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Celgene Europe Limited withdraws its application for an extension of the indication for Revlimid (lenalidomide)

 

Lndon, UK (June 21, 2012) - The European Medicines Agency has been formally notified by Celgene Europe Limited of its decision to withdraw its application for the centrally authorised medicine Revlimid for an extension of the therapeutic indication in patients with newly diagnosed multiple myeloma and for the addition of new pack sizes.

 

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Does night work put women's health at risk?

 

Paris, France (June 19, 2012) - Breast cancer is the number one cause of female mortality. It affects 100 out of 100,000 women per year in developed countries. Each year, more than 1.3 million new cases are diagnosed, 53,000 of these in France. The risk factors of breast cancer are varied. They include genetic mutations, late first pregnancy, low parity or hormone therapy, but other causes of breast cancer such as way of life, environmental or professional causes have not yet been completely identified.

 

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Weight-loss surgery increases alcohol use disorders over time

 

NIH-funded study sheds light on risk of bariatric procedures

 

Bethesda, MD, USA (June 18, 2012) - Adults who had a common bariatric surgery to lose weight had a significantly higher risk of alcohol use disorders (AUD) two years after surgery, according to a study by a National Institutes of Health research consortium.

Researchers investigated alcohol consumption and alcohol use disorders symptoms in 1,945 participants from the NIH-funded Longitudinal Assessment of Bariatric Surgery (LABS), a prospective study of patients undergoing weight-loss surgery at one of 10 hospitals across the United States. Within 30 days before surgery, and again one and two years after surgery, study participants completed the Alcohol Use Disorders Identification (AUDIT) test. The test, developed by the World Health Organization, identifies symptoms of alcohol use disorders, a condition that includes alcohol abuse and dependence, commonly known as alcoholism.

 

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Top risk of stroke for normal-weight adults: Getting under 6 hours of sleep

 

Stroke risk greatest for employed middle to older ages, normal weight and no sleep apnea, habitually sleeping less than 6 hours each day

 

Darien, IL, USA (June 11, 2012) – Habitually sleeping less than six hours a night significantly increases the risk of stroke symptoms among middle-age to older adults who are of normal weight and at low risk for obstructive sleep apnea (OSA), according to a study of 5,666 people followed for up to three years.

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Quick, simple test developed to identify patients who will not respond to the painkiller tramadol

 

Paris, France (June 10, 2012) -  French researchers have found a way to identify quickly the 5-10% of patients in whom the commonly used painkiller, tramadol, does not work effectively. A simple blood test can produce a result within a few hours, enabling doctors to switch a non-responding patient on to another painkiller, such as morphine, which will be able to work in these patients.

 

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Aspirin before heart surgery reduces the risk of post-operative acute kidney failure

 

Paris, France (June 10, 2012) -  Aspirin taken for five days before a heart operation can halve the numbers of patients developing post-operative acute kidney failure, according to research presented at the European Anaesthesiology Congress in Paris today (Sunday).

 

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Fixed-dose combination therapies in hypertension offer improved adherence as well as cost savings according to new data

 

Rome, Italy (June 8, 2012) - For patients with hypertension, fixed-dose combination (FDC) therapies offer not only improved patient adherence translating into better blood pressure control but cost savings as well, according to new data presented at a Daiichi Sankyo press briefing in Rome today. The data, based on the Sokol economic model, showed potential yearly cost savings of €1.8 million if 10,000 hypertensive patients in each of the five EU countries (Spain, UK, Italy, Germany and France) were switched from a free dose combination of two hypertension treatments to a respective FDC containing the same compounds.1 The savings were based on improved adherence to treatment translating into better blood pressure control and subsequent reduced risk of hospitalisation and associated medical costs.

 

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Sleepy medical staff run increased risks of accidents driving home after a night shift

 

Paris, France (June 8, 2012) - The drowsiness experienced by medical staff who have been on night duty can make their driving dangerous, French researchers have found. The first study to use simulated driving tests on medical staff returning home after a night shift showed that, under the monotonous driving conditions similar to those experienced on autoroutes (motorways or highways), it was more difficult for them to hold a straight line while driving than it was when they had not been working overnight. They also had greater difficulty in controlling their speed when driving in monotonous conditions.

 

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European Medicines Agency boosts EU transparency with online publication of suspected side effect reports

 

Member States and the Agency release data on medicines in compliance with EudraVigilance access policy

 

London, UK (May 31, 2012) - The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www.adrreports.eu. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency’s continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.

 

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Benefits of hypothermia for infants continue through early childhood

 

NIH study shows increased survival from treatment for oxygen deficiency at birth

 

Bethesda, MD, USA (May 30, 2012) - A treatment to reduce the body temperatures of infants who experience oxygen deficiency at birth has benefits into early childhood, according to a follow-up study by a National Institutes of Health research network.

