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May 23
FDA Approves Samsca For The Treatment Of Hyponatremia
The FDA (Food and Drug Administration) has approved Samsca (tolvaptan), in tablet form, for the treatment of hyponatremia. Hyponatremia is when levels of sodium in the blood are abnormally low - it is associated with dehydration.

Norman Stockbridge, M.D., Director, Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, FDA, said "With the approval of Samsca, physicians will have an additional tool to treat hyponatremia."

Samsca is approved to treat hyponatremia associated with congestive heart failure, liver cirrhosis, and the syndrome of inappropriate antidiuretic hormone secretion.

When levels of sodium fall in the fluid outside of cells throughout the human body, water enters the cells to balance sodium levels - this makes the cells swell. Many symptoms of hyponatremia are thought to arise from the swelling of the brain cells, the FDA informs. Symptoms include:

* Headache
* Weakness
* Confusion
* Decreased consciousness
* Nausea

Samsca removes extra body water in the urine, thus helping raise sodium levels in the blood. In clinical trials, participants taking Samsca had higher increases in blood sodium levels compared to participants receiving a placebo (dummy drug).

The approval of Samsca includes a boxed warning that alerts doctors, pharmacists, other health care professionals, and patients that the medication should be started only in a hospital where blood sodium levels can be monitored carefully. If blood sodium levels rise to quickly there is a risk of osmotic demyelination syndrome (ODS). ODS can lead to coma, and even death. It can cause the patient to have problems speaking, swallowing, as well as causing drowsiness, confusion, mood changes, seizures, and problems controlling body movement with muscle weakness in the limbs.

Even though there were no cases of ODS detected during the clinical trials of Samsca, ODS is a known risk and it is crucial that doctors be aware of it, and make sure rapid increases in sodium levels do not occur, the FDA said. In addition, the FDA is requiring a Risk Evaluation and Mitigation Strategy that requires a patient Medication Guide be given when the drug is dispensed. The Medication Guide will have information about the risks and benefits of the drug.

During the clinical trials, the following side-effects were reported by participants: thirst, dry mouth, weakness, constipation, excessive urination, frequent urination, and raised blood sugar levels.

May 23
Binge Drinking In Childhood And Adolescence
German adolescents are top at boozing! In the current edition of Deutsches Ärzteblatt International (Dtsch Arztebl Int 2009; 106 (19): 323 - 8), Martin Stolle et al. of the German Center for Addiction Research in Childhood and Adolescence in Hamburg report that the main change has been the increase in the number of intoxicated girls. In their article, the authors present motivating short-term interventions to counteract secondary problems.

According to the German Federal Commissioner for Narcotic Drugs, the number of adolescents admitted to hospital for alcohol poisoning has more than doubled, increasing from 9500 in 2007 to more than 23 000 in 2007. About 3800 of these patients were between 10 and 15 years old. Teenagers who start drinking alcohol regularly before the age of 15 have a 4-fold increased risk of becoming alcohol dependent.

The German Federal model project "Hart am Limit"("Close to the Limit/On the Edge") even starts in the emergency ambulance. The authors consider that it would be desirable to supplement this with a brief motivational intervention, based on the principle of motivational interviewing. Drinking motivation will be discussed in short individual sessions of maximally 60 minutes. Topics will include the negative consequences of drinking, such as accidents or violence. The objective is to make it clear to the adolescents that they bear responsibility for changing their own consumption behavior. Studies in the USA show that as few as one to four sessions can yield a lasting effect.

May 22
India's Smoking Epidemic Is Catastrophic Say Researchers
A new study suggests that by 2010, India's death toll due to tobacco smoking will be about 1 million people a year (10 lakh in Indian counting system), taking the country's smoking epidemic to catastrophic proportions. This figures will represent one fifth of deaths in men and one twentieth of deaths in women aged 30 to 69, with smoking causing deaths from tuberculosis, respiratory disease, cardiovascular disease, and cancer.

There are about 120 million (12 crore in Indian counting system) smokers in India. About 5 per cent of women and more than one third of men aged between 30 and 69 smoke either conventional cigarettes or bidis, a type of Asian cigarette made from one quarter of the tobacco content of a conventional cigarette and wrapped in the leaf of a temburni plant.

The researchers calculated that on average in India, compared with non smokers, men who smoke bidis die about six years earlier, women who smoke them die about eight years earlier, and men who smoke cigarettes die about 10 years earlier (about the same as in the West).

Even low levels of smoking were not found to be safe, wrote the researchers. Smoking a few bidis a day brought substantial risks, and smoking a few cigarettes a day brought even more, to the point of doubling the risk of death in middle age, they wrote.

