- Email: [email protected]
Viagra is well-tolerated by subjects with stable angina and erectile dysfunction during incremental treadmill exercise
594
593 DHEA REPLACEMENT THERAPY IN DYSFUNCTION: PRELIMINARY EXPERIENCE
FEMALE
Mirone Vincenzo, Imbimbo Ciro, Palmieri Alessandro. Paolo, Granata Antonio Maria, Fusco Ferdinand0 Urology, University
“Federico
SEXUAL
Longo
Nicola,
Verze
OF A NEW
SEXUAL
QUALITY
OF LIFE
Svmonds Tara Outcomes Research (IPCl60). Pfizer Ltd. Kent. United Kingdom
II”, Naples, Italy
INTRODUCTION & OBJECTIVES: Preliminary data has shown that female sexual dysfunction, in part, are dependent upon androgens. DHEA represents a natural precursor along the androgenic synthesis pathway and often patients affected by FSD (low desire and/or low arousal and/or diminished orgasm) show low blood androgens levels. DHEA oral replacement therapy could prove to be effective in improving sexuality in women presenting FSD and low blood androgens levels. Aim of the study: To evaluate the efficacy of oral replacement therapy with DHEA 50 mgidie in women presenting sexual dysfunction and low blood androgen levels. MATERIALS & METHODS: A questionnaire designed for exploring sexual function in women has been administered to I82 patients, 22 to 59 years old (mean age 46 years). For each patient serum DHEA and Testosterone levels were measured. 631182 patients showed both DHEA levels in the low third of the normal range and low scores at the questionnaire. 54 of these 63 patients accepted to go through a 6 months DHEA oral 50 mgidie replacement therapy. To evaluate the outcomes, for each patient serum androgens measurements were repeated at month 3 and 6. and a second copy of the questionnaire was completed at month 6. RESULTS: 4 patients were loat at follow-up. The remaining 50 patients showed increasing serum androgen levels to the high third of the normal range after 3 and 6 months. After 6 months replacement therapy, all patients showed a significant improvement (~~0.05) in the scores of the questionnaire domains exploring sexual function (desire, arousal, and orgasm). Side effects reported were mild (greasy skin 39150, increased growth of body hair 3150, hair loss 2150). No patients asked to suspend the drug. DHEA CONCLUSION: replacement improving/restoring sexual function in patients and FSD. DHEA is safe and well tolerated in a studies are needed to evaluate long-term results
THE DEVELOPMENT QUESTIONNAIRE
therapy is effective in with low serum levels of DHEA medium-term treatment. Further and tolerability.
INTRODUCTION & OBJECTIVES: Increasingly the adverse effect of erectile dvsfunction (ED) on a man’s aualitv of life fOoL) is beine recognised. It is widelv a&epted thai ED is associated bith depressive
F!
f
595 EXERCISE-INDUCED ISCHEMIA WAS NOT ADVERSELY EFFECTED BY VARDENAFIL DURING AN EXERCISE STRESS TEST IN MEN WITH CORONARY ARTERY DISEASE
Udho'Mazru
Thadam
‘Cardmlogy, America.
Jackson Graham’. Arthur’
University
‘Clinical
of Oklahoma
Pharmacology.
Health Bayer
Sci Center. Oklahoma Corporation,
City,
United
States of
Haven. United State\ of
West
AlXr1ca INTRODUCTION:
ErectlIe dysfunction
(ED)
and there i\ a small but finite
disease (CAD) \CXLI;II actwity
is common among men &iTh coronary artery increased risk of developing
ischemia
with
Vardenafil is a new potent and w+xtive PDES inhibltor in clinical development for the treatment of ED. This multicentre study in patients with atable
in these patients.
whemia
cardiac treadmill
evaluated the effect 01 vardenafil
test durq
MATERIALS & METHODS:
In a randomised,
men (1X-77 year) with stable irchemic
placebo.
An
on cardiac parameters
physical exercise at a level similar
were not currenlly
on nitmte
CAD
in an exeruw
to or greater than sexual activity.
double-blind,
croswver,
who had reproducible
study design. JI
exeru\e tests and who
medlcatmn
received G&-doses of Ill mg vardenafil or exercise treadmill tert (ETT. 5. IO METS) was performed one hour pat-dwe at
the expected time of maxm~al drug expoure.
RESULTS: Total rxerci\e treadmill affected
by
vardenafil
time and time to awareness of angina pectori\
admmistration
relative
to
placebo.
