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UroToday.com - This a randomized, double-blind, placebo controlled, parallel group, multicenter study involving 200 men with or without erectile dysfunction. Men (25-64 years of age) did not have ejaculatory dysfunction. Subjects were randomized to daily treatment with vardenafil, sildenafil or placebo for 6 months. Baseline sperm concentrations were compared to specimens acquired after 6 months of placebo or treatment.
The authors concluded that that vardenafil had no adverse effects on sperm concentration, compared with sildenafil and placebo, when administered daily at the maximum recommended dose for 6 months. Further vardenafil did not impair sperm concentration, total sperm count, sperm morphology or motility.
Editorial Comments: Phosphodiesterase type 5 inhibitors widely utilized for erectile dysfunction. As our society ages, it is likely that more men who are interested in fertility will experience ED. Furthermore, young men may experience ED when attempting conception. "Fear of failure" can become daunting to the young man who must "rise to the occasion" when his partner is ovulating. This well designed study suggests that semen parameters are not adversely affected by phosphodiesterase inhibitors. It should be remembered that the primary outcome of this study was a 50% reduction in baseline sperm concentration and that too few patients with low baseline sperm counts were included in this study to draw any conclusions in this population in which a 50% reduction could be clinically significant. Of course this does not prove the safety of this exposure with regard to fertility or reproductive outcome. Nevertheless this study does provide comfort to the patient and physician.
Keith Jarvia, Eugene Dula, Margaret Drehobl, Jon Pryor, JoAnn Shapiro, Monica Seger
J.Urol. Volume 179, Issue 3, Pages 1060-1065 (March 2008)
doi:10.1016/j.juro.2007.10.077
Reported by UroToday.com Contributing Editor Harris M. generishe cialis soft online kaufen mastercard Nagler, M.D. Chairman of the Department of Urology of the Beth Israel Medical Center Professor of Urology at the Albert Einstein College of Medicine of Yeshiva University
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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. Kaufen generishe cialis soft 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. 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).

View drug information on Levitra.
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At the request of the U.S. Food and Drug Administration, U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Natural?« Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.
The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking.
"The FDA will not tolerate companies marketing unapproved drugs — products that have not proven to be safe or effective — as dietary supplements," said Margaret O’K. Glavin, associate commissioner for regulatory affairs. "The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products."
The seized products, which originated in China, are packaged and distributed by Shangai Distributors, Inc. of Coamo, Puerto Rico. comprare il viagra pillole|comprare generico viagra|generico viagra in linea comrare|comprare il viagra senza ricetta|Generico viagra pillole senza ricetta Although the products’ labels state they are natural supplements, these products are drugs and their sale is illegal without FDA approval. Before a new drug product may be legally marketed, it must be shown to be safe and effective.
In response to a consumer complaint, the FDA conducted an inspection of Shangai Distributors Inc., in November 2007. The FDA’s investigation and testing revealed that the seized products contained active drug ingredients found in FDA-approved ED prescription drugs and/or a substance with a structure similar to such drugs that may cause similar side effects and drug interactions. None of the drug ingredients are listed on the labels of any of the seized products.
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.
Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company did not take any action to correct the violations. The FDA issued a press release on December 28, 2007 advising consumers not to buy or use the products. Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA’s enforcement actions.
The FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they believe are related to the use of these products. Consumers and health care professionals can report adverse events to FDA’s MedWatch program at 800-FDA-1088 or online at FDA recommends that consumers talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.
The complaint was filed by Assistant U.S. Attorney Jose M. Pizarro, deputy chief, Civil Division, United States Attorney’s Office, District of Puerto Rico.

