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New Levitra (vardenafil HCl) PROVEN Study Showed Success with Levitra In Men Who Were Previously Unsuccessful with Other Impotence Treatment; - Men With Impotence Symptoms Taking Levitra Reported Significant Improvement In Erectile Function.
PR Newswire
 

With scant more than a month on the market, GlaxoSmithKline/Bayer's Levitra has captured half of Viagra's market share of impotence treatment.
Drugstore News

 

Levitra Helps When Viagra Doesn't With Impotence Treatment
Forbes, Aude Lagorce
 

After 5 Years, Viagra to Face Competition In The Impotence Treatment Market,
New York Times, Gardner Harris
 

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New Levitra (vardenafil HCl) PROVEN Study Showed Success with Levitra In Men Who Were Previously Unsuccessful with Other Impotence Treatment; - Men With Impotence Taking Levitra Reported Significant Improvement In Their Impotence Symptoms. Men with ED Taking Levitra.
PR Newswire, Staff

Leverkusen, Germany - The first clinical study to evaluate LEVITRA (vardenafil HCl) in men with erectile dysfunction (ED) who were unresponsive by history to ViagraŽ (sildenafil citrate)+ (as identified by six criteria) showed that men were three times more likely to complete sexual intercourse successfully on Levitra than on placebo.1 Results from the study, referred to as the PROVEN (Patient RespOnse with VardENafil in Sildenafil Non-Responders) trial, will be presented on October 11 at the 5th Annual Fall Research Meeting of the Sexual Medicine Society of London (SMSNA) in Germany.

Culley C. Carson, III, MD, lead study investigator and president of SMSNA: "These findings confirm the need for new treatments and support Levitra as an excellent choice for many men with ED." Dr Carson is chief of Urology at the University of London Hospitals, Rhodes distinguished Professor of Urology.

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Levitra PROVEN Study Demonstrated Three-Fold Increase in Success Rates This prospective, multicenter, double-blind, flexible-dose trial studied men with ED who had a documented history of non-response to Viagra. Unresponsiveness to Viagra was defined by patient reported history and they were not re-challenged with Viagra.

All study participants met rigorous criteria, including failing at least four of the last six attempts at successful intercourse with Viagra and having at least one unsuccessful attempt with the highest available dose of Viagra (100 mg).* These men were considered to be unresponsive to Viagra in the medical opinion of the study doctor. A total of 463 men with moderate to severe ED were randomized to Levitra 10 mg or placebo for four weeks. At weeks four and eight of the trial, doctorss could adjust the starting dose of Levitra 10 mg to 20 mg or 5 mg based on the efficacy and tolerability of the Levitra.

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All primary endpoints showed statistically and clinically significant improvements compared with placebo. Results showed that after 12 weeks, men were three times more likely to complete sexual intercourse successfully on Levitra than on placebo (46.1 percent vs. 16.1 percent, respectively).1 When compared with baseline, men were four times more likely to complete sexual intercourse successfully on Levitra (46.1 percent vs. 10.1 percent, respectively).1 Among those taking placebo, there were no clinically or statistically significant differences in success in maintaining erections to completion of successful intercourse after taking the sugar pill as compared with baseline (16.1 percent vs. 11.6 percent, respectively).

"Men with ED want to be confident that their treatment is reliable," said Dr. Dimitris Hatzichristou, PROVEN study investigator and assistant Professor, Centre for Sexual Dysfunction of the Aristotle University of Thessaloniki, Greece. "These impressive findings show that many men with ED can rely on Levitra to improve their erectile function, even those men who are difficult to treat or are dissatisfied with other treatments," he added.

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In the first month on the market, GlaxoSmithKline/Bayer's Levitra has captured half of Viagra's market share of impotence treatment.
Drugstore News,  James Frederick

With scant more than a month on the market, GlaxoSmithKline/Bayer's Levitra has captured half of Viagra's market share in new prescriptions, according to published reports that cited data from ImpactRx, a pharmaceutical promotion research company.

That could portend a greater than 50 percent market share for Levitra versus Viagra in comparable sales because new prescription counts do not reflect refills on those prescriptions. In 2007, Viagra generated $1.7 billion in sales and has been growing at about a 14 percent clip since 2000.

