Treatment Failure In Kids With Serious Infections Is Lowered By Zinc Supplementation

Editor's Choice
Main Category: Pediatrics / Children's Health
Also Included In: Infectious Diseases / Bacteria / Viruses;  Nutrition / Diet
Article Date: 31 May 2012 - 17:00 PDT

Researchers in India have found that zinc supplementation, in addition to standard antibiotics, reduces the risk of treatment failure among young children with suspected serious bacterial infections by 40%. The study is published Online First in The Lancet.

In 2010, nearly 66% of deaths in children under 5 around the world were due to infections. Of these deaths, around two-fifths occurred within the first month of life.

Shinjini Bhatnagar from the Translational Health Science and Technology Institute and All India Institute of Medical Sciences in India, who conducted the study, explained:

"Zinc is an accessible, low-cost intervention that could add to the effect of antibiotic treatment and lead to substantial reductions in infant mortality, particularly in developing countries where millions of children die from serious infections every year, and where second-line antibiotics and appropriate intensive care might not be available."

In order to evaluate how effective zinc is in addition to standard antibiotic therapy for suspected serious bacterial infections, such as meningitis, pneumonia, and sepsis, the researchers enrolled children aged between 120 days old to 7 years who were undergoing antibiotic treatment for serious infections in three hospitals in New Delhi, India.

The researchers randomly assigned 352 infants to receive 10 mg zinc each day orally, and 348 to receive placebo. The researchers measured treatment failure as the need for secondary antibiotic treatment within 7 days, need for treatment in intensive care, or death within 21 days.

The researchers found that children were 40% less likely to experience treatment failure when given zinc than placebo. Out of the 332 children who received zinc, 34 treatment failures occurred vs. 55 treatment failures in the 323 participants who received placebo. Although not statistically significant, the researchers also found that there was a relative reduction (43%) in risk of mortality in children given zinc.

The researchers explained: "We would only need to give 15 children with probable serious bacterial infection zinc to prevent one treatment failure."

They conclude:

"Zinc syrup or dispersible tablets are already available in the public and private health-care systems for the treatment of acute diarrhea in many countries of low and middle income and the incremental costs to make this intervention available for young infants with probable serious bacterial infection would be small."

In a joint comment, Christa Fischer Walker and Robert Black from John Hopkins Bloomberg School of Public Health, Baltimore, USA, explained:

"This finding is important because case fatality is high in infants presenting with symptoms of probable serious bacterial infection.

The exact mechanism for the effect of supplemental zinc is unknown and needs further investigation, but the clinical benefits in diarrhea and pneumonia in children younger than 5 years, and now in probable serious infections in young infants, suggest that therapeutic use of zinc could have wide application. Additionally, zinc would be beneficial...for other serious bacterial infections, such as those causing typhoid fever or meningitis."

Written By Petra Rattue
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Dark Chocolate May Reduce Cardiovascular Events

Editor's Choice
Main Category: Cardiovascular / Cardiology
Article Date: 31 May 2012 - 16:00 PDT

Good news for chocolate lovers! Eating dark chocolate on a daily basis can reduce cardiovascular events, including heart attacks and strokes in people with metabolic syndrome, i.e. a combination of factors that increase the risk of developing heart disease and diabetes.

The study was published in British Medical Journal (BMJ) today. ''

Worldwide, cardiovascular disease is the highest cause of mortality. Dark chocolate with a cocoa solid content of at least 60% is rich in flavonoids that are known to protect the heart. However, the protecting effects have so far only been assessed in short-term studies. To predict the long-term effects, Australian researchers from Melbourne used a mathematical model to predict the long-term health effects and economic effectiveness of eating dark chocolate on a daily basis. For their study, the researchers recruited 2,013 people who were high-risk candidates for heart disease. ''

All participants were hypertensive and met the criteria for metabolic syndrome, yet they had no previous history of heart disease or diabetes and did not take medication to lower their blood pressure. The best-case scenario, i.e. a compliance of 100% meant that eating dark chocolate on a daily basis would be able to prevent 70 non-fatal and 15 fatal cardiovascular events per 10,000 people over a 10-year duration.

