A UK study, made available at the 10th Congress of the European Society of Sexual Medicine in Lisbon, has warned healthcare professionals who treat erectile dysfunction (ED) of the importance of their first patient consultation. Authors observed that the success of the first consultation and treatment is important both directly - on measures of patient well being - and indirectly - in terms of not losing patients from a management pathway and the opportunity to monitor important co-morbidities. The study was supported by a research grant from Bayer Schering Pharma.
Study authors analysed retrospective data from 630 men with ED, all of whom had received treatment with at least one PDE5 inhibitor. Results showed that when unable to have satisfactory sex with their first dose a third of men did not return to their prescriber to try an alternative treatment. Analysis showed that first dose failure impacted on overall confidence (58%), relationships (47%) and self-esteem (68%). Additionally 77% were worried that their ED was permanent and 32% reported feelings of depression.
Oxfordshire GP David Edwards, a study author, emphasized: "Primary care has yet to fully realise the importance of early treatment success in ED. The first consultation and subsequent treatment can be critical in determining the success of longer term management. This study is a first step towards highlighting the importance of this critical phase."
Authors concluded that when prescribing a treatment for ED, patient desired attributes should be taken into consideration as many do not re-consult if the treatment is unsuccessful. The research showed that 89% of patients reported that, prior to taking their first PDE5 inhibitor, ‘high success rate with first tablet’ and ‘works quickly’ were the most important attributes for an ED treatment. Furthermore, 87% reported being willing to consider switching their current therapy if they were offered alternative treatment options by their GP.
Data revealed that 72% of respondents preferred to speak to a GP about their ED in the first instance. Even so, less than half (49%) made an appointment specifically to discuss their ED. Dr Mike Callander, Chair of the Primary Care ED Society, commented, "More can be done within primary care to screen men for ED as part of a general health check. These new data show men with ED continue to 17 months on average before seeking help. How many GPs would turn down the opportunity of an early warning signal for vascular disease, or choose to have patients suffer in silence for this long? GPs and practice nurses should ask their patients about erection problems."
Study methodology
The research was conducted amongst 630 men with ED:
- Men had been suffering with ED for an average of 4.65 years
- The average age was 55 years old
- All men had taken an oral treatment for ED at some stage
- 70% of men were still taking an oral medication
- 23% were not taking a treatment for a specific reason - the most commonly cited reason was a lack of effect (32%)
References
1. ICM. ED Patient Research. Attitudes towards Erectile Dysfunction (ED) and Treatment. Commissioned by Bayer HealthCare, May 2007
LEVITRA 5 mg / 10 mg / 20 mg film-coated tablets.
(Refer to SmPC before prescribing.)
Presentation: Each tablet contains 5 mg / 10 mg / 20 mg vardenafil (as hydrochloride trihydrate).
Indications: Treatment of erectile dysfunction. To be effective, sexual stimulation is required. Not for use by women.
Dosage: Adult men: 10 mg approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg once per day. Can be taken with or without food, onset of activity may be delayed if taken with a high fat meal. Elderly men: a first dose of 5 mg should be used. Mild and moderate hepatic impairment, severe renal impairment: A starting dose of 5 mg should be considered. With other medicinal products: In combination with erythromycin, the dose of LEVITRA should not exceed 5 mg. Children and adolescents: not indicated.
Contraindications: Coadministration with nitrates or nitric oxide donors (such as amyl nitrite) in any form; patients who have loss of vision in one eye because of NAION; men for whom sexual activity is inadvisable (e.g. severe cardiovascular disorders); severe hepatic impairment; endstage renal disease requiring dialysis; hypotension; recent stroke or myocardial infarction; unstable angina; known hereditary retinal degenerative disorders; concomitant use of potent HIV protease inhibitors such as ritonavir and indinavir, concomitant use of potent CYP3A4 inhibitors (ketoconazole and itraconazole (oral form)) in men older than 75 years; hypersensitivity to vardenafil or to any of the excipients.
