Sunday, October 12, 2008

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Sildenafil offers an opportunity to treat male erectile dysfunction with an effective, licensed oral
preparation.
• It is taken on a “when required” basis and only works in the presence of sexual stimulation.
• 70-80% of men in trials show a statistically significant improvement in erectile or sexual function
compared with about 25% of men who receive placebo. In the dose-escalation study in 329 men,
around 2 men would need to be treated with sildenafil for 12 weeks for one man to report improved
erections (NNT). There is no clear figure of how this relates to successful sexual intercourse, although
69% of all attempts were successful compared to 22% with placebo.
• Open label follow up studies indicate that most men who initially respond to the drug continue to take
it. A fully-published randomised controlled trial has also demonstrated the efficacy of sildenafil in men
with diabetes mellitus and erectile dysfunction.
• Sildenafil appears to be well tolerated. 2.5% of patients withdrew from studies because of adverse
effects, compared to 2.3% with placebo. The US Food and Drug Administration has reported 69
deaths in people taking sildenafil which led to an update of the US label. Forty-six deaths were known
to be due to cardiovascular events. Since sexual activity is itself a risk factor in cardiovascular death
the role of sildenafil is difficult to determine.
• As yet there are no direct comparisons of sildenafil with alternative treatments.
• The long-term safety profile of sildenafil is yet to be established.



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Sildenafil is rapidly absorbed after oral administration
reaching maximum plasma concentration within 30-120
minutes of dosing in fasted subjects. It has a bioavailability
of about 40% and fatty food has been shown to reduce the
rate of absorption and the peak concentrations achieved,
without affecting the extent of absorption. It is therefore
advised that sildenafil is taken 30-60 minutes before planned
sexual activity. One small study, which is only available as
an abstract, has shown that sildenafil still has an effect on
erectile function for 4-5 hours after dosing [4].
Sildenafil is mainly eliminated by hepatic metabolism
(principally cytochrome P450 3A4) and converted to the
active N-desmethyl metabolite, which accounts for about
20% of its overall pharmacological effect. Both sildenafil
and the metabolite have terminal half-lives of about 4 hours
and are excreted predominately in the faeces. No significant
accumulation is expected to occur on single daily dosing.
Studies have shown that renal insufficiency (creatinine
clearance (CLcr) <30ml/min), hepatic insufficiency and age
(over 65 years) are all associated with increased plasma
concentrations when compared with matched controls.
Sildenafil and its major metabolite are highly bound to plasma
proteins


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MALE SEXUAL DYSFUNCTION. Popular drug: Cialis and viagra

Sexual Dysfunction describes any of a group of sexual disorders characterized by inhibition either of sexual 
desire or the physiological changes that usually characterize sexual response. Sexual dysfunction disorders 
are generally classified into four categories: sexual desire disorders, sexual arousal disorders, orgasm disor-
ders, and sexual pain disorders.
Male sexual dysfunction may reflect problems with the following factors: Libido, ejaculation, erectile func-
tion or a combination of these factors. Erectile Dysfunction (ED), also known as impotence, is the inability 
to achieve and maintain penile erection and thus engage in sexual intercourse. This is a common, treatable 
condition affecting an estimated 18 million men in the United States alone. Yet, data suggest that less than 
10% of affected men actually receive treatment. Male sexual dysfunction may be a result of one or more of 
the following conditions: medication side effects, endocrine disorders, peripheral vascular disease, neuro-
logical dysfunction, penile diseases, psychological disorders, and lifestyle factors. Once male sexual dys-
function is diagnosed, each of these potential causes must be carefully addressed prior to initiating
treatment.

Services eligible for coverage for men with sexual dysfunction due to organic

causes include:

a. Treatment of the underlying organic/medical condition causing sexual dysfunction.
b. Oral prescription medications for erectile dysfunction such as Viagra®, Levitra® and Cialis®. 
Most BCBSNC benefit plans have a limit of 4 tablets per 30 days. These medications have been 
shown to potentiate hypotensive effects of nitrates and are contraindicated in patients taking any 
form of nitrates or have known allergy to nitrates. Caution should also be taken in patients taking 
alpha-blockers as the combination may produce hypotension. Safety and efficacy of use with other 
treatments for erectile dysfunction have not been studied and are not recommended. Viagra®, 
Levitra® and Cialis® are not indicated for use by newborns, children or women.
c. Penile injection therapy which involves the self-injection of medications into the base of the penis. 
Papavarine, phenotolamine, and/or prostaglandin E
1
(alprostadil) (Caverject®, Edex®) are com-
monly used. This type of therapy is most useful when used for organic impotence due to neuro-
genic causes and lesser for vascular problems. Most BCBSNC benefit plans have a limit of 4 units 
per 30 days.
d. MUSE (Medicated Urethral System for Erection). This consists of a urethral suppository (alpros-
tadil) in a very small, smooth plastic applicator. Once the applicator is in place, a button is pushed 
down which pushes the suppository out into the urethra where it is absorbed. Most BCBSNC ben-
efit plans have a limit of 4 units per 30 days.
e. A vacuum erection system which is an external device used to provide erection in men and may be 
used in some cases as an alternative to the implanted device.
f.
Surgical implantation of a Penile Prosthesis. Implantation of a penile prosthesis may be considered 
medically necessary for men who meet all of the following criteria:
i.
Results from Nocturnal Penile Tumescence (NPT) and/or rigidity testing (e.g., Rigi-scan) indi-
cate that the erectile dysfunction is organic and not psychogenic in nature; and
ii. Patient has attempted the above less invasive therapies (a, b, c, d, and/or e) with failure to have 
an adequate erection.
g. Surgical revascularization. Penile revascularization may be considered medically necessary only in 
men less than 50 years old who meet all of the following criteria:
i.
The erectile dysfunction is the direct result of an arterial injury caused by blunt trauma to the 
pelvis and/or perineum; and
ii. A focal blockage of arterial inflow is demonstrated by duplex Doppler ultrasonography or arte-
riography; and
iii. Diagnostic work-up reveals normal corporeal venous function; and
iv. Member is not diabetic and has no evidence of systemic vascular occlusive disease; and
v. Member is not actively smoking.




