Pfizer statement regarding Viagra and blindness (NAION)
A review of 103 Viagra clinical trials involving 13,000 patients found no reports of non-arteritic anterior ischemic
optic neuropathy (NAION). Outside of clinical trials, Viagra has been used by more than 23 million men worldwide over the
past seven years and reports of visual field loss due to NAION are extremely rare.
There is no evidence showing that NAION occurred more frequently in men taking Viagra than men of similar age and health
who did not take Viagra.
NAION is the most common acute optic nerve disease in adults over age 50 and it shares a number of common risk factors with
erectile dysfunction: age over 50, high blood pressure, high cholesterol, diabetes. Most of the reported cases in which NAION
has occurred in men taking Viagra have involved patients with underlying anatomic or vascular risk factors associated with
the development of NAION.
Pfizer is in discussions with the Food and Drug Administration to update the Viagra label to reflect these rare ocular
occurrences.
Viagra has a strong safety profile and remains an effective medication that benefits millions of patients.
Viagra remains the market-leading ED medicine, with recent data showing more patients switching back to Viagra after trying
our competitors than ever before.
pfizer
View drug information on Viagra.
Online Treatment Service For Male Impotence To Be Launched By Chelsea And Westminster And DrThom, UK
Chelsea and Westminster Hospital NHS Foundation Trust becomes the
first NHS body to venture into online treatment by launching a remote
treatment service for erectile dysfunction in partnership with DrThom
(drthom), the UK’s leading online healthcare provider.
Chelsea and Westminster and DrThom will make it easier for the 2.3 million
UK men who suffer from erectile dysfunction to access treatment by offering
a properly regulated, safe and affordable online treatment service. Only
10% of UK men who suffer from erectile dysfunction currently seek treatment
for the condition.
Chelsea and Westminster is one of the UK’s leading providers of sexual
health services. The Trust already has a proven track record of innovation
by, for example, sending sexual health test results to patients by text
message and enabling patients to request clinic appointments online.
Revenue generated by this new service will be reinvested in NHS care.
By working with DrThom to launch a new online treatment service for erectile
dysfunction, Chelsea and Westminster hopes to help more men seek treatment
for the condition which can be an early symptom of wider health needs
including generalised cardiovascular problems.
Dr Simon Barton, Clinical Director for HIV and sexual health services at
Chelsea and Westminster, says: “We hope that the launch of this service will
be an important step in helping to improve standards of online healthcare in
the UK. All clinical aspects of this new service are overseen by Chelsea and
Westminster and all the doctors who prescribe treatment online are NHS
specialists in sexual health.”
Dr Thomas Van Every, Medical Director at DrThom, says “In an ideal world,
all men who suffer from erectile dysfunction would go to their GP for help.
The reality is that embarrassment often prevents men from seeking treatment.
By partnering with Chelsea and Westminster, DrThom will be able to offer a
specialist, trustworthy and regulatory compliant online service that we see
as a major step forward in men’s healthcare.”
Facts about erectile dysfunction
According to the Sexual Dysfunction Association, 2.3 million men in the UK
are estimated to suffer from erectile dysfunction. Only 10% of sufferers
seek treatment. 9 out of 10 men who suffer from erectile dysfunction don’t
tell their GP and 6 out of 10 don’t even tell their partners. 2 out of 10
sufferers said erectile dysfunction was the cause of their relationship
break-up.
Facts about the new service
A patient using the service will register on the DrThom website and complete
a free online questionnaire. The questionnaire and subsequent dialogue
allow a doctor to assess a patient’s suitability for treatment. To answer
the questionnaire, a patient will need to know their blood pressure. If a
doctor judges that treatment is suitable, the patient has the opportunity to
trial the treatment service for ??45. Patients pay online using a debit or
credit card. A doctor will be able to prescribe all common treatments such
as Viagra, Cialis and Levitra. DrThom will send treatment as first class
recorded delivery. To receive follow-up and ongoing treatment, a patient
will need to contact DrThom via their online patient record and tell a
doctor whether they suffered any side-effects and whether initial treatment
was effective. To comply with General Medical Council (GMC) guidelines on
remote prescribing, a patient will be given the name and GMC number of the
doctor who prescribed treatment.
Facts about the regulatory environment for online prescribing
The GMC sets clear requirements that have to be met when a doctor prescribes
treatment without meeting a patient face to face.
