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duration effectiveness of sildenafil versus tadalafil in the treatment of erectile dysfunction in male spinal cord injured patients
409 WHICH PDES-INHIBITOR DO PATIENTS PREFER? A COMPARATIVE STUDY OF 50 MG SILDENAFIL, 10 MC TADALAFIL AND 10 MG VARDENAFIL
410 A COMPARATIVE MAXIMUM DOSE Sommer F.‘, Klotr
Sommer F.‘, Mathers M.2: Klotz T.3, Bondarenko
B.‘, Capers
H.P.4, Engelmann
‘University Medical Centre Cologne, Urology, Cologne, Germany, Remscheid, Urology, Remscheid, Germany, 3Klinikum W&den, Urology, 4Paracelsus Urology Clinic, Diisseldorf, Urology, Diisseldorf, Germany
RANDOMISED OF SILDENAFIL,
T.2, Mathers
MULTICENTRE TADALAFIL
M.I, Bondarenko
STUDY OF AND VARDENAFIL
THE
B.‘, Caspers H.P.“, Engelmann
U.’
U.’
ZOffice Urology, Weiden, Germany.
& OBJECTIVES: Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men worldwide. Many drugs are now available for treating ED; oral pharmacotherapy represents the first-line option for most patients with ED. Sildenafil, an inhibitor of the enzyme phosphodiesterase type 5, is currently the most widely prescribed oral agent. Vardenafil and tadalafil are new phosphodiesterase type 5 inhibitors that have recently been approved for marketing in Europe. Both of them have significant positive efficacy-safety profiles. The question of which PDES-inhibitor is preferred by the patient remains unanswered. The purpose of this prospective, random&d. multicentre shady was to find an answer.
INTRODUCTION
& METHODS: After a 4.week treatment-free run-in period, during which baseline (BL) International Index of Erectile Function (IIEF) scores were obtained, 211 men - na~vveabout PDES-Inhibitor therapy were randomly assigned to either 50 mg sildenafil (half the maximum approved dose), 10 mg tadalafil (half the maximum approved dose); 10 mg vardenafil (half the maximum approved dose) or a placebo in a cross-over study design. After six weeks and a wash-out period of one week, medication was changed according to the protocol. All drugs were taken as needed prior to sexual activity (as described in the package insert). Primary endpoints (EP) were changes from BL on IIEF questions 3 (43) and 4 (Q4). Additional EPs included change from BL in IIEF domains and global assessment question (GAQ) responses. Patients were asked to record any adverse event during the course of the trial. In addition, patient satisfaction and preference were assessed. MATERIAL
Presently 47 of the 2 11 men have completed the trial. The changes from baseline for 50 mg sildenafil, 10 mg tadalafil and 10 mg vardenafil(l.2,0.9 and 1.5) were all improved (P
RESULTS:
‘University Medical Centre, Department of Urology, Cologne, Germany, 2Klinikum Weiden, Department of Urology, Weiden, Germany, 30ffice Urology, Remscheid, Department of Urology, Remscheid, Germany, 4Paracelsus Urology Clinic, Diisseldorf. Department of Urology, Diisseldorf, Germany & OBJECTIVES: Sildenafil is a well-known PDES-Inhibitor that has been on the market for over 5 years. Vardenafil and Tadalafil are new PDESInhibitors that were launched on the European market at the beginning of 2003. The purpose of this prospective, randomised, multicentre study was to evaluate the preference of patients with erectile dysfunction (ED).
INTRODUCTION
& METHODS: After a 4-week treatment-free run-in period, during which baseline (BL) International Index of Erectile Function (IIEF) scores were obtained, 237 men - na’ive about PDES-Inhibtor therapy - were randomly assigned to either 100 mg sildenafil; 20 mg Tadalafil, 20 mg Vardenafil or a placebo in a cross-over study design. After six weeks and a wash-out period of one week. medication was changed according to the protocol. All drugs were taken as needed prior to sexual activity (as described in the package insert). Primary endpoints (EP) were changes from BL on IIEF questions 3 (43) (vaginal penetration) and 4 (44) (maintenance of erection). Additional EPs included change from BL in IIEF domains and global assessment question (GAQ) responses. Patients were asked to record any adverse event during the course of the trial. In addition, patient satisfaction and preference were assessed.
