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Phase III testing for ED drug delayed

August 30, 2007

PTN0.65, -1.08, -62.5%) said that after a review of Phase I and Phase II clinical data, the Food and Drug Administration has expressed concerns that the drug candidate, known as bremelanotide, might raise blood pressure in certain patients.
Accordingly, the agency has questioned its benefit as a first-line therapy, suggesting it may be better suited as a therapy for men who have not responded well to other erectile-dysfunction medications, such as Viagra, Cialis or Levitra.
King and Palatin said they plan to review the FDA’s suggestions in order to determine how best to proceed with the program. End of Story

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Woman disgusted with men who use Viagra stops dating

August 23, 2007

We’ve heard from The Pharmaceutical Widow and Sore and Exhausted, both women whose experiences with Viagra, “that little blue pill” that makes men “feel like they’re 20 again” have been miserable. The Pharmaceutical Widow said her husband had “the erection of a 20-year-old in a fiftysomething-year-old body” and he didn’t want her anymore.

Sore and Exhausted said “when a man pops his Viagra, he can go like he’s 20, but if his partner is going through menopause, her body probably cannot keep up. This causes resentment on both sides. Women withdraw, and men look around.”"I want to add my voice to the women who are speaking out about Viagra. First, I have to say that I’m a woman in my 50s. I’ve been on the dating scene, if that’s what you can call it, for the past 10 years, and I’m thoroughly disgusted. Most men my age are not interested in dating anyone unless they’re at least 10 years younger than them. Quite a few men of this age seem to think that going to a younger woman and ditching the woman who bore him his children and raised them for him (while at the same time worked full time and did 99 percent of the housework) is the thing to do.

“And certainly Viagra helps him attract the sweet young things, along with his now healthy bank book, which his wife also helped him achieve. There are certain snags in this Sweet-Young-Thing Theory (which I will go into in a moment), but first I want to reflect back on the women who are left behind, the women of their same age whom they could be dating.

“We’re a hearty bunch. We watched our parents, mom at home, dad going off to work every day. When it came to be our turn, we found that we needed to do both of those jobs. While our husbands were willing to go off to work like their fathers, they also expected us to go to work, too, to earn money for the household. Yet they were not willing to help with the housework, grocery shopping or child rearing. So we did it all.

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“Then, just when we got the kids off on their own, along came Viagra and the man of the house now had the ability and the desire to woo a younger woman who can keep up with him. So, here we are, left alone. But as I said, we’re a hearty bunch, and we can usually feed, clothe and house ourselves. Maybe not in the same manner as when we were married, but at the same time, we’re very happy not to have to clean up after our husbands. And also not be expected to keep up with their Viagra. This is just not the natural thing for women of a menopausal age. Even with artificial help, it simply isn’t comfortable, certainly not for hours.

“Now back to the Sweet-Young-Thing Theory. In the area I live in, I see it all the time. There she is, shopping with her spouse, who looks to be very much her senior, in tow. He’s pushing the stroller and tending to the small children while she does the shopping. He never looks very happy. I find it particularly amusing at the grocery store. Not only did my ex never enter the grocery store with me, he never took care of the kids so I could do it without having them along. And he never pushed a stroller! So you see, Viagra is great for the men, up to a certain point.

“I recently backed off the dating scene. The men who’re interested in dating me are 10 to 20 years my senior, and I’m not interested in dating them. Men my age are either self-absorbed bores or totally unable to take care of themselves and are looking for a housekeeper who cooks, cleans and does laundry, while not minding the ill effects of Viagra. I tried that, but I find that I’m happy to be on my own.”

———-

Men, do you take Viagra or another erectile dysfunction drugs? What effect has it had on your relationship? Send your tale, along with your relationship questions and problems, to cheryllavin@aol.com or Cheryl Lavin, 435 N. Michigan Ave., Chicago, IL 60611. Please include day and evening phone numbers. Letters may be used in whole or in part and become the property of the column. Read “Tales From the Front” every Monday, Wednesday and Thursday in Tempo.

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Viagra and Golf – Is Sex Worth the Sacrifice?