The
time
m
were not
ST-segment
depre\\mn was slightly impnned by vardenafll compared to placebo. Parameter, mean (SD) Treadmill Exercise Time, set (n=39) Time to
Angina
set (~34)
tu ST-Segment
t 1 mm change
vardenafil 10 me
placebo
Ratio LS Means
433 (109)
427 (105)
I.015 (NS)
291 11231
292(llO)
0 Y76 (NS)
(vardenafihlacebo~
Gill&
Hunter’. Czomiak Michael’.
Keating Zoe’
‘Global Research and Development, Pfizer. Sandwich, United Kmgdom. ‘nia, Hungarian lnatute of Cardiology. Budapest, Hungary. ‘Cardiac Deparfment. St. Thornah Hospstal. London, United Kingdom INTRODUCTION & OBJECTIVES: Erectile dysfunction (ED) and coronary hear! disease (CHD) share common riak factors. Both silent and symptomatic CHD are common in subjects with ED. The workload of sexual activity is approximately 2-3 METS preorgasm, reaching 3-6 METS during orgasn. Therefore. any pharmacologic agent wed to treat ED should not increase the cardiac workload or reduce myocardial blood flow during sexual activity. Vlagre IS a modest va\odllator that ameliorates coronary cndothelial dysfunction and unproves coronary blood flow. Exercise stress testing 1s wed to a’ihesb cardiac patients’ ahllity fo return to normal dally itctwltle\ (including sexual activity). This study apsesed the effect of Viagra on the time to limiting angma and it\ hafcty during treadmill excrclse MATERIAL & METHODS: It was is double-blind. parallel-group. placebo-controlled, tnulflcentrr study in [men wth ED and chronic stable angina. aaxssing the effect of alldenafil on thme to onset of hmitmg angina during trcudmdl exercise. Patients wth reproducible exerciseinduced angina received I00 mg of Vqra (V) or placebo (P) I hour before treadmill enercis?. The prunary end point was time to limilmg angme: secondary end pow\ included time to angina, time to I lnm ST segment deprcwon. total exercix flme. blood pre\wre (BP), heart raw. and rate preswre product (RPP). RESULTS: A total of 144 able angina \uh.jccts (ITT) were randomwed (74 V, 70 P). IOR were e\nlunhle (56 V. 52 I’). Medical hlstory included hypertension (54% V, 53% P), myocardlel mfarctmn (57% V. 61%’ Pl. dlnheter (24% V. 36% P). and hyperlipidaemia (65% V. .540/r P). Concomitant medwation included beta-blockers (59% V. 4Y% P), calcium channel blocker, (39% V. 19’X P). ACE inhIbItor\ (35% V, 39% P) and \tatin\ (hl’% V. SO%, Pl. Viagra was noninferior ro placebo for all of the end points in the evaluahle and ITI populations. Furthermore, Viagra wu\ \lntl\tlcally \Ignificantly better than placebo m the secondary anelysi\ of time to llmitang anpme m the evaluahle population. BP rcwlution after encrcw was Fimilar m the 2 group?: RPP wa\ lower dfter \Ildenafil af rat. dur1n.e exercix. and throuehout rccoverv. There were no wxious treatmentrclutcd advex event\
from
baseline,
Viagra
3x1 (IOX)
334 (108)
I. I55 (p=n.oooJ)
Changes in blood prca\ure. heart rate,or ECG were alaocomparablc between vardenafil and placebo period\. Vardenafil was well tolerated. The most common nd\,erse events (headache and facial flushing)
Does Not Reduce
Adjusted
depression
Method Evaluable
[ITT]
set (ll=31) Mean Difference
Mean,
Treatment
the Time
to Limiting
Treatment
seconds
Difference
Angina
95% Confidence
@ED)
Interval
VZlf’”
Placebo
423.6
403.7
19.92 (9 57)
0.92
1437.61
1427.01
llO.66 (R.lY)l
l-S.551
VGe\
Lower
P Value UPPer 38.91
1 1126 X61
0.0401 IO.19571
m square bracket\ [ ] = ITT populatwn: I
were mdd or moderate and of short duration.
In rhls study IO mg vardenafil did not affect the ablllty of patients with \tahle CAD to cxcrci\e at a level exceeding that usually required for sexual intercourse.
CONCLUSION:
Keltal Maya’.
WITH STABLE INCREMENTAL
Pecturis,
first awareness. Time
596 VIAGRA IS WELL-TOLERATED BY SUBJECTS ANGINA AND ERECTILE DYSFUNCTION DURING TREADMILL EXERCISE
CONCLUSIONS: Vtagra was well-tolerated and \afc during treadmill cxenxe (approx 8 METS) in wb.ject\ with
European
Urology
Supplements
1 (2002) No. 1,
pp.