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Men’s Health News
A comprehensive re-evaluation of the largest prostate cancer prevention study ever completed produced new findings suggesting that men and their doctors should consider a more aggressive approach that includes finasteride to prevent the development of prostate cancer.
A pathologic analysis of that same study sheds light on the significance of the cancers found in that study. Additionally, this study highlights the role of prostate specific antigen (PSA) scores in treatment decision-making. Researchers found that even those men who have a low PSA screening value can have cancer that is difficult to cure.
The two studies will be published online in advanced of the June 2008 issue of Cancer Prevention Research, a journal of the American Association for Cancer Research.
The original study, the Prostate Cancer Prevention Trial (PCPT), had randomized 18,822 men to receive either a placebo or an agent known as finasteride, currently approved to control prostate growth, for seven years. Results showed that while finasteride reduced prostate cancer risk by 25 percent, it appeared to increase development of more aggressive prostate cancer in some men. Because of this finding and concerns that tumors detected had low PSA values and might be of little risk to patients, since the study’s original publication in 2003, few doctors have recommended finasteride for prostate cancer prevention.
From a new analysis of PCPT data using advanced statistical modeling techniques and a complete assessment of prostate tissue biopsies, they concluded that these concerns are now resolved: finasteride actually reduced the risk of developing prostate cancer more than researchers had originally thought, did not increase development of more aggressive cancers, and the majority of tumors prevented were those that could spread and cause death.
comprare il viagra soft pillole|comprare generico viagra soft|generico viagra soft in linea comrare|comprare il viagra soft senza ricetta|Generico viagra soft pillole senza ricetta These new findings suggest that men should take an "individualized" approach to prostate cancer prevention, said Ian M. Thompson, M.D., Chair of the Department of Urology at the University of Texas Health Sciences Center at San Antonio, who is senior author on both studies, and was also lead author for the Southwest Oncology Group (SWOG) on the original PCPT results paper, which was published in July 2003.
"Because we now know that men with even low PSAs can develop prostate tumors, if a man is worried about his risk, regardless of PSA score, he can take an agent that is now proven to be effective in lowering that risk," Thompson said.
Researchers looked at whether finasteride actually increased aggressive cancers in some men, and by studying biopsies and prostate gland tissue that had been removed, concluding that it did not. "Finasteride actually shrank the prostate gland, so it appeared in initial studies that more cancer was being found in biopsies of men who took the drug," said Mary Redman, Ph.D., a biostatistician at the Fred Hutchinson Cancer Research Center.
"What that means is that the cancer took up more prostate tissue in men who were treated, and that is why it was easier to find in a biopsy. Cancer was probably missed more often in biopsies of men on a placebo drug because the prostate gland itself was larger," Redman said.
Redman found that in addition to a 25 to 30 percent reduction in prostate cancer development overall in men taking finasteride, there was no evidence that the drug increased the rate of aggressive tumors and likey decreased their rate by 27 percent.
"We think men should not be concerned about finasteride increasing their risk of these aggressive tumors" she said.
The second study examined whether the cancers detected in the men in the trial who had a low PSA level had clinically significant disease. With about 75 percent of the tumors detected on the study were classified as those which could potentially take a man’s life, researchers concluded that there is no clear-cut PSA threshold that can be considered normal.
All patients in PCPT were to have a biopsy of their prostate gland at some point during the seven-year trial, so investigators evaluated characteristics of the biopsy in relation to each man’s PSA score. Current practice is to consider a PSA score of below four as normal and above four as abnormal.
What they found, according to lead author Scott Lucia, M.D., a pathologist at the University of Colorado, Denver, was that while a large majority of the participants diagnosed with prostate cancer had a PSA that was considered normal, 72 percent of all tumors diagnosed from biopsies in both treated and untreated men were considered significant. In short, the finding of significant disease couldn’t be predicted by the PSA score, he said. Most patients in the study who had a PSA score of four or less and then had prostate cancer diagnosed by a routine biopsy were found to have significant prostate cancer, while some men who had a high PSA were found to have insignificant cancer.
That doesn’t mean that the researchers support reducing the level by which PSA scoring should trigger therapeutic intervention, Lucia said. "Over 90 percent of men in the country diagnosed with prostate cancer opt for treatment, yet we also found that even at higher PSA levels, men are being treated for tumors that would not have threatened their health," he said. "This is the dilemma of PSA screening. While lower cut-off levels, those below four, increase risk of detection of insignificant disease, cure is more likely; conversely, more significant disease is detected with higher levels but at a greater risk of incurable disease."
It does mean that men need to speak with their physicians about their PSA, when they should be biopsied, and about potential use of finasteride, which can reduce their risk, so that they will make a decision that is right for them, researchers say. For example, Lucia says, a man whose family members have been diagnosed with the disease may decide to have a biopsy even though his PSA is below four. If cancer is found then may opt to undergo treatment; if cancer is not found, he may choose to use finasteride to prevent the cancer from developing. Another man may decide to put off a biopsy, regardless of PSA score, if he is worried about side effects of treatment.
"These are not easy decisions, especially when we know now that we cannot rely on what the PSA looks like it is telling us," Lucia said.
Emphasizing the importance of prevention, "if given the option of having my prostate cancer found early, getting it treated and then getting over the side effects of treatment or never getting cancer in the first place, I’d choose prevention any day," said Thompson.

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