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Erection Pill Associated With Normalization Of Relationships And Increased Self-esteem For Men With Erectile Dysfunction

May 30, 2006

The inability to perform sexually can have a significant negative psychosocial impact on a man’s overall health including depression, anxiety, and low self-esteem. New research shows that safe and effective oral treatment of erectile dysfunction (ED) can improve relationships, sexual confidence, and self-esteem in men with ED.

In the March issue of The Journal of Sexual Medicine, researchers have published the first investigation examining both equivalence testing and traditional statistical testing for men with ED regarding changes in sexual function, sexual self-confidence, self-esteem, and overall relationship satisfaction. Through administration both before and after taking sildenafil (Viagra) of the Self-Esteem And Relationship (SEAR) questionnaire, a multi-dimensional, psychometrically validated questionnaire, the research concluded that men with ED using sildenafil revealed normalization of their relationships, confidence, and self-esteem when compared to men without ED.

The article entitled: “Comparison Between Sildenafil-Treated Subjects with Erectile Dysfunction and Control Subjects on the Self-Esteem And Relationship Questionnaire” published in The Journal of Sexual Medicine, involved 93 men with ED in stable relationships, using sildenafil as needed for 10 weeks. These patients were compared with a control group of 94 male volunteers with no history of ED also in a stable relationships, a novel study design.

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Dr. Joseph C. Cappelleri, a director and statistical scientist in Global Research and Development at Pfizer Inc in Groton, CT, and lead author of the paper, stated that “this research indicates that men with erectile dysfunction before treatment with sildenafil have sexual relationship satisfaction, confidence, self-esteem, and overall relationship satisfaction that are much less than men with normal erectile function. This investigation is the first to report that men with erectile dysfunction who are later given treatment with sildenafil are equivalent to men with normal erectile function in terms of sexual relationship satisfaction, confidence, self-esteem, and overall relationship satisfaction. Hence, the data suggest that sildenafil is associated with normalization of relationship satisfaction, confidence, and self-esteem.”

Dr. Stan Althof, Professor of Psychology at Case School of Medicine, Executive Director of the Center for Marital and Sexual Health of South Florida, and co-author of the manuscript commented, “This study adds to the growing body of literature regarding the importance of the psychosocial consequences of ED and the positive impact that effective treatment has on these salient issues. The restoration of sexual self-confidence is arguably the most important psychological variable in the successful treatment of ED.”

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About Blackwell Publishing
Blackwell Publishing is the world’s leading society publisher, partnering with more than 665 academic, medical, and professional societies. Blackwell publishes over 800 journals and, to date, has published close to 6,000 text and reference books, across a wide range of academic, medical, and professional subjects.

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Cialis® (tadalafil) Effective In Treating Erectile Dysfunction Caused By Traumatic Spinal Cord Injury, New Data Shows

May 30, 2006

Data presented today at the 21st Congress of the European Association of Urology (EAU) show that when patients who had erectile dysfunction (ED) secondary to traumatic spinal cord injury (SCI) were treated with Cialis® (tadalafil)(1) (N=140), their International Index of Erectile Function (IIEF) Erectile Function (EF) Domain(2) scores improved from a mean baseline score of 13.5 to a score of 22.6 at endpoint. This is compared with placebo treated patients (N=44) with a mean baseline score of 13.0 and a score of 13.6 at endpoint. It is generally considered that an improvement of 4.0 points or more in the IIEF domain score reflects a clinically meaningful change.(3) Further, 54 percent of SCI patients treated with Cialis reported “normal” erectile function at the end of the treatment phase, as measured by the IIEF EF (IIEF EF domain score greater than or equal to 26).(4)

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According to GAQ question one (improved erections), 84.6 percent of patients (N=115) in the study reported improved erections after treatment with Cialis, whereas 19.5 percent of placebo treated patients (N=8) reported improved erections after treatment.

“Treating men for ED caused by a spinal cord injury is a complicated task. These results are encouraging for men who suffer from spinal cord injury,” said Francois Giuliano, MD, PhD, Neuro-Urology Unit, Department of Physical Medicine and Rehabilitation, Raymond Poincare Hospital, Garches and Medical University of Paris West, France. “Tadalafil was not only effective in improving erections, it enabled more than half the men receiving tadalafil in the trial to achieve a normal erectile function score.”