MATERIAL
Presently X6 of the 237 men have completed the trial. Compared with the placebo (P), 100 mg sildenafil (S), 20 mg Tadalafil (T) and 20 mg Vardenafil (V) significantly improved patient scores for 43 (changes from baseline for P: 0.3, for S: 1.5, for T: 1.5, for V: 1.6, P
RESULTS:
Prelimina~ results for 86 men (out of 237 in the ongoing trial) showed that treatment with 100 mg sildenatil, 20 mg Tadalafil or 20 mg Vardenafil resulted in a high efficacy in a population with mixed ED aetiologies. The results also showed that over 80% of men with ED prefer the new PDES-inhibitors, when given in their maximum dose.
CONCLUSIONS:
Preliminary results for 47 men (out of 2 11 in the ongoing trial) showed that treatment with 50 mg sildenafil, 10 mg tadaiafil or 10 mg vardenafil resulted in a high efficacy in a population with mixed ED etiologies. The results also showed that over 65% of men with ED prefer the new PDES-inhibitors, when given in their half maximom approved dose.
CONCLUSIONS:
411
412
TIME/DURATION EFFECTIVENESS OF SILDENAFIL VERSUS TADALAFIL IN THE TREATMENT OF ERECTILE DYSFUNCTION IN MALE SPINAL CORD INJURED PATIENTS
PATIENT’S SELF-EVALUATION INTRACAVERNOUS ALPROSTADIL DEGREE OF ERECTILE DYSFUNCTION
BUT TESTING
Lombardi
G., Mondaini
Casella R., Deckart
A., Gasser T.C., Sulser T., Lehmann
University
of Florence,
N., Li Marzi Urology,
V., Natali
Florence,
A., Rizzo
M., Del Pop010 G.
University
Italy
INTRODUCTION & OBJECTIVES: To compare the safety, time/duration effectiveness, and the impact on the quality of life (QoL) of Tadalafil (T) 10 mg versus Sildenafil (S) 50 mg. MATERIAL & METHODS: During a screening (visit l), a diary card was distributed, in which the subjects assessed, after each attempt at intercourse the quality of their erection, responding (Yes/No) to both Sexual Encounter Profile Questions 2 (SEP2) and 3 (SEP3). The subjects will make at least four attempts at intercourse. At Visit 2, 15 patients (group 1) were assigned S and 15 (group 2) started with T. Responses to baseline International Index of Erectile Function 5 items (IIEF-5), Questions 13-14 (IIEF 15 items) and SEP diary were recorded. Patients attempted intercourse on four separate occasions: within 4 hours of taking the first tablet, within 12 hours for the second tablet, 24 hours for the third, and the fourth after 36 hours. At visit 3 the investigators evaluated the effectiveness with the same measures used at baseline. After a wash-out period, at visit 4, Group 1 was given T, and Group 2 was given S. Patients were required to observe the same criteria in taking the 4 tablets as in visit 2. After 4 weeks (visit 5) we evaluated the patients as we did in visit 3. RESULTS: 28 patients completed the study. No subjects discontinued the drugs due to drawbacks. Tadalafil allowed a majority of men in this trial to achieve both normal sexual functioning up to 24 hours post-dosing compared to S (p < 0.01) 19 out of 28 patients (67.9% percent), against 5 out of 28 patients 17.9% with S.T improved QoL compared to Sildenafil respectively 16.86% for 413 and 36.84% regarding Q 14. CONCLUSIONS: T may have option for ED in SC1 patients.
the potential
to become
an important
treatment
Hospital,
INTRODUCTION dysfunction (ED) efficient. Appraisal choice.
A.: Wyler Urology,
S., Bachmann
NOT RESPONSE IS RELATED TO
TO THE
K.
