Aug. 1, 2000 — Daily doses of Viagra may ease the pain of diabetes — but not the way you might think. Animal studies hint that the male impotence drug reverses one of the worst miseries of diabetes: The stomach’s refusal to empty after meals.

The problem affects as many as half of all diabetics and some three-fourths of those who have had diabetes for more than five years. Called , the occasional illness causes bloating, pain, appetite loss, and sometimes fits of vomiting. Currently, there is no effective long-term treatment in the U.S. — especially since Propulsid, the most commonly used drug, has been withdrawn from the market due to safety concerns.

The new findings turn current thinking about gastroparesis inside out. “Maybe we have been thinking about it wrong,” lead researcher Christopher D. Ferris, MD, PhD, tells WebMD. “They called it gastroparesis, which means ’stomach paralysis,’ because they thought the stomach failed to squeeze stuff out. But now we know it is failure to relax — we’ve kind of turned it around.”

Ferris and co-workers at Johns Hopkins in Baltimore discovered something unusual in the muscle that opens and closes the bottom of the stomach. Using laboratory mice with diseases that mimic human diabetes, they found that emptying food from the stomach depends on the ability of nerve cells in this muscle to process an important chemical. This same problem — in a different muscle, of course — afflicts men whose impotence can be relieved by Viagra.

When Ferris’ team gave Viagra to the mice, it prevented the animals from stomach problems. Because gastroparesis in the mice was strikingly similar to gastroparesis in diabetic patients — and because Viagra already is an approved drug — Ferris says he will begin human studies in September or October of this year. Should these trials prove the treatment is safe — a major question, as diabetics are prone to heart disease and Viagra can be dangerous in heart patients — larger human studies will follow quickly. Such studies will be centered at Vanderbilt University in Nashville, Tenn., with which Ferris now is .

Should Viagra prove safe and effective, its cost will be a major issue. Insurance companies already are complaining about supplying more than six of the popular blue pills each month. Diabetics would need at least one pill per day — and those with severe cases would need three pills each day.

Ferris warns patients not to try this treatment at home until the studies can be completed. “I would caution consumers that any drug treatment is not without potential side effects,” he says. “With Viagra, there is a particular concern for patients with heart disease, which is very common in diabetics. People need to be cautious that these studies have been done only in mice, not in humans. History is littered with things that work great in mice and then never pan out. Also, Viagra is expensive. To spend a lot of money on a drug that may not help is not wise.”

The new studies also will have to prove that accepted theories about why diabetics’ stomachs fail to empty are wrong. William W. Webb, MD, who disagrees with the Ferris study, tells WebMD that the muscle at the base of the stomach — known as the pylorus — is supposed to work perfectly well in diabetic patients.

“Relaxing the pylorus is not usually the problem,” says Webb, a gastroenterologist at Henry Ford Hospital in Detroit. “The pylorus usually works fine … It’s not an open drain problem, but failure to push stuff out of the stomach.”

March 14, 2000 (Anaheim, Calif.) — New research shows that 522 patients have died while taking Viagra (sildenafil) in the first year the drug was on the market. Since its introduction in March of 1998, more than 12 million prescriptions of the blockbuster treatment for erectile dysfunction (ED) have been written. There are continued concerns that the drug could trigger heart problems in some users; already it is not recommended for patients taking nitrates for this reason.

“Our data appear to suggest that there’s a relatively high number of deaths and adverse cardiovascular events associated with the use of Viagra. I want to emphasize that in no way are we trying to imply a cause-and-effect ,” lead researcher Sanjay Kaul, MD, a critical care cardiologist at Medical Center in Los Angeles, tells WebMD. Kaul presented his findings here Tuesday at the 49th Annual Scientific Session of the American College of Cardiology.

Kaul got his numbers by lodging a Freedom of Information Act request with the FDA. Overall, he found 1,473 major adverse events in the agency’s surveillance database related to Viagra. For instance, in addition to the 522 deaths, Kaul noted 517 patients who heart attack or anginal chest pain when using the drug.

However, it’s difficult to interpret the data without comparing them to a similar population not taking the drug, and that’s why Kaul says that additional research is necessary. In the meantime, he says there’s no reason to panic.

