Viagra (Sildenafil Citrate) Reviews and Drug Information

KQ 1. The clinical utility of routine blood tests—testosterone, prolactin, LH, FSH – in identifying and affecting therapeutic outcomes for treatable causes of ED was examined using reports of measurements of serum testosterone, FSH, LH, prolactin, and/or other hormone levels, (but not gonadotrophin-releasing hormone [GnRH], Inhibin, Activin, or Follistim). It was also examined in reports of the prevalence of reversible hormonal disorders in males with erectile dysfunction. The study selection criteria included the following:

• Source: Primary study report published in English
• Study design: Any (prevalence studies)
• Population: Adults (age ≥ 18 years) diagnosed with ED with or without concurrent endocrinopathy (i.e., hypogonadism, hyperprolactinemia, abnormal levels of LH/FSH)
• Intervention (experimental): Hormonal blood tests (i.e., testosterone/prolactin/LH/FSH)
• Outcomes: Prevalence of endocrinopathies (i.e., hypogonadism, hyperprolactinemia, abnormal levels of LH/FSH)

KQ 2. Benefits of pharmaceutical treatments (e.g. oral, injections, hormonal, topical, intra-urethral suppositories) in males with ED. To address how patient specific characteristics (e.g. specific symptoms/origin, duration, severity of ED/comorbid conditions) affect prognosis/treatment success for ED patients. Evidence on the following treatment modalities was excluded from this review: Natural health products (e.g. herbals), yohimbine, vacuum constriction devices, and sex or surgical therapies (e.g. penile prosthesis implantation, penile arterial reconstructive surgery). Study selection criteria included the following:

• Source: Primary study report published in English
• Study design: RCTs (comparative efficacy and harms studies)
• Population: Adults (age => 18 years) diagnosed with ED (with or without comorbidities)
• Interventions (experimental/control): Oral (PDE–5 inhibitors, sublingual) injections (IC, cream)
• Outcomes: Clinically relevant efficacy measures (i.e., scores for the IIEF “EF” domain, IIEF–Q3/Q4, SEP-Q2/Q3, GAQ-Q1, EDITS)

KQ 3. Harms of pharmaceutical treatments (e.g. oral, injections, hormonal, topical, intra-urethral suppositories) in males with ED. Evidence on the following treatment modalities was excluded from this review: Natural health products (e.g. herbals), yohimbine, vacuum constriction devices, and sex or surgical therapies (e.g. penile prosthesis implantation, penile arterial reconstructive surgery). Study selection criteria included the following:

• Source: Primary study report published in English
• Study design: RCTs (comparative efficacy and harms studies)
• Population: Adults (age ≥ 18 years) diagnosed with ED (with or without comorbidities)

Antipsychotics Antipsychotic medications are also implicated in ED. These drugs exert their effects primarily by antagonism of dopamine receptors but have effects on several other receptors.

In addition, dopamine antagonism causes hyperprolactinemia which contributes to the sexual dysfunction associated with these drugs. Antiandrogens Antiandrogens are a well-known cause of sexual dysfunction and ED. In recent studies, finasteride has been shown to cause minimal ED at higher doses (5 mg) for prostate cancer prevention, and almost no effect on erectile function at low doses (1 mg) for the treatment of alopecia Illicit Substances and Nicotine Several illicit substances cause ED. In addition, men on methadone maintenance therapy for heroin dependence have been reported to have significant impairment of erectile function.

The use of tobacco products, and specifically nicotine, is associated with ED in both chronic and acute exposure. Nicotine produces vasoconstriction through its actions on endothelial cells through a likely underproduction and degradation of nitric oxide.

