The link between obesity and male potency dates from the Byzantine era, when it was thought that a large stomach impaired a man’s ability to have sexual intercourse. This is particularly relevant today, as the prevalence of obesity has more than doubled in the last 25 years. Excess abdominal fat, cardiovascular disease, high blood lipids and type-2 diabetes characterize a condition known as metabolic syndrome, which has recently been associated with erectile dysfunction.

The study included 2,435 male patients who sought treatment at an outpatient clinic for sexual dysfunction between 2001 and 2007. The results showed that obesity was significantly associated with a higher physical contribution to ED, while there was no difference seen with relational or psychological determinants. As the severity level of obesity increased, levels of testosterone decreased (two out of three patients with morbid obesity had low testosterone). Obese patients were also more likely to have abnormalities in penile blood flow. Psychological disturbances related to obesity did not seem to play a major role in developing obesity-related ED.

“This is a landmark study in that it shows that sexual health is clearly linked to overall health, and that improving one’s general health provides a man the opportunity to improve his erectile function” states Dr. Irwin Goldstein, Alvarado Hospital’s Sexual Medicine Director and Editor-in-Chief of The Journal of Sexual Medicine.”

Alvarado Hospital is a 306-bed acute care hospital that also operates the San Diego Rehabilitation Institute and Advanced Spine Institute, which serves patients with either inpatient or outpatient rehabilitation needs. Alvarado has more than 500 on-staff physicians, 1,000 employees and 400 volunteers who provide quality care to East County San Diego. Alvarado Hospital’s programs include cardiac services, emergency medicine services, neuroscience, orthopedics, oncology, rehabilitation, general surgical services, sexual medicine, skull base surgery, sleep center, vascular services and surgical weight reduction. http://www.alvaradohospital.com

Source
Sandy Nesheiwat
Account Executive

“Of the greatest concern is the use of telemedicine to treat erectile dysfunction,” said Dr Chris Mitchell, RACGP President and GP in Northern NSW . “The danger is that a condition will be treated in isolation without due regard to other physical and emotional factors, which might be affecting a patient”.

“General practitioners provide whole person, comprehensive and coordinated care and often have an established relationship with their patients,” said Dr Mitchell. “This allows the GP to explore a range of interventions, both pharmaceutical and non-pharmaceutical, as part of the continuing care of a patient.”

“GPs should be the first point of contact in the health care system and are well placed to deal with erectile dysfunction,” Dr Mitchell said. “The RACGP supports the House of Representatives review of the frameworks in place that allow such erectile dysfunction clinics to operate. It is of utmost import that health services are delivered in the context of continuous, safety and high quality care.”

“In general terms, impotency clinics routinely prescribe compound medications in the first instance. However, these medications have been demonstrated to be less clinically effective and more expensive than first line industry recommended treatments. These may have adverse impacts on men’s health and wellbeing,” said Dr Nathan Pinskier, who represented the RACGP at the roundtable discussion.

The RACGP believes that patients should be given the option of exploring evidence based, clinically proven treatments; something not offered by impotency clinics, Dr Pinskier said.

“Telemedicine is not necessarily the solution to a problem such as erectile dysfunction, which many men find embarrassing and difficult to discuss. Patients need to be reassured that their confidentiality is assured when they visit a general practitioner, no matter where and in what sort of community they live,” said Dr Pinskier.

Source
Royal Australian College of General Practitioners

As for which PDE-5 inhibitor to use, ACP recommends that physicians base the choice on the individual preferences of patients including ease of use, cost of medication, and adverse effects profile.

“The evidence is insufficient to compare the effectiveness or adverse effects of different PDE-5 inhibitors for the treatment of ED because there were only a few head-to-head trials,” explained the lead author of the guideline, Amir Qaseem, MD, PhD, MHA, FACP, senior medical associate at the American College of Physicians.

The guideline authors analyzed evidence gathered from 130 randomized controlled trials that evaluated oral PDE-5 inhibitors alone or combined. Treatment with a PDE-5 inhibitor resulted in statistically significant and clinically relevant improvements in sexual intercourse and erectile function in patients with ED, regardless of the cause (e.g., diabetes, depression, prostate cancer) or baseline severity. The magnitude of benefit increased with severity of ED.

