joi, 15 decembrie 2011

HPV DNA Testing Advised For Females Over 30

Editor's Choice
Academic Journal
Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology
Article Date: 15 Dec 2011 - 11:00 PST

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HPV DNA testing is better than cytology alone in preventing cervical cancer or detecting it early on for women over thirty, researchers reported in The Lancet Oncology. The authors explained, after reporting on the POBASCAM trial, that they now have compelling evidence in favour of routine HPV testing in national screening programs.

In an Accompanying Comment, Hormuzd Katki and Nicolas Wentzensen wrote:

"POBASCAM reinforces findings from cohort studies, clinical trials, and routine clinical practice by providing overwhelming evidence of the benefits of inclusion of HPV testing in screening programmes"

Experts already knew that HPV testing is better than cytology at identifying precancerous high-grade cervical lesions. However, before this study, nobody could be sure which method of testing was best over a 5-year screening interval.

Chris Meijer and team from the VU University Medical Centre, Amsterdam, carried out the POBASCAM trial, involving 45,000 females aged between 29 and 56 years. All of them attended routine cervical screening in the Netherlands.

The researchers wanted to find out whether HPV testing was associated with fewer high-grade lesions and cervical cancer during the second round of screening, because the first round had detected and treated the lesions. They also wanted to determine what the best age might be to start HIV testing.

Initially, the participants were selected at random to receive: HPV DNA testing plus cytology, orCytology aloneFive years later, all of them had a second screening which involved both HPV and cytology testing.

The researchers found that: During the first screening - Considerably more cancer precursors were identified through HPV testing compared to cytology aloneDuring the second screening (five years later) - those in the HPV testing group had considerably fewer women had CIN grade 3 or worse lesions and cervical cancer than the ones who had been in the cytology alone groupThe authors explained:

"Implementation of HPV DNA testing in cervical screening leads to earlier detection of clinically relevant CIN grade 2 or worse, which when adequately treated, improves protection against CIN grade 3 or worse and cervical cancer."

Better CIN3+ in the HPV groups was mainly due to better early detection of high-grade lesions caused by HPV16. The authors say their findings indicate that HPV testing will most likely eventually reduce death rates as well as the number of cancer-related illness.

HPV testing does not appear to be linked to over-diagnosing of regressive CIN2+ lesions in younger females either, the authors added. When they combined the data from both screening rounds, the accumulated detection of CIN2+ and CIN3+ were the same among females aged 29-33 and those aged over 33.

The authors wrote:

"Our results . . . lend support to the implementation of HPV DNA testing in programmed cervical screening starting at age 30 years."

The authors of the Accompanying Comment wrote:

"The POBASCAM trial shows that 5 year screening intervals are safe, and that conservative management of HPV-positive women can control excess CIN grade 2 or 3 while preventing cervical cancer. However, how the POBASCAM protocol would perform in other populations that have different baseline cancer rates, compliance, and management infrastructure, is unclear."

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our cervical cancer / hpv vaccine section for the latest news on this subject. "Human papillomavirus testing for the detection of high-grade cervical intraepithelial neoplasia and cancer: final results of the POBASCAM randomised controlled trial"
Dorien C Rijkaart MD a, Johannes Berkhof PhD b, Lawrence Rozendaal MD a, Folkert J van Kemenade MD a, Nicole WJ Bulkmans MD a, Daniëlle AM Heideman PhD a, Prof Gemma G Kenter MD c, Prof Jack Cuzick PhD d, Prof Peter JF Snijders PhD a, Prof Chris JLM Meijer MD
The Lancet Oncology, Early Online Publication, 15 December 2011 doi:10.1016/S1470-2045(11)70296-0 Please use one of the following formats to cite this article in your essay, paper or report:

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Schizophrenia - Single Genetic Changes In Two Genes Raise Risk

Editor's Choice
Academic Journal
Main Category: Schizophrenia
Also Included In: Psychology / Psychiatry;  Genetics
Article Date: 15 Dec 2011 - 8:00 PST

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According to a study by Johns Hopkins investigators published in the Nov. 16 issue of Neuron, the risk of developing schizophrenia may be increased by carrying single DNA letter changes from two different genes.