A recent study of healthy men between the ages of 18 and 27 reported that the use of nicotine gum immediately decreased erectile response to visual stimuli despite unchanged subjective measurements of sexual arousal. This study may imply an immediate neurogenic and hemodynamic response of the penile tissue to nicotine. Furthermore, chronic cigarette smoking is also associated with an independently increased risk of ED and clinically significant damage to penile vasculature

Ethanol
The role of ethanol, while classically thought to impede erectile function, has been less clear in the literature. Despite the association of alcohol consumption and sexual activity, very little objective evidence exists on the effect of acute ethanol intoxication on erectile function. The data on chronic ethanol exposure is also mixed. Ethanol exposure in an animal model showed histologic evidence of both endothelial damage and metabolicdysfunction.

Impairment of smooth muscle relaxation due to endothelial dysfunction was pronounced while neurogenic smooth muscle relaxation remained intact. Age and Chronic Illness There is no consensus as to whether ED is a nonpathologic, natural aspect of aging in healthy males, though older males do have higher rates of ED. The association between naturally declining testosterone level in older males, socalled andropause, and ED, is complex, but no clear association is found to date.

Interestingly, penile vibrotactile sensation of the penis decreases significantly with age, but this has not been directly linked with ED.

Approximately 82% of men with chronic renal failure (CRF) on hemodialysis have some degree of erectile function, with 45% having severe ED. Additionally, regardless of treatment, patient with CRF have significantly decreased mean nocturnal penile tumescence when compared to both normal and chronically ill controls. The pathophysiology of ED in patients with CRF is complex. A majority of men with CRF have hyperprolactinemia. Uremia also interferes with the HPA such that oligospermia, azoospermia, and impaired steriodogenesis with elevations in LH are common in uremic men.

Zinc deficiency has also been postulated as a potential cause of ED in uremic men and has been targeted for possible therapeutic interventions.

While hyperprolactinemia is often clinically associated with the existence of ED and hypoactive sexual desire, the prevalence and pathophysiology of this association are debated in the literature. The prevalence of hyperprolactinemia in men with ED or sexual dysfunction ranges from 1.5% to 10% in recent literature.

While several studies support the classic hypothesis that hyperprolactinemia causes ED through the suppression of GnRH, there is no consensus as of yet.
While severe hyperprolactinemia is a risk factor for sexual dysfunction, the role of moderate hyperprolactinemia in the pathophysiology of ED is unclear.

Thus, as with androgens, it is unclear if pathophysiologic findings from clinical studies and animal models are applicable to the clinical evaluation of ED. There is also evidence that prolactin may have a dichotomous role in erectile physiology. A recent study found that men with prolactin levels below 5 ng/mL had increased prevalence of arteriogenic ED, while men with hyperprolactinemia only had an increased prevalence of hypoactive sexual desire.

Thyroid Disease Both hypothyroid and hyperthyroid states are associated with ED, though the specific pathophysiology remains elusive. A recent study compared men with thyroid dysfunction to controls and reported that men with both hypothyroidism and hyperthyroidism had significantly increased the prevalence of and more severe ED. Overall, 79% of men with thyroid dysfunction had ED compared to 34% of controls. Both hyperthyroid and hypothyroid men had a prevalence of ED that exceeded the prevalence of ED in the control group. Additionally, both groups had significant response to treatment.

While extrapolation of specific physiologic mechanisms from clinical treatment is limited, these findings suggest that thyroid dysfunction acts at multiple sites to cause ED. There is some evidence that hypothyroidism causes a decline in both testosterone and steroid hormone binding globulin (SHBG).

Interventions (experimental/control): Oral (PDE–5 inhibitors, sublingual) injections (IC, SC), hormonal (e.g. testosterone), intra-urethral suppositories, CPAP, and/or topical (e.g. patch, cream)

Outcomes: Any adverse events, serious adverse events, withdrawals due to adverse events, and specific adverse events.

KQ 3a. The incidence of specific harms such as Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) and penile fibrosis associated with use of PDE–5 inhibitor and injection therapies, respectively. The review included reports of non-RCTs or observational studies. For identification of data on fibrosis related to use of injection therapies, only studies with at least 6 months of followup were included.