Overall, the evidence showed that PDE-5 inhibitors were relatively well-tolerated and were associated with mild or moderate adverse effects, such as headaches, flushing, upset stomach, and runny nose.

ACP does not recommend for or against routine hormonal blood tests or treatment in the management of patients with ED because the evidence is inconclusive about the effectiveness in patients with low testosterone levels. Physicians should individualize decisions to measure hormone levels based on the clinical symptoms (e.g., decreased libido, premature ejaculation, fatigue, etc.) and physical findings (for example, testicular atrophy, muscle atrophy) that suggest hormonal abnormality.

“Hormonal Testing and Pharmacologic Treatment of Erectile Dysfunction: A Clinical Practice Guideline from the American College of Physicians” appears on the Web site of Annals of Internal Medicine (http://www.annals.org/) and will be printed in the November 3 issue.

About ED

ED can be a persistent inability to achieve or maintain penile erection sufficient for satisfactory sexual performance, an inconsistent ability to do so, or a tendency to sustain only brief erections. These variations make defining ED and estimating its incidence difficult. Estimates range from 15 million to 30 million in the U.S., depending on the definition used. Estimates from the National Health and Nutrition Survey suggested that the cost of treatment of ED in the U.S. could reach $15 billion if all men sought care.

ED is a common disorder of male sexual function and affects all age groups especially individuals with advanced age, diabetes, vascular diseases, psychiatric disorders, and possibly hypogonadism (low testosterone). ED may be caused by chronic diseases such as obesity, hypertension, dyslipidemia, cardiovascular disease, or smoking; medications; psychosocial factors; or hormonal abnormalities.

ED lasting for three months is considered a reasonable length of time to warrant evaluation and consideration of treatment.

Source:
Steve Majewski
American College of Physicians

The new report entitled Erectile Dysfunction: Physicians Seek Improvements in Efficacy for Underserved Patients and Product Differentiation on Onset and Duration of Action finds that a therapy that provides greater improvement in erectile function than Levitra in patients with hypertension and that is priced at a five percent discount to Levitra would earn a 50 percent patient share in the United States and a 40 percent patient share in Europe, according to surveyed U.S. primary care physicians and European general practitioners.

Additionally, while there are several second-generation PDE5 inhibitors in clinical trials for the treatment of erectile dysfunction, interviewed experts do not expect these agents to provide efficacy superior to that of currently marketed drugs in this class. The report also finds that limited reimbursement for erectile dysfunction drugs and the availability of less-expensive generic versions of Viagra beginning in 2012, will constrain the uptake of emerging PDE5 inhibitors.

“Most therapies for erectile dysfunction do not qualify for reimbursement by third-party payers,” said Decision Resources Analyst Kathryn Benton, B.S. “As a result, many patients pay out-of-pocket for treatment — this will be among the factors that will cause premium-priced emerging therapies to struggle to capture market share.”

About the Report

Erectile Dysfunction: Physicians Seek Improvements in Efficacy for Underserved Patients and Product Differentiation on Onset and Duration of Action is a DecisionBase 2009 report. DecisionBase 2009 is a decision-support tool that provides in-depth analysis of unmet need, physician expectations of new therapies and commercial dynamics to help pharmaceutical companies optimize their investments in drug development.

The report can be purchased by contacting Decision Resources. Members of the media may request an interview with an analyst.

About Decision Resources

Decision Resources is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

Source: Decision Resources

The new system, tested successfully on a small number of animals, could potentially prevent side effects associated with oral ED medications, if study results can be replicated in humans. That could mean safer and more effective ED therapy for millions of men with heart disease and other health problems affecting erectile function. The study is published today in the online edition of the Journal of Sexual Medicine.

Tens of millions of men worldwide have benefited from oral ED medications such as sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis). However, these medications which belong to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors have limitations. They can cause systemic side effects that can be serious. These side effects include headache, facial flushing, nasal congestion, upset stomach, abnormal vision as well as isolated reports of hearing and vision loss. Men who’ve recently suffered a heart attack or stroke or have severe heart disease should use these drugs with caution or not at all. In addition, “an estimated 30 to 50 percent of men with ED do not respond to oral use of PDE5 inhibitors,” says senior author Kelvin P. Davies, Ph.D., associate professor of urology at Einstein.