Researchers have found identifying the causes for psychiatric diseases like autism and schizophrenia difficult as they might be activated by several small genetic alterations. Individually these small genetic alterations may be insufficient to cause any change, but in the right combination may cause psychiatric disease.

Schizophrenia, as well as other major mental disorders, is known to be caused by extreme DNA alterations in the genetic letters of the DISC1 gene. These drastic alterations are rare and do not apply to most of individuals with schizophrenia. DISC1 is considered a starting point for investigating the cause of schizophrenia. Defects in DISC1 together with defects in other genes might contribute to disease.

Guo-li Ming, M.D., Ph.D., professor of neurology and neuroscience and member of the Johns Hopkins Institute for Cell Engineering, explained:

"We studied the function of two proteins known to interact, FEZ1 and DISC1, in cells and animal models, which suggested that these proteins work together in adult brain development. When we looked at the human genetic sequences of DISC1 and FEZ1, we found that a combination of small DNA changes raises risk for schizophrenia."

The team used molecular biology methods to lower the amount of FEZ1 in the new neurons in the adult mouse hippocampus, the researchers then analyzed the cells under a microscope in order to find out if DISC1 and FEZ1 collaborate in adult brain development. The neurons with less FEZ1 were bigger and had longer feelers and looked similar to cells with less DISC1. Neurons use feelers to find and communicate with other nearby neurons. According to the investigators these proteins may be collaborating in neurons in order to control feeler length and cell size. Disruption of this process may cause psychiatric diseases.

In order to see if combinations of single-letter DNA alterations in FEZ1 and DISC1 made individuals more susceptible to schizophrenia, the researchers examined existing cases of the disease and analyzed a large patient database, the Genetic Association Information Network, produced by the National Institutes of Health to identify genome associated diseases. They used statistical methods to analyze 4 different single-letter DNA alterations in the FEZ1 sequence from 1,378 healthy individuals and 1,351 individuals with schizophrenia.

Individually, single-letter DNA alterations in FEZ1 did not contribute to the risk of developing the disease. Although, when they examined these 4 different FEZ1 DNA letter alterations together with a DISC1 single DNA letter alteration already known to slightly increase the risk of schizophrenia, they discovered that one particular FEZ1 DNA alteration combined with the DISC1 alteration dramatically increased the risk of developing the disease by two and half times.

Hongjun Song, Ph.D., professor of neurology and director of the Stem Cell Program at the Institute for Cell Engineering, explained:

"By continuing to examine interactions of key genes involved with disease in cells and correlating the results with patient databases, we can begin to unravel the genetic contributions of psychiatric disorders that previously were a mystery to us,Finding sets of proteins, like FEZ1 and DISC1, that synergistically work together to cause disease will also give us new drug targets to develop new therapies."

Written by Grace Rattue
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7 Great Tips To Help Quit Smoking

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Main Category: Smoking / Quit Smoking
Article Date: 15 Dec 2011 - 0:00 PST

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With New Year fast approaching, even die hard smokers start to give the habit a second thought. Giving up smoking is one of the more popular resolutions for the holiday season, as we think about ways to make positive changes for the coming year.

Giving up smoking can be extremely difficult for people, with bad moods, cravings and that lightheaded feeling propelling people to rush and buy a pack even weeks after they successfully stopped.

However, experts say that smokers should prepare a plan of attack to help them quit, and get over those moments of weakness.

Norman H. Edelman, M.D., chief medical officer of the American Lung Association said :

"Quitting smoking is the single most important step smokers can take to improve their health ... The start of a fresh New Year is a great time for smokers to implement their plan to quit smoking ... and reap the health and financial benefits of a smokefree lifestyle."

