Ed meds news and information.

Oct. 21, 2003 (Salt Lake City) — With prostate cancer treatment success often comes at a heavy price: erectile dysfunction. But, a new study shows that Viagra will work in nearly 70% of the men who have radiation-associated erectile dysfunction for years to come.

Michael Zelefsky, MD, of Memorial Sloan-Kettering Cancer Center, N.Y., tells WebMD that the radiation-associated erectile dysfunction usually “begins about six months after they have concluded therapy, but it can occur at any time during or after treatment.” He says that he has already reported that “about 70% of men initially respond to Viagra. However, they didn’t know if the response would be durable.”

In the new study, which was presented at the 45^th Annual Meeting of the American Society for Therapeutic Radiology and Oncology, Zelefsky and his colleagues studied the “” of response by following 360 men with radiation-induced erectile dysfunction who initially responded to the drug. He followed the group for an average of nearly four years after their surgery to see if they were still taking Viagra for erectile dysfunction.

The results, he says, were surprising. “I didn’t really expect them to still be taking the drug and I expected that for many men the effect would diminish with time.” But after almost four years, 96% of the men who initially responded to Viagra were still taking the drug and all but six of those men said the drug was still effective.

All of the men in the study had prostate cancer that was confined to the prostate gland. They received radiation therapy by either external beam treatment or by brachytherapy, in which radioactive “seeds” implanted in the prostate deliver radiation directly to the tumor.

The external radiation is done while the patient lies in a special box that allows multiple radiation beams to be directed directly to the prostate gland from all sides, while the rest of the body is protected from the radiation.

Prostate cancer is mainly found in older men. After prostate cancer has been diagnosed, tests are done to determine if it has spread outside the gland. Because there are different available, how much the cancer has spread this will help in deciding what treatment is best for the cancer.

Surgery to remove the cancer is one option that is used to treat prostate cancer. Radiation is another therapy used in treating this cancer. Erectile dysfunction can occur in men treated with either one of these treatments.

Zelefsky says the men who reported that Viagra stopped working were those who were treated with extremely high-dose external radiation.

Richard Valicenti, MD, associate professor radiation oncology, at Thomas Jefferson University Hospital, in , tells WebMD that the study is “important since it shows that treatment with Viagra can deliver a durable response.” But Valicenti, who wasn’t involved in the study, says that he, too, is a little surprised by the results, especially because of the fairly large range in the length of treatment and because drug tolerance is common.

“We don’t really know how often they are taking the drug. We know that with repeated use tolerance develops for many drugs and we expect it for this drug as well,” he says.

If tolerance does develop, the new erectile dysfunction drug, Levitra, could be an option says Zelefsky. He says his group is a study with this newly approved drug but notes that it will be sometime before the results are available. Meanwhile, he says that he is trying Levitra in men who don’t initially respond to Viagra.

Aug. 6, 2004 — Men with low testosterone levels who suffer from erectile and have tried Viagra without success may benefit from adding a testosterone gel to their impotence treatment plan.

Nearly 30% to 50% of men with erectile dysfunction who take Viagra don’t respond adequately to treatment. The reason could be low levels of the sex hormone testosterone, according to a new study published in the Journal of Urology.

Low levels of the hormone could lead to a low sex drive and erectile dysfunction, , fatigue, and osteoporosis in men.

The study tracked 75 men aged 18-80 years old with low levels of testosterone and erectile dysfunction. All the men were in stable, heterosexual and had failed to respond to treatment with 100 milligrams of Viagra.

For 12 weeks, the men took Viagra in combination with either the testosterone gel (AndroGel) or a placebo gel. The gel is applied to the skin and is absorbed slowly resulting in an increased blood level of testosterone. Viagra improves erectile dysfunction without causing an increase in testosterone levels.

Researchers gauged the men’s sexual function, quality of life, and testosterone levels at the start of the survey and every four weeks the study.

The men using the testosterone gel along with Viagra improved in every category. Men receiving testosterone gel reported a 34% improvement in impotence compared with a 17% improvement seen in men taking the placebo gel. They also reported a 28% improvement in orgasmic function compared with only a 4% improvement reported in men taking the placebo.

