Many Older Adults With Diabetes Are Sexually Active But Have Problems

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Main Category: Diabetes
Also Included In: Seniors / Aging;  Women’s Health / Gynecology;  Erectile Dysfunction / Premature Ejaculation
Article Date: 30 Aug 2010 – 10:00 PDT

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New research from the University of Chicago found that many middle-aged and older Americans with diabetes are sexually
active but more likely to experience sexual problems compared with counterparts without diabetes.

Lead author Stacy Lindau, associate professor of obstetrics and gynecology and of medicine at the University of Chicago, and
colleagues, wrote about their findings in a paper published 27 August in an online advanced issue of Diabetes
Care
.

Lindau told the media that:

“Patients and doctors need to know that most middle age and older adults with partners are still sexually active despite their
diabetes.”

“However, many people with diabetes have sexual problems that are not being addressed,” she added.

Senior author Dr Marshall Chin, a professor of medicine at the University of Chicago, said:

“Failure to recognize and address sexual issues among middle-age and older adults with diabetes may impair quality of life and
adaptation to the disease.”

For their study, Lindau and colleagues examined data from a survey of nearly 2,000 people aged 57 to 85 years, that was
performed between July 2005 and March 2006 as part of the National Social Life, Health and Aging Project.

1,993 participants were interviewed at home, completed questionnaires, underwent assessment of medication and gave blood
samples so researchers could assess their diabetes status..

From the survey and blood samples, using a diabetes test that measures glycosolated hemoglobin (HbA1c), the researchers were
able to categorize the participants according to diabetes status: those with diagnosed diabetes, those with undiagnosed diabetes
and those with no sign of diabetes.

The results showed that 47 per cent of the men had diabetes, with about 25 per cent aware and 22 per cent not aware that they
had the disease (ie undiagnosed). For the women, the blood test showed that nearly 40 per cent had diabetes, with 20.5 per cent
aware of it and 19 per cent unaware of it.

The authors noted that these figures were in line with previous studies of people over 60 and estimates that suggest around 12
million Americans over the age of 60 are living with diabetes (many of whom are unaware of it).

When the researchers examined the sexual activity data, they found that nearly 70 per cent of partnered men with diabetes and
62 per cent of partnered women with diabetes were sexually active: they engaged in sexual activity two or three times a month,
which is about the same as older people who do not have diabetes.

” Partnered sexual behaviors did not differ by gender or diabetes status,” wrote the authors, but they found that the disease did
exact a toll on both the desire and rewards of sexual activity.

While the proportion of men with diagnosed and undiagnosed diabetes who reported experiencing orgasm problems was about
the same as the proportion of men without diabetes, erectile difficulty and lack of interest in sex was more common among the
men with diagnosed diabetes.

Also, women with undiagnosed diabetes were less likely to talk about sex with their doctor (only 11 per cent said they did),
compared to women with diagnosed diabetes (19 per cent), men with undiagnosed diabetes (28 per cent), and men with
diagnosed diabetes (47 per cent).

Lindau said that nearly half of women in this age group don’t have a partner, and that “women with diabetes are far less likely than
women without diabetes to have a partner”.

“Those who have partners were more likely than men to avoid sex because of a problem, and were far less likely than men to
discuss a sexual problem with their doctors,” she explained.

Before this study, not much was known about sexual behavior and problems among people with undiagnosed diabetes.

Lindau explained that perhaps not knowing they have diabetes protects people not yet diagnosed with the disease (probably because it is still in the early stages) from the psychological burden of the stigma that
often follows the diagnosis.

“The elevated prevalence of orgasm difficulties in people unaware of their diabetes suggests that these are predominantly
physical,” she said, adding that:

“The erectile dysfunction and loss of interest among men with a diagnosis may be due in part to the psychological burden of
diabetes.”

The researchers suggest that diabetes may reduce sexual drive, given that just over 60 per cent of the men without diabetes
reported having masturbated in the prior 12 months compared to only 47 per cent of men with both diagnosed and undiagnosed
diabetes.