The drug-delivery system, developed by Einstein scientists, consists of nanoparticles each smaller than a grain of pollen that can carry tiny payloads of various drugs or other medically useful substances and release them in a controlled and sustained manner.

The limited number of topical formulations of ED drugs has so far proven ineffective. This study was done to evaluate whether the Einstein nanoparticles, which have been shown to penetrate the skin, might allow the targeted delivery of compounds that treat ED and thereby avoid the drugs’ systemic effects.

An effective topical therapy could be especially significant for those ED patients particularly men with diabetes who have reduced levels of nitric oxide (NO), the signaling molecule that dilates blood vessels responsible for erectile activity. These men, who often aren’t helped by oral PDE5 inhibitor drugs, may benefit from direct application of NO or the PDE5 inhibitors.

The nanoparticles were tested on a total of 18 rats bred to have age-related ED. The rats were divided into three treatment groups. One group of seven rats received nanoparticles encapsulating NO. A second group of five rats received nanoparticles encapsulating NO plus an experimental ED drug called sialorphin (which has a mechanism of action different from PDE5 inhibitors). A third group of six received nanoparticles encapsulating NO plus tadalafil (Cialis).

Five of the seven rats treated with the NO-containing nanoparticles, and all 11 rats treated with nanoparticles encapsulating NO plus sialorphin or tadalafil showed significantly improved erectile function. None of the seven rats in a control group, which received empty nanoparticles, showed any improvement.

“Most of the animals, nearly 90 percent, showed a response to treatment with the nanoparticles,” says co-author Joel M. Friedman, M.D., Ph.D., professor of physiology & biophysics and of medicine. Dr. Friedman developed the nanoparticles with his son Adam Friedman, M.D., chief resident in the division of dermatology of the department of medicine at Montefiore Medical Center, The University Hospital and Academic Medical Center for Einstein.

“The response time to the nanoparticles was very short, just a few minutes, which is basically what people want in an ED medication,” adds Dr. Davies. “In both rats and humans, it can take 30 minutes to one hour for oral ED medications to take effect.”

Postmortem examination of the tissues at the site of administration showed no signs of local inflammation or toxicity. “In addition, when we applied the nanoparticles at therapeutic doses, we found no indication of systemic side effects,” says Dr. Friedman.

The Einstein research team will carry out safety and dosing studies in rats in the coming months. Clinical studies on humans could begin in a few years if animal studies continue to show that the nanoparticle delivery system is safe and effective. But the investigators caution that the time from a proof-of-concept trial in animals to approved use in humans may be a decade or more.

The paper, “Nanoparticles as a novel delivery vehicle for therapeutics targeting erectile dysfunction,” is published in the September 18, 2009 online edition of the Journal of Sexual Medicine. The lead authors are George Han, an M.D.-Ph.D. student at Einstein, and Moses Tar, M.D., assistant professor of urology at Einstein. Dwaraka Srinivasa Rao Kuppam, a technician in the Einstein urology department, Adam Friedman, M.D., of Montefiore Medical Center, and Arnold Melman, M.D., chairman of urology at Einstein, also contributed to the research.

About Albert Einstein College of Medicine of Yeshiva University

Albert Einstein College of Medicine of Yeshiva University is one of the nation’s premier centers for research, medical education and clinical investigation. It is home to 2,775 faculty members, 625 M.D. students, 225 Ph.D. students, 125 students in the combined M.D./Ph.D. program, and 380 postdoctoral research fellows. In 2008, Einstein received more than $130 million in support from the NIH. This includes the funding of major research centers at Einstein in diabetes, cancer, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Through its extensive affiliation network involving eight hospitals and medical centers in the Bronx, Manhattan and Long Island which includes Montefiore Medical Center, The University Hospital and Academic Medical Center for Einstein the College of Medicine runs one of the largest post-graduate medical training programs in the United States, offering approximately 150 residency programs to more than 2,500 physicians in training

Source: Albert Einstein College of Medicine