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Home > Archive > Impotence Support > February 2006 > Vardenafil May Improve Both Erectile Dysfunction and Mild Depression
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Vardenafil May Improve Both Erectile Dysfunction and Mild Depression
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| Mr. Softy 2006-01-27, 11:18 am |
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Vardenafil May Improve Both Erectile Dysfunction and Mild Depression CME
News Author: Laurie Barclay, MD
CME Author: Charles Vega, MD, FAAFP
Complete author affiliations and disclosures, and other CME information, are
available at the end of this activity.
Release Date: January 18, 2006; Valid for credit through January 18, 2007
--------------------------------------------------------------------------------
Jan. 18, 2006 - Vardenafil improves both erectile dysfunction and mild
depression, according to the results of a randomized, multicenter study
reported in the January issue of the American Journal of Psychiatry.
"Erectile dysfunction and depression are highly associated," write Raymond
Rosen, PhD, from the university of Medicine and Dentistry of New Jersey in
Piscataway, and colleagues from the Vardenafil Study Site Investigators.
"Previous studies have shown benefits of phosphodiesterase-5 [PDE-5]
inhibitor treatment for erectile dysfunction associated with antidepressant
therapy or subsyndromal depression.... Vardenafil is a potent selective
PDE-5 inhibitor that has been shown to be highly efficacious in men with
erectile dysfunction, irrespective of severity or disease classification
(organic, psychogenic, or mixed) or underlying etiology."
In this 12-week, parallel-group, double-blind study, 280 men with erectile
dysfunction for at least 6 months and untreated mild major depression were
randomized to placebo or vardenafil, 10 mg/day, for 4 weeks. After each of 2
consecutive 4-week intervals, investigators had the option to titrate
vardenafil to 5 mg/day or 20 mg/day. Outcome measures included the erectile
function domain of the International Index of Erectile Function and 17-item
Hamilton Depression Rating Scale (HAM-D) scores.
Compared with placebo, vardenafil was associated with statistically
significant and clinically meaningful improvement in all erectile function
parameters. The erectile function domain score was 22.9 vs 14.9, and the
HAM-D score was 7.9 vs 10.1. Treatment with vardenafil was the best
predictor of return to normal erectile function, and improvement in
International Index of Erectile Function erectile function domain score was
the best predictor of remission in depressive symptoms.
"Vardenafil was well tolerated and highly efficacious in men with erectile
dysfunction and untreated mild major depression," the authors write.
"Significant improvements in erectile function and depression were observed
in patients treated with vardenafil versus placebo. Erectile dysfunction
treatment should be considered a component of therapy for men with
depression and erectile dysfunction."
Study limitations include the relatively short duration of treatment, lack
of generalizability to patients with more severe depression, and failure to
determine the causal relationship between symptoms of erectile dysfunction
and depression.
"It is highly unlikely that vardenafil exerts direct antidepressant effects
because it is not known to penetrate the blood-brain barrier," the authors
conclude. "Improvement in symptoms of depression is more likely attributable
to increased self-esteem and quality of life associated with improved sexual
function and satisfaction with the partner, family, and relationship. This
reinforces the concept that treatment of physical symptoms in depression can
enhance treatment outcomes and overall quality of life and reduce the risk
of relapse."
Bayer Healthcare Pharmaceuticals and GlaxoSmithKline funded this study.
Am J Psychiatry. 2006;163:79-87
Clinical Context
There is a strong association between erectile dysfunction and depression,
and the authors of the current study provide a brief review of this
relationship. the authors note that men with untreated depression have a
1.8-fold increased risk for erectile dysfunction, and the risk for erectile
dysfunction increases with increasing degrees of depression. Several factors
are most likely responsible for linking erectile dysfunction and depression,
including loss of self-esteem, performance anxiety, and a worsened quality
of life.
PDE-5 inhibitors can improve erectile dysfunction among men with depression,
but the effects of these medications on depression itself are poorly
understood. The current research examines whether vardenafil can improve
depression and erectile dysfunction in a cohort of men with both disorders.
