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Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Sildenafil (Revatio ® ) Treatments for Pulmonary Hypertension.

Information is based on the United States Food and Drug Administration drug labeling. Sildenafil is an oral medication called a phosphodiesterase-5 (PDE5) inhibitor approved for the treatment of pulmonary arterial hypertension (PAH) in World Health Organization (WHO) Group 1 patients.

The goal of this therapy is to improve exercise ability and delay clinical worsening.

Research studies showing the effectiveness of the medication included mostly patients with symptoms that were rated as WHO Functional Class II-III.Sildenafil is marketed as Revatio® for PAH and was approved by the United States Food and Drug Administration (FDA) in 2005.

Sildenafil is also marketed as Viagra® which is FDA-approved for the treatment of erectile dysfunction but not for the treatment of PAH.

PDE5 is a substance produced in the lungs and other parts of the body that breaks down another substance called cyclic guanosine monophosphate (GMP). Cyclic GMP causes the blood vessels (arteries) to relax and widen.

Sildenafil decreases the activity of PDE5, so that more cyclic GMP is available for the blood vessels inside the lungs.

This leads to relaxation, or widening, of those vessels.

Relaxing and widening of the blood vessels in the lungs decreases the pulmonary blood pressure to the heart and improves its function. This reduces blood pressure in the lungs which generally results in the ability to be more active.

Revatio® is only available as a round, white 20 mg pill, to distinguish it from Viagra®, which is a blue diamond-shaped pill.

Revatio® injection is supplied as a single-use vial containing 10 mg (12.5 mL) of sildenafil.

Sildenafil must be prescribed by a physician, and insurance approval must be obtained prior to starting therapy.

It is carried by most retail and specialty pharmacies, including Accredo Health Inc., Aetna Specialty Pharmacy, CVS Caremark, Cigna Tel-Drug, CuraScript, Kaiser Permanente Specialty Pharmacy, Precision Rx,

Walgreens

Specialty Pharmacy (Medmark) and WellCare. It is expected that most health insurance plans will pay part of the cost of this medication. However, some plans still leave patients with a high out-of-pocket responsibility. Depending on your insurance type, you may be eligible for assistance from the company that manufactures your therapy or from a non-profit charitable assistance organization.

For more information visit www.PHAssociation.org/Help or call 301-565-3004.

The most frequent side effects are: Nose bleeds Headache Upset stomach and heartburn Flushing of the skin Difficulty sleeping Worsening shortness of breath Nasal congestion.

Other side effects include: Fluid retention Nausea and diarrhea Pain in the extremity (arm or leg) Temporary muscle aches Fever Numbness. A reduction in blood pressure throughout the body may occur because sildenafil relaxes blood vessels (arteries) throughout the body.

Caution must be used in patients with low blood pressure, less than 90/50 mmHg for example. Caution is also needed in patients

with

dehydration, left-sided heart diseases and certain abnormalities of the body’s nervous system function.

Taking certain medications such as nitrates, nitric oxide donors or alpha blockers along with sildenafil can cause a significant drop in blood pressure.

This could result in loss of consciousness or even death. You should make certain that you are not taking these medications before starting sildenafil. Use of sildenafil with medications known as nitrates is CONTRAINDICATED.

Prolonged

erection

(greater than four hours) in a male patient is a rare but very serious side effect; if this should happen to you, you should go to an emergency room or contact your doctor immediately. Sudden loss of vision in one or both eyes has occurred in patients on PDE5 inhibitors. Such an event may represent serious dysfunction of the optic nerve and requires immediate medical attention. Sudden loss of hearing may occur and may be accompanied by dizziness and/or ear ringing.

Patients should seek prompt medical attention should this occur.

Your doctor may ask you to monitor your blood pressure on a regular basis particularly during your first few days on treatment or with a dose increase.

Blood pressure monitoring is not needed for most patients.

If you experience any of the symptoms mentioned in the previous section, you should promptly notify your physician.

What are considerations for use of sildenafil in special populations? The safety and effectiveness of sildenafil in pediatric PAH patients has not been established.