Children who received the hypothermia treatment as infants were more likely to have survived to ages 6 and 7, when they were evaluated again, than were children who received routine care, the study found. They were no more likely than the routine care group to experience a physical or cognitive impairment, it said. The report appears in the New England Journal of Medicine.

 

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ERA-EDTA Congress 2012

The Gift of Life

 

Darren J. Cawley (Ireland)

 

Paris, France (25. Mai 2012) - I have had CKD (chronic kidney disease) since I was twenty. I was studying for a degree in Sports & fitness Studies in college in England at that time and had no idea I was having a health problem. I was very enthusiastic about sport competing in soccer, rugby, Gaelic football and I also won provincial titles in boxing and handball. But then while studying I started to get lots of headaches and blurred visions. I put off seeing a doctor as long as I could. When I finally did see a doctor, she did not take it seriously, she just sent me to an optician – my exams were coming up and maybe she thought I was trying to get out of them. The optician, however, sent me straight into hospital. There they discovered my blood pressure was so high – it was bursting the blood vessels in my eyes. They did all the tests and a biopsy. A few days later the doctor came to my bedside and said he was very sorry, but I had end-stage renal failure. I did not know what that was all about and therefore I asked him if I was going to die. He assured me I would not but I would be starting on this strange thing called dialysis!

 

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Chronic Kidney Disease (CKD)

The forgotten illness

 

  • Prof. Raymond Vanholder (University Hospital Ghent, Belgium), President of the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA)

 

Paris, France (May 25, 2012) - At least 70 million Europeans (> 10%) have lost more than half of their kidney function, a condition named chronic kidney disease (CKD). Below this threshold, CKD causes a dramatic increase of general and cardiovascular mortality. Survival chances at the start of dialysis, one of the treatment modalities for replacement of severely damaged kidneys, is currently worse than when colon carcinoma are diagnosed. Risk calculations demonstrate that CKD is a negative cardiovascular prognostic factor as such, irrespective of the traditional mortality risks such as cholesterol or blood pressure. CKD should thus be considered a crucial health issue, necessitating specific preventive and therapeutic approaches.

 

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 May 2012

 

London, UK (May 25, 2012) - This page lists the opinions adopted at the May 2012 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

 

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NICE guideline to standardise opioid use in palliative care and address patients' concerns

 

London, UK (May 23, 2012) - A new clinical guideline published today (23 May) by the National Institute for Health and Clinical Excellence (NICE), will help ensure safe and consistent prescribing of opioids as a first-line treatment option to relieve pain for patients receiving palliative care for chronic or incurable illnesses.

 

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Committee for Orphan Medicinal Products (COMP) May 2012 highlights

 

London, UK (May 22, 2012) - During its May 2012 meeting, the Committee for Orphan Medicinal Products (COMP) adopted a total of 16 recommendations for orphan designation. Orphan designation can be granted early in the development process to substances that are intended for diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 people in the European Union (EU) or that would not be developed without incentives.

 

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Blood pressure drugs don't protect against colorectal cancer

 

Heidelberg, Germany (May 14, 2012) - A new study has found that, contrary to current thinking, taking beta blockers that treat high blood pressure does not decrease a person's risk of developing colorectal cancer. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the study also revealed that even long-term use or subtypes of beta blockers showed no reduction of colorectal cancer risk.

 

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How to minimize stroke damage

 

Maywood, Il., USA (May 14, 2012) - Following a stroke, factors as varied as blood sugar, body temperature and position in bed can affect patient outcomes, Loyola University Medical Center researchers report. In a review article in the journal MedLink Neurology, first author Murray Flaster, MD, PhD and colleagues summarize the latest research on caring for ischemic stroke patients. (Most strokes are ischemic, meaning they are caused by blood clots.)

 

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Reducing post-traumatic stress after ICU

 

Stockholm, Sweden (May 13, 2012) - Women are more likely to suffer post-traumatic stress than men after leaving an intensive care unit (ICU), finds a new study published in BioMed Central's open access journal Critical Care. However, psychological and physical 'follow-up' can reduce both this and post-ICU depression.

 

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International Nurses Day 2012: Closing the gap: from evidence to action International Nurses Day 2012

Closing the gap: from evidence to action

 

Geneva, Switzerland (May 12, 2012) - International Nurses Day is celebrated around the world every May 12, the anniversary of Florence Nightingale's birth. The International Council of Nurses commemorates this important day each year with the production and distribution of the International Nurses' Day (IND) Kit. The IND Kit 2012 contains educational and public information materials, for use by nurses everywhere.

