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Survey Reveals Hidden Incidence Of hypos Among People With Type 2 Diabetes, UK

Half (49 per cent) of people with Type 2 diabetes (excluding those treated with insulin) experienced at least one hypo an episode of low blood glucose that can result in symptoms ranging from sweating to a loss of consciousness during a fortnight period, according to a new survey by Diabetes UK.

Sponsored by BristolMyers Squibb (BMS) and AstraZeneca (AZ), the survey questioned 1,954 people with Type 2 diabetes in the UK and provides insight into the prevalence and impact of mild to moderate hypos.

Time off work

Over half (52 per cent) of those surveyed believe mild to moderate hypos affect their quality of life and one in ten reported having to take at least one day off work in the last year as a result of a mild to moderate hypo.

Everyday impact

“Previous research around hypoglycaemia has tended to focus on the impact of severe hypoglycaemia,” said Simon ONeill, Diabetes UKs Director of Care, Information and Advocacy.

“This survey, however, reveals the everyday impact of mild and moderate hypos among people with Type 2 diabetes.

Hypos despite not taking insulin

“Importantly, this survey has also shown us that even people who are not taking insulin are having regular hypos. These people need to be reassessed by their GP to ensure they are taking the appropriate medication.

No structured patient education received

“Almost 90 per cent of people with diabetes in the UK have never received structured diabetes education, which is key to improved selfmanagement and a reduced risk of hypoglycaemia. Its therefore vital that we make this area a priority for improvement. We want to see hypos become the exception rather than the rule.”

Daytoday tasks affected

The survey also revealed that more than one third reported that mild to moderate hypos affect their ability to carry out daytoday tasks, including housework (35 per cent), social activities (37 per cent), sports activities (35 per cent) and sleep (35 per cent). Nearly half of those questioned said they worry about having a mild to moderate hypo (47 per cent) and that their emotional wellbeing is affected (47 per cent).

Hypos and Type 2 diabetes

Type 2 diabetes is treated with a healthy balanced diet and regular physical activity, but medication is often also required. Hypos only occur in people with Type 2 diabetes who have to take certain medications.

Treating a hypo

Treating a hypo is usually simple and requires taking some fastacting carbohydrate, such as a sugary drink or some glucose tablets, and following this up with some longeracting carbohydrate, such as a cereal bar or sandwich.

“Nagging fear”

Tim Page, 53, from Wadhurst, East Sussex, was diagnosed with Type 2 diabetes in November 2003.

He said “I experience hypos fairly regularly, most of which are mild but nonetheless have a huge effect on my life.

“Even the mildest of hypos can leave me feeling weak and disorientated, very tired in fact, exhausted.

Octubre 5th, 2009 by admin

Urologic Oncology Services Expanded At Cancer Institute Of NJ

Keeping with its mission of offering a comprehensive array of services to patients, The Cancer Institute of New Jersey (CINJ) has expanded its Urologic Oncology Program, which has gained formal recognition as a Section of Urologic Oncology under the Department of Surgery at UMDNJRobert Wood Johnson Medical School. The program provides highly specialized care for patients with tumors of the genitourinary tract including cancers of the prostate, testis, kidney, and bladder. CINJ is a Center of Excellence of UMDNJRobert Wood Johnson Medical School.

CINJs Section of Urologic Oncology is a leader in laparoscopic renal procedures and has extensive experience with robotic prostatectomy, which boasts such patient benefits as shorter hospital stays, lower blood loss, and faster recovery. Leading this effort is Isaac Yi Kim, MD, PhD, associate professor of surgery at UMDNJRobert Wood Johnson Medical School, who is an expert in the area of robotic prostatectomy and developed the Athermal Intrafascial Robotic or AIR prostatectomy. The AIR procedure spares more nerves than the traditional method and leads to faster recovery of sexual function and bladder control. CINJ has developed a Center of Excellence for robotic surgery and Kim and colleagues have performed more than 550 robotic prostatectomies over the last four years alone.

In addition to its extensive prostate cancer focus, the Section of Urologic Oncology is also building on its excellence in bladder and kidney cancers, having just recruited a pair of urologic oncologists with special expertise in these areas. Michael E. Karellas, MD, is a urologic oncologist at CINJ and an assistant professor of surgery at UMDNJRobert Wood Johnson Medical School. Dr. Karellas, who recently completed fellowship training at Memorial SloanKettering Cancer Center (MSKCC), has a clinical interest in the treatment of bladder cancer. Thomas L. Jang, MD, MPH, is a urologic oncologist at CINJ and an assistant professor of surgery at UMDNJRobert Wood Johnson Medical School, who specializes in kidney cancer. Dr. Jang, who also just completed fellowship training at MSKCC, will be responsible for building the programs new prostate cancer database, which will link histological and clinical data from prostate cancer tumors in an effort to further facilitate translational research.

The Section of Urologic Oncology and the Dean and Betty Gallo Prostate Cancer Center offer a wide breadth of clinical trials for patients with tumors of the genitourinary tract as well as several trials studying the prevention of prostate cancer. In addition, the Dean and Betty Gallo Prostate Cancer Center provides a hub for basic and clinical research specific to prostate cancer and serves as a forum for prostate cancer outreach and education activities.

