42.1% 40.0%

858 626 732

56.3% 57.9% 60.0%

57 8%

“Numbers for ED Severi@do not add up to N becausenot all randomized patientscompleted the IlEF EF domain questionnaire. CONCLUSIONS: In thusstudy, most men wth ED (57.8%) preferred the an-demandregimen of tadalafil 20 mg. A subsrantial number of men (42.2%) preferred the 3 timesiweek regimen of tadalatil. The two treatment regumns, togetherwith the 36 hours of effectivenessof tadalafil, provide addmonal options and unque flexibility in dosing for men with ED andtbe~rpartners.

European

Urology

Supplements

3 (2004)

No. 2, pp. 104

L.5, for the S U R

Surgery, Naples, Italy, ZClinic Germany, 3Maranon Hospital, Cialis Product Team; Toronto, United Kingdom

MATERIAL & METHODS: The SURE study is a 14 European country, multicenter, crossover, and open-label study. Men with ED (N=4262) were randomized to tadalafil20 mg treatment 3 times/week or on demand (maximum one dose per day) before sexual activity for a period of 5-6 weeks. After a l-week washout period, patients were crossed over to the alternate regimen for another 5-6 weeks. RESULTS: Efficacy and safety results from all randomized patients are presented in the table. Forty-five patients (1.1%) reported at least 1 serious adverse event. Seven of these events were possibly related to study drug in 6 patients. There were no deaths. Efficacy

CONCLUSIONS: whether taken

and Safety

These data further confirm the efficacy and safety of tadalafil on a regimen of 3 times/week or on demand.

407 AN EVALUATION OF TWO DOSING REGIMENS WITH TADALAFIL MEN WITH ERECTILE DYSFUNCTION: RESULTS FROM THE STUDY IN 14 EUROPEAN COUNTRIES

WITH RESULTS

INTRODUCTION & OBJECTIVES: Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor that improves erectile function for up to 36 hours post-dose in men with erectile dysfunction (ED). We analyzed data from the SURE study to evaluate the efficacy and safety of tadalafil taken 3 times/week or on demand.

Tadalafil

CONCLUSIONS: Vardenatil provides rapid erection achievement with reliable efficacy regardless of time from dosing. A number of men in this study who received vardenafil were able to obtain an erection rapidly, even wthin the first 15 minutes post-dose. despite being nonresponswe to sildenafil by history. In addition, a sigmficant proportion of vardenafil users were able to reliably achieve an erection at every recorded post-dose time interval, including a number of men achieving erections beyond 6 hours post-dose.

AND SAFETY OF TWO DOSING REGIMENS IN MEN WITH ERECTILE DYSFUNCTION: SURE STUDY IN 14 EUROPEAN COUNTRIES

408 THE 3 PDE 5 INHIBITORS NAFIL: RESULTS OF COMPARATIVE STUDY Porst H. Arnds -> Urological

S., Kleingarn

Practice,

SILDENAFIL, TADALAFIL AND VARDEAN INDEPENDENT INTRAINDIVIDUAL M.

Private Institute,

Hamburg,

Germany

INTRODUCTION & OBJECTIVES: The 3 PDE 5 inhibitors sildenafil, tadalafil and vardenafil are launched in Europe since 6 months but no data of comparator trials between these drugs are available to date. MATERIAL & METHODS: 149 pts (mean age 58 years) with chronic ED (mean duration 6 years) were exposed in an open trial to all 3 PDE 5 inhibitors one after the other. According to the outcome of the diagnostic procedures (hormones, penile duplexsonography, intracavemousal injection-test with 20 ,ug PGE-1) 44% (66) were allocated to psychogenic and 56% (83) to organic aetiology. The patients were requested to try at least 6 tablets per drug, starting with the mid-dose and up-titrating ,if necessary and desired. After at least 6 attempts the patients returned to the office, filled out the International Index for Erectile Function (IIEF) and a new preference module, comprising 9 items. After the first two drugs and at the end of the trial, when all 3 drugs were tried, the patients were asked upon their preference. RESULTS: 45% (67) of the pts. finally preferred tadalafil(l0 mg : 16,20 mg : 51) with 97% of them reporting the preference item “how long the medication is effective”. The mean EF-domain scores in this group were for tadalatil 26.4, for vardenafil 23.5 and for sildenafil 22.0, respectively. 30% (44) of the pts. preferred vardenafil (10 mg: 21, 20 mg: 23) with 63% of them reporting as main reason “how long it takes until medication works”. The mean EFdomain scores in this group were for vardenafi125.3, for tadalafil22.1 and for sildenafil 20.3, respectively. 13% (20) of the pts. preferred sildenafil (50 mg: 7, 100 mg: 13) with 70% of them reporting as main reasons each “hardness of erection” and “how long it takes until medication works”. The mean EF-domain scores in this group were for sildenafi123.8, for vardenafil 2 1.6 and for tadalafil 2 1 .O, respectively. 12% (18) did not indicate any preference, nearly all of them being poor or nonresponders to all 3 drugs. Most frequent side-effects > 10% were headache (sildenafil: 24%, vardenatil: 18% and tadalafil 15%) and flushing (sildenafil: 14%, vardenatil 11% and tadalafil 9%). CONCLUSIONS: In a real life at home setting with no restrictions in terms of inclusion-and exclusion criteria, except the contraindications as indicated in the labelling, the overwhelming majority of the ED-patients prefer the new PDE 5 inhibitors with tadalafil being at the first position.