Sildenafil does not exhibit harm to the fetus in animal studies; however it has not been evaluated in pregnant women or women who are breastfeeding. It should be used in pregnant or nursing mothers only if the potential benefit justifies the risk to the fetus or infant. Safety and efficacy in pediatric patients has not been established, and this drug should not be used in patients under 18 years of age. Mild-to-moderate liver disease does not require a dose adjustment.

No dose adjustment is required in patients with kidney disease. Sildenafil may be associated with a serious condition known as vaso-occlusive crisis in patients with PH and sickle cell disease. The effectiveness of sildenafil in PH secondary to sickle cell anemia has not been established. Sildenafil is not recommended in patients with either of two rare diseases often associated with PAH: pulmonary veno-occlusive disease and pulmonary capillary hemangiomatosis.

What are important drug interactions with sildenafil? (Please see package insert for full details) Sildenafil should not be used in combination with nitrates or nitric oxide donors as an unsafe drop in systemic blood pressure may occur. Caution should be used if sildenafil is to be used in combination with either alcohol or anti-hypertension or blood-pressure-lowering medications. Sildenafil is broken down predominantly by an enzyme called CYP3A in the liver; therefore, important interactions may occur with medications that affect this enzyme pathway.

Simultaneous use of bosentan and sildenafil may result in increased bosentan blood levels and decreased sildenafil blood levels. It is not known if these changes are clinically significant. Although a drug interaction has been demonstrated with sildenafil and bosentan, dose adjustments are presently not recommended for either drug.

Patients with human immunodeficiency virus (HIV or AIDS) who are taking medicines called antiretroviral agents should not use a phosphodiesterase inhibitor such as sildenafil since it can dramatically impair the efficacy of the antiretroviral.

Use of sildenafil with epoprostenol may reduce the blood level of sildenafil. Use of sildenafil with beta blockers (another type of heart or blood pressure medicine) may increase the levels of sildenafil. Miscellaneous considerations: Is there any risk of blindness when using sildenafil? There have been rare reports of blindness with use of all the currently available PDE5 inhibitors, including sildenafil.

This type of blindness, which may be permanent, is called non-arteritic anterior ischemic optic neuropathy (NAION). It is not yet clear whether this is related to the use of sildenafil or to the underlying cardiovascular diseases that place the persons at risk for this particular type of blindness, even in the absence of sildenafil use.

There is no research to determine whether use of sildenafil is beneficial or safe in patients with retinitis pigmentosa, and use in these patients is not recommended. As noted above, patients taking sildenafil should seek immediate medical attention in the event of sudden vision loss.

Yes, studies have evaluated sildenafil in both men and women with PAH, and no differences in side effects have been reported between genders.

Studies have not shown any effect on sexual function in women who have taken sildenafil. Viagra is now being used to treat not only erectile dysfunction (ED) but also pulmonary hypertension.

And the drug may have potential for treating several other conditions, according to a recent report.

The three ED medications currently on the market—Viagra, Levitra, and Cialis—all work by the same means, and they have similar side effects.

The most common are headaches and facial flushing, which occur in 15% of men.

Other reactions include nasal congestion, indigestion, and back pain.

The most important worry about ED pills is their ability to widen arteries enough to lower blood pressure.

And men who are taking nitrates should never use any of the ED pills.

Although some of the drugs’ side effects may be troublesome, others may be helpful, and scientists are studying whether ED pills might help treat a variety of nonsexual problems.

Viagra (sildenafil) has been on the market longest and is most studied.

It’s yet not clear if the other ED pills offer similar benefits, but Viagra, at least, may prove useful for some other conditions, including these: Pulmonary hypertension. Viagra is now marketed under the name Revatio for this uncommon but serious disorder of high pressure in the blood vessels leading to the lungs.

Viagra can reduce pulmonary artery pressure at high altitude and improve the ability to exercise in low oxygen conditions. In affected individuals, exposure to the cold triggers spasm of the small arteries that supply blood to the fingers, toes, or both, which become pale, cold, and painful. Both Viagra and Levitra have been helpful in clinical trials.