Warnings and Precautions: Medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes. Consider cardiovascular status, since there is a degree of cardiac risk associated with sexual activity. Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. Use with caution in patients with anatomical deformation of the penis or conditions which predispose to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). Combination with other treatments for erectile dysfunction is not recommended. Concomitant use with potent CYP 3A4 inhibitors (itraconazole and ketoconazole (oral form)) should be avoided. A dose of 5mg vardenafil must not be exceeded when given concomitantly with erythromycin. acheter levitra mastercard Patients on stable alpha-blocker therapy: initiate vardenafil therapy at a starting dose of 5mg and consider a time separation of dosing. Prolongation of QTc interval - avoid use in patients with relevant risk factors. Advise patients that in the case of sudden visual defect to stop taking Levitra and consult a physician. Avoid grapefruit juice. Administration to patients with bleeding disorders or active peptic ulceration only after careful benefit-risk-assessment.
Undesirable Effects: Most common: flushing, headache, dizziness, nasal congestion, dyspepsia, nausea. Serious side effects include: tachycardia, palpitations, angina pectoris, hypersensitivity, laryngeal oedema, priapism, intraocular pressure increased, NAION, retinal vascular occlusion, visual field defect, myocardial infarction. Serious cardiovascular events, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia reported post marketing in temporal association with another medicinal product in this class. Prescribers should consult the SmPC in relation to other side effects.
Legal Category: POM
Marketing Authorisation Numbers: EU/1/03/248/001-012.
Marketing Authorisation Holder: Bayer AG, D-51368 Leverkusen, Germany.
Package Quantities and Costs: Packs of 4, 5mg tablets ??16.59; Packs of 8, 5mg tablets ??33.19; Packs of 4, 10mg tablets ??22.24; Packs of 8, 10mg tablets ??44.47; Packs of 4, 20mg tablets ??23.50; Packs of 8, 20mg tablets ??46.99.
Further information available from: Bayer plc, Pharmaceutical Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom.
Version: 008 Date of preparation: July 2006
- Agents for the treatment of ED should not be used in men for whom sexual activity is inadvisable
- The co administration of Levitra or any PDE5 inhibitor with nitrates or nitric oxide donors is contraindicated
- Concomitant use of Levitra with ritonavir and indinavir is contraindicated. Concomitant use with potent CYP3A4 inhibitors such as itraconazole and ketoconazole should be avoided. A dose of 5mg Levitra must not be exceeded when given concomitantly with erythromycin
- The recommended starting dose of Levitra is 10mg. In elderly men or men with mild-moderate hepatic or severe renal impairment, or in men on stable alpha blocker therapy a first dose of 5mg should be used.
- The maximum recommended dosing frequency is once per day
- The use of PDE5 inhibitors including Levitra is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION).
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Cook Medical , announced the launch of www.MensHealthPD.com, an informational microsite dedicated to educating physicians, men and their partners about the symptoms, treatment options and latest research on Peyronie’s disease, a common form of erectile dysfunction thought to affect more than 80, 000 men in the UK, with one study suggesting 1% of the male population may suffer. MensHealthPD.com is designed to provide the latest information on the painful ailment and also offers medical professionals, patients and their partners public and physician forums for discussing the disease, posting questions and sharing personal experiences about the condition.
For many men and their partners, erectile dysfunctions, such as Peyronie’s disease, are embarrassing and uncomfortable to discuss. It is also often difficult to find a centralised repository on the web with the helpful information needed to obtain answers on these conditions. MensHealthPD.com is changing all this by offering these individuals a one-stop, discreet Peyronie’s resource armed with the following assets:
- Video answers to the most commonly asked questions about Peyronie’s disease provided by some the world’s leading Peyronie’s doctor experts.
- Buy soma without prescription A Q&A forum where patients, partners and doctors can discuss available Peyronie’s treatments, exchange ideas on coping with the disease and more.
- Details of the signs, symptoms and progression of Peyronie’s disease.
- A helpful list of questions to prepare a man afflicted with Peyronie’s for his first doctor’s visit
Many men living with Peyronie’s disease go untreated because so few GPs understand the disease. In fact, a recent study showed that over half of primary care physicians were unsure any effective treatments for the disease existed. Therefore, many men never get referred to a urologist who may be able to treat the condition.
MensHealthPD.com will serve as a single source where GPs, urologists and other physicians from around the world can access the latest peer-reviewed research on Peyronie’s treatment options as well as other relevant published scientific data. The following resources are available on the microsite to educate these doctors on the wide array of treatment options available for Peyronie’s sufferers:
- A summary of current surgical and non-surgical treatment options with links to the most current published research.