August 18, 2007

I was driving to a client’s office this morning and I heard a radio ad for Viagra and its claim that an estimated 17 million men have ED. Yes, erectile dysfunction. I was shocked to hear that so many men can’t bring themselves to attention. I also didn’t know that we have an epidemic on our hands. According to Webster’s New World Medical Dictionary, an epidemic is defined as “The occurrence of more cases of a disease than would be expected in a community or region during a given time period.” How did our society reproduce with so many men that couldn’t get it up? Is there something in our water? I digress.

What struck me as quite interesting was that the ad closed with “…and see our ad in Golf Magazine.” That made me rise up in my seat. Why did the advertiser mention Golf Magazine as the only place where the print ad was running? Is there some sort of connection between ED and golf? Why didn’t they mention Forbes, Fortune or Maxim? What about Rolling Stone, Sports Illustrated or Science? Don’t any of these publications’ readers have ED? Is it only those who read Golf Magazine that have this dreaded disease?

Perhaps we should thrust ourselves into a deeper understanding of the connection between golf and ED? Yes, I think we should.

A quick check of Golf Magazine’s 2006 media kit is very telling:

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95% of the readership is male – VERY MALE
They have an average net worth of over $1 million — RICH
They have an average household income of $148,000 — RICH
They have played golf an average of 25 years — OLD
They play an average of 58 rounds per year – PLAY LOTS OF GOLF
83% are professional or managerial – IN MANAGEMENT

What do we have: rich old male managers that play too much golf and according to Viagra, they have an ED problem. Clearly a target rich market.

So, I think the conclusion we can draw from this is that playing too much golf (58 rounds/year mind you) leads to ED and so your choices are:

A) Stop playing golf. — NOT
B) Stop playing golf, take Viagra and still have sex. - NOT
C) Keep playing golf, take Viagra and still have sex. — POSSIBLE
D) Keep playing golf and stop having sex. - ???

Hmmmm…. don’t rush me, I’m still thinking about it.

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Maker of Asian ‘viagra’ launches complete lines in Bacolod

August 15, 2007

ACTOR and health counselor Ricardo Cepeda was here last Saturday as part of the team that launched the complete product lines of Dynapharm, a Malaysian-based multi-products company.

In Bacolod, Dynapharm is owned and managed by multi-awarded businessman Roberto Montelibano. Dynapharm is selling almost all kinds of coffee and other beverages made of herbs used by Asians since ancient times and a long product lines of generic and vitamins extracts.

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According to Cepeda, “Its ‘Dano’ coffee and ‘Tongkat Ali’ products that had made an initial dent in the Philippine market especially Tongkat Ali because it is popularly known as the Asian viagra.”

“But now, we are here to explain why Tongkat Ali had become popular. It is simply because it worked. A lot of Tongkat drinkers, male and female, found it to be effective, improved their sexual lives and very safe because it’s only coffee extract but with only about three percent caffeine,” Cepeda said.

“Here in Bacolod, under the leadership of Mr. Montelibano, you will see that Tongkat Ali is manufactured by Dynapharm and there’s a hundred other product lines from coffee to cosmetics, household items, vitamins, generic drug for all diseases and many more to come,” Cepeda Added.

Cepeda stressed that while Dynapharm will be using the networking marketing schemes, Bacolod people need not be afraid, saying, “This is not ‘pyramiding.’

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For your P1,200 initial investment, you will immediately get a promo kit worth P1,500. Either you keep it or use it, it is our policy not to engage in hard selling.”

“Since majority of our products are household items, your P1,200 will entitle you to automatic 20 percent discount. Or, you sell them or organize a network and we don’t need to explain that you get a rebate everytime you recruit,” Cepeda said.

“We will not deal so much with telling you who became millionaires here or that the more you recruit, the more your earn things. We believed in the effectiveness of our products and making everyone earn or buy household items at a discounted price is our focus,” he added.

Cepeda talked to around 30 initial recruits gathered during the launching last Saturday.

Meanwhile, Montelibano stressed that for his part while people whom he recruited will earn, his investment under Dynapharm is his ‘tuition fee’ in learning network marketing.