“The most important message is that in most patients at low risk, Viagra is generally safe. However, you need to evaluate the patient’s cardiac risk before you prescribe Viagra,” says Kaul.

Meanwhile, another Viagra study presented here Tuesday came to a very different conclusion. This research, done in collaboration with Pfizer, Viagra’s manufacturer, compared some 4,500 patients taking the drug to about 3,100 on placebo. The bottom line is that the rates of heart attack and death in men with ED treated with Viagra were low, and there wasn’t any real difference between the groups.

“It’s reassuring that … in general, for most patients, even those with existing coronary heart disease … resuming sexual activity is very unlikely to trigger a coronary event,” says lead researcher Murray A. Mittleman, MD, an internist and preventive cardiologist at Beth Israel Deaconess Medical Center in Boston.

Mittleman says that the FDA database is better at spotting unusual events than seeing aberrations in common conditions like heart attacks. However, the agency concedes that drug problems are drastically underreported, with perhaps only one in 10 eventually getting the FDA’s attention.

Jan. 9, 2003 — While looking into the of blood clotting, researchers stumbled on a finding that may explain the mysterious deaths of a small number of men who took the impotence drug Viagra. say the drug may actually encourage potentially dangerous blood clots to form in men with certain risk factors, such as hardening of the arteries.

Viagra was originally developed as a drug to fight heart disease — thought to increase blood flow by opening up blood vessels and prevent blood clots. But researchers have now found that the popular impotence drug may do exactly the opposite — encouraging blood-clotting cells known as platelets to clump together and form clots. Their study appears in the Jan. 10 issue of the journal Cell.

During their research, Xiaoping Du and colleagues discovered that the enzyme that Viagra affects in the body to improve erections — called cGMP — may be the cause behind the increase in blood clots. Du is associate professor of pharmacology at the University of Illinois at Chicago College of Medicine.

Viagra helps stimulate erections by increasing levels of cGMP — which is also involved in blood clotting. Therefore, by increasing levels of cGMP, Viagra may actually increase the risk of blood clots, according to the researchers.

To check this theory, the researchers tested the effect of Viagra on platelets. Alone, Viagra had no effect. But when exposed to an environment that simulated an injured blood vessel — as in hardening of the arteries — Viagra caused the platelets to clump. This occurred even at levels well below that found in men taking Viagra.

That means that if someone with an already damaged blood vessel takes Viagra, this clotting action may be enough to cause problems, according to the researchers.

“Viagra, by itself, probably is not to cause a heart attack in healthy people, but our research suggests that it may present a risk for patients with preexisting conditions such as atherosclerosis,” says Du, in a news release.

SOURCE: Cell, Jan. 10, 2003. News release, University of Illinois at Chicago.

May 1, 2000 (Atlanta) — Move over guys. Another “men only” sign is coming down. Studies reported here at the world’s major urology conference suggest that the revolutionary male impotence drug Viagra may work for the other half of the population, too.

Experts warn that the studies, while interesting, offer no proof whatsoever that Viagra actually helps women. Such proof can be obtained only from larger studies. But two provocative studies of women with female sexual dysfunction show that by several measures, sexual improves in some women who take the drug.

Are physicians already offering Viagra prescriptions to women? “They certainly can, and they do, and they are now,” the co-author of one of the studies, Jennifer R. Berman, MD, tells WebMD. “There are a number of prescriptions that have been written for women — I don’t have the number, but it is not small,” she says.

Mariann Caprina, spokeswoman for Pfizer, the of Viagra, says that more information on women and Viagra may be reported at a medical conference later this month. “Right now, it isn’t indicated for women, and we’re certainly not going to recommend it until we have some data,” she tells WebMD.

Irwin Goldstein, MD, who co-authored the study with Berman, warns that it doesn’t prove anything. He points to a study in Europe in which seven out of 10 women with sexual dysfunction said a pill improved their sex lives. What the women didn’t know was that it was a sugar pill and had no effective ingredients. Goldstein says, “women who have sexual dysfunction in the year 2000 must have a full clinical and psychological evaluation. … By 2005 or 2006 we should understand much more. But we don’t know this yet and to discuss Viagra is premature.”