Basel, Switzerland
& OBJECTIVES: Modem baseline assessment of erectile should be individualized, reliable, non-invasive, and costbased on patient’s self-evaluation may be the method of
MATERIAL & METHODS: Using a self-report method 63 consecutive ED patients were prospectively investigated. Semi-quantitative parameters on seven criteria were assessed and intracavemous injection test with alprostadil was performed. Performance of self-reporting and intracavernous testing in predicting penetrative ability were compared. RESULTS: Twenty-three (37%) men had erection insufficient for penetration even with manual assistance, 26 (41%) men needed manual assistance, and 14 (22%) could penetrate without manual assistance but erection was not sufficient for satisfaction. In addition to impaired penetrative ability, six criteria (intercourse frequency, patient’s and partner’s satisfaction, penile rigidity, duration of erection, and need for extra-stimulation) deteriorated over time (p
Urology
Supplements
3 (2004)
No. 2, pp. 105
410 A COMPARATIVE MAXIMUM DOSE Sommer F.‘, Klotr
Sommer F.‘, Mathers M.2: Klotz T.3, Bondarenko
B.‘, Capers
H.P.4, Engelmann
‘University Medical Centre Cologne, Urology, Cologne, Germany, Remscheid, Urology, Remscheid, Germany, 3Klinikum W&den, Urology, 4Paracelsus Urology Clinic, Diisseldorf, Urology, Diisseldorf, Germany
RANDOMISED OF SILDENAFIL,
T.2, Mathers
MULTICENTRE TADALAFIL
M.I, Bondarenko
STUDY OF AND VARDENAFIL
THE
B.‘, Caspers H.P.“, Engelmann
U.’
U.’
ZOffice Urology, Weiden, Germany.
& OBJECTIVES: Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men worldwide. Many drugs are now available for treating ED; oral pharmacotherapy represents the first-line option for most patients with ED. Sildenafil, an inhibitor of the enzyme phosphodiesterase type 5, is currently the most widely prescribed oral agent. Vardenafil and tadalafil are new phosphodiesterase type 5 inhibitors that have recently been approved for marketing in Europe. Both of them have significant positive efficacy-safety profiles. The question of which PDES-inhibitor is preferred by the patient remains unanswered. The purpose of this prospective, random&d. multicentre shady was to find an answer.
INTRODUCTION
& METHODS: After a 4.week treatment-free run-in period, during which baseline (BL) International Index of Erectile Function (IIEF) scores were obtained, 211 men - na~vveabout PDES-Inhibitor therapy were randomly assigned to either 50 mg sildenafil (half the maximum approved dose), 10 mg tadalafil (half the maximum approved dose); 10 mg vardenafil (half the maximum approved dose) or a placebo in a cross-over study design. After six weeks and a wash-out period of one week, medication was changed according to the protocol. All drugs were taken as needed prior to sexual activity (as described in the package insert). Primary endpoints (EP) were changes from BL on IIEF questions 3 (43) and 4 (Q4). Additional EPs included change from BL in IIEF domains and global assessment question (GAQ) responses. Patients were asked to record any adverse event during the course of the trial. In addition, patient satisfaction and preference were assessed. MATERIAL
Presently 47 of the 2 11 men have completed the trial. The changes from baseline for 50 mg sildenafil, 10 mg tadalafil and 10 mg vardenafil(l.2,0.9 and 1.5) were all improved (P
RESULTS:
‘University Medical Centre, Department of Urology, Cologne, Germany, 2Klinikum Weiden, Department of Urology, Weiden, Germany, 30ffice Urology, Remscheid, Department of Urology, Remscheid, Germany, 4Paracelsus Urology Clinic, Diisseldorf. Department of Urology, Diisseldorf, Germany & OBJECTIVES: Sildenafil is a well-known PDES-Inhibitor that has been on the market for over 5 years. Vardenafil and Tadalafil are new PDESInhibitors that were launched on the European market at the beginning of 2003. The purpose of this prospective, randomised, multicentre study was to evaluate the preference of patients with erectile dysfunction (ED).
INTRODUCTION
& METHODS: After a 4-week treatment-free run-in period, during which baseline (BL) International Index of Erectile Function (IIEF) scores were obtained, 237 men - na’ive about PDES-Inhibtor therapy - were randomly assigned to either 100 mg sildenafil; 20 mg Tadalafil, 20 mg Vardenafil or a placebo in a cross-over study design. After six weeks and a wash-out period of one week. medication was changed according to the protocol. All drugs were taken as needed prior to sexual activity (as described in the package insert). Primary endpoints (EP) were changes from BL on IIEF questions 3 (43) (vaginal penetration) and 4 (44) (maintenance of erection). Additional EPs included change from BL in IIEF domains and global assessment question (GAQ) responses. Patients were asked to record any adverse event during the course of the trial. In addition, patient satisfaction and preference were assessed.