The Seven recommendations from the American Lung Association are : Talk to your doctor or pharmacist about the various types of treatments and different over-the-counter and prescription medications that are available to help you quit smoking.Look into the different options available to help smokers quit. Visit www.lung.org/stop-smoking or call 1-800-LUNG-USA (1-800-586-4872) for suggestions.Take time to plan. Pick your quit date a few weeks ahead of time and mark it on the calendar. If you can, pick a day when life's extra stresses are not at their peak, such as after the holidays. Mark a day on the calendar and stick to it. As your quit day approaches, gather the medications and tools you need and map out how you are going to handle the situations that make you want to smoke.Get some exercise every day. Walking is a great way to reduce the stress of quitting. Exercise is proven to not only combat weight gain but also to improve mood and energy levels.Eat a balanced diet, drink lots of water and get plenty of sleep.Ask family, friends and co-workers for their help and support. Having someone to take a walk with or just listen can give a needed boost.You don't have to quit alone. Help is available online and in your community. Consider joining a stop-smoking program like Freedom From Smoking® (http://www.ffsonline.org/) from the American Lung Association.Dr. Edelman said :

"Smokers don't have to go it alone when they attempt to quit smoking ... In fact, research shows that people who develop a support system and use programs like Freedom From Smoking® Online have greater success in quitting for good, compared to those who try to quit "cold turkey.""

American Lung Association holds giving up smoking as it's a public health priority. It began its Freedom From Smoking® group clinic program in 1981, which includes a comprehensive variety of evidence based cessation techniques. The association has helped hundreds of thousands of smokers quit. The American Lung Association recently introduced Freedom From Smoking® Online, a highly successful, self-paced online adaptation of the group clinic that is available 24 hours a day.

As Mark Twain famously said :

To cease smoking is the easiest thing I ever did. I ought to know because I've done it a thousand times.

Written by Rupert Shepherd
Copyright: Medical News Today
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Want To Stop Bed Bug Bites? Don't Shave Off That Body Hair

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Academic Journal
Main Category: Biology / Biochemistry
Also Included In: Dermatology;  Tropical Diseases
Article Date: 15 Dec 2011 - 7:00 PST

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Hairy skin helps stop bed bugs biting, according to new research from the University of Sheffield in the UK. Apparently, not only does the fine hair that covers our bodies help us feel the presence of parasitic insects on our skin, it also acts as a barrier to stop them biting us. The findings of the study appeared in an online before print issue of the Royal Society journal Biology Letters on 14 December.

Although humans seem relatively naked compared to other primates, our bodies are covered in a layer of two types of fine hair. One type is called vellus, which is short and nearly invisible, and the other is called terminal hair which is longer and more visible. The follicles are also quite close together on the skin.

The researchers note there are "relatively few explanations for the evolutionary maintenance of this type of human hair," so they wanted to test the idea that perhaps it acts as a defense against ectoparasites or bed bugs.

First author and Sheffield Zoology graduate Isabelle Dean picked the study as the subject of her honours project, which she carried out under the supervision of co-author Professor Michael Siva-Jothy, of the University´s Department of Animal and Plant Sciences.

For the study they recruited 29 healthy volunteers who had one arm shaved and one arm left with hairs on, and then allowed hungry bed bugs to be placed on the skin of both arms.

The results show that the fine body hair acts to our advantage because it helps us detect the presence of bed bugs in two ways: by increasing the time it takes for the parasite to find a suitable site to start sucking blood, and by helping us feel their presence on our skin.

They also showed that this advantage was greater for those participants who had more layers of hair: the insects took longer to find an ideal feeding site on their arms.

The study helps explain why bed bugs and other parasites such as mosquitoes, midges, ticks, and leeches, seek out the less hairy body sites such as wrists and ankles.

Siva-Jothy explained to the press:

"The hairs have nerves attached to them and provide us with the ability to detect displacement. By forming a barrier and providing detection these hairs prolong search time and make detection more likely because the bug has to spend more time clambering over them."

The authors suggest the findings also help explain why we have lost the thick coat of our primate cousins, but still retained some body hair.