By reducing the compliance rate to 80%, they could potentially prevent 55 non-fatal and 10 fatal events respectively, which is still a substantial reduction and effective intervention. ''

According to the model, governments would be able to spend $A40 (£25; '31; $42) per person per year cost effectively on dark chocolate prevention strategies. This saving could be used for advertising, educational campaigns, or subsidizing dark chocolate in this high-risk population. ''

The researchers point out that their study only assessed non-fatal stroke and non-fatal heart attacks, and that further tests are required to evaluate the potential impact on other cardiovascular events like heart failure.

They also stress that these protective effects only apply to dark chocolate with a cocoa content of at least 60-70% cocoa, an not to milk or white chocolate. This could be because of the fact that dark chocolate has a much higher level of flavonoids.

They conclude by stating that dark chocolate's blood pressure and cholesterol lowering properties "could represent an effective and cost effective strategy for people with metabolic syndrome (and no diabetes)."

Written By Petra Rattue
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Diabetes Drug Pioglitazone Associated With Bladder Cancer Risk

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Main Category: Cancer / Oncology
Also Included In: Urology / Nephrology;  Diabetes
Article Date: 31 May 2012 - 16:00 PDT

According to a study published in British Medical Journal (BMJ), a drug for treating type 2 diabetes called Pioglitazone is linked to a higher risk of bladder cancer and taking the drug continuously for longer than two years doubles the risk. The researchers stress, however, that the risk in absolute terms is relatively low with up to 137 extra cases per 100,000 person years. ''

Rosiglitazone, which is a similar drug, showed no increased risk. Both pioglitazone and rosiglitazone are thiazolidinediones, which help control blood sugar levels in patients with type 2 diabetes and are known to increase the risk of heart failure, yet following a safety review, the European Medicines Agency (EMA) decided to keep pioglitazone on the market. ''

A Canadian team of researchers decided to investigate if pioglitazone was linked to a higher risk of bladder cancer in people with type 2 diabetes and after obtaining data from the General Practice Research Database (GPRD), they evaluated 115,727 patients who initiated diabetes therapy from 1988 to 2009. The GPRD contains anonymous patient records from over 600 UK GPs. The team identified cases of bladder cancer and matched them to up to 20 healthy control patients. ''

The results revealed that from 376 cases that were matched against 6,699 controls, 470 patients were diagnosed with bladder cancer during the average 4.6 years of follow-up, which translates to a rate of 89 per 100,000 person years, whilst the rate of bladder cancer in the general UK population aged 65 years and above is 73 per 100,000 person years. ''

Patients who had taken pioglitazone at any time were found to have a 83% higher risk of bladder cancer, which translates into 74 per 100,000 person years. The figures increased to 88 per 100,000 person years for those who had taken the drug for two years or longer and increased even further, to 137 per 100,000 person years those who had taken 28,000mg or more. ''

The researchers cross-checked the results in several further analyses, but the results remained consistent, and "provide evidence that pioglitazone is associated with an increased risk of bladder cancer, whereas no increased risk was observed with the thiazolidinedione rosiglitazone."''

They believe that these links may have been underestimated during earlier observational studies and comment that doctors, patients and regulatory agencies "should be aware of this association when assessing the overall risks and benefits of this therapy."''

Dominique Hillaire-Buys and Jean-Luc Faillie from the Department of Medical Pharmacology and Toxicology in Montpellier, France comment in a linked editorial: "It can confidently be assumed that pioglitazone increases the risk of bladder cancer. It also seems that this association could have been predicted earlier."

They continue saying that in view of pioglitazone's benefits of reducing cardiovascular events being questionable, they remark that, "prescribers who are ultimately responsible for therapeutic choices can legitimately question whether the benefit-risk ratio of pioglitazone is still acceptable for their patients with diabetes."

Written By Petra Rattue
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Does A Safe Suntan Exist? Apparently Not

Editor's Choice
Main Category: Melanoma / Skin Cancer
Also Included In: Women's Health / Gynecology;  Cancer / Oncology
Article Date: 28 May 2012 - 20:00 PDT

Dermatologists from Penn State University say that a safe tan does not exist. The incidence of melanoma, a fatal form of skin cancer, was eight times higher among women and four times higher among men in 2009 compared to 1970. Sixty thousand people are diagnosed with melanoma each year in the USA - one American dies every hour from the disease. The American Cancer Society says that among 25 to 29 year olds, melanoma is the most common form of cancer - it is the second most common form among 15 to 29 year-olds.