Study Highlights
Men eligible for study participation had a history of erectile dysfunction
for at least 6 months as well as an untreated mild depressive disorder. This
disorder correlated with a score between 11 and 17 on the HAM-D at baseline.
Originally, the researchers included patients with a HAM-D score between 13
and 23. Men with other psychiatric disorders, uncontrolled medical diseases,
substance abuse, or who had previously failed treatment with sildenafil were
excluded from study participation.
Following a 4-week run-in period, subjects were randomized to receive 10 mg
of vardenafil daily or matching placebo. After 4 weeks, study therapy could
be altered between 5 and 20 mg/day.
The study period lasted 12 weeks. The primary outcomes were measures of
erectile dysfunction along with HAM-D scores. A measurement of subjects'
self-esteem was also performed.
280 men entered the trial. Baseline demographic and disease data were
similar between randomization groups. The mean age of participants was 53
years old, and slightly more than 70% had a mixed organic and psychogenic
etiology of erectile dysfunction. The mean duration of erectile dysfunction
was 3.5 years, and the mean HAM-D score was 14.3 at baseline.
Vardenafil was associated with significantly improved erectile function,
sexual desire, and overall satisfaction vs placebo. Rates of vaginal
penetration and erection maintenance to the completion of intercourse were
1.5 and 1.8 times higher in the vardenafil group vs the placebo group.
Overall, rates of positive responses as to whether treatment improved
erections were 83% and 30% in the vardenafil and placebo groups,
respectively.
Depression outcomes were only measured among patients whose erectile
dysfunction improved. The mean HAM-D scores in the vardenafil and placebo
groups had fallen to 7.9 and 10.1 by the end of the trial, a significant
difference favoring vardenafil. Remission of depressive symptoms was defined
by a HAM-D score less than 7, and 58% and 32% of the vardenafil and placebo
groups achieved this outcome, respectively. Treatment response was defined
by at least a 50% reduction in the HAM-D score, and 55% and 30% of the
vardenafil and placebo groups achieved this outcome.
Self-esteem scores improved in the vardenafil vs placebo groups.
Normalization of erectile dysfunction was linked to better HAM-D scores.
Participants whose erectile dysfunction improved had a mean HAM-D of 6.4 vs
a mean of 10.3 among subjects with continuing erectile dysfunction.
Severe adverse events were rare, and the rates of study discontinuation were
3% and less than 1% in the vardenafil and placebo groups, respectively.
Pearls for Practice
Depression increases the risk for erectile dysfunction in proportion to the
severity of depression, and loss of self-esteem, performance anxiety,, and a
worsened quality of life can contribute to the relationship between
depression and erectile dysfunction.
In the current study comparing vardenafil and placebo, vardenafil produced
superior outcomes in terms of erectile dysfunction and depression. A
reduction in erectile dysfunction correlated with improved depression
scores.
For questions regarding the content of this activity, contact the accredited
provider for this CME/CE activity: CME@webmd.net. For technical assistance,
contact CME@webmd.net.
--------------------------------------------------------------------------------
Authors and Disclosures
As an organization accredited by the ACCME, Medscape requires everyone who
is in a position to control the content of an education activity to disclose
all relevant financial relationships with any commercial interest. The ACCME
defines "relevant financial relationships" as financial relationships in any
amount, occurring within the past 12 months, including financial
relationships of a spouse or life partner, that could create a conflict of
interest.
Medscape encourages Authors to identify investigational products or
off-label uses of products regulated by the US Food and Drug Administration,
at first mention and where appropriate in the content.
News Author
Laurie Barclay, MD
is a freelance writer for Medscape.
Disclosure: Laurie Barclay, MD, has disclosed no relevant financial
relationships.
Clinical Reviewer
Gary Vogin, MD
Senior Medical Editor, Medscape
Disclosure: Gary Vogin, MD, has disclosed no relevant financial
relationships.
CME Author
Charles P Vega, MD
Associate Professor, Residency Director, Department of Family Medicine,
University of California, Irvine
Disclosure: Charles Vega, MD, FAAFP, has disclosed that he has received
grants for educational activities from Pfizer.