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates how
medicines are promoted. The MHRA’s publication ‘The Blue Guide’ gives clear
guidelines that govern how one can advertise services that may result in
patients being prescribed prescription-only medicines.
The Healthcare Commission regulates and inspects private healthcare
providers to ensure that they meet national minimum standards of healthcare.
Online healthcare providers are not exempt from the rules that govern who
has to ‘register’ with the Healthcare Commission.
Facts about Chelsea and Westminster Hospital NHS Foundation Trust
Chelsea and Westminster is a leading NHS Foundation Trust and was one of 5
trusts highlighted by Monitor, the Foundation Trust regulator, for achieving
strong financial performance, meeting all healthcare targets and national
core standards in 2006/07.
Facts about Dr Thom
DrThom is the only medical service formally regulated by the Healthcare
Commission to prescribe treatment remotely. DrThom was set up and is
overseen by Dr Thomas Van Every, a doctor working at Chelsea and
Westminster’s Victoria Clinic for HIV and Sexual Health.
drthom
View drug information on Cialis; Levitra; Viagra.
Muscular Dystrophy: New Study To Examine Effect Of ED Drugs On Muscle Blood Flow
A Cedars-Sinai Heart Institute cardiologist has been awarded a three-year, nearly $1 million grant from the Muscular Dystrophy Association (MDA) to study whether drugs used to treat erectile dysfunction could also be used to improve muscle blood flow and reduce fatigue in muscular dystrophy patients.
The study, led by Ronald G. Victor, M.D., associate director of the Cedars-Sinai Heart Institute, co-directed by Gail Thomas, Ph.D. and funded by the Muscular Dystrophy Association (MDA), is intended to build on recent findings published in the journal Nature showing beneficial effects of tadalafil (also known as Cialis) in mice with an animal version of Duchenne and Becker muscular dystrophy. Only two doses of tadalafil improved muscle blood flow, allowing the dystrophic mice to perform more exercise with less muscle injury.
Victor’s new short-term clinical trial will move the testing from animals to human patients with Becker muscular dystrophy and examine the effects of acute tadalafil dosing on muscle blood flow during a bout of exercise. Patients will take two doses of tadalafil prior to exercising. Then doctors will measure whether muscles receive increased blood flow and therefore are better protected during exercise.
Duchenne muscular dystrophy is an inherited wasting disease characterized by weakness and progressive degeneration of the muscles — including the heart muscle – and is caused by a genetic mutation of dystrophin, a protein vital to healthy muscles. Muscle degeneration usually begins in the legs and pelvis, but later affects the whole body. By age 10, most patients experience heart problems. By their early-teenage years, most people with Duchenne muscular dystrophy are in a wheelchair. Becker muscular dystrophy is a milder form of muscular dystrophy that typically is diagnosed in early-adulthood.
“This is an exciting next step in the research I have been doing for 25 years, because we don’t need to create a new drug — the drug already exists,” Victor said. “We now have the opportunity to find out if tadalafil can offer some hope for improving the lives of patients and allow them to do more exercise with less muscle injury.”
Victor’s study is open to adult males 18 – 55 who have Becker muscular dystrophy as well as adult males who don’t have it. The study includes includes hand grip exercise testing, measurements of muscle blood flow and oxygen delivery, and magnetic resonance imaging of the muscles.
Source:
Sally Stewart
Cedars-Sinai Medical Center
View drug information on Cialis.
Penile Size And Erectile Function Comparison After High-intensity Focused Ultrasound And Targeted Cryoablation For Localized Prostate Cancer
UroToday – Penile length and girth are reportedly decreased following radical prostatectomy for prostate cancer (CaP). However, it is not known whether patients experience similar shortcomings after HIFU or targeted cryoablation of the prostate (TCAP). A report in the online version of the Journal of Sexual Medicine by Dr. Li and colleagues form China evaluates this issue.
The study was a non-randomized prospective assessment of differences in erectile function and penile size in men undergoing HIFU or TCAP for clinically localized CaP. Entry criteria also included IIEF-EF scores >26 prior to treatment, normal serum total testosterone and no prior hormonal therapy. For HIFU the Sonoblate 500 device was used and for TCAP treatment an argon-based cryotherapy system was used. Color-duplex ultrasonography was performed following a single intracavernosal injection of PGE1 (20ug) followed by stimulation. Artificial tumescence was graded I-IV (I worst, IV best) by a physician observer. Penile length was measured from the tip of the glans to the pubopenile skin junction and penile circumference was measured at the middle third of the penile shaft. The study included an evaluation of intra-observer variability in a group of 10 men. Following treatment, all men underwent penile rehabilitation using sildenafil sulfate 3 times weekly and they were encouraged to also use an erection vacuum device once daily. Post-treatment assessment was performed using IIEF-EF scores, serum testosterone levels, penile Doppler ultrasound and penile size at 6, 12, 18, 24, and 36 months.