According to the April issue of Mayo Clinic Proceeding, the dramatic increase in melanoma cases among young women is partly due to their increasing usage of tanning beds. Up to 80% of tanning salon clients are female.

Rogerio Neves, professor of surgery, dermatology, pharmacology and medicine, says that the increase in indoor tanning bed usage is one of the main reasons for the rise in the number of melanoma cases in America.

10% of America's population, 30 million people, use tanning beds annually. They have long been linked to an increase in skin cancer. An Icelandic study found that melanoma rates rose considerably after tanning beds were introduced in the country. Iceland is a cold nation and its people have relatively little exposure to the sun.

Tanning beds have become increasingly popular over the last thirty years, especially among young women

Cancer awareness has improved - so why do people still use tanning salons?

More people are aware of the dangers of getting sunburnt, and that over-exposure to sunlight can raise the risk of developing skin cancer. Information on the danger of tanning beds is widespread. So why do people still use them?

The tanning industry is a multi-billion dollar business that, according to a Congressional Report published on February 1, targets teenage females with promotions and advertising. The Report accuses the industry of denying the known risks, providing inaccurate and false data on tanning benefits, and does not follow FDA recommendations on how often people should tan.

WHO (World Health Organization) International Agency for Research on Cancer classes tanning beds as carcinogenic to humans. Cigarettes, arsenic, plutonium and mustard gas have the same category.

Some US states have introduced legislation aimed at protecting young people by requiring parents to sign a consent form before their under-18 children are allowed to use tanning beds. Professor Neves says that, so far, their efforts are not working, mainly because so many tanning salons ignore the legislation. In some cases, teenagers provide fake consent forms (by falsely signing as their parents).

Professor Neves wrote:

"There are currently two separate bills in the Pennsylvania General Assembly that address the use of tanning salons. The leadership of the Penn State Hershey Melanoma Center is working closely with members of the House and Senate to ensure that legislation is passed to put appropriate measures in place to protect consumers and restrict the use of tanning beds by minors. The reason is simple: tanning beds are dangerous and there is no such thing as a safe tan."

Written by Christian Nordqvist
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World's First Stem Cell Drug From Osiris: Approved

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Main Category: Pediatrics / Children's Health
Also Included In: Stem Cell Research
Article Date: 20 May 2012 - 11:00 PDT

There is great news for parents suffering the harrowing ordeal of their child needing a bone marrow transplant. The announcement came from Osiris Therapeutics Inc. (NASDAQ: OSIR) on Friday that Health Canada has approved its groundbreaking stem cell therapy Prochymal® (remestemcel-L). The drug can be used to treat children with acute graft-vs-host disease. (GvHD).

The decision is a historic one, as it's both the first stem cell drug going into formal use, as well as the first treatment for GvHD. The disease is a devastating breakdown occurring after a bone marrow transplant and kills around 80% of children affected, often within a matter of weeks.

Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal confirmed :

"I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope ... As a result of Health Canada's comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine."

The approval process for Prochymal was implemented under Health Canada's Notice of Compliance with conditions (NOC/c) pathway. The basis of the procedure allows a new drug to come onto the market where there are unmet medical needs. The approval is granted with the provision that the drug has demonstrated risk / reward benefits in previous clinical trials and that the manufacturer agrees to undertake additional confirmatory clinical testing.

C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris confirmed his' companies happiness at being able to help conquer the disease :

"Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies ... Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last."

Where children with GvHD are not responding to treatment with steroids, which is presumably most of them, the use of Prochymal will now be authorized. Health Canada based it's approval on previous clinical studies of the drug, in which 64% of patients showed results; the survival rate compared to historical data was drastically improved, even in patients with severe cases. Additional clinical evaluation of Prochymal now will be undertaken, including enrolling patients in a registry to discover any long term effects.

Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal

"Refractory GvHD is not just deadly to the patients it afflicts, but is devastating for the family, friends, and caregivers who watch helplessly as the disease progresses ... I have personally seen Prochymal reverse the debilitating effects of severe GvHD in many of my patients and now, after nearly two decades of research, the data demonstrating consistently high response rates, a strong safety profile and improved survival clearly support the use of Prochymal in the management of refractory GvHD."