A similar pattern was observed among the women: although fewer overall reported having masturbated in the previous 12 months
(22.5 per cent), the proportion of women without diabetes who reported doing so was 29 per cent compared with only 15 per cent
of women with diagnosed and undiagnosed diabetes.

Also, as with the men, the women with diagnosed and undiagnosed diabetes reported a higher rate of orgasm
difficulties.

Chin said:

“Sexual problems are common in patients with diabetes, and many patients are not discussing these issues with their
physicians.”

The study was supported by funds from the National Institutes of Health’s National Social Life, Health and Aging
Project.

“Sexuality Among Middle Age and Older Adults with Diagnosed and Undiagnosed Diabetes: A National, Population-Based Study.”
Stacy Tessler Lindau, Hui Tang, Ada Gomero, Anusha Vable, Elbert S. Huang, Melinda L. Drum, Dima M. Qato, and Marshall H.
Chin.
Diabetes Care, published ahead of print 27 August 2010.
DOI:10.2337/dc10-0524

Additional source: University of Chicago Medical Center.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today



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LEVITRA 10mg Orodispersible Tablet For The Treatment Of Erectile Dysfunction Approved In Europe

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 07 Sep 2010 – 0:00 PDT

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The European Commission has approved a new formulation of Levitra® (vardenafil HCI). Levitra 10mg orodispersible tablet will be the first erectile dysfunction (ED) medication available in this novel and convenient formulation. In contrast to other drugs of the same class, Levitra 10mg orodispersible tablet allows men a discreet and convenient intake without water, dissolving on the tongue within seconds with a minty flavour. In Europe the launch roll-out will start as of November 2010. In the United States the medication has been approved in June 2010 and will be marketed by GlaxoSmithKline and Merck Co., Inc. under the tradename STAXYN™.

“Bayer Schering Pharma is committed to men’s health and continuously striving to find new and innovative treatment options in the treatment of erectile dysfunction,” said Dr. Flemming Oernskov, Head of the Business Unit Women’s Healthcare and General Medicine at Bayer Schering Pharma in Berlin. “As part of these efforts, we believe men with ED will appreciate a convenient and easy to take medication. Levitra orodispersible tablet allows men with ED to be prepared, anytime, anywhere. This should help to bring spontaneity into the sex life of men with ED.”

The overall efficacy and safety of vardenafil has been widely demonstrated in numerous clinical trials (1 – 10). For this registration, Levitra 10mg orodispersible tablet was tested in the Phase III multinational trials POTENT I and II (Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction: a fixed-dose, double-blind, raNdomized multicenter Trial). These pivotal studies compared the efficacy and safety of 10mg vardenafil orodispersible tablet with placebo after 12 weeks of treatment in a general population of men with ED. These two international twin studies were conducted with identical study design, enrolling a total of 882 men above the age of 18 years who had ED for more than 6 months. (11,12), For both POTENT I and POTENT II studies, vardenafil orodispersible therapy was statistically significantly superior to placebo for all primary (IIEF-EF, SEP2, SEP3) and secondary efficacy measures (all p

About Erectile Dysfunction

Erectile dysfunction (ED) is the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. An estimated 152 million men worldwide, 16 percent of all men aged 20-75 worldwide (13), experience erection difficulties. It is predicted that the worldwide prevalence of ED will increase to 322 million by 2025 (14). Despite its wide prevalence, recent data suggest that many men with ED do not seek treatment. Moreover, ED can be a first signal for cardiovascular comorbitidies and should therefore be taken seriously by patients and physicians (15). More education and information on the physicians and patient side is needed to change this.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Reference

(1) Cheng, E. Real-life safety and efficacy of vardenafil in the treatment of erectile dysfunction results from 30,010 U.S. patients. J Sex Med 2007;4:432-439.

(2) Eardley, I, Lee, JC, Shabsigh, R, Dean, J, Maggi, M, Neuser, D, Norenberg, C. Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications. J Sex Med 2009:In press.

(3) Edwards, D, Hackett, G, Collins, O, Curram, J. Vardenafil improves sexual function and treatment satisfaction in couples affected by erectile dysfunction (ED): a randomized, double-blind, placebo-controlled trial in PDE5 inhibitor-naive men with ED and their partners. J Sex Med 2006;3:1028-1036.