Study selection criteria included the following:

Source: Primary study report published in English

Study design: Non-RCTs (experimental or observational case-control and cohort studies, case reports and case-series)

Population: Adults (age ≥ 18 years) diagnosed with ED (with or without comorbidities) Interventions (experimental/control): Oral (PDE–5 inhibitors), injections (IC, SC)

Outcomes: NAION, penile fibrosis Systematic and narrative reviews, case reports, editorials, commentaries or letters to the editor were excluded for all questions except Q3–a (specific harms). Studies evaluating interventions such as penile implant devices or natural health products used for the treatment of ED were also excluded.

The results of the literature search were uploaded to the software program TrialStat SRS version 4.0 along with screening questions developed by the review team and any supplemental instructions. A calibration exercise was undertaken to pilot and refine the screening process. One reviewer screened bibliographic records (i.e., title, authors, key words, abstract) using broad screening criteria (Appendix B). All potentially relevant records and those records that did not contain enough information to determine eligibility (e.g. no abstract was available) were retained. The reasons for exclusion are noted in the QUOROM flow diagram. Two reviewers independently performed full-text relevance screening. Disagreements were resolved by consensus.

Relevant studies were then evaluated to determine study design and were categorized accordingly for inclusion by question. The level of eligible evidence on efficacy was limited to RCTs, since systematic bias is minimized in RCTs compared with all other study designs (e.g. cross-sectional, retrospective cohort).

Estimates from the National Health and Nutrition Examination Survey (NHANES) suggests that the cost of treatment of ED in the U.S. could reach $15 billion if all men sought care.

Analyses by the Erectile Dysfunction subgroup for the Urologic Diseases in America Project identified that almost 1.5 percent of privately insured males between the ages of 18 and 64 had at least 1 claim related to ED in 2002; shifting forms of health care were demonstrated, as the use of diagnostic tests for underlying causes of ED markedly decreased and utilization of pharmacological therapy especially with oral PDE-5 inhibitors, increased.

National pharmacy claims data indicated an increased prevalence of sildenafil use from 1.5 percent in 1998 to 2.9 percent in 2002, with its use increasing with age. For example, in 2002, 6 percent of men aged 55 or older had one or more claims for sildenafil.

Furthermore, the Department of Veteran Affairs (VA) indicated a nine-fold increase in treatment for ED between 1999 and 2003, with 9.3 percent of men 55-64 years of age reporting filling a prescription for oral agents in 2003. The overall use of pharmacological treatment for ED increased from 17,458/100,000 in 1999 to 56,716/100,000 in 2003. This is reflected by data from the VA Pharmacy Benefits Management Group, as prescriptions for specific ED drugs increased from 681/100,000 to 6,120/100,000 during this period. According to national sales, in 2005, the pharmaceutical costs of sildenafil, tadalafil, and vardenafil were $1.6 billion, $747 million, and $327 million, respectively.

Harms Observed in Clinical Trials Headache, flushing, rhinitis, and dyspepsia are the most commonly observed adverse events related to treatment with PDE–5 drugs. There also have been concerns regarding the excess incidence of cardiovascular events and visual disturbances occurring in patients receiving PDE–5 drugs; however, the current evidence does not indicate any marked trends for increased rates of these events in ED patients taking PDE–5 drugs compared with those in the general population

ED is a common disorder of male sexual function that affects all age groups and has a profound impact on quality of life. Given the increasing trends in life expectancy across the Western world (i.e., the aging of the general population) and the high prevalence of diabetes and cardiovascular disease, the impact on lifestyle and quality of life imposed by ED in men is projected to be substantial.

– It was estimated that, in 1995, over 152 million men worldwide experienced ED.

– For 2025, the prevalence of ED is predicted to be approximately 322 million worldwide.

The severity, prevalence and incidence of ED increase with age.