“I’d like to emphasized that all Dynapharm products had passed the Bureau of Food and Drugs (BFAD) examinations. Bacolod is assured of safety and health for all these products,” Montelibano said.

“Also, Dynapharm, while imported, the prices are reasonable and some are even lower than the more popular brands,” Montelibano added.

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Viagra, Cialis imitations seized in London raid

August 7, 2007

In the latest episode of illegal drug trading, a hoard of unlicensed medicines was seized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) last week, taken from a London lock-up containing a stash of various male impotence drugs.

The drugs were unlicensed, generic versions of Pfizer’s Viagra (sildenafil citrate) and Eli Lilly’s Cialis (tadalafil), going by the names Kamagra (in tablet and sachet form), Lovegra and Apcalis.

The confiscated goods were worth around £350,000 (€519,000), and most likely manufactured in the Far East before being imported into the UK, according to an MHRA spokesperson.

Viagra and Cialis were two of the most widely faked drugs in Europe over 2006, with a rich black market trade in imitation and purportedly genuine tablets gnawing away at authentic drug sales and posing a significant risk to the health of those who purchase them.

“It is essential the medicines are licensed correctly,” said MHRA head of criminal operations Danny Lee-Frost.

“The type of medicines we seized cannot be guaranteed to be acceptably safe because they have not gone through the correct licensing regulatory process. At best these medicines could be a waste of money, at worst they could be severely detrimental to your health.”

Although the MHRA was unable to comment on how the seized meds were likely to reach the market, a spokesperson from the agency did agree that the unlicensed medicines are widely available through a host of online pharmacies claiming to offer cheaper, easily accessible alternatives to the authentic branded drugs.

“There are people out there illegally selling these medicines online,” the MHRA spokesperson told in-PharmaTechnologist

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“These male impotence drugs, lifestyle drugs, are certainly the kind of things widely peddled online.”

Many of these internet pharmacies will be located in countries outside the regions regulated by the MHRA, with a similar situation for equivalent authorities representing other countries. As such, the agency warns that the risk of substandard or fake medicines is vastly increased through buying online.

In a bid to try and establish some kind of standard or policing method of these internet pharmacies, in 2006 the Royal Pharmaceutical Society of Great Britain (RPSGB) initiated a pilot logo scheme to help the public identify whether a specific website is linked to a bona fide, registered pharmacy.

Through the scheme, online pharmacies carry a logo which, although not an accreditation by the RPSGB in any way, legitimises the pharmacy’s online activity and links it to a real bricks-and-mortar pharmacy on the street.

The initial pilot involved 20 online pharmacies, and once the scheme is launched fully, it will be compulsory for all pharmacies registered with the RPSGB and trading online to carry the logo.

The project is still in development, and although original plans were for the scheme to launch next month, technical delays have meant that it is more likely that the fully-fledged logo programme will kick off in the new year.

Last week’s West London seizure was the latest success in the MHRA Enforcement Team’s continuous clamp-down on the sale and distribution of unlicensed and illegal drug products. Although no arrests have been made as yet, any individual convicted of offences under the UK Medicines Act can be sentenced to a maximum of two years imprisonment and/or an unlimited fine.

If found to have financially benefited from the proceeds of the crime, the MHRA can also cite the Proceeds of Crime Act in order to recoup illicit earnings from guilty parties.

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Viva Viagra?

August 2, 2007

The setting is a folksy bar off a dusty highway. The scene: a group of guys who have gotten together for a jam session, to sing about … the wonders of erectile dysfunction medication.

The new commercial for Pfizer Inc.’s Viagra is striking for a few reasons.

For one thing, there are no women in it — this is a commercial all about guys bonding with other guys over the good times this medication has brought them, not sharing an intimate moment with their female partner. And secondly, some of the guys here strike the viewer as pretty young for erectile dysfunction.

Is Viagra taking things too far? The AIDS Healthcare Foundation thinks so. It alleges that the ad’s take on the celebratory ditty “Viva Las Vegas” — in their version, it’s “Viva Viagra” — helps encourage the use of Viagra as a party drug rather than a more serious medication.