The cohort included 102 Asian men, all with at least 36 months follow-up. In general there was good adherence to the use of the vacuum device (>50%) in the first 24 months, then it decreased. The erectile function recovery rate at 36 months post-treatment was 46.8% for the TCAP group and 65.5% for the HIFU group. Testosterone levels decreased for both treatments significantly across the 24 month follow-up period. There was no significant difference in the proportion of patients in either group with grade III or IV artificial erection during penile Doppler ultrasound. Changes in peak systolic velocity correlated with changes in IIEF-EF scores, but there were no significant differences in end diastolic velocity or resistance index after treatments. There were no significant reductions in penile length or circumference under flaccid or erect conditions following HIFU or TCAP at any post-treatment time point compared with baseline, nor were there differences between treatment groups.
Li LY, Lin Z, Yang M, Gao X, Xia TL, Ding T
J Sex Med. 2010 Mar 11. Epub ahead of print.
doi:10.1111/j.1743-6109.2010.01751.x
UroToday Contributing Editor Christopher P. Evans, MD, FACS
UroToday – the only urology website with original content global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:
www.urotoday
Copyright © 2010 – UroToday
Fake Viagra – Charges Laid Against Two Ontario Pharmacies and their Owner
On September 27, 2005, the RCMP laid charges against two Ontario pharmacies and their pharmacist owner for allegedly selling and distributing counterfeit Viagra. These charges follow a search warrant executed by the RCMP on July 13, 2005, at Direct Compounding Ltd. and Optimum Compounding Pharmacy Ltd., both located in Richmond Hill, Ontario. All product related to the investigation was seized in July.
The Ontario College of Pharmacists secured the closure of Direct Compounding effective July 22. Direct Compounding subsequently closed its business. The College also placed restrictions on the licence of the pharmacist and Optimum Compounding that prevent the dispensing of any erectile dysfunction drugs. The pharmacist and pharmacies have been referred to the College’s discipline committee.
Health Canada informed the pharmacist owner that his activities contravened the Food and Drugs Act and its regulations. This meant that the he had sold a drug not authorized for sale by Health Canada. Health Canada has received confirmation that all non-compliant activities at those pharmacies have ceased.
Reported incidents of pharmacies selling counterfeit drugs remain rare; Health Canada will continue to assist the RCMP and other regulatory agencies in safeguarding the drug distribution system. Health Canada is responsible for the review and approval of the safety, efficacy and quality of drugs in Canada, while the pharmacy regulatory bodies across Canada are responsible for the licensing of pharmacies.
Canadian consumers are encouraged to familiarize themselves with the name of the pharmaceuticals they are taking as well as the size, shape, colour and imprints on the tablets. If they have any questions about their medication, they should speak with a pharmacist or consult with another health care professional.
For additional information on pharmacy care, visit the Ontario College of Pharmacists Web Site.
HEALTH CANADA.
View drug information on Viagra.
Erectile Dysfunction And Diabetes
“Men with diabetes who are having trouble keeping an erection could be at increased risk of serious heart problems”, BBC News reported. It said that a study has found that those with erectile dysfunction are twice as likely as other men with diabetes to develop heart disease. This finding could apparently be used to “alert both patients and healthcare providers to the future risk of coronary heart disease”.
This study followed 2,306 diabetic men for four years and found that the men with erectile dysfunction were 1.58 times more likely to have a cardiac event (fatal or non-fatal heart attack or surgery for heart disease). It has some potential weaknesses, for example it might not have used the most accurate method for classifying erectile dysfunction, some of the participants may already have had heart disease before the study began, and other drugs they were taking could have had an effect.
Despite its shortcomings however, this research corroborates what other studies have suggested. It suggests that an assessment of erectile dysfunction could be useful when assessing the risk of heart disease in men with diabetes.
Where did the story come from?