Studies suggest Viagra might help patients with congestive heart failure or diastolic dysfunction.

Further details are published in the August 2007 issue of Harvard Men’s Health Watch.

April 28, 2003 -- A new study has found that the impotence drug Viagra could ramp up the sex lives of women who take it, just as it has done for men. The 12-week study focused on 202 post-menopausal or post-hysterectomy women who complained of female sexual arousal disorder. The women in the group who took Sildenafil — the little blue pill commonly known as Viagra — took notes after each sexual experience, and reported better overall sexual satisfaction compared with those who took a placebo. Their enhanced sex lives included better arousal, lubrication and orgasm. The study was conducted by Laura Berman, director of the Berman Center and a professor of OB-GYN and psychiatry at Northwestern University in Chicago, and Dr.

Jennifer Berman, director of the Female Sexual Medicine Center at UCLA Medical Center in Los Angeles.

The researchers say that the results are preliminary.

"In terms of ability to achieve orgasm, there was a statistically significant movement," Laura Berman said on ABCNEWS' Good Morning America.

"It increases blood flow to the genital area, increases the sensation of warmth, tingling and fullness," she said.

More than 50 million women experience some type of sexual dysfunction.

Jennifer Berman said it's important for women to remember that this pill can't overcome mental and emotional barriers to a satisfying sex life.

"At this point, we can say that women with significant emotional or relationship problems and women that have desire problems related to their interest in being sexual might not be the best candidates," Jennifer Berman said. "It's for women who were satisfied with their sexual response at one point and now, for whatever medical reason, are no longer able to respond," she said.

Women who suffer from female sexual arousal disorder can experience a variety of symptoms, including lack of "excitement," vaginal dryness, loss of sensation and sensitivity in the genitals and nipples and low blood flow to the genitals. Women in the study were screened to make sure that psychological or relationship issues were not the cause of the problem.

Since Viagra enhances sexual arousal in men by increasing the blood flow to the penis, the Bermans theorized that the drug could have a similar effect on women, increasing the

blood

flow to the female genitals and thereby producing better arousal, sensation and lubrication in the genital area. Women in the study were given doses of 50 milligrams, which was increased to 100 milligrams only once during the study based on how well the lower dose was working, and the women's tolerance to it. The pill was to be taken prior to sexual activity but no more than once daily.

Each patient had to engage in sexual activity at least once a week and keep a personal log about it. During the course of the study, neither the patients nor the doctors knew which patients were receiving the Viagra. Women taking Viagra reported mild to moderate side effects, including headache, flushing, nausea, and vision symptoms — the same side effects reported by men who take the drug. Effect of Regular Sildenafil on Blood Pressure and Arterial Function in Hypertension. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U.S. Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record. Condition or disease Intervention/treatment Phase Hypertension Drug: Sildenafil citrate Phase 2.

Inhibitors of phosphodiesterase type 5 (PDE5), such as sildenafil, relax blood vessels. In the penis this facilitates erection and sildenafil has proved a very effective treatment for male erectile dysfunction. To date, most work on the effects of sildenafil on blood pressure have mainly been investigated in single dose studies.

These have shown that sildenafil causes a modest reduction in blood pressure, even when taken with other blood pressure-lowering drugs, providing reassurance on safety when taken as a single dose for erectile dysfunction. However, these

studies

do not offer any insight into the potential of PDE5 inhibition in the long-term treatment of hypertension. We will address this question by investigating the effects of regular administration of sildenafil on blood pressure. It may also be postulated that, because of its mechanism of action, sildenafil will also improve the function of the endothelium, the single layer of cells that lines all blood vessels. Therefore, the effect of regular sildenafil on endothelial function in hypertension will also be investigated in the study. The study will be performed in a randomised, placebo-controlled, double blind, 2-way crossover manner.

Sildenafil and matched placebo will each will taken three times daily for 2 weeks, with a washout of at least 6 days between treatments.

Measurements will be made acutely (before and 1 hour after oral sildenafil) of heart rate, blood pressure, pulse wave analysis (a measure of wave reflection in arteries), pulse wave velocity (a measure of arterial stiffness) and flow-mediated dilatation (a measure of endothelial function). These measurements will be repeated 2 weeks later (again just before and 1 hour after oral sildenafil).