Pfizer disagrees. Spokesman Francisco Gebauer said the ad is intended to help men get over the embarrassment of talking about erectile dysfunction with their physicians, and that the company is committed to safe and appropriate use of the drug.

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He said all the men in the commercial are over age 40, and that the company’s research shows that 50 percent of men over age 40 struggle with erectile dysfunction to some degree.

We’ve certainly come a long way from the days of then 70something Bob Dole earnestly hawking Viagra. But then again, over the past few years plenty of pharmaceutical companies have started taking more humorous and daring approaches to promote their medications. Also, Viagra now faces much fiercer competition in the market, so it needs to do more to stand out.

Still, is it appropriate for prime-time television? When Ads of the Weird wrote about a commercial for Trojan condoms earlier this summer, plenty of readers wondered why major networks refused to show that commercial during peak television viewing hours, while they seem to have no problem with commercials for “E.D.” drugs.

“Viva Viagra” debuted during the “NBC Nightly News.” It will air on network and cable programming with more than 90 percent adult viewers, Gebauer said.

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Guangzhou Culinary Delicacy And Viagra Substitute: Here Kitty!

July 26, 2007

Not all Chinese meat eaters are bothered by the high price of pork, the culprit behind China’s runaway inflation. Consumers in the southern Chinese city of Guangzhou savor an alternative delicacy: cat meat.

An investigative report on Tuesday by the city’s famous muckraking newspaper Xin Kuai Bao added cat to the long list of rare meats Guangzhou diners are devouring, including the cat’s favorite prey, rat. While rat has recently been sold as “heavenly dragon meat” in Guangzhou, cats are being packaged into a dish called “a scramble of dragon and tiger.”

In accordance with its longstanding investigative tradition, Xin Kuai Bao sent reporters to pose as customers and took a batch of photos exposing the brutality of the cat-cooking process. Pictures posted online show a skinny white cat being boiled alive while a worker beat it with a wooden stick, said to help mix the blood with the meat and thus enhance the flavor of the dish. Its skin was later stripped off completely by a machine.

Beyond purely culinary considerations, the flesh and blood of cats are considered to have a particular benefit in restoring male sexual potency. In spite of the widespread piracy of Viagra in China — or perhaps because the fake Viagra doesn’t work — men continue to turn to such extraordinary sources for help.

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The newspaper traced the cat consumption trade back to the countryside or the streets of towns in several central Chinese provinces: Henan, Hebei, Jiangxi, Anhui and Zhejiang. Commercial cat owners sell their animals to wholesalers, and stray cats are rounded up and sold by cat catchers, many of them farmers, at less than 3 yuan (17 cents) per creature, a meager price but nonetheless an important income supplement for poor rural dwellers.

At Guangzhou’s largest live animal wholesale market in the suburbs, tens of thousands of cats change hands at a price of 7 yuan (92 cents) each. These are then marked up to sell to several Guangzhou restaurants at about 20 yuan ($2.64) per Chinese jin (500 grams). A full serving of “a scramble of dragon and tiger” can fetch a price of between 150 yuan ($19.80) and 380 yuan ($50) in top restaurants, the report said.

Guangdong province, of which Guangzhou is the capital, was the origin of the SARS epidemic that erupted in 2003. The disease was thought to have spread through the eating of civets, a catlike carnivore that is a carrier of the SARS virus, though some scientists have now fingered bats as the original reservoir of the disease.

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Media & Society | HIV/AIDS Group Reacts to Pfizer’s New Viagra Ad Campaign

July 25, 2007

The AIDS Healthcare Foundation has expressed concern over Pfizer’s new television advertising campaign for its erectile dysfunction drug Viagra, Bloomberg/Arizona Republic reports. Pfizer on Monday launched the ad, which features a group of men in their 40s and 50s singing “Viva Viagra” to the tune of the Elvis Presley song “Viva Las Vegas,” according to Bloomberg/Republic. Pfizer said the ad aims to make men less embarrassed about the condition. The ad, which premiered Monday during NBC’s “Nightly News”, will air during programs that have a 90% adult audience. Pfizer has not commented on how frequently the ad will run or how much it is spending on the campaign. “This disease is very stigmatized, and there are a lot of misperceptions,” Ponni Subbiah, Pfizer’s medical director for Viagra, said, adding, “Men are very willing to talk to their doctors about back pain or injuries but not ED.”