Dr Ronald Ching-Wan Ma and colleagues from the Chinese University of Hong Kong carried out the research. The study was supported by an MSD University Grant and by the Hong Kong Foundation for Research and Development in Diabetes. The study was published in the Journal of the American College of Cardiology.
What kind of scientific study was this?
It is known that men with diabetes have a higher risk of erectile dysfunction and its prevalence increases with age, and duration and severity of the diabetes. Previous research has suggested a close association between erectile dysfunction and atherosclerosis, while other studies have indicated that it could be used as an indicator of coronary, peripheral or cerebrovascular disease.
The authors of this study aimed to be the first to use a prospective analysis to see if the presence of erectile dysfunction can be used as a predictor of adverse cardiovascular events such as coronary heart disease. In this prospective cohort study, the researchers included men with diabetes at the Prince of Wales Hospital Diabetes Centre, Hong Kong between 1995 and 2005. The suitability of 3,640 men who had been referred to the centre was assessed. The researchers excluded any men who had type 1 diabetes, cardiovascular disease at the start of the study (through medical history or abnormal ECG or stress test) or for whom there was incomplete information on erectile dysfunction.
This left 2,306 men with type 2 diabetes who had been assessed for the complications and risk factors associated with their condition. The participants had a series of clinical and laboratory assessments, including at least two urine collections to measure protein levels. This would give an indication of kidney function. In addition, they were asked whether they suffered from erectile dysfunction (they could answer yes or no).
The researchers followed up the participants for an average of four years, during which time they collected data on hospital admissions and mortality. In Hong Kong, all residents have a unique identification number and researchers used this to link hospital records and diagnoses (e.g. death from acute heart attack or other coronary cause, or non-fatal cardiac events) with the participants’ original data from the study. In this way, they could see if there was an association between heart problems and erectile dysfunction in men with diabetes.
When analysing this association, the researchers took into account other factors that can have an influence on erectile dysfunction or heart disease, including; smoking history, age, how long they had diabetes, use of blood pressure and other medications, blood pressure, blood cholesterol, BMI and waist circumference.
What were the results of the study?
The researchers found that at the beginning of the study, 27% of the men reported having erectile dysfunction. These men were older, had higher blood pressure, had had diabetes for longer, and had higher blood cholesterol.
During approximately four years of follow up, new cardiac events occurred in about 5% of men. Men with erectile dysfunction were 1.58 times (HR 1.58, 95% CI 1.08 to 2.30) more likely than men without erectile dysfunction to experience a cardiac event during follow up. This analysis took into account some other factors that might be responsible for the association. Erectile dysfunction was not the only factor that increased cardiac events; age, duration of diabetes, high levels of protein in urine, and use of medications for high blood pressure were also independently associated.
What interpretations did the researchers draw from these results?
The researchers conclude that there is an association between erectile dysfunction and new cardiac events in men with type 2 diabetes. They say that erectile dysfunction is a “surrogate marker” for future heart problems.
What does the NHS Knowledge Service make of this study?
The researchers raise several possible problems associated with this study. These should be kept in mind when interpreting the results:
- Studies that assess sensitive topics such as erectile dysfunction are difficult to carry out accurately. The men who took part might not have fully reported the extent of their erectile dysfunction, leading to an underestimation of the problem. For example, if a large number of men with erectile dysfunction did not report it and were free of cardiac events during follow up, their results may have swayed the conclusions to being not significant. On the other hand, if some men didn’t report their erectile dysfunction and experienced cardiac events, the study will have underestimated the strength of the association.
- The researchers say that the single question they asked to determine whether a man suffered from erectile dysfunction, may not have been as appropriate as using other questionnaires that ask more objective questions. If men with more severe dysfunction were more likely to answer yes, then the study’s findings would be biased.
- The study was carried out in Hong Kong and the men who took part might not be representative of men from other countries. In particular, it’s unclear if the findings from the study are applicable to men in western countries as lifestyle factors across cultures may contribute differently to a person’s overall risk profile.
- Though the researchers tried to exclude any men with evidence of cardiac problems, they say that “comprehensive cardiac assessments were not routinely performed in asymptomatic patients”. This means that people with no obvious clinical symptoms could have been included. If this were the case, the researchers had no way of identifying those whose erectile dysfunction was actually a result of their heart problems.