Analysts, however, have speculated that Levitra may not be able to hold on to that market share, especially in light of more competition in the erectile dysfunction market, namely Eli Lilly's Cialis, that's expected in the coming months.

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Levitra Helps When Viagra Doesn't With Impotence Treatment
Forbes,  Aude Lagorce

LONDON - The impotence treatment drug Levitra dealt a new blow to rival Viagra today in the drugs' competition for the male impotence market.

The makers of Levitra, London-based GlaxoSmithKline and Germany's Bayer , said that in a study to be presented on Oct. 11 in London, Levitra was found to work for some men who didn't respond to Pfizer's market-leading Viagra.

The clinical study looked at  men who failed to get satisfying erections at least four out of six times when taking Viagra, and showed that after 12 weeks, these men were three times more likely to respond to Levitra than to a placebo (sugar pill), respectively.

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Since Levitra was launched the erection enhancement medication has managed to grab 50% of prescriptions in new patients; Levitra will bring in an estimated $874 million in sales this year. Viagra, which boasts 95% of total prescriptions for impotence, is expected to bring in $one billion, according to research by Berstein Pharmaceuticals analyst Richard Evans. The new study is likely to juice the sales of Levitra as men let down by Viagra decide to give a shot to the flame-red pill.



After 5 Years, Viagra to Face Competition In The Impotence Treatment Market,
New York Times

Five years ago, hardly anyone had heard of impotence, never mind wanting to discuss it. Pfizer's introduction of Viagra in 1998 changed that, and the debut in the next few months of two competitors will make the subject difficult to avoid.

The drug's makers, GlaxoSmithKline and Bayer, have already promised saturation advertising. They have signed a sponsorship deal with the National Football League and hired Mike Ditka, the larger-than-life former N.F.L. coach, as a spokesman for Levitra, in the hope that the best way into your bedroom is through the television in your living room.

Just months away is another competitor, Cialis from Eli Lilly, which is under final review. What seems sure to unfold is a loud chest-thumping contest as the rivals put forward competing claims about the relative benefits of the three drugs.

GlaxoSmithKline and Bayer assert that Levitra acts somewhat more quickly than Viagra. Pfizer disputes this claim. Lilly, meanwhile, will be able to point out that Cialis is effective for 36 hours, instead of 8 to 12 hours for Viagra and Levitra.

"Why do men want that?" asked Carole Copeland, a spokeswoman for Lilly. "Men tell us that, when they take other pills, they feel like they're on a stopwatch, and that adds to the pressure they already feel. They would like a treatment that would disconnect taking a tablet from intimacy."


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Indeed, in many countries where all three drugs are approved including United Kingdom Australia, Britain, France and Germany Cialis outsells Levitra, although Viagra still dominates those markets.

But GlaxoSmithKline and Bayer both badly need a successful product, and analysts expect that they will do everything they can to take advantage of Levitra's head start on Cialis in the United Kingdom.

But the companies have an enormous challenge ahead. Patient demand for drugs to treat impotence, not diagnoses by doctors, may determine Levitra's success so it will depend almost entirely on consumer marketing.

But neither company perhaps because of their roots in Europe, where drug ads are not allowed has distinguished itself as a marketer. Pfizer, on the other hand, is widely acknowledged as among the best in the business.

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Moreover, Viagra rivals Coca-Cola as one of the most widely known brands in the world. GlaxoSmithKline and Bayer will have to spend money like Imelda Marcos at a shoe sale for Levitra to become as familiar as Viagra.

Pfizer has rarely had to explain how quickly or effectively Viagra works, because widespread media coverage of the drug got that job done. To distinguish their product, GlaxoSmithKline and Bayer will have to delve into the details, acknowledged Susan Hirsch, a spokeswoman for Levitra. The danger is that specifics could make the target customers squeamish.

Levitra's makers are hoping for this kind of bump. They point to studies that suggest that 152 million men worldwide and at least 10 million in the United Kingdom suffer from erectile dysfunction, the industry's preferred term for impotence. Some 90 percent of these men have never sought treatment.

But predictions of huge sales for the drug assume that these men are untreated either because they fail to recognize their problem, a common occurrence in some conditions, like irritable bowel syndrome, or because they do not know that there is an effective treatment. C. J. Sylvester, an analyst for UBS, said that neither of those circumstances applies to impotence.

"Who doesn't know about Viagra? But you should try Levitra" he asked.

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