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When Treatment of Male Sexual Dysfunction is not covered


When the above medical criteria and guidelines are not met.

Viagra®, Levitra® and Cialis® are not indicated for newborns, children, or women.

Policy: Sexual Dysfunction Treatment, Male


Treatment of sexual dysfunction not related to organic disease is excluded under most plans.

Sural nerve graft in association with radical prostatectomy is considered investigational.

Oral yohimbine therapy.

Arterial reconstructive procedures, dorsal vein arterialization procedures, or penile venous occlusive
surgery (e.g., venous ligation, dorsal vein ligation) in men with erectile dysfunction secondary to arte-
riosclerotic occlusive disease are considered investigational.

Topical cream or gel containing vasodilators are considered investigational.

Extracorporeal shock wave therapy (ESWT) for Peyronie’s Disease is considered investigational.

Policy: Sexual Dysfunction Treatment, Male


Iatrogenic
any adverse condition in a patient occurring as a result of treatment by a physician or surgeon, espe-
cially to infections acquired by the patient during the course of treatment.
Neurogenic
arising from or caused by the nervous system.
Neurological
pertains to the nervous system.
Organic
refers to a physiological cause; pertaining to or arising from an organ or the organs.
Potentiate
increasing of potency; particularly, the synergistic action of two drugs, being greater than the sum of the
effects of each used alone.
Prostatectomy
surgical removal of the prostate gland.
Vascular
pertains to blood vessels in the body.



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MALE SEXUAL FUNCTION


MALE SEXUAL FUNCTION

Stage One - Excitement
• Vasocongestion, or the accumulation of blood in the pelvic area during early sexual arousal contributes to
erection of the penis. The degree of erection during this phase depends on the intensity of sexual stimuli. 
• Routing of blood to the penis requires a working nervous system and the body to be relaxed enough and free
from anxiety. Constriction of blood vessels, due to stress or anxiety, does not allow enough blood to enter
the penis to cause an erection. 
• During an erection, the inner diameter of the urethra doubles and the scrotum pulls toward the body. 
Muscular tension increases in the body. Heart rate and blood pressure both increase. 
• It is normal for men to experience periods when the erection is lost during sex play, but then regained. 
• Distraction can lead to loss of excitement and erection. 
• Emotional or mental well-being can affect desire, excitement/arousal and therefore, erectile functioning. For 
example, depression is associated with increased sexual problems.
Stage Two - Plateau Phase 
• The penis increases in size slightly during second stage of sexual response, particularly toward the glans or
“head.” 
• It is less likely for a man to lose his erection if distracted during plateau phase than during excitement. 
• The testes increase in size by 50 percent or more and become elevated toward the body. 
• Muscular tension heightens considerably and involuntary body movements increase as orgasm approaches.
Heart rate increases to between 100-175 beats per minute. 
• Usually during the plateau phase, a man will notice a small amount of clear fluid at the opening of the urethra
that is released from the Cowper’s gland. This is known as “pre-cum” and serves to change the Ph balance
of the urethra so that sperm may survive. This pre-ejaculatory fluid may be released during the excitement 
phase, may vary with each man and each sexual act. The pre-ejaculatory fluid may contain Sexually 
Transmissible Infections (STI’s) or, sometimes, sperm that has remained in the urethra from previous 
ejaculations. 
Stage Three - Orgasm 
• Actual climax and ejaculation are preceded by a distinct inner sensation that orgasm is imminent. This is 
called ejaculatory inevitability. Almost immediately after that feeling is reached, the male senses that
ejaculation cannot be stopped. 
• The most noticeable change in the penis during orgasm is the ejaculation of semen. The muscles at the
base of the penis and around the anus contract rhythmically, with intervals of about 0.8 second between the 
first three or four contractions. 
• Physiologically, the sensations of orgasm and the response of ejaculation are two separate functions. As 
such, a man can experience orgasm without ejaculation, or vice versa. However, these two functions most 
often occur at about the same time. 
• Males often have strong involuntary muscle contractions through the body during orgasm and can exhibit 
involuntary pelvic thrusting. The hands and feet show spastic contractions and the entire body may arch
backward or contract in a clutching manner. 
Stage Four - Resolution 
• Immediately following ejaculation, the male body begins to return to its unexcited state. About 50% of the
penile erection is lost right away, and the remainder of the erection is lost over a longer period of time. 
• Muscular tension usually is fully dissipated within five minutes after orgasm, and the male feels relaxed and 
drowsy. 
• Resolution is a gradual process that may take as long as two hours.

Refractory Period

• During resolution, most males experience a period of time in which they cannot be re-stimulated to 
ejaculation. 
• On average, men in their late thirties cannot be re-stimulated for 30 minutes or more. 
• Very few men beyond their teenage years are capable of more than one orgasm during sexual encounters. 
• Most men feel sexually satiated with one orgasm