- This study suggests that there are several independent factors associated with erectile dysfunction – namely age, use of medications, duration of diabetes and high protein levels in urine. Determining which of these is the most important is difficult. Future studies should particularly assess the contributions made by drugs such as lipid lowering statins that are known to cause erectile dysfunction. Most people with diabetes will be on multiple drugs with the potential to cause this condition.
It is known that men with diabetes are more likely to have erectile dysfunction and that this problem is associated with atherosclerosis (narrowing and hardening of the arteries). This study provides data to support the association that other studies have found between erectile dysfunction and cardiac problems. It is important that these results are confirmed in larger populations and across cultures.
Links to the headlines
Sex problems ‘may be heart alert’. BBC News, May 21 2008
Links to the science
Erectile Dysfunction Predicts Coronary Heart Disease in Type 2 Diabetes.
R C-W Ma, So W-Y, Yang X, et al.
J Am Coll Cardiol 2008; 51: 2045-2050
This news comes from NHS Choices
Topical Erectile Dysfunction Therapy Shows Promise
An innovative drug-delivery system nanoparticles encapsulating nitric oxide or prescription drugs shows promise for topical treatment of erectile dysfunction (ED), according to a new study by scientists at Albert Einstein College of Medicine of Yeshiva University.
The new system, tested successfully on a small number of animals, could potentially prevent side effects associated with oral ED medications, if study results can be replicated in humans. That could mean safer and more effective ED therapy for millions of men with heart disease and other health problems affecting erectile function. The study is published today in the online edition of the Journal of Sexual Medicine.
Tens of millions of men worldwide have benefited from oral ED medications such as sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis). However, these medications which belong to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors have limitations. They can cause systemic side effects that can be serious. These side effects include headache, facial flushing, nasal congestion, upset stomach, abnormal vision as well as isolated reports of hearing and vision loss. Men who’ve recently suffered a heart attack or stroke or have severe heart disease should use these drugs with caution or not at all. In addition, “an estimated 30 to 50 percent of men with ED do not respond to oral use of PDE5 inhibitors,” says senior author Kelvin P. Davies, Ph.D., associate professor of urology at Einstein.
The drug-delivery system, developed by Einstein scientists, consists of nanoparticles each smaller than a grain of pollen that can carry tiny payloads of various drugs or other medically useful substances and release them in a controlled and sustained manner.
The limited number of topical formulations of ED drugs has so far proven ineffective. This study was done to evaluate whether the Einstein nanoparticles, which have been shown to penetrate the skin, might allow the targeted delivery of compounds that treat ED and thereby avoid the drugs’ systemic effects.
An effective topical therapy could be especially significant for those ED patients particularly men with diabetes who have reduced levels of nitric oxide (NO), the signaling molecule that dilates blood vessels responsible for erectile activity. These men, who often aren’t helped by oral PDE5 inhibitor drugs, may benefit from direct application of NO or the PDE5 inhibitors.
The nanoparticles were tested on a total of 18 rats bred to have age-related ED. The rats were divided into three treatment groups. One group of seven rats received nanoparticles encapsulating NO. A second group of five rats received nanoparticles encapsulating NO plus an experimental ED drug called sialorphin (which has a mechanism of action different from PDE5 inhibitors). A third group of six received nanoparticles encapsulating NO plus tadalafil (Cialis).
Five of the seven rats treated with the NO-containing nanoparticles, and all 11 rats treated with nanoparticles encapsulating NO plus sialorphin or tadalafil showed significantly improved erectile function. None of the seven rats in a control group, which received empty nanoparticles, showed any improvement.
“Most of the animals, nearly 90 percent, showed a response to treatment with the nanoparticles,” says co-author Joel M. Friedman, M.D., Ph.D., professor of physiology & biophysics and of medicine. Dr. Friedman developed the nanoparticles with his son Adam Friedman, M.D., chief resident in the division of dermatology of the department of medicine at Montefiore Medical Center, The University Hospital and Academic Medical Center for Einstein.
“The response time to the nanoparticles was very short, just a few minutes, which is basically what people want in an ED medication,” adds Dr. Davies. “In both rats and humans, it can take 30 minutes to one hour for oral ED medications to take effect.”
Postmortem examination of the tissues at the site of administration showed no signs of local inflammation or toxicity. “In addition, when we applied the nanoparticles at therapeutic doses, we found no indication of systemic side effects,” says Dr. Friedman.