(4) Fisher, WA, Rosen, RC, Mollen, M, Brock, G, Karlin, G, Pommerville, P, Goldstein, I, Bangerter, K, Bandel, TJ, Derogatis, LR, Sand, M. Improving the sexual quality of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil. J Sex Med 2005;2:699-708.

(5) Giuliano, F, Rubio-Aurioles, E, Kennelly, M, Montorsi, F, Kim, ED, Finkbeiner, AE, Pommerville, PJ, Colopy, MW, Wilkins, HJ, Wachs, BH. Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Neurology 2006;66:210-216.

(6) Hatzichristou, D, Montorsi, F, Buvat, J, Laferriere, N, Bandel, TJ, Porst, H. The efficacy and safety of flexible-dose vardenafil (Levitra®) in a broad population of European men. Eur Urol 2004;45:634-641; discussion 641.

(7) Hellstrom, WJ, Gittelman, M, Karlin, G, Segerson, T, Thibonnier, M, Taylor, T, Padma-Nathan, H. Vardenafil for treatment of men with erectile dysfunction: efficacy and safety in a randomized, double-blind, placebo-controlled trial. J Androl 2002;23:763-771.

(8) Ralph, D, Eardley, I, Kell, P, Dean, J, Hackett, G, Collins, O, Edwards, D. Improvement in erectile function on vardenafil treatment correlates with treatment satisfaction in both patients and their partners. BJU Int 2007;100:130-136.

(9) Rosen, R, Shabsigh, R, Berber, M, Assalian, P, Menza, M, Rodriguez-Vela, L, Porto, R, Bangerter, K, Seger, M, Montorsi, F. Efficacy and tolerability of vardenafil in men with mild depression and erectile dysfunction: the depression-related improvement with vardenafil for erectile response study. Am J Psychiatry 2006;163:79-87.

(10) Stief, C, Porst, H, Saenz De Tejada, I, Ulbrich, E, Beneke, M. Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction. Int J Clin Pract 2004;58:230-239.

(11) Sperling H et al. The POTENT I randomised trial: efficacy and safety of an orodispersable vardenafil formulation for the treatment of erectile dysfunction. The Journal of Sexual Medicine.

(12) Gittleman M et al. The POTENT II randomised trial: efficacy and safety of an orodispersable vardenafil formulation for the treatment of erectile dysfunction.

(13) Rosen RC, Fisher WA, Eardley I, et al; Men’s Attitudes to Life Events and Sexuality (MALES) Study. The multinational men’s attitudes to life events and sexuality (MALES) study: Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin. 2004;20(5):607-617

(14) Aytac IA, McKinlay JB, Krane RJ. The likely world increase in erectile dysfunction between 1995 and 2065 and some possible policy consequences. BJU Int. 1999; 84:50-56

(15) Haro JM, Beardsworth A, Casariego J, et al.Treatment-seeking behavior of erectile dysfunction patients in Europe: Results of the Erectile Dysfunction Observational Study.J Sex Med. 2006 May;3(3):530-40.

Source: Bayer Schering Pharma



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Suspended Sentence For The Illegal Sale And Supply Of Sex Drugs

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Litigation / Medical Malpractice
Article Date: 09 Sep 2010 – 3:00 PDT

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A 61-year-old man from Sutton Coldfield, West Midlands received a nine month prison sentence suspended for two years last Monday, with supervision for one year, at Birmingham Crown Court for the illegal sale and supply of erectile dysfunction medicines.

An investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) discovered that John Henry Atkinson was illegally promoting the sale of unlicensed erectile dysfunction drugs.

In September 2009 MHRA investigators seized a large amount of erectile dysfunction drugs from his residential address. The seizures consisted of two boxes containing an estimated 7,000 Kamagra tablets, a box containing 2,000 Savitra tablets, a carrier bag of 61 Apcalis 20mg oral jelly sachets and ten boxes containing Kamagra 100mg oral jelly sachets. The total estimated value of the drugs seized was £53,000.

Atkinson pleaded guilty on 26 July 2010 to the sale of Kamagra and Apcalis which are unlicensed medicines.

