Jun 18 2008

Tadalafil Helps Spinal Cord Injury Patients With Erectile Dysfunction

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Buy fosamax without prescription Men with spinal cord injuries appear to have better erectile function when they take tadalafil, according to a report published in Archives of Neurology (JAMA/Archives), November 2007 issue.
Spinal cord injuries are much more common than many people realize; globally about 10.4 to 83 people per million are affected by spinal cord injuries annually, say the authors. "Throughout the world, spinal cord injury occurs most often in young men, resulting in negative physical, social and psychological consequences. Erectile dysfunction, defined as the inability to attain and maintain penile erection sufficient for satisfactory sexual performance, is a common complication in men with spinal cord injury."
The authors point out that only about one quarter of men with spinal cord injuries manage to have an erection adequate for having sexual intercourse.
Francois Giuliano, M.D., Ph.D., Raymond Poincare Hospital, Garches, France, and team, carried out a randomized, double-blind study on 197 men with spinal cord injuries; their average age was 38. First of all they were all monitored, without treatment for erectile dysfunction. Then 142 of them were randomly selected to receive tadalafil, while 44 received a placebo. The treatment lasted 12-weeks - the participants were asked to take their medication whenever they needed it; before sexual activity, maximum dose one per day. The tadalafil group were given a 10-milligram dose initially, and then 20-milligrams four weeks later, depending on their response to the initial treatment.
The researchers used the International Index of Erectile Function questionnaire. It consists of 15 questions; if a person scores lower than 25 he is deemed as someone who suffers from varying degrees of erectile dysfunction. At the beginning of the study the participants’ average score was 13.4. At the end of the twelve week period the average score for the tadalafil group went up to 22.6. The placebo group’s score rose slightly to 13.6.
Those on tadalafil managed to successfully achieve penetration 75.4% of the time, while successfully attempting intercourse for 47.6% of the time. The participants on the placebo managed to successfully achieve penetration 41.1% of the time while successfully attempting intercourse for 16.8% of the time.
The researchers wrote "Tadalafil was safe and well tolerated with few treatment-emergent side effects," the authors write. Fifty (35%) of patients in the tadalafil group and 15 (34%) of those in the placebo group experienced at least one adverse effect. Among those taking tadalafil, the most common side effects were headache (8.5% of patients) and urinary tract infection (7.7% of patients). As in other erectile dysfunction studies that include patients who were difficult to treat owing to pre-existing conditions (e.g., prostatectomy, diabetes mellitus), tadalafil was efficacious for the treatment of erectile dysfunction after a traumatic spinal cord injury," the authors write. "On-demand treatment with tadalafil (10 milligrams or 20 milligrams) may help improve the sex lives of patients with erectile dysfunction and spinal cord injury and their partners."
"Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury"
Fran?§ois Giuliano, MD, PhD; Antonio Sanchez-Ramos, MD; Dieter L?¶chner-Ernst, MD; Giulio Del Popolo, MD; Natalio Cruz, MD; Albert Leriche, MD; Giuseppe Lombardi, MD; Susanne Reichert, MD; Palle Dahl, MSc; Albert Elion-Mboussa, MS; Joaquin Casariego, MD
Arch Neurol. 2007;64:(doi:10.1001/archneur.64.11.nct70001).
Click here to view abstract and article online
Written by: Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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Jun 17 2008

FDA Approves Cialis(R) (tadalafil) For Once Daily Use For The Treatment Of Erectile Dysfunction

