Archive for June, 2008

Jun 17 2008

Young macho men with serious injuries often abuse alcohol

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Men’s Health News
Men with serious injuries, such as traumatic brain injury or spinal cord injury, must deal with a range of emotions.
generic diflucan online buy If these men have strong traditional masculine ideas and abuse alcohol, it becomes even more difficult to help them heal and come to terms with their emotions and situations. A University of Missouri psychology researcher studied these challenging factors to find better ways to understand and treat men who fit this mold, such as the injured soldiers coming back from Iraq and Afghanistan.
"It is really a triple whammy," said Glenn Good, professor of educational, school and counseling psychology in the MU College of Education. "Counselors face many challenges when it comes to helping men deal with emotions surrounding serious injuries. Newly injured men often face adjustments in the level of personal assistance they require, and this may result in struggles with some aspect of the traditional masculine role, such as a ‘go it alone’ mentality. When three factors - injury, traditional male role and alcohol abuse - occur together, the rehabilitation process may be a challenge. In this study, we examined the combination of all three factors with the aim of better understanding how to treat men with several challenges."
Good and his colleagues found that a young man with a serious injury would often report a greater pursuit of status, higher drive for dominance and increased risk taking. However, they were more open to accepting assistance. Older men in the study tended to hold to the masculine attitude that they could do everything on their own and did not need any help, presenting a greater challenge.
"Unfortunately, we are going to have a country full of men like this coming back from Iraq and Afghanistan," Good said. "Soldiers have been trained to be hyper-masculine and, after a serious injury, could easily turn to alcohol use to deal with their new challenges. We have to confront this problem and create interventions that address all of these issues and not just one behavior or problem at a time. Our systems of care for people with spinal cord injuries, veterans and non-veterans, must address these issues proactively and with adequate resources to face these multiple challenges."
Good found alcohol use was common regardless of age. In the study, binge drinking was defined as five or more drinks per occasion.
"Some men are drinking instead of seeking appropriate help, but some have been heavy drinkers all along," Good said. "The binge drinking is problematic. Some may drink to suppress their bad feelings about being injured and their perceived loss of masculinity. They may think they are being strong by not seeking help when in fact turning to alcohol could be even more detrimental."

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Jun 17 2008

Men who develop diabetes in mid-life have increased risk of Alzheimer’s

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Men’s Health News
Men who develop diabetes in mid-life appear to significantly increase their risk of developing Alzheimer’s disease, according to a long-term study published in the April 9, 2008, online issue of Neurology, the medical journal of the American Academy of Neurology.
"Our results have important public health implications given the increasing numbers of people developing diabetes and the need for more powerful interventions," said study author Elina R?nnemaa, MD, with Uppsala University in Uppsala, Sweden.
The study involved 2,269 men in Sweden who underwent glucose testing at age 50 to test for diabetes, which is caused by abnormal insulin levels. During an average follow up of 32 years, 102 participants were diagnosed with Alzheimer’s disease, 57 with vascular dementia and 235 with other types of dementia or cognitive impairment.
Buy acomplia pills The study found that the men with low insulin secretion capacity at age 50 were nearly one-and-a-half times more likely to develop Alzheimer’s disease than people without insulin problems. The risk remained significant regardless of blood pressure, cholesterol, body mass index and education.
"Our results suggest a link between insulin problems and the origins of Alzheimer’s disease and emphasize the importance of insulin in normal brain function," said R?nnemaa. "It’s possible that insulin problems damage blood vessels in the brain, which leads to memory problems and Alzheimer’s disease, but more research is needed to identify the exact mechanisms."
The study also found the association between diabetes and risk of Alzheimer’s disease was strongest in people who did not have the APOE4 gene, which is known to increase the risk of Alzheimer’s disease. R?nnemaa says this shows that insulin problems are an important risk factor for Alzheimer’s disease when the high risk gene is missing.