“I am thrilled to welcome Drs. Karellas and Jang to New Jerseys only National Cancer Institutedesignated Comprehensive Cancer Center,” said Dr. Kim. “Their experience complements an already strong team with varied and unique expertise and will help us grow the program even more.”

Additional information about CINJs Urologic Oncology Program can be found at cinj.org/treatment/urologic.html.

Source

Octubre 4th, 2009 by admin

Antiabortion Protesters Alleged Killer Deemed Unfit For Trial

A Michigan man accused of fatally shooting an antiabortionrights protester outside a high school last month has been deemed incompetent to stand trial and committed to the Michigan Department of Mental Health, the New York Times reports.

Harlan Drake is charged with fatally shooting James Pouillion on Sept. 11 in what is believed to be the first slaying of someone protesting abortion rights. On Wednesday, Judge Terrance Dignan of the 66th District Court in Corunna, Mich., ordered Drake to begin psychiatric treatment. If rendered competent, a preliminary examination would be set to determine whether he could stand trial. Dignan wrote that “there is a substantial probability” that Drake, if provided a course of treatment, will be competent to stand trial, according to chief assistant prosecutor Sara Edwards (Chapman, New York Times, 10/1).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Octubre 2nd, 2009 by admin

Scientists Find New Research On The Brain And Fear That Could Help Victims Of Post Traumatic Stress Disorder

The brain is a complex system made of billions of neurons and thousands of connections that relate to every human feeling, including one of the strongest emotions, fear. Most neurological fear studies have been rooted in fearconditioning experiments. Now, University of Missouri researchers have started using computational models of the brain, making it easier to study the brains connections. Guoshi Li, an electrical and computer engineering doctoral student, has discovered new evidence on how the brain reacts to fear, including important findings that could help victims of posttraumatic stress disorder (PTSD).

“Computational models make it much easier to study the brain because they can effectively integrate different types of information related to a problem into a computational framework and analyze possible neural mechanisms from a systems perspective. We simulate activity and test a variety of “what if” scenarios without having to use human subjects in a rapid and inexpensive way,” Li said.

From previous experiments, scientists have found that fear can subside when overcome with fear extinction memory, but it is not permanently lost. Fear extinction is a process in which a conditioned response to a stimulant that produces fear gradually diminishes over time as subjects, such as rats in auditory fear experiments, learn to disassociate a response from a stimulus. One theory has concluded that fear extinction memory deletes fear memory, and another concluded that fear memory is not lost, but is inhibited by extinction memory as fear can recover with the passage of time after extinction.

“Fear extinction memory is not well understood, and our computational model can capture the neuron response well in rat during auditory fear conditioning with a mixture of mathematics and biophysical data,” said Li. “Our main contribution is that our model predicts that fear memory is only partially erased by extinction, and inhibition is necessary for a complete extinction, which is a reconciliation of the erasure and inhibition theories. Furthermore, our model shows that the inhibitory connection from interneurons to pyramidal cells serve as an important site for the storage of extinction memory.”

For PTSD victims, the fear circuit is disrupted and they cannot retrieve the fear extinction memory. However, the fear extinction memory exists, so the fear memory dominates every time victims get a fear cue. Li and his collaborators are targeting the inhibitory connection in the brain that makes it possible to retrieve the extinction memory. Li hopes that his research can contribute to new drugs that can help PTSD victims.

“Treatment for PTSD patients depends on which connection stores the fear extinction memory and which circuit misfires,” Li said. “With our model, we can figure out what specific connections store fear/extinction memory and how such connections are disrupted in the pathology of PTSD, which may lead to the suggestions of new drugs to treat the disease.”

Li, in collaboration with Satish Nair, professor of electrical and computer engineering who just received a threeyear National Institute of Health grant for further research in fear modeling, and Gregory Quirk, a neuroscientist in the University of Puerto Rico School of Medicine research, has been published in the Journal of Neurophysiology and Psychiatric Annals.

Source
Kelsey Jackson

Octubre 1st, 2009 by admin

Acrux Announces Successful AXIRON™ Phase III Trial Results

Australian company, Acrux, announced positive results from a Phase III trial evaluating the safety and efficacy of AXIRON™ in 155 men with testosterone deficiency (hypogonadism), across 26 sites in six countries.

AXIRON™ is applied to the underarm using a unique “notouch” applicator. Upon approval, AXIRON™ would be the first and only pharmaceutical product applied to the armpit in much the same way as an antiperspirant. As well as existing patents that protect AXIRON™ to 2017, Acrux has a new patent that, when granted, will extend protection of this novel, classleading feature until 2026.

Phase III trial results

The trial met its primary endpoint by demonstrating that after four months of treatment with AXIRON™, 84 percent of subjects achieved average blood levels of testosterone within the normal range, exceeding the requirement of 75 percent that was agreed upon by the U.S. Food and Drug Administration (FDA).

After only two weeks of treatment, it was found that 76 percent of subjects had average blood levels of testosterone within the normal range.