India's Health Minister, Dr Abumani Ramadoss, said he was alarmed at the results of the study, and that:

"The government of India is trying to take all steps to control tobacco use; in particular by informing the many poor and illiterate of smoke risks."

Professor Prabhat Jha of the Centre for Global Health Research (CGHR), St. Michael's Hospital at the University of Toronto in Canada, who led the study said:

"The extreme risks from smoking that we found surprised us, as smokers in India start at a later age than those in Europe or America and smoke less. And, smoking kills not only from diseases like cancer and lung diseases but also from tuberculosis and heart attacks."

The large study employed some 900 field workers to carry out a nationally representative survey of 1.1 million (11 lakh) homes throughout India. From this the researchers were able to compare the smoking histories of 74,000 adults who had died (33,000 women and 41,000 men) with 78,000 living unmatched controls (35,000 women and 43,000 men). They then worked out the risk ratios for death comparing smokers and non smokers and adjusted them for age, educational level, and alcohol consumption.

The results showed that among men who died at ages 30 to 69, smoking was responsible for:

* 38 per cent of all deaths from tuberculosis (1,174 deaths out of 3,119).
* 31 per cent of all deaths from respiratory disease (1,078 of 3,487).
* 20 per cent of all deaths from vascular disease (1,102 of 5,409).
* 32 per cent of all deaths from cancer (709 of 2,248).
* 23 per cent of all deaths from any disease (5,651 of 25,290)

Jha and colleagues found that 61 per of male smokers are likely to die between the ages of 30 and 69 compared with only 41 per cent of their non smoking counterparts. For women the researchers calculated the figures to be 62 per cent can expect to die in the age range 30 to 69 compared with only 38 per cent of their non smoking counterparts.

The study also found that:

* Smoking 1 to 7 bidis a day raised risk of death by one-third, and smoking 1 to 7 cigarettes a day nearly doubled it.

* Smoking is responsible for most of the gap between male and female rates of death in middle age.

* The risks were significant among both educated and illiterate adults, in both urban and in rural areas.

* Quitting smoking works, but only 2 per cent of adults in India have quit, mostly after falling ill.

Professor Amartya Sen, well known Indian economist and philosopher who won the Nobel Prize for Economics in 2001, said:

"It is truly remarkable that one single factor, namely smoking, which is entirely preventable, accounts for nearly one in ten of all deaths in India."

He said that the study "brings out forcefully the need for immediate public action in this much neglected field".

May 22
India Reduces Rate Of HIV Transmission In Some States, UNAIDS Report Says
India has managed to reduce the rate of HIV transmission in some states through increased awareness, resources and legislation, according to a report released Monday by India's Prime Minister Manmohan Singh, Reuters reports.

According to the report, titled "Redefining AIDS in Asia: Crafting an Effective Response," about 440,000 people die annually of AIDS-related causes in Asia, and the rate is expected to rise to about 500,000 by 2020 if measures are not taken (Majumdar, Reuters, 6/30). The report -- conducted by a UNAIDS-supported independent group called the Commission of AIDS on Asia and the Pacific -- noted that $3.1 billion annually would be required to effectively respond to the epidemic on the continent, United News of India reports.

According to the report, India accounts for about half of the estimated five million HIV-positive people in Asia (United News of India, 6/30). The report warned that India must be extremely cautious because many people are still unaware about the benefits of condom use in preventing HIV transmission, especially among injection drug users and women in rural parts of the country. India's efforts are garnering positive results in the southern states of Tamil Nadu and Andhra Pradesh and Maharashtra in the west, according to the report.

Denis Broun, head of UNAIDS in India, said the country "has managed to slow down the epidemic in some states with more decisive planning." He added, "We have really worked a lot in mobilizing politicians and they have been able to visit around the country and understand the realities of AIDS and interact with people." Broun said that new HIV diagnoses are "dropping in Tamil Nadu and it has been successful in Maharashtra," and "[w]e are sure we are going to see success in Andhra Pradesh before a year" .

May 22
First Patients Treated In India Using CyberKnife Radiosurgery
Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today that the first patients in India have been treated using CyberKnife radiosurgery. The CyberKnife System, which is located at the Apollo Specialty Cancer Hospital in Chennai, India, treated six patients in its first week of operation, with eight more patients in the treatment planning process being readied for treatment.

"Our new CyberKnife System allows us to deliver highly precise radiosurgical treatments to patients with tumors throughout the body," said Prathap C. Reddy, M.D., executive chairman, Apollo Hospitals Group. "We are very glad to have begun treating patients and look forward to witnessing the benefits that the System offers, including real-time tracking of tumors that move with respiration."