In addition, ambulatory blood pressure will be recorded after 2 weeks of treatment (baseline ambulatory BP will be taken as the recording made at diagnosis).

Older men like Playboy’s Hugh Hefner and actor Michael Douglas have sung the praises of Viagra, but now scientists say the erectile dysfunction pill is not only good for your sex life — it’s good for your heart.

In the bedroom, Viagra allows greater blood flow to the penis.

But in the heart, the “little blue pill” can prevent heart muscle thickening and early-stage heart failure, according to research published today in the open access journal BMC Medicine.

"Large clinical trials are now urgently needed to build on these encouraging findings,” said lead author Dr.

Isidori, associate professor of endocrinology at Sapienza University of Rome.

Dosages used for heart ailments are lower than those used for erectile dysfunction, and patients in the study showed few side effects. “Surprisingly, in over 1600 treated subjects, no increased risk of visual disturbance, photosensitivity and ‘blue haze,’ was observed,” he told NBC News. The active ingredient in Viagra is sildenafil citrate, which is a phosphodiesterase type 5 inhibitor (PDE5i).

The inhibitor blocks the enzyme PDE5, which prevents relaxation of smooth muscle tissue. Researchers analyzed randomized trials that had been published between January 2004 and May 2014, choosing 24 involving mixed populations of patients who were treated with PDE5i or a placebo. PDE5i was given to men who had cardiovascular disorders, but who did not necessarily suffer from sexual impotence, according to Isidori.

The study found that the inhibitor prevented the heart from changing shape in patients suffering from left ventricular hypertrophy, a condition that causes thickening and enlargement of the heart muscle. The drug also improved functioning of the heart in patients with a variety of cardiac conditions, with no effect on blood pressure. In fact, researchers found that the drug improved efficiency when the heart pumped blood into vessels, along with relaxation between beats. “Very few drugs used in cardiology can actually affect these parameters.

For this reason their implications in the treatment and prevention of heart failure are huge.” However, Isidori notes that because these studies were conducted exclusively on men, the next step should be a larger trial on women. This site is protected by recaptcha Privacy Policy | Terms of Service. "A significant number of subjects suffering from erectile dysfunction are much happier to take pills for heart failure or high blood pressure than to improve their erections." “I am not surprised and it’s good news,” said Dr. Kloner, professor of medicine in the cardiovascular division at the Keck School of Medicine at USC in California. “We can always use a new drug

for

heart failure." Kloner co-authored the book, “Viagra: How the Miracle Drug Happened & What It Can Do for You.” He said this is not the first time, scientists have looked to Viagra for potential heart benefits.

In 1989, British scientists tested sildenafil citrate as a medication to treat high blood pressure and angina.

By the 1990s in early trials of the drug, researchers noticed an interesting side effect — an increase in erections. In 1996, the pharmaceutical company Pfizer patented it as Viagra, and in just two years, doctors had ordered more than 40,000 prescriptions of the new wonder drug.

“When the drug first came out there was a big scare — is this going to kill people?” said Dr.

Kociol, director of the heart failure program at the CardioVascular Institute at Beth Israel Deaconess Medical Center in Boston.

“But in all studies, to the best of my knowledge, it’s not shown any increase in cardiac events in patients who take these drugs,” he said.

Past studies have suggested Viagra and other PDE5 inhibitors may have benefits for heart failure by decreasing pulmonary artery resistance and providing cardio-protective effects in settings with low blood flow, according to Kociol.

“They also improve exercise tolerance in patients with heart failure,” he said.

The drug may even reduce the size of a heart attack.

But Kociol said scientists have to “temper” their enthusiasm as more studies are necessary.

“As interesting as this paper is, there have been conflicting results,” he said. “If there is a silver bullet, it remains to be seen.” Kociol added that researchers also need to “pay more attention” differences between men and women and between racial groups. Some earlier research suggests that drugs like Viagra might interact differently with estrogen, which is known to have naturally protective properties for

the

heart.

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