 

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FDA issues alert on potential dangers of unproven treatment for multiple sclerosis

 

Silver Spring, MD, USA (Mai 10, 2012) - The U.S. Food and Drug Administration is alerting health care professionals and patients (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm) about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

 

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Researchers Say Urine Dipstick Test is Accurate Predictor of Renal Failure in Sepsis Patients

 

Detroit, Mich., USA (May 10, 2012) – Henry Ford Hospital researchers have found that the presence of excess protein in a common urine test is an effective prognostic marker of acute renal failure in patients with severe sepsis.

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High-risk behaviors for skin cancer common among young adults

 

Half of adults younger than age 30 report being sunburned; indoor tanning rates highest among white women

 

Atlanta, GA, USA (May 10, 2012) - Young adults are increasing their risk for developing skin cancer, according to two studies by the Centers for Disease Control and Prevention and the National Cancer Institute.

One study, of people aged 18-29, found that 50 percent reported at least one sunburn in the past year, despite an increase in protective behaviors such as sunscreen use, seeking shade, and wearing long clothing to the ankles. Another report found that indoor tanning is common among young adults, with the highest rates of indoor tanning among white women aged 18-21 years (32 percent) and 22-25 years (30 percent). Both reports evaluated data from the National Health Interview Survey’s Cancer Control Supplement. They are published in today’s issue of CDC’s Morbidity and Mortality Weekly Report.

 

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European Centre for Disease Prevention and Control (ECDC)

New joint risk assessment on risks to human health of the Schmallenberg virus

 

Stockholm, Sweden (May 8, 2012) - ECDC, in conjunction with the Robert Koch Institute (RKI) in Germany and National Institute of Public Health and the Environment (RIVM) in the Netherlands, has published a new risk assessment on the risks to human health of the Schmallenberg virus.

 

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Researchers unveil new assessment for diagnosing malnutrition

 

A new systematic assessment of malnutrition, created by researchers at Penn State, will aid dietitians and other health care providers in diagnosis and treatment

 

Washington, DC, USA (May 3, 2012) - Up to 50 percent of patients in hospitals and nursing facilities are estimated to be malnourished, according to Gordon Jensen, professor and head of nutritional sciences, Penn State. Although malnutrition is widespread, confusion exists in the clinical community on how to best make this diagnose. Malnourished patients are frequently not identified as such, and those not affected are sometimes thought to be malnourished.

 

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How to get a good night's sleep

Earplugs in the intensive care unit ward off confusion

 

(Mai 3, 2012) - Patients in an intensive care unit (ICU) often become confused or delirious soon after, or within a few days of, admittance to the ICU. New research published in BioMed Central's open access journal Critical Care shows that use of earplugs can result in better sleep (as reported by the patients), lower the incidence of confusion, and delay the onset of cognitive disturbances.

 

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Bladder tests before urinary incontinence surgery in women may be unnecessary

 

NIH-funded study finds pre-operative office visit alone sufficient for comparable outcomes

 

Bethesda, MD, USA (May 2, 2012) - An invasive and costly test commonly done in women before surgery for stress urinary incontinence may not be necessary, according to a study funded by the National Institutes of Health. The study compared results after both a pre-operative check-up in a doctor's office and bladder function tests to results after only the office check-up. Women who had only the office check-up had equally successful outcomes after surgery.

 

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Avastin and Lucentis are equivalent in treating age-related macular degeneration

 

Bethesda, MD, USA (April 30, 2012) - At two years, Avastin (bevacizumab) and Lucentis (ranibizumab injection), two widely used drugs to treat age-related macular degeneration (AMD), improve vision when administered monthly or on an as needed basis, although greater improvements in vision were seen with monthly administration for this common, debilitating eye disease, according to researchers supported by the National Institutes of Health.

 

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Quality of Life as Important as Quantity of Life

Research emphasis on making psychosocial care part of routine cancer care pays off for patients

 

TAMPA, Fla. (April 27, 2012) - Researchers at Moffitt Cancer Center have placed new emphasis on gathering data on cancer patient quality of life during both treatment and survivorship. Their focus is on gathering and using that data to develop interventions to improve the quality of life for patients in treatment and for cancer survivors.

 

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Post-cancer fatigue “overestimated"

 

Sydney, Australia (April 26, 2012) - Despite widespread belief to the contrary, as few as 6 percent of women experience cancer-related persistent fatigue a year after undergoing treatment for breast cancer, a new study has found.

Prolonged and disabling fatigue is a common side-effect of many cancer treatments, with large numbers of women reporting that cancer-related fatigue persists for many months after treatment ends. Some studies put the figure as high as 50 percent.