- The latest peer-reviewed research on Peyronie’s disease posted in the MEDLINE database of citations and abstracts and indexed through PubMed, offered by the US National Library of Medicine and the National Institutes of Health (NIH).
- A secure, physicians-only Q&A forum where doctors can share best practices and increase their collective knowledge with their colleagues.
Raj Persad, a Consultant Urologist at United Bristol Healthcare NHS explains: "This is a distressing disease with huge potential psychosexual impact. In an area such as this where treatment options for different stages of the disease are limited and often confusing for patients we need to share as much information as possible about new management options. This website will benefit both clinicians and patients alike in enabling the sharing of experience and information which could be of benefit to all’
About Peyronie’s Disease
Peyronie’s disease, also known as penile curvature, is estimated to affect nearly four out of every 100 males between the ages 45 and 65[3]. The disease is linked to erectile dysfunction in 20 to 40 percent of the sufferers and is characterised by the formation of a plaque or hardened scar tissue beneath the skin of a man’s penis. The scarring is non-cancerous and may lead to a painful erection and curvature of the penis during erection.
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For couples worldwide, erectile dysfunction (ED) is one of the leading contributors to a man’s inability to perform. As millions of men in America each year look for a solution, many seek alternative treatments to prescription medications and surgery that may have dangerous side effects. A new published study reveals that Prelox, a patented and proprietary blend of Pycnogenol, (pic-noj-en-all), an antioxidant plant extract from the bark of the French maritime pine tree, combined with L-Arginine aspartate, an amino acid, is the natural answer to enhancing erectile quality.
The study, to be published in an upcoming edition of the International Journal of Impotence Research, shows improvement in men with ED after just one day. The study investigated the mechanism involved in relaxation of arteries as it is required for improved blood flow in erectile function. Prelox was found to cause a markedly increased nitric oxide production, the key mediator involved in expanding arteries for elevated blood flow during erections. By the end of the study, all men taking Prelox experienced almost a 100 percent increase of orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction.
Prelox is a patented unique blend of two circulation-enhancing ingredients including Pycnogenol, which contains powerful bioflavonoids that originate from plants and help keep blood vessels dilated for optimal blood flow. L-Arginine, an amino acid found in many foods, is the other ingredient coupled with Pycnogenol that ultimately promotes blood flow.
Pycnogenol and L-Arginine work together to enhance nitric oxide, a crucial chemical for sexual arousal, said Steven Lamm MD, from New York University School of Medicine Prelox is the perfect solution for men who want the same outcome as other prescription nitric oxide enhancers, but with a natural approach.
Buy diflucan pills The randomized placebo-controlled study was conducted at the Medical University of Sofia, Bulgaria. Fifty patients with moderate erectile problems were asked to take two Prelox or placebo tablets in the morning and evening. The erectile quality of men was monitored using the same methodology as applied in clinical trial with pharmaceutical drugs - in a diary consisting of a questionnaire. In addition, semen, spermatozoa and blood samples were collected to measure nitric oxide and testosterone. The study consisted of a four-week period, followed by a wash-out period, another four-week period, and a final washout.
At the end of the treatment period, patients treated with Prelox achieved high questionnaire scores, whereas the placebo group had no significant effects. The erectile function score of men (mean age 37 years) at trial start was in average 14 out of a maximum 30. After one month on Prelox, the erectile function score increased to 27, which resembles almost completely healthy values such as those found in twenty year old men. Parallel to the increase of erectile function, the mean number of intercourse more than doubled during treatment for those who took Prelox. Treatment with Prelox produced a steep increase of nitric oxide activity in most patients and no changes were indicated for the placebo group.
This European study confirms my experience in a clinical trial with Prelox I carried out two years ago said Lamm. "This is the third clinical study showing that men can achieve greater erectile quality with Prelox, move past their performance anxiety and get more satisfaction from their sex lives."
Blood analysis revealed an increased testosterone level during supplementation with Prelox. This is not a direct result of the supplement but is typical for men with increased sexual activity. The men in this trial reported a dramatic increased frequency of morning erections. Moreover, their partners noted a higher interest for sex as well as better performance.