The Massachusetts Male Aging Study surveyed 1,709 men aged 40–70 years between 1987 and 1989, using a self-administered questionnaire that asked participants to rate themselves as not having ED, or having minimal ED, moderate ED, or complete ED. There was a total prevalence of erectile dysfunction of 52 percent when participants with minimal (17.2 percent), moderate  (25.2 percent) and complete (9.6 percent) dysfunction were combined. Both the prevalence and severity of erectile dysfunction increased proportionally with age. When adjusted for age, patients with lower level of education, heart disease, hypertension, and diabetes had a higher probability of ED.

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– In the same study, a sample of 847 men without ED at baseline (1987– 1989) was followed prospectively until 1995–1997.

The crude incidence rate of ED in this population was estimated to be about 26 cases per 1,000 man-years (95% CI: 22.5–29.9).

The annual age-specific incidence rate of ED increased with each decade of age.

For example, the incidence rates (and 95% CIs) for men in two age groups of 50–59 and 60–69 years were

• 29.8 cases per 1,000 man-years (95% CI: 24.0–37.0)
• 46.4 cases per 1,000 man-years (95% CI: 36.9–58.4), respectively.

In a Canadian cross-sectional survey of primary care facilities, about 50 percent of 3,921 men aged 40–88 years had ED (IIEF “EF” domain score <21). The presence of cardiovascular diseases or diabetes was associated with an increased risk of having ED after adjustment for age and other confounders.

Erectile dysfunction (ED) is defined as the persistent inability to achieve or maintain penile erection sufficient for satisfactory sexual performance. The 1992 National Institutes of Health (NIH) Consensus Development Conference recommended the use of erectile dysfunction as the preferred term to impotence, the former being more precise. There is no universal consensus or agreed criteria as to how consistent the problem (i.e., inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance) has to be and for what duration it should last to fulfill this definition. A period of persistence over 3 months has been suggested as a reasonable clinical guideline.

The diagnosis of ED involves a clinical evaluation including medical/physical examination as well as documentation of sexual and psychosocial history. Erectile dysfunction is one of many symptoms of sexual disorders including premature ejaculation, increased latency time associated with age, psycho-sexual relationship problems, and loss of libido. During diagnosis of ED, it is important that other sexual dysfunctions (e.g. loss of libido) be recognized and taken into account. A few validated instruments are used in diagnosing ED, grading its severity, and assessing treatment satisfaction. Some examples of such instruments are the International Index of Erectile Function (IIEF),15 the modified 5-item version of IIEF (IIEF–5), and the Erectile Dysfunction Index of Treatment SatisfactionEDITS). The IIEF is a self-administered 15-item questionnaire consisting of five distinct domains:

• erectile function (total score range 1– 30),
• orgasmic function (total score range 0–10),
• sexual desire (total score range 2–10),
• intercourse satisfaction (total score range 0–15),
• overall satisfaction (total score range 2– 10).

Recommendations based on biochemical investigation may consist of hormonal screening to detect hypogonadism or other underlying common diseases such as hyperprolactinemia, diabetes and dyslipidemia. Other methods that may be used are urine analysis, blood count, lipid levels, or prostate-specific antigen (PSA) concentration. There are also specialized evaluation techniques such as duplex ultrasonography, penile tumescence studies, RigiScan, test injections, audio-visual stimulation and penile brachial index measurement.

Viagra for women serve very much similar purpose as the male Viagra does for men, it increments the women’s libido for sex. Just like Viagra can be had in many forms, the same goes in case of Viagra for women as well. A bunch full of alternatives are available in the market in this regard including capsules, trans dermal patches, cream, et al. It would be reasonable to buy female Viagra in any of these forms if you are really desirous to overcome those mood swings and outperform your male counterpart on bed.

Why Viagra for women?