The average testosterone level for the responder group after 120 days treatment with AXIRON™ was 504ng/dl (the normal range being 3001,050ng/dl). The average baseline testosterone level in subjects prior to treatment was 190ng/dl.

Four different dose levels of AXIRON™ were tested, and the trial demonstrated that the optimum dose for 75 percent of subjects was 60mg testosterone per day, equivalent to one single application of AXIRON™ to each armpit.

Subjects were permitted to use an underarm deodorant or antiperspirant during the trial. More than half of the men continued to apply an underarm deodorant or antiperspirant as part of their daily routine, and an analysis of these subgroups showed that this had no impact on the efficacy of AXIRON™ treatment.

Analysis of mood, sexual desire, sexual activity and sexual performance before and after four months of treatment showed significant improvement from baseline across all measures.

There were no serious adverse events related to treatment with AXIRON™ and no adverse trends were identified with the biochemical safety measures, including prostate specific antigen, haematocrit, and the ratio of dihydrotestosterone to testosterone.

Fiftytwo men continued treatment for an additional two months specifically to monitor skin safety with six months of continuous use. Eight subjects reported some form of transient application site reaction during the main treatment phase of four months; however, these reported events were all mild or moderate and resolved quickly without any intervention. No patient withdrew due to a skin reaction.

“In terms of the proportion of responders to testosterone replacement using AXIRON™, the pharmacokinetic parameters and the response from this multicenter clinical trial, the results are very exciting and precisely what we had hoped to see,” commented lead investigator Professor Christina Wang, MD, at Los Angeles Biomedical Research Institute and Professor of Medicine at David Geffen School of Medicine at UCLA. “The posttreatment changes demonstrated positive responses in sexual desire, sexual activity, mood and general wellbeing, underpinning the patient reported benefits of this treatment. Patient compliance and acceptance of the unique notouch axilla application technique was very good, as evidenced by the high completer rate,” added Professor Wang.

Earlier this month, Acrux announced it had held a preNDA meeting with the FDA in Washington, DC and the FDA had agreed Acrux may proceed to file a New Drug Application (NDA) in the United States, which Acrux is targeting for the end of 2009.

Acrux has already received strong interest from a number of potential marketing partners for AXIRON™. Following release of the Phase III trial results, formal partnering discussions with interested parties will be progressed in October 2009.

If approved by the FDA, market entry for AXIRON™ could occur in early 2011, and may play an important role in the treatment of patients living with hypogonadism. Based on IMS data, global sales in this market for the year to March 2009 exceeded U.S. $1 billion for the first time, and sales in the U.S. market grew by more than 20 percent. Sales of testosterone gels in the U.S. grew to U.S. $0.7 billion for the year to March 2009.

Last year Acrux published results from market research conducted in both patients and physicians in the USA, in which two thirds of patients confirmed that they would prefer AXIRON™ to their existing gel treatment and 87 percent of physicians said that they would offer AXIRON™ to their patients that currently use gels. Importantly, 94 percent of patients who tried AXIRON™ rated it better than the testosterone gels in its ability to reduce the risk of transference of testosterone to others. In addition, 92 percent of physicians surveyed who prescribe gels as first line therapy rated AXIRON™ as very good or excellent in its ability to reduce the risk of transference to others when compared to the gels.

“We are excited by the AXIRON™ Phase III trial results and are now well positioned to submit our NDA by the end of 2009,” said Dr. Richard Treagus, CEO and Managing Director of Acrux. “These results, along with our recent meeting with the FDA, place us in a strong position as we initiate a process to select marketing partners for what is a unique testosterone delivery system that we believe will be a patient preferred treatment for hypogonadal men,” he said.

About AXIRON™ (testosterone solution) 2%

Testosterone deficiency in men (hypogonadism) is associated with a number of symptoms including lethargy, depression, reduced libido and decrease in muscle mass and bone density. Estimates of men over 50 years of age having testosterone levels below the normal healthy range vary from 10 percent to 39 percent1. However, in the majority of men this remains undiagnosed, with only around five percent to 10 percent of those with the condition receiving treatment. With a high incidence rate and low but growing treatment rates, the male testosterone deficiency market will remain an attractive commercial opportunity. AXIRON™ has been designed to overcome the significant issues and drawbacks associated with the current gel treatments. Large volumes of gel are applied by hand and rubbed on to the abdomen, shoulders or arms. They are considered messy, sticky, slowdrying and may have an unpleasant odour to some patients. One of the biggest drawbacks is the risk of transference to other people through contact with the application site or from residue left on the hands following application. AXIRON™ is a fasterdrying and pleasant smelling solution that is applied to the armpits once daily, using a convenient and ergonomic “notouch” applicator designed in Australia. The armpit is a unique application site for transdermal drug delivery and it offers significant advantages to the patient in terms of convenience and may have a lower risk of transference from patient to others. A factsheet on AXIRON™ is available for download at acrux.com.au.

1 Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years the HIM study. Int J Clin Pract. 2006;60(7)762769

Octubre 1st, 2009 by admin