Recorder Rochford whilst sentencing Atkinson said “you were preying on the weaknesses of people with difficulties” and “you acted purely out of greed without any regard to the danger this would involve.”

MHRA Head of Operations Danny Lee-Frost said “This is a serious example of a man who has no regard for others. These medicines Atkinson was promoting are unlicensed medicines. As a result you simply don’t know what you may be taking and that can pose a great danger to your health.”

Notes

1. If an individual is convicted of offences under the Medicines Act 1968, they can be sentenced to a maximum of two years imprisonment and/or an unlimited fine. Where appropriate the MHRA will use the Proceeds of Crime Act 2002 to determine whether or not benefits were accrued through criminal activity and will recoup illicit earnings if the individual is found guilty. In cases involving counterfeit medicines, the MHRA will use the Fraud Act or Trade Marks Act which both carry a maximum of 10 years imprisonment.

2. Anyone who has concerns about misleading advertising or promotional offers of medicines should contact the MHRA Advertising Standards Unit, 14-112, Market Towers, Vauxhall, London SW8 5NQ or phone 020 7084 2000. Alternatively, contact the pharmaceutical self-regulatory bodies, the Proprietary Association of Great Britain (PAGB) for advertising for over the counter medicines, or the Prescription Medicines Code of Practice Authority (PMCPA) for advertisements to health professionals for prescription medicines.

3. The advertising of medicines is controlled by a combination of statutory measures (with both criminal and civil sanctions) enforced by the MHRA, and self-regulation through Codes of Practice for the pharmaceutical industry, administered by trade associations.

4. The ‘Blue Guide on Advertising and Promotion of Medicines in the UK’ explains the regulations and provides clarification on the Agency’s interpretation of them and how advertising of medicines is regulated.

Source:

MHRA



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LIFESPAN Labs Research Reveals Men’s Beliefs And Behavior Surrounding Erectile Dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Men’s health
Article Date: 16 Sep 2010 – 3:00 PDT

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A new poll of men and women over 50 years old reveals that, while most men report some level of erectile dysfunction (ED), women generally aren’t aware of the problem in their partners. The problem extends beyond simple communication since ED can often be a symptom of overall health and well-being in men.

“The fact that women don’t know everything about their man’s health is interesting, especially when it comes to sexual intimacy”

The independent survey, conducted by New Leaf Perspectives, was commissioned by LIFESPAN labs, the manufacturer of men’s sexual health supplement, 112 Degrees, to gain insights into the attitudes, beliefs and behavior surrounding the sexual health of men over 50 years old. Among the key findings is that while men say they are open to discuss ED, most are not truthful: 100% of the men in the survey reported ED symptoms, but only 32% of the women said they were in a relationship that had ED experiences. The survey also revealed that more than half of men believe ED is a symptom of overall health, but take prescriptions that only treat ED symptoms.

“The fact that women don’t know everything about their man’s health is interesting, especially when it comes to sexual intimacy,” said Dr. Marcus Laux, a licensed naturopathic physician and advisor for LIFESPAN labs. “And communication can be a key factor since men don’t always realize that ED usually is an early warning of a more grave health concern looming, which caught early is very reversible and naturally corrected. With sexual health challenges, men are better served by looking beyond just fixing the momentary symptoms and more toward addressing the larger core issues that may be eroding their mental and physical health.”

When it comes to men seeking help for ED symptoms, the largest percent (33%) said they waited over a year before acting on their symptoms. The woman in the respondent’s life is deemed to be influential in their decision to seek help (87%) by either convincing them to get help, and/or providing the necessary emotional support. According to the survey, more than two-thirds of men with ED symptoms primarily rely on their doctor over non-physician treatments, yet the majority (59%) prefers a non-prescription treatment. In addition, 80% of men were favorable toward an ED treatment that also provides overall health benefits.

“Men are seeking advice and treatment from their physicians, yet physicians generally are only addressing the symptoms through prescription drugs,” says Laux. “There’s a disconnect here in that men turn to their doctors for the best treatment option, yet are receiving prescription drugs that only treat symptoms rather than corrective measures that mitigate their health risks once and for all. A potentially quick fix could be worthwhile, but not at the expense of long term vitality and health.”