The Einstein research team will carry out safety and dosing studies in rats in the coming months. Clinical studies on humans could begin in a few years if animal studies continue to show that the nanoparticle delivery system is safe and effective. But the investigators caution that the time from a proof-of-concept trial in animals to approved use in humans may be a decade or more.
The paper, “Nanoparticles as a novel delivery vehicle for therapeutics targeting erectile dysfunction,” is published in the September 18, 2009 online edition of the Journal of Sexual Medicine. The lead authors are George Han, an M.D.-Ph.D. student at Einstein, and Moses Tar, M.D., assistant professor of urology at Einstein. Dwaraka Srinivasa Rao Kuppam, a technician in the Einstein urology department, Adam Friedman, M.D., of Montefiore Medical Center, and Arnold Melman, M.D., chairman of urology at Einstein, also contributed to the research.
About Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University is one of the nation’s premier centers for research, medical education and clinical investigation. It is home to 2,775 faculty members, 625 M.D. students, 225 Ph.D. students, 125 students in the combined M.D./Ph.D. program, and 380 postdoctoral research fellows. In 2008, Einstein received more than $130 million in support from the NIH. This includes the funding of major research centers at Einstein in diabetes, cancer, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Through its extensive affiliation network involving eight hospitals and medical centers in the Bronx, Manhattan and Long Island which includes Montefiore Medical Center, The University Hospital and Academic Medical Center for Einstein the College of Medicine runs one of the largest post-graduate medical training programs in the United States, offering approximately 150 residency programs to more than 2,500 physicians in training
Source: Albert Einstein College of Medicine
View drug information on Cialis; Levitra; Viagra.
No-Nose Bicycle Saddles Improve Penile Sensation And Erectile Function In Bicycling Police Officers
An innovative study appearing in the August issue of The Journal of Sexual Medicine examined, for the first time, if noseless bicycle saddles would be an effective intervention for alleviating deleterious health effects, erectile dysfunction and groin numbness, caused by bicycling on the traditional saddle with a protruding nose extension. Results from this study may be useful for the estimated 5 million recreational cyclists to alleviate perineal discomfort and maintain sexual health.
Ninety bicycling police officers from 5 metropolitan regions in the U.S. (Northwest, Southern, Desert West, Midwest, and Southeast) using traditional saddles were evaluated prior to changing saddles and then again after 6 months of using the noseless bicycle saddle.
The findings show that use of the noseless saddle resulted in a reduction in saddle contact pressure in the perineal region. There was a significant improvement in penile tactile sensation, and the number of men indicating they had not experienced genital numbness while cycling for the preceding 6 months rose from 27 percent to 82 percent using no-nose saddles. Use of the noseless saddle also resulted in significant increases in erectile function as assessed by the initial evaluation, but there were no significant changes noted in Rigiscan® measures, a method used to record penile rigidity while the subject sleeps. With few exceptions, bicycle police officers were able to effectively use no-nose saddles in their police work and 97 percent of officers completing the study continued to use the no-nose saddle afterward.
Dr. Steven Schrader of the National Institute for Occupational Safety and Health in Cincinnati, first author of the study and the recent co-recipient along with his research team of a Bullard-Sherwood Research-to-Practice Award in the Interventions Category for “Health Effects of Occupational Cycling” stated, “No-nose saddles are a useful intervention for bicycling police officers alleviating pressure to the groin and improving penis health. Different saddle designs may require some re-learning of ‘how to ride a bicycle,’ but the health benefits to having unrestricted vascular flow to and from the penis and less penile numbness is self-evident.”
Dr. Irwin Goldstein, Director, Sexual Medicine, Alvarado Hospital, San Diego C.A., and editor-in-chief of The Journal of Sexual Medicine, wrote an accompanying editorial entitled “The A, B, C’s of The Journal of Sexual Medicine: Awareness, Bicycle Seats, and Choices”.
“For the first time, we have a prospective study of healthy policemen riding bikes on the job, using wider, no-nose bike saddles for 6 months. Not only did their sensation improve, their erectile function also improved. Changing saddles changed physiology. This is a landmark study for our field that that is important for future riders, and modification of lifestyle showing improvement without any active treatment.”
“Cutting Off the Nose to Save the Penis.”
Steven M. Schrader, Michael J. Breitenstein, Brian D. Lowe.
The Journal of Sexual Medicine
DOI: 10.1111/j.1743-6109.2008.00867.x Volume 5 Issue 8 (August 2008).