Study Design

In this study, 186 patients with a mean age of 38 were randomized to receive placebo or Cialis in a double-blind, parallel, flexible-dose study in four European countries (France, Germany, Italy and Spain). Patients were treated for 12 weeks with assessments after each four-week interval.

Following a four-week, treatment-free run-in period, patients were randomized to 10 mg Cialis or placebo. After this first treatment interval, patients receiving 10 mg Cialis were either increased to 20 mg Cialis or left unchanged based on patient response to the 10 mg Cialis dose. After the second treatment interval, Cialis dosing was increased, decreased, or unchanged, based on patient response to the first treatment interval.

The study population included patients with varying degrees of SCI severity. As determined by the American Spinal Injury Association (ASIA) scale, 69.4 percent (N=186) of patients had a complete spinal cord lesion, reflecting the greatest degree of neurological impairment. Further, patients with all levels of the spinal lesion (N=179, 84.3 percent thoracic or lumbo- sacral lesions) and all degrees of erectile dysfunction (N=184, 69 percent of patients had moderate to severe ED) were included.

Study results show that Cialis improved all efficacy endpoints when compared with placebo (p < 0.001). Cialis was generally well tolerated with mild or moderate treatment-emergent adverse events. The most common treatment-emergent adverse events (greater than or equal to 5 percent incidence) were headache (8.5 percent Cialis; 4.5 percent placebo) and urinary tract infection (7.7 percent Cialis; 6.8 percent placebo). Discontinuation due to an adverse event occurred in 2.8 percent of the patients receiving tadalafil and 2.3 percent of those receiving placebo.

About ED

ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. ED affects an estimated 189 million men worldwide.(9) Experts believe that 80 - 90 percent of ED cases are related to a physical or medical condition, like diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 - 20 percent are due to psychological causes.(10,11) In many cases, however, both psychological and physical factors contribute to the condition.(12)

About Cialis

Cialis® (tadalafil) was approved by the FDA in November 2003 for the treatment of erectile dysfunction. Cialis is available by prescription only and is not for everyone. Men taking nitrates, often used for chest pain, should not take Cialis. Such a combination could cause a sudden, unsafe drop in blood pressure. The most common side effects with Cialis were headache, upset stomach, delayed backache or muscle ache. As with any ED tablet, in the rare event of priapism (an erection lasting more than four hours), men should seek immediate medical attention to avoid long-term injury. Men should not drink alcohol in excess with Cialis.

Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV. In rare instances, men taking prescription ED tablets (including Cialis) reported a sudden decrease or loss of vision. It's not possible to determine if these events are related directly to the ED tablets or to other factors. If a man has a sudden decrease or loss of vision, he should stop taking any ED tablet and seek immediate medical attention.

Men should discuss their medical conditions and all medications with their doctors to ensure Cialis is right for them and that they are healthy enough for sexual activity. The standard recommended starting dose of Cialis for most patients is 10 mg. Patients with certain medical conditions or taking concomitant medications may need to start at a lower dose. For full patient information, visit http://www.cialis.com.

About Lilly ICOS LLC

Lilly ICOS LLC, a joint venture between ICOS Corporation (Nasdaq: ICOS) and Eli Lilly and Company (NYSE: LLY), developed tadalafil for the treatment of erectile dysfunction.

ICOS Corporation, a biotechnology company headquartered in Bothell, Washington, is dedicated to bringing innovative therapeutics to patients. ICOS is working to develop treatments for serious unmet medical conditions such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer and inflammatory diseases. Additional information about ICOS is available at http://www.ICOS.com.

Lilly, a leading innovation-driven corporation is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at Posted by Administrator under Cialis News | Comments (0)

Cialis Is Effective In The Treatment Of Men With Erectile Dysfunction Regardless Of Previous Effective Viagra Use

May 30, 2006

UroToday.com - The phosphodiesterase type 5 (PDE-5) inhibitors have revolutionized the pharmacologic management of erectile dysfunction (ED). Viagra‚ (sildenafil citrate) was the first of the class to be introduced in 1998 and later followed by Levitra‚ (Vardenafil) and Cialis‚ (Tadalafil) in 2003. Therefore, men currently taking Cialis‚ may have had previous experience with Viagra‚. Because of the unique properties of each drug, many patients will try more than one of these agents.