"For example, if you have a heavy coat of long thick hairs it is easier for parasites to hide, even if you can detect them. Our proposal is that we retain the fine covering because it aids detection and if we lost all hair, even the relatively invisible fine hair, our detection ability goes right down," said Siva-Jothy.

Siva-Jothy leads a team that is investigating the biology of blood-sucking insects, how they reproduce and retain immunity. They want to discover new ways to control these parasites, which can help us develop better ways to reduce transmission of insect-borne diseases.

He said men have more body hair than women, a result of their increased testosterone at puberty. But this does not mean women are more likely to be bitten:

"Blood-sucking insects are likely to have been selected to prefer to bite hosts in relatively hairless areas," said Siva- Jothy.

Written by Catharine Paddock PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our biology / biochemistry section for the latest news on this subject. "Human fine body hair enhances ectoparasite detection"; Isabelle Dean and Michael T. Siva-Jothy; Biol. Lett. published online before print 14 December 2011; DOI:10.1098/rsbl.2011.0987; Link to Abstract.
Additional source: University of Sheffield Please use one of the following formats to cite this article in your essay, paper or report:

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Regaining Weight After Losing It Might Harm Menopausal Women

Editor's Choice
Academic Journal
Main Category: Menopause
Also Included In: Women's Health / Gynecology;  Obesity / Weight Loss / Fitness
Article Date: 15 Dec 2011 - 8:00 PST

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According to a study recently published in the American Journal of Clinical Nutrition, older women who lose weight but do not maintain the loss might suffer some negative consequences in their overall health. The National Institute on Aging sponsored the investigation.

Investigators at Wake Forest Baptist Medical Center, demonstrated that within a year, some older women gain a considerable amount of weight back after losing it.

Barbara Nicklas, Ph.D., a gerontologist at the J. Paul Sticht Center on Aging and Rehabilitation at Wake Forest Baptist and lead researcher for the investigation, explained:

"The body composition of some of the women was worse than before their weight loss. When older women lose weight, they also lose lean mass. Most women will gain a lot of the weight back, but the majority of the weight regained is fat."

78 postmenopausal women were analyzed in the study, one year after losing 12% of their body weight by dieting in a completely separate studey. Participants averaged 58 years of age. The team recorded their body composition, including change in body weight, fat and muscle, immediately before and after initial weight loss, and then again 6 and 12 months later. During the first year after initial weight loss no weight loss intervention occurred.

Their was to find out if the composition of body weight regained following intentional weight loss is comparable to the composition of body weight lost.

At the six-month follow-up after the study ended, 53 of 78 (68%) of women regained some weight, while 52 of 68 (76%) of women regained some weight at the 12-month follow-up. 16 women (24%) continues to lose weight after the program, while 11 women (16%) weighed more than they did at baseline at the 12-month follow-up.

75% of women who regained weight gained over 4.4 pounds at the 6-month follow-up. At 12-month follow-up this number increased to 84%. The researchers examined whether lost lean mass from intentional weight loss was recovered in women who regained more weight.

The team discovered that the fat mass in these women was rising to a higher level than was lean mass during the post-intervention period.

During the diet program, 67% of weight loss was fat while 33% was muscle. 81% of the entire weight regained during 12 months of follow up was fat, while 19% was muscle. On average, 26% of fat lost was regained by 12-months after the diet program, while only 6% of muscle lost was gained back.

Nicklas explains:

"Most people will regain their weight after they lose it. Young people tend to regain weight in the proportion that they lost it. But the older women in our study did not appear to be regaining the muscle they lost during initial weight loss in the same way."

Although researchers are unsure what the long term effects of losing muscle mass in middle age and older women are, combined with loss of bone density which is known to occur as individuals age, the loss of muscle may increase their risk of falling, as well as other things.

Nicklas said:

"There are certainly a lot of health benefits to weight loss, if you can keep the weight off. For older women who lose weight, however, it is particularly important that they keep the weight off and continue to eat protein and stay physically active so that, if the weight does come back, it will be regained as muscle instead of fat."