Past research on Prelox scientifically demonstrated its effectiveness in increasing and enhancing sexual performance in three clinical studies in the United States and Europe. In these studies, almost 85 percent of Prelox users said it improved erectile function and more than 70 percent of Prelox users said it was easier to initiate and sustain an erection. In a study at the New York University School of Medicine, more than 80 percent of male subjects rated Prelox as effective in improving their ability to engage in sexual activity.
Furthering evidence of its effectiveness, Prelox has been awarded a U.S. patent (U.S. 6,565,851 B2) for the relief of the symptoms of erectile dysfunction. NHS and Horphag Research have granted exclusive product licenses to several companies world-wide. Horphag Research just announced a new partnership with Xion Corporation. Xion will launch Prelox to practitioners in North America.
Prelox is safe and easy to use "two tablets, twice a day for the first two weeks; then one to two tablets, twice a day to maintain and sustain enhanced pleasure and performance. Prelox is exclusively available at Purity Products , Herbalife, GVI and Xion. For more information visit
—————————-
Article adapted by Medical News Today from original press release.
—————————-
About Prelox
Prelox is a clinically tested and patented combination of two potent ingredients, L-Arginine aspartate, an amino acid that plays an important role in nitric oxide mechanisms in the body, and Pycnogenol, a natural plant extract originating from bark of the Maritime pine that grows along the coast of southwest France and expands and supports healthy blood vessels. Research shows that Prelox helps protect, restore and sustain blood flow to the genital area, naturally enhancing erections and the body’s sexual response. For more information, visit the Prelox Web site at
Natural Health Science Inc. (NHS), based in Hoboken, New Jersey, is the North American distributor for Prelox on behalf of Horphag Research. Prelox and Pycnogenol are registered trademarks of Horphag Research Ltd., Guernsey, and its applications are protected by U.S. patents #6,565,851 B2. NHS has the exclusive rights to market and sell Prelox in North America. For more information, visit the Prelox web site at
Source: Melanie Nimrodi
MWW Group
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Results of the first
prospective trial specifically designed to evaluate erectile function in
erectile dysfunction (ED) patients with dyslipidemia show that LEVITRA(R)
(vardenafil HCl), used in treating ED, significantly improves the ability
of men with ED and dyslipidemia to achieve and maintain an erection for
successful sexual intercourse. These data were presented at the Sexual
Medicine Society of North America (SMSNA) Fall Meeting held in Chicago, IL.
The double-blind, placebo-controlled study is the first study to
measure the safety and efficacy of a PDE 5 inhibitor in a cohort of men who
all had ED and dyslipidemia. Results from the study of 395 men show that
LEVITRA significantly increased rates of penetration (as measured by SEP2
scores) and the ability to maintain an erection (as measured by SEP3
scores) compared to placebo.
"ED is associated with high cholesterol, yet many physicians are not
treating ED, a life-changing condition," said Dr. Martin Miner, Clinical
Associate Professor of Family Medicine at Brown University’s Warren Alpert
School of Medicine. "This study provides further support that LEVITRA can
successfully treat ED, even in men with a serious common condition like
high cholesterol."
Nearly 70 percent of the estimated 30 million men in the United States
who have ED also have other common conditions such as dyslipidemia
(including high cholesterol), hypertension, or diabetes, which may lead to
erectile dysfunction. Previous studies have demonstrated the efficacy and
safety of LEVITRA in men with ED who also have high blood pressure or
diabetes.
About the Study
In the double-blind, placebo-controlled study, 395 men ages 18 to 64
that had ED and dyslipidemia were randomized to treatment with LEVITRA or
placebo for 12 weeks.
Men treated with LEVITRA had statistically significant and clinically
relevant improvements in SEP2 scores (a rating system that measures
penetration) and SEP3 scores (a rating system that measures maintenance of
erection) versus placebo (79.1% and 66.7%, respectively, for LEVITRA, vs.
51.9% and 33.8%, respectively, for placebo). IIEF-EF (International Index
of Erectile Function) scores also were significantly higher for the LEVITRA
group compared to the placebo group. These scores are evaluated based on a
patient questionnaire and their daily diary response to specific questions
about sexual performance.