Prochymal is currently available in several countries, including the United States, under an Expanded Access Program (EAP). Prochymal will be commercially available in Canada later this year. Peter Friedli, Chairman and Co-founder of Osiris concludes:

"Today Osiris turns the promise of stem cell research into reality, delivering on decades of medical and scientific research ... It took 20 years of hard work and perseverance and I want to personally thank everyone involved for their dedication to this important mission."

Osiris has 48 patents protecting Prochymal, and Health Canada's have agreed to provide Prochymal with regulatory exclusivity within their territory. Canada affords eight years of exclusivity to Innovative Drugs, such as Prochymal, with an additional six-month extension because it addresses a pediatric disease. Parents, doctors and shareholders can all rest easy.

Written by Rupert Shepherd.
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Imaging Agent Flutemetamol Presented At Neurology Meeting

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Main Category: Radiology / Nuclear Medicine
Also Included In: MRI / PET / Ultrasound
Article Date: 03 May 2012 - 9:00 PDT

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Results from 4 pooled brain biopsy studies, as well as results from a brain autopsy study of the investigational PET amyloid imaging agent, [18F]flutemetamol, were presented as part of the Emerging Science Program at the American Academy of Neurology's 64th Annual Meeting in New Orleans in April, 2012.

Flutemetamol is a GE Healthcare PET imaging agent currently being developed for the detection of beta amyloid.

The study demonstrated a high sensitivity and specificity of both biopsy and autopsy study images. There was also a strong concordance between Alzheimer's disease-associated beta amyloid brain pathology and [18F]flutemetamol PET images. The data confirm that [18F]flutemetamol could be used as a potential imaging agent to detect beta amyloid plaque, a pathology linked to Alzheimer's disease (AD) in living patients.

In addition, results from these studies support an application for regulatory approval of [18F]flutemetamol, which is intended to be filed later in 2012.

David Wolk, M.D., Assistant Professor of Neurology in the Cognitive Neurology Division, Department of Neurology, University of Pennsylvania, presenter and lead researcher for the biopsy study, explained:

"Currently, the standard for definitively confirming AD is through detection of pathology, including amyloid plaque in the brain during autopsy.

Because accurate detection of brain amyloid in vivo can help physicians make a more accurate clinical diagnosis and potentially enhance patient management, we are particularly pleased to see that flutemetamol performed in a similar manner in both the autopsy and biopsy studies."

The researchers pooled analysis from 4 studies involving 49 patients receiving flutemetamol, either before or after brain biopsy, during shunt placement or intracranial pressure measurement. In addition, the team examined 68 autopsy patients in order to determine the presence of brain amyloid pathology.

Results of the study indicated that for patients with biopsy tissue samples, flutemetamol identified beta-amyloid with a pooled specificity of 100% and pooled sensitivity of 93%.

Sensitivity is defined as the percentage of amyloid-positive brains correctly identified by flutemetamol image readers as being positive and that correspond to abnormal amyloid pathology, whilst the definition of specificity means the percentage of amyloid-negative brains that are correctly identified by image readers as negative flutemetamol images that correspond to normal pathology. In autopsy patients the team found that flutemetamol demonstrated the ability to identify beta-amyloid with a specificity of 92% and sensitivity of 86%.

In autopsied subjects, [18F]flutemetamol showed the ability to detect beta-amyloid with a sensitivity of 86 percent and specificity of 92 percent.

Researchers believe that the accumulation of beta amyloid in the brain has an impact on the degeneration of neurons in AD and is one of many pathological characteristics implicated in its development.

In post-mortem brain samples, AD is currently verified by histopathological identification of core features, including beta amyloid plaques.

Researchers are currently researching targeted amyloid imaging agents in order to determine their ability to assist physicians identify amyloid deposition in living humans.

Jonathan Allis, General Manager, PET, GE Healthcare Medical Diagnostics explained:

"We know that AD-related pathological markers such as amyloid plaques may appear decades before clinical symptoms are observed, and these studies show flutemetamol images may prove to be a clinically valuable component of a broader diagnostic workup that neurologists conduct when assessing patients with cognitive impairments who may have AD.

Additionally, the ability to help rule out AD by reliably showing an absence of amyloid deposits in the brain could assist physicians in making appropriate disease management decisions. The results from these studies are encouraging in that they demonstrate the potential of flutemetamol imaging in living patients."

Flutemetamol is one component of a broad portfolio of diagnostic solutions that GE Healthcare is currently developing in the Alzheimer's field. GE Healthcare is studying AD via its ongoing research in order to identify the causes, risks and physical effects of the disease.