Some advocacy groups and officials in the past have criticized Pfizer for its Viagra marketing methods. FDA in 2004 said that an ad featuring a man who grew devil horns while walking past a lingerie store was misleading and did not adequately warn of risks associated with the drug, and Pfizer had to withdraw the ad.

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AHF earlier this year sued Pfizer for its Viagra marketing strategies (Bloomberg/Arizona Republic, 7/23). The lawsuit was filed in Los Angeles Superior Court against Pfizer for allegedly promoting recreational use of Viagra in ads. AHF said Pfizer’s ads for the drug have increased risky sexual behavior, as well as cases of HIV and other sexually transmitted infections, among men. The suit asked that Pfizer stop running ads that promote Viagra as a lifestyle drug and that the company fund ads promoting awareness about the risks associated with Viagra and STIs. In addition, the suit asked that Pfizer forfeit profits gained from the ads and pay for AHF’s costs of treating cases of HIV/AIDS and other STIs that it has linked to Viagra. AHF in December 2006 launched an ad campaign against Pfizer, saying the company’s ads for Viagra promote recreational use. Pfizer at the time denied that the ads encourage recreational use of the drug and said that its advertising states that the drug does not protect against STIs (Kaiser Daily HIV/AIDS Report, 2/16). According to AHF President Michael Weinstein, the suit has been dismissed.

“Pfizer has been an outlier in shamelessly promoting Viagra as a party drug,” Weinstein said, adding, “All those Sin City references, everything associated with Vegas, that is what they want the association to be. It’s not about a medical condition; it’s about performance anxiety.” AHF has met with FDA in the past to discuss its concerns about Viagra, according to Weinstein.

Pfizer is examining new drug formulations and a possible nonprescription version of Viagra that could increase usage, according to Subbiah, who would not comment on specific research projects (Bloomberg/Arizona Republic, 7/23). AHF in February announced it will petition FDA to reject Pfizer’s request to sell Viagra without a prescription (Kaiser Daily HIV/AIDS Report, 2/16).

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Group Therapy Helps Men With Impotence

July 21, 2007

Group therapy can help men with erectile dysfunction even if they are already using popular drugs like Viagra.

Group therapy could even be a feasible alternative to some treatments for impotence.

While the number of men studied overall was small, the reviewers found that group therapy appeared to be about as successful as suction devices and injections in terms of promoting erections. One analysis showed therapy worked for nearly two-thirds of participants.

The findings spotlight the importance of “integrating sex therapy and other psychological techniques into office practice” to help impotent patients, said lead author Tamara Melnik, professor of psychiatry at the University of São Paulo in Brazil.

The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

Before the days of Viagra and its sibling drugs, many considered erectile dysfunction to be a difficult-to-treat psychological disorder. Now, drugs allow millions of men to achieve normal erections by allowing blood to flow more freely to the penis; the more serious side effects are rare.

However, drugs are not always an automatic cure for men with erectile dysfunction, especially those whose impotence relates to psychological factors.

A 2001 study of 115 impotent men found that psychological factors were responsible for the problems in 43 percent of the men and physical factors were responsible for problems in another 43 percent. In the rest of the men, researchers blamed impotence on a combination of mental and physical factors.

In the new review, Melnik and colleagues examined 11 studies from the last 32 years to compare the value of group therapy to other treatments such as oral drugs, injections and suction devices.

The review studies nearly 400 men: 141 received group therapy, 109 took drugs, 68 took drugs and took part in psychotherapy, 20 used “vacuum” (suction) devices and 59 were in control groups that did not receive any treatment.

Half of the men in the studies were from the United States and the average age of the men was 47.4 years.

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By pooling data from five of the studies, the researchers found that 36 of 55 men who took part in group therapy reported successful intercourse compared with 5 of 45 who were on waiting lists and had no treatment, Melnik said.