 

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The Generation X report

Food in the lives of GenXers

 

ANN ARBOR, Mich. (April 26, 2012) Generation X adults prepare an average of 10 meals a week, and eat out or buy fast food an average of three times a week, according to a University of Michigan report that details the role food plays in the lives of Americans born between 1961 and 1981.

 

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Stroke risk high when anti-clotting drugs stopped

 

Dallas, TX, USA (April 25, 2012) - Some patients with irregular heartbeats who are taken off anti-clotting medication face a high risk of stroke or blood clotting within a month, according to new research presented at the American Heart Association's Emerging Science Series webinar.

Patients with certain types of atrial fibrillation, or irregular heartbeat, take these drugs to reduce the risks of clots that could lead to a stroke. Sometimes they are instructed to stop taking the medication temporarily before surgery or permanently because of side effects.

 

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Protecting your brain: 'Use it or lose it'

A new study in Biological Psychiatry examines the underlying biology

 

Philadelphia, PA, USA (April 25, 2012) – The findings of a new study suggest that the protective effects of an active cognitive lifestyle arise through multiple biological pathways.

For some time researchers have been aware of a link between what we do with our brains and the long term risk for dementia. In general, those who are more mentally active or maintain an active cognitive lifestyle throughout their lives are at lower risk.

 

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Intensive kidney dialysis indicates better survival rates than conventional dialysis

 

LONDON, GB (April 25, 2012) – Patients suffering with end-stage renal disease could increase their survival chances by undergoing intensive dialysis at home rather than the conventional dialysis in clinics. A new study by Lawson Health Research Institute shows the potential of more intensive dialysis completed in a home setting.

 

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Choosing the right hospital may save your baby's life

 

Philadelphia, PA, (April 25, 2012) - Choosing the right hospital may make the difference between life and death for very low birth weight infants, according to research led by the University of Pennsylvania School of Nursing and released today in JAMA, The Journal of the American Medical Association.

 

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Blood transfusions still overused and may do more harm than good in some patients

 

Johns Hopkins study shows wide variation in transfusion use in operating rooms

 

Baltimore, Maryland, USA (April 24, 2012) - Citing the lack of clear guidelines for ordering blood transfusions during surgery, Johns Hopkins researchers say a new study confirms there is still wide variation in the use of transfusions and frequent use of transfused blood in patients who don't need it.

 

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Outpatient surgery patients also at risk for dangerous blood clots

 

  • University of Michigan study reveals need for better screening, prevention of venous thromboembolism as outpatient surgery grows
  • Study helps identify who's at risk for blood clots after outpatient surgery

 

ANN ARBOR, Mich., USA (April 23, 2012) - A University of Michigan Health System study examined who’s having outpatient surgery in the U.S. today, and showed 1 in 84 highest-risk patients suffers a dangerous blood clot after surgery. Hospitalized patients are often warned of the possibility of venous thromboembolism, which include blood clots that can form in the veins and travel to the lungs.

 

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Soda consumption increases overall stroke risk

 

Research is the first to examine soda and stroke risk

 

Cleveland, Ohio, USA (April 20, 2012) – Researchers from Cleveland Clinic's Wellness Institute and Harvard University have found that greater consumption of sugar-sweetened and low-calorie sodas is associated with a higher risk of stroke. Conversely, consumption of caffeinated or decaffeinated coffee was associated with a lower risk.

 

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European Medicines Agency gives new advice to better manage risk of adverse effects on the heart with Gilenya

 

London, UK (April 20, 2012) - The European Medicines Agency recommends new advice to healthcare professionals to reduce the risk of adverse effects on the heart associated with the use of the multiple sclerosis (MS) treatment Gilenya (fingolimod).

 

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 April 2012

 

London, UK (April 20, 2012) - This page lists the opinions adopted at the April 2012 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

 

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Study shows decreased vaccine effectiveness of the seasonal influenza vaccine

 

ECDC Director urges to develop more effective vaccines

 

Stockholm Sweden (April 13, 2012) - On 12 April 2012, the Eurosurveillance journal published early estimates of the effectiveness of the 2011/2012 influenza vaccine, showing a rather low protective effect of the vaccine of around 43% in a study across eight European countries. This is about ten percentage points lower than what was found using the same methodology last season (2010/2011).

 

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Risk of suicide and fatal heart attack immediately following a cancer diagnosis

 

Stockholm, Sweden (April 5, 2012) - People who are diagnosed with cancer have a markedly increased risk of suicide and cardiovascular death during the period immediately after being given the diagnosis. This has been shown in a new study from Karolinska Institutet, published in the prestigious scientific journal The New England Journal of Medicine.

 

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