Overall satisfaction also improved, with men receiving AndroGel reporting a 32% improvement compared with a 10% improvement in overall satisfaction in men on placebo.

The benefits were noted about four weeks into the study.

The conclude that men seeking treatment for erectile dysfunction should be screened for low testosterone before beginning therapy and using testosterone gel along with Viagra may be better for men with erectile dysfunction and low testosterone levels than just taking Viagra alone.

June 8, 2005 — The FDA has approved Viagra’s active ingredient to treat pulmonary , a rare, life-shortening lung disorder that causes high blood pressure in the lungs.

Viagra’s maker, Pfizer, a WebMD sponsor, announced the approval in a news release. Pfizer will repackage Viagra’s key ingredient (sildenafil) and market it as Revatio.

Revatio would be used to improve exercise ability in patients with pulmonary hypertension, says Pfizer. The approved dose is limited to 20 three times daily. The white, round pills will look different from Viagra’s blue diamonds and should be available by mid-July, says Pfizer.

Rare Condition

Pulmonary hypertension involves dangerously high pressure in the blood vessels that lead from the heart to the lungs. It affects an estimated 100,000 people worldwide, says Pfizer.

Most cases of pulmonary hypertension are due to some condition, such as chronic lung or heart disease. Nearly 300 cases, mostly women in their 30s, are diagnosed per year, says the National Heart, Lung, and Blood Institute (NHLBI). There is no known cause.

Symptoms include difficulty breathing, dizziness, and fatigue. Without treatment, patients live less than three years from the time of diagnosis, on average, says Pfizer.

Another oral drug, Tracleer, is also used to treat the condition. Revatio’s effectiveness hasn’t been evaluated in patients taking Tracleer, says Pfizer. The drug company says Revatio is the first oral treatment approved for patients with an early stage of the progressive condition.

Study’s Results

The FDA’s approval was based on a study of 277 people with pulmonary hypertension, says Pfizer. Patients were randomly assigned to get a placebo or 20, 40, or 80 milligrams of Revatio three times daily.

After 12 weeks, all three Revatio groups showed “highly significant improvements” in the distance they could walk in six minutes, compared with the placebo group, says Pfizer. Average pressure in the lung arteries and other heart functions also improved with Revatio, and in a year-long trial, 94% of patients taking Revatio were still alive, says Pfizer.

No dose had an advantage, and the lowest dose was approved.

Side Effects

Pfizer says Revatio was generally well tolerated, with side effects similar to those seen with Viagra.

The most common side effects for Revatio were headache, indigestion, flushing, insomnia, and nosebleeds. Viagra’s most common side effects are headache, facial flushing, and upset stomach; less common (and brief) side effects are bluish vision, blurred vision, or sensitivity to light, says Pfizer.

Pfizer also recently said it is talking with the FDA about possible label changes to Viagra regarding extremely rare reports of vision loss.rare reports of vision loss. The drug company says there is no evidence that those rare cases occurred more often in men taking Viagra. Pfizer says no such problems were seen in clinical trials of Viagra, and no cases were noted in the Revatio news release.

Ongoing Care Needed

It’s important to get ongoing medical care for pulmonary hypertension, says the NHLBI. The NHBLI also recommends walking for patients who can do so, as well as eating healthfully, getting enough rest, and not smoking. Relaxation exercises, stress reduction, and a positive attitude may also help patients stay active for as long as possible, says the NHLBI.

May 5, 2003 (New Orleans) — Depression takes all the joy out of life, even the joy of sex. for many people, many symptoms of depression diminish once they begin treatment with antidepressant drugs such as Prozac. But for many women, when the depression leaves the sexual dysfunction remains, says H. George Nurnberg, MD, professor of psychiatry at the University of New Mexico.

For these women, he says that Viagra can change their lives.

In fact, he tells WebMD that Viagra is just as good at reversing sexual dysfunction in women as it is in reversing similar symptoms in men.

And he presented his evidence at the 51st annual clinical meeting of the American College of Obstetricians and .