LEVITRA was well tolerated. Treatment-emergent adverse effects
(occurring in = 5% of patients) included headaches (9% for LEVITRA, 1% for
placebo) and upper respiratory tract infections (5% for LEVITRA, 3% for
placebo).
Background: Erectile dysfunction
Erectile dysfunction (ED) is the consistent or recurrent inability of a
man to attain and/or maintain a penile erection sufficient for sexual
performance. ED can be a total inability to achieve an erection, an
inconsistent ability to do so, or a tendency to sustain only brief
erections. It is estimated that some degree of ED affects up to 30 million
men in the United States.
Some of the most common treatments for ED include adjustments to
lifestyle and better control of concomitant medical conditions as well as
the use of oral medications or other forms of therapy. Treating related
health conditions or reducing stress may help maintain erectile function.
About LEVITRA
LEVITRA (vardenafil HCl) is a prescription medicine that is indicated
to treat erectile dysfunction (ED). Consistent with the effects of PDE5
inhibition, administration of LEVITRA with nitrates and nitric oxide donors
is contraindicated.
Caution is advised when PDE5 inhibitors, including LEVITRA, are used
concomitantly with stable alpha-blocker therapy, because of the potential
for lowering blood pressure.
LEVITRA is not recommended for patients with uncontrolled hypertension
(>170/110 mmBuy zithromax pills Hg).
In men for whom sexual activity is not recommended because of their
underlying cardiovascular status, any treatment for erectile dysfunction,
including LEVITRA, generally should not be used.
In patients taking certain CYP3A4 inhibitors (eg, ritonavir, indinavir,
saquinavir, atazanavir, ketoconazole, itraconazole, erythromycin, and
clarithromycin), lower doses of LEVITRA are recommended, and time between
doses of LEVITRA may need to be extended. See prescribing information for
LEVITRA for dosing guidance.
In clinical trials, the most commonly reported adverse events with
LEVITRA were headache, flushing, and rhinitis. Adverse events were
generally transient.
Nonarteritic anterior ischemic optic neuropathy (NAION) has been
reported rarely postmarketing in temporal relationship with the use of PDE5
inhibitors, including LEVITRA. Sudden loss of hearing, sometimes with
tinnitus and dizziness, also has been reported rarely in temporal
association with the use of PDE5 inhibitors, including LEVITRA. It is not
possible to determine if these events are related to PDE5 inhibitors or to
other factors. Physicians should advise patients to stop use of PDE5
inhibitors, including LEVITRA, and seek prompt medical attention in the
event of sudden loss of vision or hearing.
The recommended starting dose of LEVITRA is 10 mg. Titrate up to 20 mg
or down to 5 mg based on efficacy and side effects.
The maximum recommended dosing frequency is once daily.
LEVITRA is available in 2.5-mg, 5-mg, 10-mg and 20-mg tablets.
For Prescribing Information please visit
About GlaxoSmithKline
GlaxoSmithKline - one of the world’s leading research-based
pharmaceutical and healthcare companies - is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline at
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. Schering-Plough’s vision is to "To Earn Trust, Every Day"
with the doctors, patients, customers and other stakeholders served by its
approximately 50,000 people around the world. The company is based in
Kenilworth, N.J., and its Web site is
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release contains certain "forward-looking" statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
related to the potential market for LEVITRA. Forward-looking statements
relate to expectations or forecasts of future events. Schering-Plough does
not assume the obligation to update any forward-looking statement. Many
factors could cause actual results to differ materially from
Schering-Plough’s forward- looking statements, including market forces,
economic factors, product availability, patent and other intellectual
property protection, current and future branded, generic or
over-the-counter competition, the regulatory process, and any developments
following regulatory approval, among other uncertainties. For further
details about these and other factors that may impact the forward-looking
statements, see Schering-Plough’s Securities and Exchange Commission
filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough’s
third quarter 2007 10-Q.
Schering-Plough
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The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.
In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.
The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.
"Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it," said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.
Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.
A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 postmarketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. comprare generico levitra In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.
Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.
Product Web sites, marketing and educational materials, and advertisements for PDE5 inhibitors will reflect the revised product labeling. The label revisions can be viewed here.
For more information
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