151
593 DHEA REPLACEMENT THERAPY IN DYSFUNCTION: PRELIMINARY EXPERIENCE
FEMALE
Mirone Vincenzo, Imbimbo Ciro, Palmieri Alessandro. Paolo, Granata Antonio Maria, Fusco Ferdinand0 Urology, University
“Federico
SEXUAL
Longo
Nicola,
Verze
OF A NEW
SEXUAL
QUALITY
OF LIFE
Svmonds Tara Outcomes Research (IPCl60). Pfizer Ltd. Kent. United Kingdom
II”, Naples, Italy
INTRODUCTION & OBJECTIVES: Preliminary data has shown that female sexual dysfunction, in part, are dependent upon androgens. DHEA represents a natural precursor along the androgenic synthesis pathway and often patients affected by FSD (low desire and/or low arousal and/or diminished orgasm) show low blood androgens levels. DHEA oral replacement therapy could prove to be effective in improving sexuality in women presenting FSD and low blood androgens levels. Aim of the study: To evaluate the efficacy of oral replacement therapy with DHEA 50 mgidie in women presenting sexual dysfunction and low blood androgen levels. MATERIALS & METHODS: A questionnaire designed for exploring sexual function in women has been administered to I82 patients, 22 to 59 years old (mean age 46 years). For each patient serum DHEA and Testosterone levels were measured. 631182 patients showed both DHEA levels in the low third of the normal range and low scores at the questionnaire. 54 of these 63 patients accepted to go through a 6 months DHEA oral 50 mgidie replacement therapy. To evaluate the outcomes, for each patient serum androgens measurements were repeated at month 3 and 6. and a second copy of the questionnaire was completed at month 6. RESULTS: 4 patients were loat at follow-up. The remaining 50 patients showed increasing serum androgen levels to the high third of the normal range after 3 and 6 months. After 6 months replacement therapy, all patients showed a significant improvement (~~0.05) in the scores of the questionnaire domains exploring sexual function (desire, arousal, and orgasm). Side effects reported were mild (greasy skin 39150, increased growth of body hair 3150, hair loss 2150). No patients asked to suspend the drug. DHEA CONCLUSION: replacement improving/restoring sexual function in patients and FSD. DHEA is safe and well tolerated in a studies are needed to evaluate long-term results
THE DEVELOPMENT QUESTIONNAIRE
therapy is effective in with low serum levels of DHEA medium-term treatment. Further and tolerability.
INTRODUCTION & OBJECTIVES: Increasingly the adverse effect of erectile dvsfunction (ED) on a man’s aualitv of life fOoL) is beine recognised. It is widelv a&epted thai ED is associated bith depressive
F!
f
595 EXERCISE-INDUCED ISCHEMIA WAS NOT ADVERSELY EFFECTED BY VARDENAFIL DURING AN EXERCISE STRESS TEST IN MEN WITH CORONARY ARTERY DISEASE
Udho'Mazru
Thadam
‘Cardmlogy, America.
Jackson Graham’. Arthur’
University
‘Clinical
of Oklahoma
Pharmacology.
Health Bayer
Sci Center. Oklahoma Corporation,
City,
United
States of
Haven. United State\ of
West
AlXr1ca INTRODUCTION:
ErectlIe dysfunction
(ED)
and there i\ a small but finite
disease (CAD) \CXLI;II actwity
is common among men &iTh coronary artery increased risk of developing
ischemia
with
Vardenafil is a new potent and w+xtive PDES inhibltor in clinical development for the treatment of ED. This multicentre study in patients with atable
in these patients.
whemia
cardiac treadmill
evaluated the effect 01 vardenafil
test durq
MATERIALS & METHODS:
In a randomised,
men (1X-77 year) with stable irchemic
placebo.
An
on cardiac parameters
physical exercise at a level similar
were not currenlly
on nitmte
CAD
in an exeruw
to or greater than sexual activity.
double-blind,
croswver,
who had reproducible
study design. JI
exeru\e tests and who
medlcatmn
received G&-doses of Ill mg vardenafil or exercise treadmill tert (ETT. 5. IO METS) was performed one hour pat-dwe at
the expected time of maxm~al drug expoure.
RESULTS: Total rxerci\e treadmill affected
by
vardenafil
time and time to awareness of angina pectori\
admmistration
relative
to
placebo.