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The investigators found that Cialis‚ at 10 or 20 mg improved erectile function over placebo regardless of previous Viagra use or PDE-5 inhibitor naive patients. Conclusions were based on results measured by the International Index of Erectile Function (IIEF) EF domain score, Sexual Encounter Profile (SEP) questions Q2 (successful penetration) and Q3 (successful intercourse) and a Global Assessment Question (GAQ1) about erectile improvement.

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Potent reaction

May 5, 2006

Sex sells, yet the racy ads that introduced erectile dysfunction drugs were more successful at raising public outrage than boosting sales.

Levitra and Cialis now have new campaigns that forego the provocative in favor of depicting erectile dysfunction as a medical condition, not simply a lifestyle concern. The commercials are a recognition of the prior approach’s failure to expand the market, as well new guidelines adopted by the industry in January to address critics’ concerns and improve ads’ accuracy.

Cialis’s new ad, launched Monday, leads with a frisky couple, then a doctor surfaces to explain the drug’s risk and benefits. Levitra’s commercials, which have been airing since March, focus on how diabetes and high blood pressure can lead to erectile dysfunction. Meanwhile, a Cialis campaign started in January is similar to earlier efforts focused on its ability to last for 36 hours.

The more clinical approach has won kudos from some experts, although no one is sure if that will translate to higher sales. Revenues have fallen short of expectations and growth was flat last year as two of the drug makers cut back on ad spending while revising their messages.

Roughly 30 million U.S. men over the age of 40 suffer from some kind of erectile dysfunction, leading many to believe the market for impotency pills would explode when Cialis and Levitra joined the category in 2003. That never happened, so now some analysts and doctors are wondering whether the market will grow or just sink into a three-way slugfest for market share.

Last year, the U.S. market for the drugs was flat at $1.4 billion, according to IMS Health, a health care information company. Cialis’s total sales slumped 2 percent last year, to $1.6 billion, after falling 11 percent in 2004. Sales of Levitra and Cialis, the latter of which is sold by Eli Lilly & Co. and ICOS Corp., rose, but they were coming off a much lower base and grabbed market share from Cialis.

“I think the market is pretty well-defined,� said Barbara Ryan, an analyst at Deutsche Bank. “There are many reasons people don’t have sex. Maybe they have relationship dysfunction. Sex goes beyond just getting an erection.�

Recognizing that not all men with erectile dysfunction want to have sex or have a willing partner, Cialis maker Pfizer estimates the true U.S. market size at about 15 million men. One doctor puts the number at 10 million men.

Last year, total spending on advertising for erectile dysfunction ads fell 41 percent, to $241 million, according to TNS Media Intelligence. Much of the drop can be attributed to a lack of Cialis TV ads and only half a year of commercials for Levitra.

Regulators asked Pfizer to stop running its Cialis campaign in November of 2004 because it violated several regulations.

Levitra TV ads ended in May so the approach could be retooled, said Nancy Leone, a spokeswoman for GlaxoSmithKline PLC, which markets the drug along with Schering-Plough Corp.

Regardless of the market size, these drugs have to be advertised because demand is almost totally driven by consumers. A doctor may not ask a patient about ED as part of a routine physical, unless a patient brings up the issue.

“There is limited time in an exam room and it may not be a priority (for the doctor),� said Dr. Timothy Schuster, assistant professor urology at the University of Michigan.

Patrick Kelly, president of Pfizer US Pharmaceuticals, said he believes the new campaign will revitalize Cialis sales as it strikes the right balance between playful and medical. In the ad, a man watching a sports event hesitates when his partner signals she desires romance before realizing he can tape the game. A doctor then appears to give medical information about Cialis.

“We want to be clear that this is a medical condition, but at the same time you don’t want to be only clinical so people become bored or anesthetized,� said Kelly.

Dr. Natan Bar-Chama, a urologist at Mt. Sinai Hospital in New York, said that advertising approaches which only dealt with ED in a sexual context and not as a medical issue didn’t help men overcome the embarrassment that often accompanies the problem. He said that ads were simply “asking men to declare themselves as impotent,� which isn’t easy.

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Hello world!

May 5, 2006

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