The researchers also combined data from two similar studies from 2000 and 2005 and found that men who took Viagra in conjunction with group therapy were more likely to report successful intercourse than those who took the drug alone.

The total number of men in the two studies was small — just 71.

The review authors did not find much difference in erection success rates between those who tried injections or suction devices and those who took part in group therapy alone.

According to Melnik, the goal of group therapy is to help men gain confidence and reduce anxiety. Most men feel comfortable in the setting of group therapy because they can share their difficulties with other men who have the same problem, Melnik said.

“Most people only wonder about the easiest and most rapid way to reach remission of erectile dysfunction,” Melnik said. “Group therapy takes more time than using medication, but in some cases dealing with psychological aspects is fundamental to achieving a successful outcome and maintaining the results.”

The review does not examine issues of cost nor how group therapy expenses compare to those of other treatments. The review authors did not look at the availability of group therapy for erectile dysfunction patients.

Hossein Sadeghi-Nejad, M.D., a New Jersey urologist, said psychological factors play a role in some cases of impotence. While drugs like Viagra can help people with erectile dysfunction caused by mental factors, the medications “do not work unless the patient is in the right frame of mind,” said Sadeghi-Nejad, director of the Center for Male Reproductive Medicine at Hackensack University Medical Center.

Indeed, while some people assume that Viagra and other drugs cause erections on their own, sexual stimulation is still necessary. Moreover, as generations of psychologists have discovered, mental issues can wreak havoc on a person’s sexual thoughts and sensations.

Sadeghi-Nejad added that stress, in particular, could cause problems and reduce the effectiveness of erectile dysfunction drugs

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Researchers Find Why Viagra May Likely Help Patients with Heart Failure

July 17, 2007

In a new study that will be published in the July 17th issue of the journal Circulation, Canadian researchers reveal that the erectile dysfunction drug Viagra (Sildenafil), may likely be effective in the treatment of patients with right-sided heart failure, principally because their study shows that only the hearts of these patients exhibit the target molecules that can be blocked by these types of drugs.

The study was led by Drs. Jayan Nagendran, a cardiac surgery resident and Evangelos Michelakis, professor in the Department of Surgery and the Department of Pharmacology at the University of Alberta in Canada.

The researchers wanted to gain insight into the mechanism of how Viagra may benefit patients with pulmonary hypertension (high blood pressure in the lung vessels). This devastating condition usually leads to right-sided (right ventricle) heart failure.

In their study, the researchers evaluated heart specimens from 9 patients to assess their phosphodiesterase type-5 (PDE-5) activity and their response to specific type-5 PDE inhibitors such as Viagra.

PDE-5 is an enzyme that degrades the activity of cGMP, a chemical that relaxes smooth muscle cells. In the vasculature, relaxation of smooth muscle cells causes vessels to dilate thereby increasing blood flow.

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PDE-5 is preponderant in the corpus cavernosum of the penis. When it’s inhibited, it leads to higher cGMP levels and less dilation (more constriction) of the blood vessels that let blood escape from the corpus cavernosum and thereby leading to a sustained erection.

The researchers essentially found that PDE-5 was not expressed in heart samples from patients that were healthy. Conversely, they did discover that patients with enlarged right heart ventricles had marked increased PDE-5 activity.

When the research team used Viagra (the PDE-5 inhibitor) in their experiments, they found that it increased the activity of isolated cardiac cells and the strength of heart contractions only in unhealthy samples and patients and not in any of the healthy controls.

In the press release from the University of Alberta, Dr. Nagendran stated that “there are a number of medical conditions in both children and adults for which there is a need to boost the performance of the right ventricle, and this drug can be clinically and immediately relevant to help these patients”

Dr. Michelakis also added that “We have a number of drugs and therapies available to treat the left ventricle of the heart to prevent it from failing or to treat it after it has failed, bet we don’t have anything for the right ventricle. The phosphodiesterase type-5 inhibtors, which include Viagra, Cialis, and Levitra, may offer some important benefits in this case.”

Viagra (Sildenafil) has been recently approved in the treatment of pulmonary hypertension.

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