The
time
m
were not
ST-segment
depre\\mn was slightly impnned by vardenafll compared to placebo. Parameter, mean (SD) Treadmill Exercise Time, set (n=39) Time to
Angina
set (~34)
tu ST-Segment
t 1 mm change
vardenafil 10 me
placebo
Ratio LS Means
433 (109)
427 (105)
I.015 (NS)
291 11231
292(llO)
0 Y76 (NS)
(vardenafihlacebo~
Gill&
Hunter’. Czomiak Michael’.
Keating Zoe’
‘Global Research and Development, Pfizer. Sandwich, United Kmgdom. ‘nia, Hungarian lnatute of Cardiology. Budapest, Hungary. ‘Cardiac Deparfment. St. Thornah Hospstal. London, United Kingdom INTRODUCTION & OBJECTIVES: Erectile dysfunction (ED) and coronary hear! disease (CHD) share common riak factors. Both silent and symptomatic CHD are common in subjects with ED. The workload of sexual activity is approximately 2-3 METS preorgasm, reaching 3-6 METS during orgasn. Therefore. any pharmacologic agent wed to treat ED should not increase the cardiac workload or reduce myocardial blood flow during sexual activity. Vlagre IS a modest va\odllator that ameliorates coronary cndothelial dysfunction and unproves coronary blood flow. Exercise stress testing 1s wed to a’ihesb cardiac patients’ ahllity fo return to normal dally itctwltle\ (including sexual activity). This study apsesed the effect of Viagra on the time to limiting angma and it\ hafcty during treadmill excrclse MATERIAL & METHODS: It was is double-blind. parallel-group. placebo-controlled, tnulflcentrr study in [men wth ED and chronic stable angina. aaxssing the effect of alldenafil on thme to onset of hmitmg angina during trcudmdl exercise. Patients wth reproducible exerciseinduced angina received I00 mg of Vqra (V) or placebo (P) I hour before treadmill enercis?. The prunary end point was time to limilmg angme: secondary end pow\ included time to angina, time to I lnm ST segment deprcwon. total exercix flme. blood pre\wre (BP), heart raw. and rate preswre product (RPP). RESULTS: A total of 144 able angina \uh.jccts (ITT) were randomwed (74 V, 70 P). IOR were e\nlunhle (56 V. 52 I’). Medical hlstory included hypertension (54% V, 53% P), myocardlel mfarctmn (57% V. 61%’ Pl. dlnheter (24% V. 36% P). and hyperlipidaemia (65% V. .540/r P). Concomitant medwation included beta-blockers (59% V. 4Y% P), calcium channel blocker, (39% V. 19’X P). ACE inhIbItor\ (35% V, 39% P) and \tatin\ (hl’% V. SO%, Pl. Viagra was noninferior ro placebo for all of the end points in the evaluahle and ITI populations. Furthermore, Viagra wu\ \lntl\tlcally \Ignificantly better than placebo m the secondary anelysi\ of time to llmitang anpme m the evaluahle population. BP rcwlution after encrcw was Fimilar m the 2 group?: RPP wa\ lower dfter \Ildenafil af rat. dur1n.e exercix. and throuehout rccoverv. There were no wxious treatmentrclutcd advex event\
from
baseline,
Viagra
3x1 (IOX)
334 (108)
I. I55 (p=n.oooJ)
Changes in blood prca\ure. heart rate,or ECG were alaocomparablc between vardenafil and placebo period\. Vardenafil was well tolerated. The most common nd\,erse events (headache and facial flushing)
Does Not Reduce
Adjusted
depression
Method Evaluable
[ITT]
set (ll=31) Mean Difference
Mean,
Treatment
the Time
to Limiting
Treatment
seconds
Difference
Angina
95% Confidence
@ED)
Interval
VZlf’”
Placebo
423.6
403.7
19.92 (9 57)
0.92
1437.61
1427.01
llO.66 (R.lY)l
l-S.551
VGe\
Lower
P Value UPPer 38.91
1 1126 X61
0.0401 IO.19571
m square bracket\ [ ] = ITT populatwn: I
were mdd or moderate and of short duration.
In rhls study IO mg vardenafil did not affect the ablllty of patients with \tahle CAD to cxcrci\e at a level exceeding that usually required for sexual intercourse.
CONCLUSION:
Keltal Maya’.
WITH STABLE INCREMENTAL
Pecturis,
first awareness. Time
596 VIAGRA IS WELL-TOLERATED BY SUBJECTS ANGINA AND ERECTILE DYSFUNCTION DURING TREADMILL EXERCISE
CONCLUSIONS: Vtagra was well-tolerated and \afc during treadmill cxenxe (approx 8 METS) in wb.ject\ with
European
Urology
Supplements
1 (2002) No. 1,
pp.
151