Laura A. Berman, PhD, Jennifer Berman’s sister and at Boston University Medical Center, notes that the hysterectomy — surgical removal of uterus, or womb — appears to be a risk factor for sexual dysfunction. She says surgeons might cut through as-yet unidentified nerves and/or blood vessels that could be important for sexual arousal. The Bermans, Goldstein, and their colleagues enrolled 35 women, on average about 50 years old, who had hysterectomies at least two years previously. After the operation, these women found they lost much of their ability to feel sexual sensations.

After taking Viagra, these symptoms dramatically improved. Before taking Viagra, all the women reported low sexual sensation and no orgasms. After taking Viagra, 27 of the 35 women had improved sensation and 29 had orgasms. Sexual desire, pain or discomfort during sex, and lubrication of the vagina also improved in more than half the women who took Viagra.

A second, very small study tested Viagra in 16 women with sexual dysfunction. University of Maryland researcher Toby C. Chai, MD, and colleagues used a noninvasive device to measure blood flow in the genital area. They then gave the women two identical bottles of three pills — one containing 100 mg Viagra and one containing identical sugar pills — and told them to take one pill at least an hour prior to sex.

The results were dramatic for every measure of sexual function. Viagra improved sexual experience, sensation, and lubrication in 10 of the 16 women, and it increased the ability to achieve orgasm in nine of them. Only one woman said the sugar pills had the same effects. “Some women with sexual dysfunction will respond to Viagra,” Chai tells WebMD. “However, the drug doesn’t seem as effective for women as it does for men.”

Even more important than the Viagra studies — if less dramatic — were several conference reports of studies about what sexual dysfunction in women actually is. Jennifer Berman notes that between 30% and 60% of U.S. women report some form of sexual problem. But whether this represents true dysfunction or just remains unknown.

“There is a school of thought that says the standards of sexuality in the U.S. are unrealistic, in much the same way that we have an unrealistic standard for body image,” Laura Berman tells WebMD. “That is not to say that there are not many women out there with real problems.” Only now, notes Jennifer Berman, have women felt able to discuss their sexuality with their physicians.

Goldstein notes that scientific study of sexual dysfunction in women began only recently. “We’ve been doing this for two years — a short time,” he says.

A large proportion of sexual dysfunction in men is caused by problems with blood vessels, which inhibit erection. Goldstein notes they don’t see as many of these problems in women. Most female sexual dysfunction is hormonal or caused by problems with the nervous system. Having children can play a role as well, he says. “Postdelivery the vagina recovers from this 10-pound item coming through it, but all functions are not always restored.”

Aug. 5, 2004 — Erectile dysfunction isn’t just an older man’s problem anymore. Young men, even some who are , are leading the surge in Viagra use.

New research indicates that the use of Viagra skyrocketed 312% among men aged 18-45 between 1998 and 2002. There’s also been a twofold increase — 216% — among men between ages 45 and 55, says Tom Delate, PhD, whose research analyzed data on medical insurance claims by some 5 million patients across the country.

“We tried to see if these patients had an underlying medical condition and we couldn’t identify one in the majority,” says Delate, director of research for Express Scripts, Inc., a St. Louis-based firm that conducts pharmaceutical research for insurers, managed care organizations, and other companies.

“What we found was that problems typically seem to start in a man’s 40s and affected only about 40% of the men in these age groups.”

Enhancer Rather Than Remedy?

Does this suggest a growing trend in using the drug for rather than medical purposes — such as for a sex enhancer?

“That would be my guess,” Delate tells WebMD.

While Delate notes that men older than age 56 continue to fill the lion’s share of prescriptions for Viagra, his study — published in the August issue of the Journal of Impotence — also shows a 13% increase in Viagra prescriptions for women between ages 18 and 45. While some studies indicate that Viagra can increase sex drive and satisfaction levels in women, especially before menopause, this is not a consistent finding.

Delate also finds that two in three prescriptions came from primary care physicians, rather than urologists.

“One suggestion about what may be going on: It could be that patients are coming in, asking for the drug, and the prescriber wants to please the patients and meet their expectations,” he tells WebMD. “It could be the primary care physician doesn’t have a lot of time to spend with them, and may not be asking questions.”