Source:

LIFESPAN labs



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Ban Tobacco Ads And Restrict Alcohol And Erectile Dysfunction Ads, Urges The American Academy Of Pediatrics

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Main Category: Pediatrics / Children’s Health
Also Included In: Smoking / Quit Smoking;  Alcohol / Addiction / Illegal Drugs;  Erectile Dysfunction / Premature Ejaculation
Article Date: 27 Sep 2010 – 9:00 PDT

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The monumental task of persuading children and adolescents to say “No” to drugs, alcohol and tobacco is being constantly undermined by the $25 billions’ worth of advertising and marketing each year, which has precisely the opposite effect, says the American Academy of Pediatrics (AAP). The AAP adds that children should not be exposed to erectile dysfunction ads before ten at night.

A new AAP policy statement – “Children, Adolescents, Substance Abuse and the Media” – appears in the latest issue of the peer reviewed medical journal Pediatrics.

The policy statement calls for a total ban on all tobacco advertising, restrictions on the advertising of alcoholic drinks, and a ban on erectile dysfunction drug ads before 10pm.

Parents should be wary about letting their children watch PG-13 and R-rated movies and TV programs, the AAP adds. These shows and movies frequently feature substance abuse.

Pediatricians are advised to urge parents to restrict unsupervised media and TV channels which overexpose the viewer to substance abuse.

The White House Office on Drug Control Policy is being called on to start creating and broadcasting anti-smoking and anti-drinking public service announcements.

A study this year found that recurrent teen headaches are linked to smoking, overweight and physical inactivity. (Link)

According to a recent sub-study, part of long-term Nicotine Dependence in Teens (NDIT) study based at the University of Montreal Hospital Research Centre, University of Toronto and the University of Montreal, professionals discovered that smoking can increase depressive symptoms in teens. (Link)

Although the rate of overall illegal drug use among young people in 2009 remained below 2002 levels, youth use was higher in 2009 compared to 2008 (10.0% of youth in 2009, compared to 9.3% in 2008, versus 11.6% in 2002). The rate of marijuana use in this age group followed a similar pattern, declining from 8.2 percent of young people in 2002, to 6.7 percent in 2006, remaining level until 2008, and then increasing to 7.3 percent in 200. (Link)

“Policy Statement – Children, Adolescents, Substance Abuse, and the Media”
Published online September 27, 2010
PEDIATRICS (doi:10.1542/peds.2010-1635)

Written by Christian Nordqvist

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so why not HFCS

posted by Eli on 27 Sep 2010 at 10:59 am

Look the real issue is not whether some kids will have a sip of bear. I mean any teen you tell them not to do something they do the opposite. I did, when my mom told me not to smoke every hour of every day then my freshmen year of college I started smoking. (since then I have stopped) My point is that if your going to do this also include HFCS (High Fructose Corn Syrup) That substance is in nearly 90% of our foods and studies have shown that rats eating the same amount of Corn Syrup as apposed to sugar cain gained weight much faster and suffered symptoms of depression. Obesity is the main cause of death in this country so why go after things that kids will try at some point anyway?

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Researchers Discover A Drug Combination That Shrinks Prostate Tumors In Vivo

 

Main Category: Prostate / Prostate Cancer
Also Included In: Cardiovascular / Cardiology;  Erectile Dysfunction / Premature Ejaculation
Article Date: 28 Sep 2010 – 3:00 PDT

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Virginia Commonwealth University School of Medicine and VCU Massey Cancer Center researchers have shown that the impotence drug Viagra, in combination with doxorubicin, a powerful anti-cancer drug, enhances its anti-tumor efficacy in prostate cancer while alleviating the damage to the heart at the same time.

For more than four decades the chemotherapeutic agent doxorubicin has been used to treat a number of human cancers, including that of the prostate. Despite doxorubicin’s clinical efficacy for cancer treatment, its use is associated with irreversible heart damage, often presenting several years after treatment stops. Researchers have been working over the past 15 years to find an optimal therapeutic intervention for protecting the heart against the cytotoxicity associated with doxorubicin.