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Jun 17 2008

FDA Requests Recall Of Xiadafil VIP Tabs

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The U.S. Food and Drug Administration requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person’s blood pressure and can cause other life-threatening side effects. These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction (ED).
Today’s formal request follows an action by the state of Florida to prevent the further distribution of this product into consumer channels. FDA is advising consumers not to buy or use this product. The agency may take further regulatory action to protect consumers from this illegal product.
Although labeled as a dietary supplement and touted as "all-natural," Xiadafil VIP Tabs are an illegally marketed drug that contains a potentially harmful undeclared ingredient. FDA chemical analysis revealed that Xiadafil VIP Tabs contains hydroxyhomosildenafil, which is an analog of sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED.
This undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. acheter cialis soft mastercard ED is a common problem in men with these medical conditions.
"Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."
The FDA has not approved Xiadafil VIP Tabs for ED or any other drug use, and the safety and effectiveness of this product is unknown. The product is promoted and sold over the Internet, was given away as free samples at trade shows, and is sold in health food stores nationwide. The product may be packaged in bottles of eight tablets or blister cards of two tablets.
On May 13, 2008 Florida officials issued a "stop sale" action at SEI’s distribution facility in Miami, Fla. This action required the firm to hold, intact, violative Xiadafil VIP Tabs found on-hand at the facility. The state of Florida’s action to control the supply of the product, coupled with today’s formal request by FDA to recall this product from the marketplace, will further reduce the likelihood that this potentially dangerous product is used by unsuspecting consumers.
Alternative products like Xiadafil VIP Tabs are often sought out because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should also be aware that the safety, efficacy, and purity of these ingredients have not been verified by the FDA.
The FDA advises consumers who have used this product to discontinue use immediately and consult their health care professional if they have experienced any adverse events that they believe may be related to the use of this product.
Consumers and health care professionals can report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or online here.
Additionally, the FDA recommends that consumers talk to their health care professional about FDA-approved treatments for ED.
For more information, visit here.