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Eli Lilly and Company
(NYSE: LLY) announced that the U.S. Food and Drug Administration
(FDA) has approved Cialis(R) (tadalafil)(1) for once daily use (2.5 mg and
5 mg), an oral medication taken once per day to treat erectile dysfunction
(ED). When Cialis for once daily use is taken daily, men can attempt sexual
activity at anytime between doses.
Currently available in parts of Europe, this low-dose daily treatment
option of Cialis may be most appropriate for men with ED who anticipate
more frequent sexual activity (e.g. twice weekly). For other men, Cialis
taken as needed - the previously approved dosing regimen - may be most
appropriate.
In clinical trials, when taken without restrictions on the timing of
sexual activity, Cialis for once daily use improved erectile function over
the course of therapy.
"ED can be a chronic condition like diabetes or high blood pressure,"
said Ridwan Shabsigh, M.D., Director of the Division of Urology at
Maimonides Medical Center in New York. "As a urologist, I know couples like
to have choices and will appreciate the availability of Cialis for once
daily use."
Cialis for use as needed transformed the U.S. ED market when it was
approved in 2003 as the first and only PDE5 inhibitor clinically proven to
provide
sustained efficacy for up to 36 hours. Cialis for once daily use
provides a new option for men who may be looking for a dosing option that
can be taken without regard to timing of sexual activity. In consultation
with their physician, patients now have the freedom to choose the dosing
regimen that is appropriate for them.
"We strive to provide patients with solutions that fit their needs and
Cialis for once daily use delivers on this promise," said Shawn Heffern,
Cialis U.S. Director of Brand Marketing at Lilly. "Now, patients have two
options - some may prefer the up to 36 hours of efficacy provided by Cialis
for use as needed while others may want the unique benefit provided by this
daily dosing option."
Additionally, Lilly’s wholesale pricing for Cialis for once daily use
will be comparable to Cialis for use as needed such that patients who
currently use two or more pills per week of Cialis for use as needed should
not experience higher treatment costs with Cialis for once daily use.
The FDA’s approval of Cialis for once daily use was based upon the
evaluation of the comprehensive data package for the daily dosing option.
The data include results from three phase III randomized, double-blind,
placebo- controlled studies. Men with ED who participated in these clinical
studies and who took tadalafil 2.5 mg and 5 mg once daily without regard to
their timing of sexual activity experienced improved erectile function
compared with those taking placebo.(2) Cialis 5 mg, 10 mg and 20 mg have
been approved in the United States for as-needed treatment of ED since
November 2003.
The most commonly reported adverse events were headache, indigestion,
back pain, muscle aches, nasal congestion, flushing and pain in limb. Most
adverse events reported with tadalafil were transient and generally mild or
moderate.
About ED
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. Experts believe that 80 percent
to 90 percent of ED cases are related to a physical or medical condition,
such as diabetes, cardiovascular diseases, and prostate cancer treatment,
while 10 percent to 20 percent are predominantly due to psychological
causes.(3,4) In many cases, however, both psychological and physical
factors contribute to the condition.(5)
About Cialisz
Cialis(R) (tadalafil) is approved for the treatment of erectile
dysfunction on an as-needed basis or in a daily regimen. The recommended
starting dose of Cialis for use as needed in most patients is 10 mg, taken
prior to anticipated sexual activity. The dose may be increased to 20 mg or
decreased to 5 mg, based on individual efficacy and tolerability. As part
of a daily regimen, Cialis may be taken as 2.5 mg or increased to 5 mg,
based on individual efficacy and tolerability.
Important Safety Information for Cialis
Cialis is available by prescription only and is not for everyone. 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. Men taking nitrates, often used for chest pain, should
not take Cialis. Such a combination could cause a sudden, unsafe drop in
blood pressure. Cialis for once daily use provides continuous plasma
tadalafil levels which should be considered when evaluating the potential
for interactions with certain medications (e.g., nitrates, alpha-blockers,
anti- hypertensives and potent inhibitors of CYP3A4) and with substantial
amounts of alcohol. 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.
In rare instances, men taking prescription ED tablets (including
Cialis) reported a sudden decrease or loss of vision or hearing (sometimes
with ringing in the ears and dizziness). 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 or hearing, he should stop
taking any ED tablet and seek medical attention right away.
Cialis does not protect a man or his partner from sexually transmitted
diseases, including HIV. Men should not drink alcohol in excess with
Cialis. Individual results may vary. Cialis has not been studied for
multiple attempts per dose.
Individual results may vary. Cialis has not been studied for multiple
attempts per dose. For full patient information and/or full prescribing
information, visit
About Eli Lilly and Company
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 world-wide 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 P-LLY
Certain of the matters discussed herein with respect to clinical
studies and Lilly’s products may constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements are based on current expectations,
estimates and projections about the industry, management beliefs and
certain assumptions made by management. Investors are cautioned that
matters subject to forward- looking statements involve risks and
uncertainties, including economic, competitive, governmental, technological
and other factors discussed in the respective filings with the Securities
and Exchange Commission, which may affect the business and prospects of
Lilly. More specifically, there can be no assurance that this product will
achieve commercial success or that competing products will not pre-empt any
market opportunity that might exist for the product.
References
(1) Cialis is a registered trademark of Eli Lilly.
(2) Cialis prescribing information, updated January 2008.
(3) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost
Intimacy. New York: Kensington.
(4) Erectile Dysfunction,
Data accessed
09/28/07.
(5) Lue, Tom F. Kaufen generishe cialis Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.
Eli Lilly and Company