MATERIAL
Presently X6 of the 237 men have completed the trial. Compared with the placebo (P), 100 mg sildenafil (S), 20 mg Tadalafil (T) and 20 mg Vardenafil (V) significantly improved patient scores for 43 (changes from baseline for P: 0.3, for S: 1.5, for T: 1.5, for V: 1.6, P
RESULTS:
Prelimina~ results for 86 men (out of 237 in the ongoing trial) showed that treatment with 100 mg sildenatil, 20 mg Tadalafil or 20 mg Vardenafil resulted in a high efficacy in a population with mixed ED aetiologies. The results also showed that over 80% of men with ED prefer the new PDES-inhibitors, when given in their maximum dose.
CONCLUSIONS:
Preliminary results for 47 men (out of 2 11 in the ongoing trial) showed that treatment with 50 mg sildenafil, 10 mg tadaiafil or 10 mg vardenafil resulted in a high efficacy in a population with mixed ED etiologies. The results also showed that over 65% of men with ED prefer the new PDES-inhibitors, when given in their half maximom approved dose.
CONCLUSIONS:
411
412
TIME/DURATION EFFECTIVENESS OF SILDENAFIL VERSUS TADALAFIL IN THE TREATMENT OF ERECTILE DYSFUNCTION IN MALE SPINAL CORD INJURED PATIENTS
PATIENT’S SELF-EVALUATION INTRACAVERNOUS ALPROSTADIL DEGREE OF ERECTILE DYSFUNCTION
BUT TESTING
Lombardi
G., Mondaini
Casella R., Deckart
A., Gasser T.C., Sulser T., Lehmann
University
of Florence,
N., Li Marzi Urology,
V., Natali
Florence,
A., Rizzo
M., Del Pop010 G.
University
Italy
INTRODUCTION & OBJECTIVES: To compare the safety, time/duration effectiveness, and the impact on the quality of life (QoL) of Tadalafil (T) 10 mg versus Sildenafil (S) 50 mg. MATERIAL & METHODS: During a screening (visit l), a diary card was distributed, in which the subjects assessed, after each attempt at intercourse the quality of their erection, responding (Yes/No) to both Sexual Encounter Profile Questions 2 (SEP2) and 3 (SEP3). The subjects will make at least four attempts at intercourse. At Visit 2, 15 patients (group 1) were assigned S and 15 (group 2) started with T. Responses to baseline International Index of Erectile Function 5 items (IIEF-5), Questions 13-14 (IIEF 15 items) and SEP diary were recorded. Patients attempted intercourse on four separate occasions: within 4 hours of taking the first tablet, within 12 hours for the second tablet, 24 hours for the third, and the fourth after 36 hours. At visit 3 the investigators evaluated the effectiveness with the same measures used at baseline. After a wash-out period, at visit 4, Group 1 was given T, and Group 2 was given S. Patients were required to observe the same criteria in taking the 4 tablets as in visit 2. After 4 weeks (visit 5) we evaluated the patients as we did in visit 3. RESULTS: 28 patients completed the study. No subjects discontinued the drugs due to drawbacks. Tadalafil allowed a majority of men in this trial to achieve both normal sexual functioning up to 24 hours post-dosing compared to S (p < 0.01) 19 out of 28 patients (67.9% percent), against 5 out of 28 patients 17.9% with S.T improved QoL compared to Sildenafil respectively 16.86% for 413 and 36.84% regarding Q 14. CONCLUSIONS: T may have option for ED in SC1 patients.
the potential
to become
an important
treatment
Hospital,
INTRODUCTION dysfunction (ED) efficient. Appraisal choice.
A.: Wyler Urology,
S., Bachmann
NOT RESPONSE IS RELATED TO
TO THE
K.
Basel, Switzerland
& OBJECTIVES: Modem baseline assessment of erectile should be individualized, reliable, non-invasive, and costbased on patient’s self-evaluation may be the method of
MATERIAL & METHODS: Using a self-report method 63 consecutive ED patients were prospectively investigated. Semi-quantitative parameters on seven criteria were assessed and intracavemous injection test with alprostadil was performed. Performance of self-reporting and intracavernous testing in predicting penetrative ability were compared. RESULTS: Twenty-three (37%) men had erection insufficient for penetration even with manual assistance, 26 (41%) men needed manual assistance, and 14 (22%) could penetrate without manual assistance but erection was not sufficient for satisfaction. In addition to impaired penetrative ability, six criteria (intercourse frequency, patient’s and partner’s satisfaction, penile rigidity, duration of erection, and need for extra-stimulation) deteriorated over time (p
Urology
Supplements
3 (2004)
No. 2, pp. 105