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Jun 17 2008

Estrogen drives distinct, aggressive prostate cancer

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Men’s Health News
Using a breakthrough technology, researchers led by a Weill Cornell Medical College scientist have pinpointed the hormone estrogen as a key player in about half of all prostate cancers.
Estrogen-linked signaling helps drive a discrete and aggressive form of the disease caused by a chromosomal translocation, which in turn results in the fusion of two genes.
"Fifty percent of prostate cancers harbor a common recurrent gene fusion, and we believe that this confers a more aggressive nature to these tumors," explains study senior author Dr. Mark A. Rubin, professor of pathology and laboratory medicine, and vice chair for experimental pathology at Weill Cornell Medical College. Dr. Rubin is also attending pathologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
"Interfering with this gene fusion — or its downstream molecular pathways — will be crucial in the search for drugs that fight the disease. Buy propecia without prescription Based on our new data, we now believe that inhibiting estrogen may be one way of doing so," he says.
The findings are published in the May 27 online edition of the Journal of the National Cancer Institute. Dr. Rubin conducted the study while at the Brigham and Women’s Hospital and in collaboration with Dr. Todd Golub and other members of the Broad Institute of MIT and Harvard, in Cambridge, Mass. His team is now continuing this line of research at Weill Cornell.
Dr. Rubin, along with researchers at the University of Michigan, first discovered and described the common fusions between the TMPRSS2 and ETS family member genes subset of prostate cancer in the journal Science in 2005. "The discovery showed that these malignancies occur after an androgen (male hormone)-dependent gene fuses with an oncogene — a type of gene that causes cancer," he explains.
Experts have long understood that male hormones help spur prostate cancer — in fact, androgen-deprivation therapy is a first-line treatment against the disease. And yet the disease can progress despite androgen reduction, suggesting that other pathways might be at work.
"So, we wanted to learn more — what is the genetic and molecular ‘fingerprint’ of this aggressive subset of prostate tumor?" Dr. Rubin says.
Answering that question required the analysis of 455 prostate cancer samples from trials in Sweden and the United States that were conducted as far back as the mid-1970s.
"These samples were placed in fixative and not frozen, so we needed new methods of retrieving the genetic information," Dr. Rubin says. To do so, his team led by co-lead authors Dr. Sunita Setlur and Dr. Kirsten Mertz developed an innovative technology for effectively "reading" the gene transcription profiles hidden in the samples.
"That led us to perform the largest gene-expression microarray analysis yet conducted in prostate cancer research, amassing information on more than 6,000 genes," Dr. Rubin says. "This allowed us to obtain a robust, 87-gene expression ’signature’ that distinguishes fusion-positive TMPRSS2-ERG cancers from other prostate malignancies."
A close analysis of the signature yielded a surprise: that estrogen-dependent molecular pathways appear to play a crucial role in regulating (and encouraging) this aggressive subset of prostate cancer.
While estrogen is typically thought of as a "female" hormone, men produce it as well.
"Now, we show for the first time that this natural estrogen can stimulate the production of the cancer-linked TMPRSS2-ERG transcript, via the estrogen receptor (ER)-alpha and ER-beta. These receptors are found on the surface of some prostate cancer cells," Dr. Rubin explains.
The finding could have implications for prostate cancer research, including drug development. According to Dr. Rubin, "We now believe that agents that dampen estrogen activity (ER-beta antagonists) could inhibit fusion-positive prostate cancers. Alternatively, any intervention that boosts estrogen activity (ER-alpha) might also give a boost to these aggressive malignancies."
Research into just why fusion-positive prostate cancers are so aggressive — and potential molecular drug targets to help curb that aggression — will continue under Dr. Rubin’s direction at Weill Cornell, in collaboration with members of his group and with computational biologist Dr. Francesca Demichelis.
"The technological achievement of using fixed samples that were up to 30 years old is significant," Dr. Rubin says. "In the future, we hope to explore banked tissues from clinical trials to help understand why they failed. This should lead to insight for designing the next trial."
This work was funded by the U.S. National Institutes of Health, a Prostate SPORE grant at the Dana-Farber/Harvard Cancer Center, Swiss Foundation for Medical-Biological Grants SSMBS, U.S. Department of Defense and the Prostate Cancer Foundation.
Co-researchers include study co-lead authors Dr. Sunita Setlur and Dr. Kirsten Mertz of Brigham and Women’s Hospital and Harvard Medical School, Boston; Dr. Yujin Hoshida and Dr. Todd Golub of the Broad Institute and the Dana-Farber Cancer Institute, Boston; Dr. Francesca Demichelis of Weill Cornell Medical College and Harvard Medical School, Boston; Dr. Mathieu Lupien of the Dana-Farber Cancer Institute; Dr. Sven Perner and Jeff Tang of Weill Cornell Medical College; Andrea Sboner of Yale University, New Haven; Dr. Yudi Pawitan and Dr. Katja Fall of the Karolinska Institutet, Stockholm, Sweden; Dr. Ove Andren, Dr. Jan-Erik Johansson and Dr. Swen-Olof Andersson, of Orebro University Hospital, Orebro, Sweden; Laura A. Johnson of Brigham and Women’s Hospital, Boston; Dr. Hans-Olov Adami, of Karolinska Institutet, Sweden, and Harvard School of Public Health, Boston; Dr. Stefano Calza, of the Karolinska Institutet, Sweden, and the University of Brescia, Italy; Dr. Arul M. Chinnaiyan, Dr. Daniel Rhodes and Scott Tomlins, of the University of Michigan Medical School, Ann Arbor; Dr. Lorelei Mucci and Dr. Meir Stampfer of Harvard Medical School, Harvard School of Public Health and Brigham and Women’s Hospital, Boston; Dr. Philip Kantoff of Dana-Farber Cancer Institute and Harvard Medical School; Dr. Eberhard Varenhorst, of University Hospital Linkoping, Sweden; and Dr. Myles Brown of the Dana-Farber Cancer Institute.
Dr. Mark A. Rubin, Dr. Francesca Demichelis, Dr. Sven Perner, Dr. Arul M. Chinnaiyan and Scott Tomlins are co-inventors on a patent filed by the University of Michigan and the Brigham and Women’s Hospital, covering the diagnostic and therapeutic fields for ETS fusions in prostate cancer.

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Jun 17 2008

New Patient Research Shows Importance Of Early Success In Treating Erectile Dysfunction

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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. 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. kaufen cialis Ohne Rezept 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).

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