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Jun 17 2008

Good sleep patterns paramount to health in older men

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Men’s Health News
It
appears that disrupted rest and activity rhythms are associated with increased mortality rates among older men, according to new University of Minnesota research.
A group of about 3,000 men older than 67, were tested for rest and activity biological rhythms via a wrist device called an actigraph. The device tracked participants’ movement, including the peak times of rest and activity, as well as the robustness of the activity for 24 hours a day for an average of about a week between Dec. 2003 and March 2005. As of January 2008, there were 180 deaths in the group, and men who had peak activity times that were the earliest or latest, in comparison with the groups’ average, had a much greater risk of death.
"It’s important to have a regular routine of waking and going to sleep," said Misti Paudel, M.P.H., principal investigator of the study and a member of the School of Public Health. "Waking early, staying up late, and severely disturbed sleep patterns may have a detrimental impact on health in older men, especially since this group was generally in good health. A good night sleep is important."
This is the first study to report strong associations between disturbed rest and activity rhythms and mortality rates in older men, who are still living in their homes (not institutionalized) - however, studies in cancer patients as well as institutionalized Alzheimer’s patients have reported similar findings.
Paudel will be presenting information from the study during the Associated Professional Sleep Societies Conference today in Baltimore, MD.
Lack of sleep can lead to a number of problems in older adults including depression, memory problems, and decreased attentiveness, and also can lead to serious health problems such as an increased risk of obesity, cardiovascular disease, and diabetes, Paudel said.
Another key study finding is that men with more robust rest/activity rhythms had much lower mortality rates. Having greater levels of activity during the day and/or lower levels of activity during the night (better sleep quality) are characteristics of robust rhythms.
"From a sleep standpoint, getting a good night’s sleep appears to be important factor for health and longevity for people of all ages, and especially for older adults - where complaints of insomnia and other sleep disturbances are much more common than in younger cohorts," she said. "It is important that anyone who has concerns about their sleep quality should consult their physician."
Buy cialis without prescription Future research should examine association with specific causes of death and with health related outcomes, Paudel said. The study was funded by the National Institute on Aging.

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Jun 17 2008

Low Testosterone May Cause Health Problems That Lead To Erectile Dysfunction

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Men with erectile dysfunction should be examined for testosterone deficiency and the metabolic syndrome, because these conditions commonly occur together, a new study shows. The results will be presented at The Endocrine Society’s 90th Annual Meeting in San Francisco.
"Erectile dysfunction is a portal into men’s health," said the study’s senior author, Aksam Yassin, MD, PhD, of the Clinic for Urology and Andrology of the Segeberger Clinics in Norderstedt, Germany. "It is becoming clear that obesity, diabetes, high blood pressure, cholesterol problems and erectile difficulties are intertwined, and a common denominator is testosterone deficiency."
Yassin’s research, performed with scientists from The Netherlands, Germany and the United Arab Emirates, aimed to determine in men with erectile dysfunction (ED) the prevalence of hypogonadism, the scientific term for testosterone deficiency.
Over a two-year period the investigators studied 771 patients who sought treatment for ED. Their average age was 56. The patients received a comprehensive screening for low testosterone and indicators of the metabolic syndrome, a cluster of risk factors that increase the chances of developing heart and vascular disease and type 2 diabetes. Having three of the following five risk factors establishes the diagnosis of this syndrome: increased waist circumference (abdominal fat), low HDL ("good") cholesterol, high triglycerides (fats in the blood), high blood pressure, and high blood sugar.
Among the 771 men, 18.3 percent of the men (141 men) had testosterone deficiency, which had previously been undetected, the authors found. The prevalence of hypogonadism in the general population of men age 45 and older is about 12 percent, Yassin said.
Of all the men in the study, 270 (35 percent) had type 1 or type 2 diabetes; in eight of the men, diabetes was a new diagnosis, according to study data. High blood pressure was found in 239 men (31 percent), and 12 of these men had been unaware of it. Among the 162 men (21 percent) who had dyslipidemia abnormal cholesterol or triglycerides nine of them had not previously been diagnosed. And 108 men, or 14 percent, had varying degrees of coronary heart disease. Five of them received this diagnosis for the first time, Yassin said.
Men with ED especially older men should therefore receive evaluation not only for ED but also for testosterone deficiency and any underlying signs of the metabolic syndrome, he advised.
Kaufen viagra soft pillen mastercard Yassin disclosed that he is on the speakers’ bureau for Bayer Schering, which makes a brand of testosterone.
Founded in 1916, The Endocrine Society is the world’s oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society, and the field of endocrinology, visit our web site at
Endocrine Society
8401 Connecticut Ave., Ste 900
Chevy Chase, MD 20815
United States