Nicklas warns that study results were restricted to sedentary, abdominally obese, postmenopausal women, and the among younger populations or men the discoveries may differ. "Future studies of weight cycling are needed to determine its effects on muscle strength, quality, and function and body composition in older adults after all weight lost is regained", she said.

The investigators explain:

"Many health complications associated with overweight and obesity are improved with weight loss. However, negative consequences (such as loss of muscle mass and bone density) are also associated with weight loss and are detrimental for older adults, which results in a reluctance to recommend international weight loss in this population. Because lean mass loss in older adults may be associated with the development of adverse health events and disability, it is important to examine whether the benefits of weight loss outweigh the risks in this population."

Written by Grace Rattue
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Sleep Apnea - CPAP Face Mask Improves Overall Cardiovascular Health

Editor's Choice
Academic Journal
Main Category: Sleep / Sleep Disorders / Insomnia
Article Date: 15 Dec 2011 - 8:00 PST

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Patients with obstructive sleep apnea who use a face mask during their slumber hours were found to have significantly improved blood pressure, levels of stomach fat (visceral fat), and cholesterol and blood sugar levels - all factors closely related to metabolic syndrome and heart health, researchers reported in NEJM (New England Journal of Medicine).

As background information, the authors explain that approximately 18 million people in the USA live with obstructive sleep apnea. Many sufferers are unaware of their condition, because they are asleep when the breathing is halted - whoever sleeps with them is generally the first to notice.

Obstructive sleep apnea (British spelling: apnoea), also known as OSA is a disorder of sleep in which the sufferer stops breathing for at least ten seconds while asleep. The throat muscles (soft tissue in the back of the throat) collapse and close, resulting in blocked airways. Each episode of halted breathing is called an apnea. Apnea means without breath.

Patients with sleep apnea may wake up during an apnea, but are rarely aware of their problem - they do not know why they woke up.

Obstruction ventilation apnée sommeil
During an "apnea" the airway becomes blocked

Standard treatment involves a CPAP machine - this includes a mask that is attached to continuous airway pressure. A significant proportion of CPAP machine users stop using them within a year because they are cumbersome devices.

Lead author, Surendra Sharma, from the All India Institute of Medical Sciences in New Delhi, said:

"These patients need to be properly counseled for regular use of CPAP machines. In a real- life situation, the machine will be used for a longer period and more benefits will be observed."

Pharmaceutical giant, Pfizer Inc. funded the trial. Clinical trials government number NCT00694616. The company does not make or sell sleep apnea devices.

CPAPmask
A CPAP mask (Source: Philips)

Obstructive sleep apnea patients were randomly selected to have therapeutic CPAP followed by placebo CPAP (sham CPAP). This was followed by a 1-month washout period, after which the groups swapped (the placebo ones used the mask for three months, while the other group used the placebo).

At the beginning and end of each three-month intervention, the researchers took measurements of the participants' blood pressure, insulin resistance, fasting blood sugar (glucose) levels, fasting blood lipid profile, visceral fat, carotid intima-media thickness, and glycated hemoglobin levels.

The authors reported the following results on 86 patients who completed the trial; 87% of whom had metabolic syndrome: Those on the CPAP treatment had considerable improvements in the following readings, compared to those on sham CPAP in the following:

- Systolic blood pressure
- Diastolic blood pressure
- Serum total cholesterol
- Non-high-density lipoprotein cholesterol
- Low-density lipoprotein cholesterol
- Triglycerides

Metabolic syndrome reversal was found in 11 of 86 patients on CPAP therapy, compared to 1 of 86 on sham CPAP therapyThe authors concluded in an Abstract in the journal:
"In patients with moderate-to-severe obstructive sleep apnea syndrome, 3 months of CPAP therapy lowers blood pressure and partially reverses metabolic abnormalities."