Since years, Viagra has only been identified as blue pills, used for the treatment of Erectile Dysfunction among men as if women would never have had any sex related issues. But in fact, women may also be compelled to face the problems of decreased sex desire due to many reasons and the decision to buy female Viagra could provide them deep routed respite from such afflictions. There could be many reasons for the sluggish sex desire that may include hormonal changes such as pre-menstrual or post pregnancy illness and physical, emotional or psychological turmoils. Besides these, stress and depression are also the big culprit to kill the women’s erotic senses. To overcome all these problems and help the women to play active part in a sex drive, Viagra for women truly holds the key.

How female Viagra works?

Women who buy Female Viagra undoubtedly are desirous of instant results and these viable medicines are just bang on target to fulfill such a desire. Most of the Viagra for women are effective herbal alternatives and increase blood flow thereby allowing clitoral engorgement to a great extent, just like a male Viagra works actively towards erecting the penis by increasing the blood flow. This in turn makes the female’s vagina to produce moisture in the form natural juices. Mostly available in the form of cream or gel that is applied to the clitoral region, Viagra for women hence enhances the size of the vagina and makes it highly sensitive to penetration by the hard and erected penis of their male partners.

Side-effects of Viagra for women

While you buy female Viagra, you can be rest assured of its efficacy in giving a significant twist to your aphrodisiac sexual urge. In the meantime, if you are worrying of its side-effects, then you need not to do so. Fortunately, unlike their other versions for men, Viagra for women are completely sanctified from the harmful side-effects and are more likely to bring about the desired results without causing any problem to your health. This is probably due to the reason that these Viagra drugs are mostly composed of natural and organic botanical constituents. Hence any possibility of perfume, preservative or any other such unnatural ingredient in their composition is discouraged thereby making them duly sanctified from side-effects.

A 47 years old, of Cincinnati uses Viagra regularly says that unlike men, Viagra in women can lead to a clear sense of where you are. “I felt like a tingling in the pelvic area,” he says. “I almost could increase blood flow. It was like there was an increase in sensitivity.

The woman gave to your doctor Viagra after a hysterectomy, which is almost impossible to orgasm. She said that Viagra has more than 70% of sexual function. The level of orgasm “is not exactly what I had before – not as full,” he says. “But it’s easier.”

Early studies of Viagra and women do not find work, but doctors say that the studies were not sufficiently selective, and even women with desire disorders, such as men who have such problems, can not be helped by Viagra.

As with men, Viagra is blood flow to the genitals in women. For women who have difficulty achieving orgasm, vaginal dryness or lack of feeling of excitement or engorgement, Viagra may help.

In a recent study of 200 postmenopausal women who had experienced either, and hysterectomy, all in some kind of sexual arousal disorder, half were given Viagra for woman and half received a placebo. The researchers found that 57% of women, Viagra reported improved sensation in the genital area, compared with 44% in the placebo group.

Although many researchers say sexual problems are more complicated in women than in men, and unlikely Viagra always work as well as for women than for men.

What are the Most Common Side Effects, and brings them all?

In addition to helping you have sex, Viagra often gives you headaches, a stuffy nose and a drain, his face beet red. But anyone who uses it seems to forget that a lot. In studies, only about 1% of the population declined because of side effects – exactly the same as those of a placebo.

A strange side effect is visual disturbances, including a blue-green tinge to vision, which is about 3% of the time. In studies, about half of the men, the Viagra experience at least one side, and the incidence is higher at higher doses. For men, the Viagra 100 mg in five trials, 23% had headaches, 17% a red face, and 12% had stomach pain. Side effects appear to be similar for women. Side effects tend to disappear with use, if a patient said he liked the Viagra gave him a headache because I knew that meant he was ready.

David Nail, 39, of West Hollywood, California, began with Viagra after a car accident has with spinal cord injury. He says sex is actually better than before his accident and experienced a strong orgasm. Initially, 50 mg of Viagra he bluish vision and a slight headache. Now rarely gets a headache, and the vision side effect has stopped