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Jun 17 2008

Men Treated For Prostate Cancer Experience High Levels Of Psychological Distress After Treatment

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Men treated for prostate cancer have high levels of psychological distress and many suffer ongoing sexual dysfunction and lower urinary tract symptoms, according to a survey of men in England designed to explore their supportive care needs.
Prostate cancer is the commonest solid cancer in men, accounting for one in every four cancers diagnosed in males in England in 2004. Fortunately, the survival rate for this cancer is improving, reflecting the slow growing nature of the disease and its successful treatment in many men. Nearly three-quarters (71%) of men are still alive five years after being diagnosed with prostate cancer.
A range of treatment options - include surgery, radiotherapy and hormonal treatments - are available for prostate cancer, with the choice being determined by a man’s age, the stage of his cancer and any other conditions that he has. Some of the treatments can have long-term effects on sexual and urological function.
The primary aim of treatment is to optimise cancer control, but some doctors also take into account a man’s urological and sexual function before treatment and the patient’s views on the balance of treatment efficacy against side-effects.
Relatively little is known about the support care needs - the requirements for care arising during illness and treatment to manage symptoms and side-effects - in men treated for prostate cancer. To find out more about how the disease and its treatment affects men, nursing researchers surveyed men with prostate cancer in six areas of England.
The researchers invited 1848 men who had been diagnosed with prostate cancer in the previous three to 24 months, from across six NHS Trusts (geographical regions in the National Health Service) to take part in the research study. Those who replied (820 men) were sent a postal questionnaire asking about their supportive care needs, prostate symptoms, quality of life, their cancer and its treatment; 741 were returned.
Three-quarters of the men taking part in the survey were 65 years old or over, Half (51%) had received hormonal therapy, one-quarter (25%) had radical prostatectomy and 28% had radiotherapy to the prostate. Just under half (46%) of the men said their cancer was in remission.
The survey revealed that the men had significant unmet supportive care needs. The areas of greatest need were related to psychological distress, sexuality-related problems and the management of enduring lowering urinary tract symptoms. The researchers noted: "High levels of psychological distress were reported, and those reporting psychological distress reported greater unmet supportive care needs."
Men who were uncertain of their remission status had higher levels of psychological need, while those not in remission were more likely to have needs for information.
Kaufen viagra soft pillen mastercard Nearly one-third (30%) of the men taking part in the survey reported moderate or extreme anxiety or depression. A similar number had difficulty with undertaking usual activities. Some or extreme pain was reported by 26% of the men and 22% had problems with mobility.
Virtually all (97%) of the men reported that they had experienced lower urinary tract symptoms, including frequency or needing to urinate during the night, during the month before the survey. Urinary symptoms were affected by treatment, remission status and time since last treatment. They were least severe in men who were in remission, in those who had undergone radical prostatectomy and/or in those who had completed their treatment 19-24 months before the survey.
Unmet needs related to sexuality were more common in younger men and in those who had undergone radical prostatectomy.
The researchers, led by Emma Ream, from the Florence Nightingale School of Nursing and Midwifery, King’s College London, UK, said: "The survey identified high levels of psychological distress within the sample, even though the majority had completed treatment over a year previously." They suggested that need for psychological care was particularly high in men not in remission or whose remission status was uncertain. "The need for systematic assessment and better management of psychological distress in men with prostate cancer was evident in this study," they concluded, adding that sexual dysfunction and lower urinary tract system symptoms also required greater attention by prostate services.
Reference
Supportive care needs of men living with prostate cancer in England: a survey.
Ream E, Quennell A, Fincham L. et al.
British Journal of Cancer advance online publication 2008, 1-7, doi:10.1038/sj.bjc.6604406
Cancer Research Summaries are overviews of important cancer research findings that have been reported in leading cancer publications. The Cancer Research Summaries are provided by the Cancer Media Service (CMS) in collaboration with Nature Clinical Practice Oncology.
"This summary is provided by the European School of Oncology’s Cancer Media Service"
Cancer Media Service
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