In the study published online the week of Sept. 27 in the Early Edition of the journal Proceedings of the National Academy of Sciences, researchers using a variety of powerful in vitro and in vivo approaches, have shown that a combination of Viagra, generically known as sildenafil, and doxorubcin significantly enhances the generation of reactive oxygen species that trigger cell death, or apoptosis, in prostate cancer cells. They also observed that the combination did not harm the normal, healthy prostate epithelial cells.

“We believe sildenafil could be an excellent candidate for incorporation into cancer treatment protocols – with the potential of enhancing the anti-tumor efficacy, while protecting the heart against both short term and long term damage from doxorubicin,” said principal investigator Rakesh C. Kukreja, Ph.D., scientific director of the VCU Pauley Heart Center and the Eric Lipman professor in cardiology in the VCU School of Medicine, and Anindita Das, Ph.D., assistant professor in the Department of Internal Medicine the VCU School of Medicine.

Kukreja is excited about the potential translational impact of this work. “My team and I are hoping to move the research Root Explorer Apk is an ultimate file manager especially for the rooted Android phone users.  forward to a clinical trial and plans are under way to do so,” he said. The clinical trial would evaluate the effectiveness of the drug combination in cancer patients.

Kukreja’s laboratory is one of the first to explore the area of preconditioning. This preconditioning effect was modeled in his lab by “pretreating” mice with doses of sildenafil which also increases therapeutic levels of nitric oxide in the heart.

A preconditioned or pretreated heart has an improved ability to produce nitric oxide and directly improves a patient’s outcome following a heart attack. Generally, damage following a heart attack is related to an inability to recover from lack of oxygen.

Notes:
The work was supported in part by a MERIT Award to Kukreja from the National, Heart, Lung and Blood Institute of the National Institutes of Health.

Kukreja and Das collaborated with Paul Dent, Ph.D., a research member with the VCU Massey Cancer Center. Also contributing to this work were VCU researchers David Durrant, Clint Mitchell, a postdoctoral fellow in Dent’s lab, Eric Mayton, a research assistant in Kukreja’s lab, Nicholas N. Hoke, a graduate student in Kukreja’s lab, Fadi N. Salloum, assistant professor of Internal Medicine and researcher with the VCU Pauley Heart Center, Margaret A. Park, a postdoctoral fellow with Dent’s lab, Ian Quershi, a graduate student in Kurkeja’s lab, and Ray Lee, former assistant professor of internal medicine.

Source:
Sathya Achia Abraham
Virginia Commonwealth University

 





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Sexual Issues A Major Concern For Cancer Patients Taking New Targeted Drugs

Main Category: Cancer / Oncology
Also Included In: Sexual Health / STDs;  Erectile Dysfunction / Premature Ejaculation
Article Date: 13 Oct 2010 – 0:00 PDT

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New drugs that target specific molecular mechanisms of cancer have improved the treatment of cancer patients in recent years, but those benefits may come with a cost to the patient’s sex life, researchers have found.

At the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy, French researchers reported on one of the few studies to investigate the impact of cancer therapy on the sexual functioning of patients.

Dr Yohann Loriot and Dr Thomas Bessede from Institut Gustave Roussy in Villejuif, France and colleagues found that patients taking targeted therapies had significantly decreased levels of sexual function and satisfaction.

“The new molecular targeted therapies have been available for 6 or 7 years and researchers and physicians have observed some new side-effects not often reported with chemotherapy such as cutaneous side-effects and gastro-intestinal toxicity. But very few studies have been conducted in the field of sexuality, mainly because patients are not willing to talk with their physicians on this topic,” Dr Loriot said.

The researchers surveyed 51 patients (40 men and 11 women) who had been taking molecular targeted therapies for more than three months without progressive disease about changes in their sexual life.

The drugs involved were sunitinib, sorafenib, temsirolimus, everolimus, bevacizumab, tarceva and cetuximab. Men completed the International Index of Erectile Function (IEEF) questionnaire –which includes questions on erectile function, intercourse satisfaction, orgasmic function, sexual desire and overall satisfaction.