About News CME
News CME is designed to keep physicians and other healthcare professionals
abreast of current research and related clinical developments that are
likely to affect practice, as reported by the Medscape Medical News group.
Send comments or questions about this program to cmenews@medscape.net.
Medscape Medical News 2006. © 2006 Medscape
Legal Disclaimer
The material presented here
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| Wanderer 2006-01-27, 11:18 am |
| On Tue, 24 Jan 2006 19:53:04 -0500, Mr. Softy wrote
(in message <QZzBf.37039$PY6.9366@tornado.ohiordc.rr.com> ):
> "Erectile dysfunction and depression are highly associated," write Raymond
> Rosen, PhD, from the university of Medicine and Dentistry of New Jersey in
> Piscataway, and colleagues from the Vardenafil Study Site Investigators.
No shit, Sherlock. Thank God we've got a crackerjack team of experts to tell
us that not being able to get a hardon and depression are "highly
associated." LMAO
Wanderer
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| Mr. Softy 2006-01-27, 11:18 am |
|
"Wanderer" <unlikely@nowhere.net> wrote in message
news:0001HW.BFFCE210000346C0F068C550@news.verizon.net...
> On Tue, 24 Jan 2006 19:53:04 -0500, Mr. Softy wrote
> (in message <QZzBf.37039$PY6.9366@tornado.ohiordc.rr.com> ):
>
>
>
> No shit, Sherlock. Thank God we've got a crackerjack team of experts to
> tell
> us that not being able to get a hardon and depression are "highly
> associated." LMAO
I think it lends some support to the observation made here. I can recall
some similar assertions about ED meds and libido. I think it is the same
thing. ED drugs don't directly treat depression (or libido), but by
eliminating the ED, your mental state improves.
| |
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| ----- Original Message -----
From: "Mr. Softy" <mrsofty@cnci.rr.com>
Newsgroups: alt.support.impotence
Sent: Wednesday, January 25, 2006 2:23 PM
Subject: Re: Vardenafil May Improve Both Erectile Dysfunction and Mild
Depression
>
> "Wanderer" <unlikely@nowhere.net> wrote in message
> news:0001HW.BFFCE210000346C0F068C550@news.verizon.net...
SNIP
[vbcol=seagreen]
> I think it lends some support to the observation made here. I can recall
> some similar assertions about ED meds and libido. I think it is the same
> thing. ED drugs don't directly treat depression (or libido), but by
> eliminating the ED, your mental state improves.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Orgasm is a great reliever of tension - mental and physical. I wonder how
many guys - me included - use/have used orgasm at times of stress? It's
something which is denied to guys living with untreated/untreatable ED and
adds substantially to the burden.
Malcolm
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| After reading this article over a few times, I wonder what this
experiment proved. They first eliminated all those who had previously
failed to respond positively to Viagra. They are saying that, of the
remainder of men, taking Cialis brought their libido or erection
possibilities up and also their depression went down. (not the exact
terms used in the study. I would think they would have to try to
differentiate more. Sure some men improved their mood when the they
were able to get an erection using Cialis. Soooooo. I'll bet my
depression would lessen too, if a could have erections easily after
taking a pill The study really sounds like a waste of money, but I
will stand to be
corrected, if they find something out that will lessen both ED and
Depression.
| |
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| Slug wrote:
> After reading this article over a few times, I wonder what this
> experiment proved. They first eliminated all those who had previously
> failed to respond positively to Viagra. They are saying that, of the
> remainder of men, taking Cialis brought their libido or erection
> possibilities up and also their depression went down. (not the exact
> terms used in the study. I would think they would have to try to
> differentiate more. Sure some men improved their mood when the they
> were able to get an erection using Cialis. Soooooo. I'll bet my
> depression would lessen too, if a could have erections easily after
> taking a pill The study really sounds like a waste of money, but I
> will stand to be
> corrected, if they find something out that will lessen both ED and
> Depression.
>
How about increasing Testosterone levels?
--
LMac
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