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our sleep / sleep disorders / insomnia section for the latest news on this subject. "CPAP for the Metabolic Syndrome in Patients with Obstructive Sleep Apnea"
Surendra K. Sharma, M.D., Ph.D., Swastik Agrawal, M.D., Deepak Damodaran, M.D., Vishnubhatla Sreenivas, Ph.D., Tamilarasu Kadhiravan, M.D., Ramakrishnan Lakshmy, Ph.D., Priya Jagia, M.D., and Atin Kumar, M.D.
N Engl J Med 2011; 365:2277-2286December 15, 2011 Please use one of the following formats to cite this article in your essay, paper or report:

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Christian Nordqvist. "Sleep Apnea - CPAP Face Mask Improves Overall Cardiovascular Health." Medical News Today. MediLexicon, Intl., 15 Dec. 2011. Web.
15 Dec. 2011. APA

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Epilepsy In Children - Adverse Events of Invasive EEG, Study

Editor's Choice
Academic Journal
Main Category: Epilepsy
Also Included In: Pediatrics / Children's Health
Article Date: 15 Dec 2011 - 8:00 PST

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According to an investigation led by Dr. Thomas Blauwblomme and his team of Great Ormond Street Hospital, London, in the December issue of Operative Neurosurgery, a quarterly supplement to Neurosurgery, official journal of the Congress of Neurological Surgeons, almost half of all children suffering with severe epilepsy who receive invasive electroencephalography (EEG) recordings, experience some type of side effect.

The study reveals that no other method can obtain the vital information needed for planning complicated epilepsy procedures that EEG recordings provide.

The team examined side effects associated to invasive EEG recordings in 95 children between 1994 and 2009. The majority of epilepsy cases in children can be controlled with drugs, although surgery is highly effective when medications are not successful. In order to plan the surgery, surgeons need accurate information on the region of the brain which controls seizure activity.

EEG recordings are required in some complex cases to gather this information. EEG recordings use electrodes placed on the brain surface or into the brain tissues. The novel investigation set out to obtain detailed information regarding the risks connected with EEG recordings. In the study the children had extremely severe epilepsy, averaging over 200 seizures per month. The average age of the children was around 11 years.

The researchers discovered that in total, nearly half of the children (49%) experienced some form of side effect. Approximately 30% of children had more severe events that increased the time they were hospitalized. None of the adverse events caused permanent neurological damage or death.

Side effects included: Infection - 15%Brain swelling - 6%Bleeding - 17%Cerebrospinal fluid leakage - 11%In most of the children who experienced bleeding and in some of those with infection, further surgery was required. After surgeons began using a novel type of graft material in 2002, no further problems with CSF leakage were reported.

Brain swelling was more prevalent among older children, while the complication rate was lower (20%) in children under the age of 2. Length of EEG recording, or if recordings used electrodes on the surface or implanted in the brain, was not associated with the risk of side effects.

In 69% of patients, EEG recordings successfully recorded the location of the seizure zone in brain activity during seizures. In total, 89% of children received surgery for epilepsy. The success rate of surgery was highest the more precise the invasive EEG recordings were in localizing the seizure zone.

The investigation notes the considerable risk of side effects associated to EEG recordings in children with the condition. Although the EEG is invasive, it provides "invaluable information" for locating the source of seizure activity within the brain.

The team highlight the relatively low risk of adverse events in children under 2 years - which adds to recent evidence backing early surgery for children with epilepsy that doesn't respond to drugs.

Dr. Blauwblomme and coauthors explain:

"For all children undergoing invasive EEG recordings, parents should receive detailed information on the risks and benefits of the procedure."

In addition, the researchers stress that the surgery should be performed at a treatment center with experience in invasive EEG recording, with cautious planning prior to the procedure and close patient follow-up afterward.