Women in the study completed the Female Sexual Function Index (FSFI) questionnaire, which includes questions on desire, arousal, lubrication, orgasm, satisfaction and pain.

The median overall IIEF score for men was 40, just 53% of the maximum score. For women, the median FSFI score was 8.4, just 24% of the maximum.

“The sex lives of the patients in our study had reduced quality and intensity,” Dr Loriot said. “We also found that more than half of the patients expressed a wish for a satisfying sexuality, but many of them found it difficult to initiate a discussion on the topic with their doctors.”

The impact of treatment on the sexuality of cancer patients is poorly understood, and is generally not considered in clinical trials of treatments, Dr Loriot said.

“Oncologists can address this issue first by assessing this concern more often in clinical trials, and by talking with their patients about it,” he said.

He suggested that oncologists could offer patients an assessment for sexual disorders during their treatment course, establish an outpatient clinic to deal with sexual disorders, or, if needed, refer patients to a specialist.

Sexuality is a major concern for cancer patients, as it is for everyone, noted Professor Raphael Catane, Chair of the department of oncology at Sheba Medical Center in Tel Hashomer, Israel. “The disease itself, and frequently its therapy, may have a major detrimental effect on the patient’s sex life. It is hoped that the new biological/targeted treatments would be less injurious to the sexual life of cancer patients. ”

“The study by this French group has taken an important step toward understanding the effect of biological/targeted treatments on sexuality,” Prof Catane said. “They meticulously reviewed the sexual function of their patients receiving biological agents. The results show a diminished sexual drive and pleasure, but the degree and the duration, and how it compares to the standard/conventional therapy, is not yet known. This study can be a basis for further investigation of this very important aspect of cancer therapy.”

Source:
Vanessa Pavinato

European Society for Medical Oncology





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NovaDel Pharma Inc. Announces Positive Data From Pilot Pharmacokinetic Study Comparing Duromist™ (Sildenafil Citrate Oral Spray) To Viagra(R)

 

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 20 Oct 2010 – 1:00 PDT

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NovaDel Pharma Inc. (OTCBB: NVDL), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed pharmaceutical products, announced pharmacokinetic (PK) and safety results from its pilot PK study comparing Duromist™ to Viagra®. Duromist™ is NovaDel’s oral spray formulation of sildenafil citrate. Viagra® is the tablet formulation of sildenafil citrate developed and marketed by Pfizer. Sildenafil citrate is a leading drug indicated for the management of pulmonary hypertension and erectile dysfunction. NovaDel now plans to review the results from this study with the FDA to obtain guidance on defining definitive clinical trial requirements as a pathway to NDA approval.

Objectives of the Study

This pilot PK study was designed primarily to assess the relative bioavailability of one, two and three doses of 10 mg/0.12ml of Duromist™, compared to that of the 25 mg Viagra® tablet in healthy adult male subjects.

The secondary objective was to assess the relative safety of Duromist™ following single oral dose administration compared to that of 25 mg Viagra® tablets. Safety assessments included evaluation of changes in orthostatic hypotension, oral irritation, vital sign and electrocardiogram assessments.

Results of the Study

The preliminary study data demonstrated that 20 mg or two sprays of Duromist™ is bioequivalent to the 25 mg Viagra® tablet with respect to systemic exposure (AUC0-inf). The mean AUC0-inf for the 10 mg or one spray dose was approximately 40% of the 25 mg Viagra® tablet, as expected. The mean AUC0-inf for the 30 mg (or three spray) dose was approximately 40 % higher than the 25 mg Viagra® tablet which is about 20% higher than expected. The increased systemic exposure (AUC) observed with the 20 and 30 mg oral spray doses compared to the Viagra® tablet is suggestive of absorption of sildenafil via the oral transmucosal route.

A slightly lower Cmax than that of the 25 mg Viagra® tablet was observed with the 20 mg oral spray dose. The Tmax for the 20 mg oral spray dose was essentially the same as the 25 mg Viagra® tablet (1.10 and 1.04 hour, respectively).

N-desmethylsildenafil is an active metabolite of sildenafil formed as a result of first-pass liver metabolism. TheDownload the best Android apps and games on Aptoide apk  Discover, download and share Android APK rate of metabolite formation with the oral spray is different than that observed with the reference tablet and is consistent with transmucosal absorption.