To view the abstract for this article, please click here.
The Journal of Sexual Medicine was founded in 2004 and is the official journal of the International Society for Sexual Medicine, its five regional affiliated societies and the International Society for the Study of Women’s Sexual Health. It publishes multi-disciplinary basic science and clinical research to define and understand the scientific basis of male and female sexual function and dysfunction.
The Journal of Sexual Medicine
VIVUS Announces Additional Results Of Phase 3 Avanafil Study In Erectile Dysfunction Showing Efficacy In 15 Minutes
VIVUS, Inc. (Nasdaq: VVUS) announced new data from an analysis of the recently completed phase 3 study (REVIVE TA-301) of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED). Patients who attempted intercourse within 15 minutes of dosing were successful 67%, 69% and 72% of the time on 50, 100 and 200 mg of avanafil, respectively, as compared to 29% of the patients on placebo (p
REVIVE is the first of four phase 3 avanafil trials. Additional phase 3 studies include treatment in diabetic males with ED (REVIVE-Diabetes, TA-302) and in males with ED following a radical prostatectomy (TA-303), each with a treatment period of approximately 16 weeks. In March 2009, VIVUS initiated an open-label safety study (TA-314) evaluating the long-term safety and tolerability of avanafil as part of its path toward NDA filing. TA-314 is being conducted over one year in approximately 600 patients across 40 U.S. centers; patients completing either the 16-week REVIVE or REVIVE-Diabetes studies are eligible to participate in TA-314. Results of the study are expected to be available by late-2010.
In total, the phase 3 avanafil clinical program will enroll approximately 1,300 patients.
About Avanafil
Avanafil is a next-generation, highly selective oral phosphodiesterase type 5 (PDE5) inhibitor therapy being investigated for the treatment of ED. Studies to date have demonstrated that avanafil has a fast onset of action, with activity apparent in 15 minutes or less after administration. The unique profile of avanafil suggests that the compound may be selective, potentially resulting in lower incidence of the side effects most commonly associated with PDE5 inhibitor therapies.
About Erectile Dysfunction (ED)
Erectile Dysfunction (ED) is defined as the inability to attain and maintain an erection sufficient for sexual intercourse. According to the Massachusetts Male Aging Study (MMAS), ED affects an estimated 52 percent of men between the ages of 40 and 70. The prevalence of ED increases with age and can be affected by a variety of factors, including certain medications such as anti-hypertensives and histamine receptor antagonists; lifestyle, such as tobacco or alcohol use; diseases, including diabetes and cardiovascular conditions; and spinal cord injuries.
About VIVUS
VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health. The company’s lead product in clinical development, Qnexa®, has completed phase 3 clinical trials for the treatment of obesity and an NDA was submitted to the FDA in December 2009. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor for the treatment of erectile dysfunction, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE® (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on VIVUS’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ended December 31, 2008 and periodic reports filed with the Securities and Exchange Commission.
Source: VIVUS, Inc
A Genetic Link To Premature Ejaculation
Premature ejaculation can be embarrassing, but a new study suggests that it might be a genetic disorder.
Researchers from Turku, Finland, interviewed more than three thousand men – all pairs of male twins and their older or younger brothers – about the first time they had sex. Many participants in the study reported that they had suffered from erectile dysfunction and premature ejaculation at their first sexual encounter. These common problems are often attributed to external factors, such as intoxication or nervousness due to peer pressure. This research confirms that such factors do cause erectile dysfunction. On the other hand, premature ejaculation appears to be strongly linked to genetic factors, and is not just psychological.
In an earlier study, researchers in The Netherlands linked premature ejaculation to a gene for serotonin regulation in a group of two hundred men. The new data from Finland independently show a genetic link to premature ejaculation in a much larger group, and rule out environmental factors. Faculty of 1000 Medicine member David Goldmeier notes that the increasing evidence for a genetic cause of premature ejaculation opens the way for the development of new drug treatments – something that many men might benefit from. However, both Goldmeier and reviewer Taylor Segraves emphasize that drug therapy is not the only solution: psychotherapy will continue to be a valuable and useful form of treatment for sexual dysfunctions – even those with a genetic cause.
The study by Pekka Santtila, Kenneth Sandnabba and Patrick Jern was published in the Journal of Sex & Marital Therapy in March 2009.
Source:
Kathleen Wets
Faculty of 1000: Biology and Medicine