Written by Grace Rattue
Copyright: Medical News Today
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Visit our epilepsy section for the latest news on this subject. Operative Neurosurgery, published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health. Please use one of the following formats to cite this article in your essay, paper or report:

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European Commission Grants Marketing Authorization For Astellas Pharma Europe Ltd.'s DIFICLIR™ For Use In The EU

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Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: GastroIntestinal / Gastroenterology;  Regulatory Affairs / Drug Approvals
Article Date: 14 Dec 2011 - 9:00 PST

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The European Commission has granted a marketing authorization for DIFICLIR™ (fidaxomicin) tablets to treat adults with Clostridium difficile infections (CDI), also known as C. difficile-associated diarrhea (CDAD), in the European Union. The announcement was made by Astellas Pharma Europe Ltd., a European subsidiary of Tokyo-based Astellas Pharma Inc. and Optimer Pharmaceuticals, Inc.

Ken Jones, President and CEO of Astellas Pharma Europe Ltd commented:

"Treatment for CDI has changed little in the past 20 years, even though the disease has a major impact on patients' health and quality of life and is potentially fatal. The EU approval of DIFICLIR, a novel macrocyclic antibiotic that specifically targets C. difficile bacteria, is therefore an important advance for patients suffering from CDI."

CDI, one of the most common causes of diarrhea linked to antibiotics, can lead to bowel surgery and even death in severe cases. In hospitals, nursing homes and other long-term care facilities, CDI represents a substantial problem, with recurrence rates of up to 25% in patients within 30 days of initial treatment with current therapies.

DIFICLIR's EU approval was granted based on two Phase III clinical studies, which compared the efficacy and safety of 400mg/day oral DIFICLIR with the only approved treatment of CDI, 500mg/day oral vancomycin, for a 10-day duration of treatment in adults with CDI in Europe and North America.

DIFICLIRs primary endpoint was determined as non-inferiority to vancomycin, which was met by achieving clinical cure in similar proportions of participants in a comparison of both drugs. In both trials, researchers determined clinical cure as patients who no longer needed further CDI therapy two days after completion of study medication.

The researchers also observed potential advantages of DIFICLIR over vancomycin; DIFICLIR reduced the rate of CDI recurrence substantially in comparison with vancomycin. Patients who received DIFICLIR had a substantially higher chance of their diarrhea to resolve without recurrence within 30 days of completing the therapy compared with those patients who received vancomycin. The researchers also reported that the disruption of the normal intestinal flora was minimal in patients treated with DIFICLIR and that the drug caused only few systemic adverse events compared with vancomycin.

Professor Mark Wilcox, Professor of Medical Microbiology at the Leeds Teaching Hospitals & University of Leeds commented:

"The high rate of disease recurrence is the greatest limitation of current treatments for CDI. The significant reduction in disease recurrence by DIFICLIR compared with vancomycin is a key step to reducing the morbidity associated with CDI, and this new treatment option is a welcome addition that has the potential to improve the patient experience".

DIFICLIR, known as DIFICID™ in the U.S. was discovered and developed by Optimer and gained the US FDA approval (US Food and Drug Administration in May 2011 to treat CDAD in adults aged 18 years and above. Optimer's exclusive licensee for DIFICLIRs development and commercialization in Europe, the Middle East, Africa and the Commonwealth of Independent States is a company called Astellas Pharma Europe Ltd.

CDI is caused by an infection of the internal lining of the colon through C. difficile bacteria and is a serious disease. The bacteria produce toxins, which cause inflammation of the colon as well as diarrhea. In severe cases, CDI can lead to death. Patients commonly develop CDI after using broad-spectrum antibiotics. These disrupt the normal gastrointestinal flora and enable C. difficile bacteria to flourish. Patients aged 65 years or older are at a particularly high risk of developing or recurring CDI.

CDI incidents are a substantial financial burden to healthcare systems, particularly in cases where extended hospitalization is required.

Written by Petra Rattue


Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our infectious diseases / bacteria / viruses section for the latest news on this subject. Source: Astellas Pharma Europe Ltd. Please use one of the following formats to cite this article in your essay, paper or report:

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Petra Rattue. "European Commission Grants Marketing Authorization For Astellas Pharma Europe Ltd.'s DIFICLIR™ For Use In The EU." Medical News Today. MediLexicon, Intl., 14 Dec. 2011. Web.
15 Dec. 2011. APA

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