The CyberKnife treatment team at Apollo Hospital consists of a trained team of highly experienced radiation oncologists, radiation therapists and a neurosurgeon. The team plans to focus on CyberKnife radiosurgery for lung, liver and prostate treatment as well as head, neck and spine treatments. Lung cancer is currently one of the leading cancer incidences and causes of death amongst men in India. (National Cancer Registry, ICMR-New Delhi)

"Since India is the second most populous nation in the world, we are excited that CyberKnife radiosurgery is now an option for its population and that the first patients have received treatment," said Eric P. Lindquist, senior vice president and chief marketing officer at Accuray. "We believe this is just the first step in the opening of a large market for the CyberKnife System, as illustrated by the momentum within this System's first week of use."

Advanced Medical Systems (headquartered in Singapore), the company responsible for placing the CyberKnife at Apollo Hospital, will assist in marketing and providing end user support for the new CyberKnife System through its Accuray trained team of engineers and applications specialists based in India.

May 22
Chagas Disease Not Addressed By World Health Assembly
The World Health Organization (WHO) has cut short its annual health ministers meeting because of influenza A (H1N1) preparations and has postponed discussions about Chagas disease. Much needed progress in diagnosing and treating people for this neglected disease must not be further delayed, warned the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontičres (MSF) today.

This week's World Health Assembly (WHA), the annual gathering of health ministers in Geneva, was an opportunity for countries to commit collectively to stepping up the fight against Chagas, a largely neglected tropical disease endemic in many Latin American countries, which affects an estimated 14 million people and kills about 15,000 people every year.

"At the 100th anniversary of the discovery of Chagas we had expected that the WHA would adopt a resolution where all affected countries agree to integrate care of acute and chronic Chagas patients into their primary healthcare systems, and to invest more in research," said Roger Teck, MSF director of operations. "People affected by this neglected disease are once again neglected. However, even though Chagas is now off the WHA agenda, this should not be used as an excuse for inaction. Governments of endemic countries should step up through developing and implementing better national and international protocols to fight Chagas."

Chagas programs have traditionally focused on preventing the disease by controlling the "kissing bugs," the blood-sucking insects that transmit the disease. But MSF's experience in Honduras, Nicaragua, Guatemala, and Bolivia since 1999 has shown that prevention is far from enough.

"The focus on prevention ignores the needs of those who are already infected and are suffering in silence. In endemic countries, governments should actively screen, diagnose, and treat many more patients," said Gemma Ortiz, senior advocacy officer for Chagas at MSF. "Access to diagnostics and treatment must be made a priority."

MSF also urges WHO member states to review a range of alternative financing mechanisms, such as prize funds, to stimulate research and development for better tools to diagnose and treat Chagas patients in all stages of the disease. The lack of commercial incentives to invest in research and development has meant that Chagas has been neglected for decades.

May 21
Schizophrenia Still Misunderstood, Research Finds
A new study conducted by SANE Australia finds almost half of all Australians still have a very limited understanding of schizophrenia and the everyday reality of living with the illness.

The study (conducted in conjunction with Virtual Medical Centre), surveyed nearly 900 people with 49 per cent admitting to having a poor understanding of schizophrenia and its impact.

'The findings are disappointing but not surprising,' says SANE Australia's Executive Director Barbara Hocking. 'A lot of education is still needed about the realities of schizophrenia - the fact is, with treatment, the majority of those affected lead full lives and participate in the community.

'Unfortunately there is still a lot of stigma and discrimination towards those with schizophrenia, which is not helped by persistent myths about the illness. The most common myth confuses schizophrenia with so-called 'split personality', which is not the case.

'Another myth is that people affected by schizophrenia are violent, when in fact research shows that they are more likely to be victims of violence than to commit violent acts themselves.'

One in a hundred people will develop schizophrenia during their lives. More males than females are affected and 75% develop the illness between 16 and 25 years.

Schizophrenia is an illness which influences the normal functioning of the brain, affecting its ability to interpret information and make sense of the world. Symptoms can include confused thinking, delusions, hallucinations, difficulty expressing emotions and withdrawal from others. There is no cure for schizophrenia but treatment, which includes medication, psychological therapy and community support and accommodation programs, can do much to reduce and even eliminate the symptoms.

'Through events such as Schizophrenia Awareness Week we can hope to break down the stigma surrounding the illness by encouraging conversation and help-seeking behaviour,' says Ms Hocking.

SANE produces a number of education resources about schizophrenia to help people understand and make sense of the illness, as a first step to coping with its effects. SANE also operates a StigmaWatch program, which works with the community to monitor media portrayals of mental illness and suicide, advocating for an end to misrepresentations of schizophrenia.