For instance, GE Healthcare is collaborating with pharma in order to identify a biosignature, or biological indicator, that may assist physicians diagnose AD prior to the onset of clinical symptoms.

Written By Christine Kearney
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After Breast Lumpectomy Brachytherapy Linked To More Complications Than Whole-Breast Irradiation

Editor's Choice
Main Category: Breast Cancer
Also Included In: Radiology / Nuclear Medicine
Article Date: 02 May 2012 - 14:00 PDT

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A study in the May 2 edition of JAMA reveals that older women with invasive breast cancer who were treated with brachytherapy after lumpectomy were more likely to develop complications and had a lower risk of long-term breast preservation than women who received whole-breast irradiation, however, there was no difference in overall survival.

The researchers write:

"Brachytherapy is a means of delivering radiation using an implanted radioactive source and has been used to treat various malignancies. In recent years, the use of breast brachytherapy after lumpectomy for early breast cancer has increased substantially despite a lack of randomized trial data comparing its effectiveness with standard whole-breast irradiation (WBI).

Because results of long-term randomized trials will not be reported for years, detailed analysis of clinical outcomes in a nonrandomized setting is warranted."

To date, at least 50,000 older women with breast cancer in the United States have undergone brachytherapy. According to the researchers, up to 10% of breast cancer patients are currently treated with this procedure.

Grace L. Smith, M.D., Ph.D., M.P.H., of the University of Texas MD Anderson Cancer Center, Houston, and her team conducted the retrospective population-based study in order to compare breast brachytherapy with WBI and to examine the risk of long-term breast preservation complications and survival among older Medicare patients diagnosed with invasive breast cancer.

The study included 92,735 women aged 67+ who were diagnosed with incident invasive breast cancer between 2003 and 2007. Patients received follow-up until 2008. After lumpectomy, 6,952 women underwent brachytherapy and 85,783 received WBI.

The team discovered that women who underwent breast brachytherapy were more likely to require a mastectomy in the future than patients treated with WBI (5-year cumulative incidence of 3.95% vs. 2.18%, respectively).

In addition, the researchers found patients treated with brachytherapy were also more likely to suffer from infectious and noninfectious postoperative complications. By 1 year, more patients treated with brachytherapy experience skin or soft tissue infection than those treated with WBI (1,126 patients [16.20%) vs. 8,860 [10.33%), respectively).

The researchers write:

"Similarly, by 1 year. 1,132 patients (16.25 percent) treated with brachytherapy experienced noninfectious postoperative, complications compared with 7,721 (9.00 percent) treated with WBI."

According to the researchers, women treated with brachytherapy generally had a higher risk of developing postradiation complications. They explain:

"Specifically, 5-year cumulative incidence of breast pain was 14.55 percent in patients treated with brachytherapy vs. 11.92 percent in patients treated with WBI; fat necrosis was 8.26 percent vs. 4.05 percent; and rib fracture was 4.53 percent vs. 3.62 percent."

The researchers found no considerable difference in the five-year overall survival rate; 87.66% patients treated with brachytherapy vs. 87.04% WBI.

At 5-years, an absolute 1.77% excess mastectomy risk in patients treated with brachytherapy compared with WBI meant that 1 woman underwent an unnecessary mastectomy for every 56 treated with breast brachytherapy, whilst the 1-year 10.64% excess postoperative risk of complication in women with brachytherapy meant that for every 9 women with brachytherapy, 1 woman suffered unnecessary postoperative complications.

The researchers conclude:

"Potential public health implications of these findings are substantial, given the high incidence of breast cancer, along with the recent rapid increase in breast brachytherapy use. Although these results await validation in the prospective setting, they also prompt caution over widespread application of breast brachytherapy outside the study setting."

Written By Grace Rattue
Copyright: Medical News Today
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"Association Between Treatment With Brachytherapy vs Whole-Breast Irradiation and Subsequent Mastectomy, Complications, and Survival Among Older Women With Invasive Breast Cancer"
Grace L. Smith, MD, PhD, MPH; Ying Xu, MD, MS; Thomas A. Buchholz, MD; Sharon H. Giordano, MD, MPH; Jing Jiang, MS; Ya-Chen Tina Shih, PhD and Benjamin D. Smith, MD
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