Duromist™ demonstrated an excellent safety profile and was well tolerated in this pilot PK study. There was no evidence of oral irritation and no adverse events were reported after administration of up to three doses of Duromist™. Vital signs were within normal range and there were no episodes of orthostatic hypotension observed in any of the four treatment periods. No changes were observed in the subjects’ electrocardiograms in any of the four treatment periods.

“These results are encouraging and demonstrate that greater bioavailability can be achieved with sildenafil administered as an oral spray form with the potential for a differentiated, patented Duromist™ product,” commented Mr. Steven B. Ratoff, NovaDel’s Chairman of the Board, President Chief Executive Officer. “This initial clinical study provides NovaDel with a solid foundation for our future clinical development efforts.”

About the Study

This was a single-center, open-label, single-dose, randomized, four-period, four-treatment crossover study under fasting conditions. The total number of healthy adult male subjects enrolled in the study was 24. All subjects were required to stay at the clinical site for at least 24 hours after each treatment period.

The Duromist™ oral spray test article used in this study was supplied as 10 mg/120 µl sildenafil per spray actuation. The 25 mg sildenafil citrate tablet was supplied from commercial sources as Viagra® from Pfizer Inc.

Measurements:

Pharmacokinetic: The following parameters were used in the data analysis for plasma sildenafil and N-desmethylsildenafil concentrations: AUC0-t, The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration; AUC0-inf, Calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant; AUC0-t/AUC0-inf, The ration of the AUC0-t to AUC0-inf; Cmax, The maximum measured plasma concentration observed; Tmax, defined as the time point of Cmax; Kel, The apparent first-order terminal elimination rate constant; T1/2, The apparent first-order terminal elimination half-life; Ratio Metabolite/Parent, The ratio of the metabolite/parent assessed at each concentration, Cmax, AUC0-t, AUC0-inf.

Safety: Vital signs (supine and standing); Electrocardiogram at screening and post-dose; Changes in physical examinations, including oral soft tissue examinations at and after each oral spray dosing, laboratory parameters and adverse events.

About Erectile Dysfunction

Erectile dysfunction (ED) is a condition in which men are unable to achieve penile erection or are unable to sustain an erection sufficient for successful sexual intercourse. In the United States alone, it is estimated that 18 million individuals suffer from ED with the disorder being most prevalent in men age 40 years and above. Since the risk of developing ED increases with age, the increasingly aged population and other risk factors such as physical inactivity, smoking and high cholesterol are expected to lead to an increase in the number of men with this condition over the next few years.

Source:

NovaDel Pharma Inc.

 





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Apricus Bio Announces First Patent Grant For Femprox(R) In Japan

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 20 Oct 2010 – 2:00 PDT

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Apricus Biosciences, Inc., (“Apricus Bio”) (Nasdaq: APRI) backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that the Japanese Patent Office has issued a Decision to Grant a Patent for the Company’s application on Femprox entitled, “Compositions and Methods for Amelioration of Human Female Sexual Dysfunction.” This patent, when issued, will provide Japanese patent protection to December 2019, and is one in a series of patents and pending applications that Apricus Bio owns on Femprox and the underlying NexACT technology.

“Compositions and Methods for Amelioration of Human Female Sexual Dysfunction.”

Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, “We are very pleased with our first patent allowance for Femprox in Japan. We continue to aggressively pursue intellectual property (“IP”) coverage for our technology and product candidates under development and this allowance adds to the strength of our overall IP position. In addition to the newly allowed claims in Japan, we have corresponding coverage and protection for Femprox in many other major international markets. The advancement of our patent portfolio comes at an optimal time, as we are in active discussions with potential partners to out-license Femprox.”

Femprox is an alprostadil-based cream intended for the treatment of female sexual arousal disorder. Apricus has completed nine clinical studies to date, including one, 98-patient Phase 2 study in the U.S. and a 400-patient proof-of-concept Phase 2/3 study in China, where the cost for conducting clinical studies was significantly lower than in the U.S.

Source:

Apricus Biosciences




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