Nurnberg, who has already published a study in the Journal of the American Medical about the efficacy of Viagra in men who have sexual dysfunction associated with treatment for depression, says that 84% of women in his study had a return of sexual enjoyment after treatment with Viagra.

The study enrolled 42 women who had no history of sexual dysfunction before treatment for depression. All of the women were treated with one of the SSRI type of antidepressants such as Prozac or Zoloft, which often have sexual dysfunction as a side effect. All the women were “no longer depressed after being treated with those drugs for six to eight weeks,” he says. But all the women “reported sexual dysfunction related to the SSRI treatment.”

The women are randomly selected to take either Viagra or dummy pills for eight weeks. Neither the women nor the doctors knew which pills the women were getting.

Nurnberg and his colleagues assessed response using a standard psychiatric test designed to measure sexual function. The test, called the Clinical Global Impression-Sexual Function or CGI-SF, scores responses about arousal or sexual satisfaction, using a 1 to 7 rating system, with lower scores indicating better functioning.

At the end of the study, “84% of women had a score of 2 or less,” he says. Moreover, he says that Viagra can be given at the same time as the antidepressant, which might make women “less likely to discontinue antidepressant treatment, which is a real problem since only about 20% of women are willing to stick with a full course of antidepressant therapy.” He says that often this reluctance to stay the course with treatment is related to the sexual dysfunction side effect.

Gerald F. Joseph Jr., MD, medical director of women’s services at St. John’s Health System in Springfield, Mo., tells WebMD that Nurnberg’s results are but he is not entirely sold on Viagra. He says, for example, that “placebo effect is very powerful in studies of sexual dysfunction, and I’m not sure these findings are not really just a placebo effect.”

Joseph, who wasn’t involved in the study, says that as a surgeon he thinks the only way that Viagra could work in women is if the women have sexual dysfunction that is “associated with an abnormality in the erectile tissue present in the genitals. Otherwise, it just doesn’t make sense.”

Jan. 7, 2004 — Viagra can do wonders for men. But a new study shows it also improves sex for some postmenopausal women.

The findings come from a research team led by gurus Jennifer R. Berman, MD, and Laura A. Berman, PhD. The placebo-controlled study, funded by Viagra maker Pfizer Inc., evaluated 202 postmenopausal women diagnosed with female sexual arousal disorder (FSAD). This disorder is defined as distress from an inability to attain or maintain sexual excitement.

Half the women were treated with Viagra; the other half got inactive placebo pills. Many of the women who got the placebo reported improved genital sensation. Some even reported more sexual . But both of these were much more common among women who took Viagra.

The little blue pill didn’t work for women who, in addition to FSAD, also had something called hypoactive sexual desire disorder or HSDD. While many women with FSAD have difficulties with genital blood flow — suggesting a physical problem that Viagra can help — women with HSDD may be more likely to have an underlying emotional or relationship problem leading to lack of sexual desire.

“Unresolved emotional or relational issues should be addressed before beginning medical therapies,” Berman and colleagues stress. Their report appears in the December 2003 issue of The Journal of Urology.

Viagra, Genital Sensation, and Sexual Satisfaction

Women were included in the study if they were postmenopausal or if they had a hysterectomy. Their ages ranged from 30 to 71 with an average age of about 51.

The Berman team focused on the women’s answers to two questions after taking Viagra or placebo:

• After taking the study medication, the sensation/feeling in my genital (vagina, labia, clitoris) area during intercourse or seemed to be: (a) more than before, (b) less than before, or (c) unchanged.
• After taking the study medication, intercourse and/or foreplay was (a) pleasant and satisfying; better than before taking the study medication; (b) unpleasant; worse than before the study medication; (c) unchanged; no difference; or (d) pleasant but still not like it used to be or I would like it to be.

Among placebo recipients, 44% reported improvement in the first question and 28% reported improvement in the second question.

Among all Viagra recipients, 57% reported improvement in the first question and 42% reported improvement in the second question.

But among Viagra recipients with sexual arousal disorder who did not have HSDD, the results were more striking: 69% reported improvement in the first question. This group was eight times more likely to report improvement than women without HSDD who got placebo.