May 21
Link Between Obstructive Sleep Apnea And Diabetic Retinopathy
The eyes may be the window into the soul, but they may also contain important medical information. According to new research presented at the American Thoracic Society's 105th International Conference in San Diego on May 19, patients with diabetes who have retinopathy should also be screened for obstructive sleep apnea (OSA).

"We know from our earlier research that 23 percent of men with type 2 diabetes have OSA and this is under-recognized and under-treated," said Sophie D. West, M.D., of the Oxford Centre for Respiratory Medicine in the United Kingdom, who led the research. "This study suggests that OSA is linked to retinopathy in type 2 diabetes."

The researchers analyzed data from 118 men who had participated in the earlier study on the prevalence of OSA in type 2 diabetes in Oxford, England, and who also had retinal images to review. (All patients with type 2 diabetes in the U.K. are offered annual retinal screening to look for signs of retinopathy.) The images were studied by ophthalmology graders for evidence of retinopathy and the sleep study data was reviewed to determine the presence or absence of OSA.

The researchers found that retinopathy was present in more than half - 54 percent - of those who had OSA, compared to fewer than a third - 31 percent - of those without OSA, independent of the effects of glucose control, age, body mass index, high blood pressure and the duration of the diabetes. This was statistically significant.

"These results suggest an association between OSA and retinopathy that should be further investigated," said Dr. West. "While the study only analyzed data from men, there is no reason to believe that gender would play a role in the results."

There has been very little work previously regarding the relationship between OSA and retinopathy. Previous studies have found strong links between poor glucose control and high blood pressure with retinopathy and these have been the main areas upon which treatment has been targeted in diabetes in order to prevent retinopathy from developing and to delay its progression. However, in this study, OSA had a far stronger relationship with retinopathy than did glucose control or high blood pressure.

"While there is clearly more research to be done, there is an immediate implication to consider," said Dr. West. "Our message would be for doctors and nurses who see patients with type 2 diabetes to consider whether they could have OSA and whether they should therefore be referred for a sleep study."

Symptoms of possible OSA include snoring, apneas (stopping breathing) and daytime sleepiness. "Future research will try to determine whether the treatment for OSA, that is continuous positive airway pressure (CPAP), can delay the development or progression of retinopathy, associated with diabetes."

May 21
Those With Darker Skin Might Be More Susceptible To Nicotine Addiction, Study Finds
Blacks and others with darker skin might be at greater risk for tobacco addiction than whites and those with lighter skin because the greater the amount of melanin, the coloring pigment in skin, the more nicotine appears to be stored, according to preliminary findings published in the journal Pharmacology, Biochemistry and Behavior, the New York Times reports. For the study, lead researcher Gary King, a professor of biobehavioral health at Pennsylvania State University, looked at 150 black smokers and measured their levels of melanin and cotinine, a byproduct of nicotine. They also surveyed the participants to determine the level of their smoking habit.

Those with the most melanin were found to smoke the most and have the most cotinine in their system. They also had the highest level of dependence on tobacco. The findings might indicate why some people are more affected by nicotine than others.

May 21
Folic Acid May Improve Asthma, Allergies
Folic acid, or vitamin B9, may help treat allergic reactions and allergy symptoms, according to researchers from the Johns Hopkins Children's Center.

Folate occurs naturally in food while folic acid is the synthetic form of this vitamin. Sources include cereals, baked goods, leafy vegetables, asparagus, fruits, legumes, yeast, mushrooms and organ meat (such as beef liver or kidneys).

Previous studies have noted a potential link between folate and inflammatory conditions such as heart disease.

In the study, funded by the National Institutes of Health (NIH), researchers reviewed medical data from in 8,083 patients ages 2-85 who participated in the 2005-2006 National Health and Nutrition Examination Survey (NHANES). During the study, serum folate levels and total IgE levels were measured. IgE, or immunoglobulin E, is a class of antibodies that mediates allergic reactions. The authors also recorded asthma and respiratory symptoms.

Higher levels of folate were linked to lower IgE levels, fewer reported allergies, less wheezing and a lower likelihood of developing asthma. People with the lowest folate levels (less than eight nanograms per milliliter of blood) had a 40 percent increased risk of wheezing, 30 percent increased risk of having elevated IgE levels, 31 percent increased risk of allergic symptoms and a 16 percent higher risk of asthma compared to those with the highest levels of folate (above 18 nanograms per milliliter of blood).

However, additional research is needed to confirm these early findings and to determine exactly how folate may work. The researchers plan to compare the effects of folic acid to placebo in people with allergies and asthma.

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