Similarly, among Viagra recipients with sexual arousal disorder who did not have HSDD 50% reported improvement in the second question. This group was 11 times more likely to report improvement than non-HSDD women who got placebo.

The authors note that women who respond to Viagra may need to have normal levels of estrogen and . For many postmenopausal women, that may mean menopausal replacement therapy. In the present study, the women had normal hormone levels or were receiving menopausal replacement therapy.

SOURCE: Berman, J.R. The Journal of Urology, December 2003; vol 170: pp 2333-2338.

Feb. 1, 2005 — A new use for Viagra may be in the works. The erectile drug may help protect against lung problems resulting from high altitudes, say French .

High altitude can cause illness, in people with existing heart and lung problems. The thinner air or lack of oxygen at higher altitudes can cause blood vessels to constrict. When this occurs within the lungs, the constriction of blood vessels can put more force on the heart, leading to life-threatening heart failure. The higher altitude can cause blood vessels in the lung to leak fluid and build up in the lung, with oxygen exchange.

Viagra works by relaxing blood vessels, allowing more blood to flow freely through vessels. The researchers used this drug to block the effects of high altitude on blood vessels on the lung. They looked at whether the use of Viagra would help the lungs continue to get oxygen while ascending to higher altitudes.

In a recent experiment, Viagra was better than a placebo at protecting men’s lungs. The results appear in the February issue of the American Journal of Respiratory and Critical Care Medicine.

This was no ordinary lab test. Instead, 12 men perched on a French mountain about 2.7 miles (4,350 meters) above sea level, pushing their lungs to the limits in the name of science.

The participants were normal, healthy men around 29 years old. They weren’t mountaineers. None was used to high altitudes. The closest any of them had gotten to Mount Everest was probably seeing it in a photo.

But they were in for an adventure when they enrolled in the study.

June 28, 2005 — Pfizer officials say they have found no sign of increased
blindness risk in men taking its drug Viagra.

Pfizer staff have reviewed all reports of eye-related events since the drug
has been on the market, according to a news release from the pharmaceutical
company.

“There is no evidence that Viagra causes blindness or any other serious
ocular condition,” says Joseph Feczko, MD, in the news release. Feczko is
Pfizer’s chief medical officer.

Pfizer is a WebMD sponsor.

Rare Vision Problem

“Men taking Viagra are at no greater risk for blindness than men of
similar age and health not taking the medicine,” says Feczko.

That includes a rare vision problem called nonarteritic anterior ischemic
optic neuropathy (NAION), says Feczko. NAION is a painless swelling of the
optic nerve that causes a rapid reduction in vision.

A journal report earlier this year noted
NAION in 14 Viagra users. Most had other health problems or
eye problems that raised their risk of NAION. None of the men in the
study went blind, although their vision loss was permanent and reportedly
started within 24-36 hours of taking Viagra.

Pfizer: No Evidence Seen in More Than 27 Million Users

“After more than 10 years of rigorous clinical study and worldwide
safety monitoring of a medicine used by more than 27 million men, there is no
evidence to suggest a link between Viagra and blindness or other serious ocular
events,” says Feczko.

“In addition, several studies specifically looking into the effect of
Viagra in the eye by Pfizer as well as independent ophthalmologic experts found
Viagra to have no serious adverse effects on the eye,” he says.

Pfizer, FDA Discussing Label Changes

According to Pfizer’s statement,
the company is still talking to the FDA about changing Viagra’s label to
reflect rare vision problems in men who have used the drug.

The update would reflect rare reports of NAION in some men who have used the
drug.

However, the FDA concluded that no causal relationship between Viagra and
NAION has been established, says Pfizer.

Talks between Pfizer and the FDA were first reported in May.

Label Changes for Other ED Drugs?

Other erectile drugs may also update their labels.

“It is Pfizer’s understanding that the FDA has asked that similar
information be included in the labels of all oral ED (erectile dysfunction)
medicines,” the company’s statement reads.

Patients should consult their doctors about using Viagra and follow the
drug’s information, as with any other medicine, says Pfizer.