viernes, 28 de febrero de 2014

Study Sees No Evidence Linking Diabetes Drugs With Pancreatic Cancer: MedlinePlus

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Study Sees No Evidence Linking Diabetes Drugs With Pancreatic Cancer

But FDA assessment calls for further look at injectable type-2 treatments

Wednesday, February 26, 2014

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WEDNESDAY, Feb. 26, 2014 (HealthDay News) -- There's no firm evidence that the type 2 diabetes medications known as incretin-based drugs cause pancreatitis or pancreatic cancer, U.S. and European health officials say.

But it's too early to say there's definitely no link between the injectable drugs and pancreatitis or pancreatic cancer, according to the safety assessment by the U.S. Food and Drug Administration (FDA) and its counterpart overseas, the European Medicines Agency (EMA).

"Both agencies agree that assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer, as expressed recently in the scientific literature and in the media, are inconsistent with the current data," states the report in the Feb. 27 issue of the New England Journal of Medicine. "The FDA and the EMA have not reached a final conclusion at this time regarding such a causal relationship."

Incretin-based drugs are among the newest medications available to treat type 2 diabetes, a chronic condition characterized by high levels of sugar in the blood. Nearly 26 million people in the United States and 33 million in the European Union have diabetes, and type 2 is by far the most common type.

There are two types of incretin-based medications: GLP-1 agonists and DPP-4 inhibitors.

Examples of GLP-1 agonists include exenatide (Byetta) and liraglutide (Victoza). Exenatide, the first incretin-based drug approved by the FDA, was approved in 2005.

Examples of DPP-4 inhibitors include sitagliptin (Januvia) and saxagliptin (Onglyza). Sitagliptin was the first DPP-4 inhibitor approved by the FDA, receiving consent in 2006.

GLP-1 agonists slow stomach emptying and increase insulin secretion, which help keep blood sugar lower. They also suppress secretion of a hormone that raises blood sugar levels.

DPP-4 inhibitors slow the absorption of carbohydrates through the stomach, help increase insulin levels and suppress the blood-sugar elevating hormone, said Dr. Robert Ratner, chief scientific and medical officer at the American Diabetes Association.

One of the challenges in diabetes control is keeping blood sugar levels low while avoiding hypoglycemia, or dangerously low blood sugar. "The clinical data suggests these are very [effective] drugs that don't cause hypoglycemia," said Ratner.

Also, unlike some diabetes drugs that promote harmful weight gain, GLP-1 agonists cause weight loss, while DPP-4 inhibitors are weight neutral. Weight loss often improves diabetes.

After the drugs received approval, the FDA and EMA received reports of pancreatitis (inflammation of the pancreas) and pancreatic cancer in people taking the drugs.

"There was a disproportionate reporting of these adverse events detected," said the lead author of the safety assessment, Dr. Amy Egan, deputy director for safety in the FDA's division of metabolism and endocrinology products.

However, the risks of pancreatitis and pancreatic cancer are already elevated in people with type 2 diabetes, said Egan. In addition, because they can aid weight loss, GLP-1 agonists are often prescribed to heavier people. Obesity is also a known risk factor for pancreatitis disease, Egan noted.

Because these and other factors can confound findings of an association in people taking the drugs, the FDA and EMA conducted extensive reviews of the available data from animals. The FDA reviewed 250 toxicology studies conducted in nearly 18,000 healthy animals. The EMA conducted a similar review. Neither agency found an increased risk of pancreatitis related to incretin-based drugs.

And neither agency found any drug-induced pancreatic tumors in rats and mice treated for two years (their adult life span) with the drugs.

Both agencies also reviewed data from hundreds of trials in humans and found no convincing link. Two large clinical trials are currently underway, and experts hope they will provide a more definitive answer.

So what's a person taking these medications supposed to do in the meantime?

"In June, the American Diabetes Association, the European Association for the Study of Diabetes and the International Diabetes Federation released a statement recommending that no patient should discontinue their medication without consulting their doctor first. And patients taking these medications should be informed of all the possible risks and benefits so they can make the best decision for themselves," said Ratner.

The FDA and EMA have further validated that position, Ratner said. "We need to continue to be vigilant, but as of now, there doesn't seem to be any reason to change our approach," he noted.

The FDA concluded that the current labeling for these drugs contains the necessary information and isn't recommending any labeling changes at this point.

SOURCES: Amy Egan, M.D., M.P.H., deputy director for safety, division of metabolism and endocrinology products, and acting deputy director, Center for Drug Evaluation's Office of Drug Evaluation III, U.S. Food and Drug Administration; Robert Ratner, M.D., chief scientific and medical officer, American Diabetes Association; Feb. 27, 2014, New England Journal of Medicine

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Common Strep Bacteria May Be Morphing Into 'Superbug': MedlinePlus

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Common Strep Bacteria May Be Morphing Into 'Superbug'

Doctors report on antibiotic resistance in two unrelated cases

Wednesday, February 26, 2014

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WEDNESDAY, Feb. 26, 2014 (HealthDay News) -- Doctors warn that a garden-variety type of bacteria, which is normally present in the human intestinal tract, may be morphing into a tough-to-treat superbug.

A new report from physicians in New York, New Mexico and the U.S. Centers for Disease Control and Prevention describes the cases of two patients with group B streptococcus infections that turned out to be resistant to vancomycin, often considered an antibiotic of last resort.

In the past, group B strep infections were relatively easy to subdue because the bacteria were vulnerable to penicillin and other common antibiotics.

"Every time there is information about another genus, species or strain of bacteria showing resistance to yet another class of antibiotic, that's bad news because it means that yet another antibiotic weapon is about to become useless," said Elizabeth Scott, co-director for the Center for Hygiene and Health in Home and Community at Simmons College in Boston.

In the new cases, reported in a letter in the Feb. 27 issue of the New England Journal of Medicine, both patients were infected by strains of strep B that had acquired a gene that gives protection against vancomycin.

Doctors usually reserve vancomycin for use in cases when other antibiotics have failed.

"Although the report is for only two cases, they were unrelated, indicating that the bacterial genetic mutation is popping up in different locations or spreading rapidly," said Scott, who was not involved in the research.

Further testing showed that beyond vancomycin, the bacteria were impervious to other classes of antibiotics as well.

Strep B bacteria are a leading cause of meningitis and bloodstream infections. About one in four pregnant women carries the bacteria, which can cause life-threatening infections in newborns. Strep B is also a common cause of joint and skin infections in the elderly and those with compromised immune systems, according to the CDC.

Dr. Connie Park, an infectious disease fellow at Montefiore Medical Center in New York City, took care of the New York patient. She was an 82-year-old woman with diabetes who developed a step B infection of her ankle joint after surgery to repair a fracture.

The infection eventually spread to her bloodstream. After more surgery to drain and clean the wound and a change of antibiotics -- from vancomycin to another strong drug called linezolid -- she eventually recovered.

The second patient, a New Mexico man, 48, who was on dialysis because of kidney disease, developed a bloodstream infection from strep B that spread from a skin wound. When doctors cultured the bacteria, they discovered it was resistant to vancomycin. He, too, recovered from his infection.

The two patients had no apparent connection, suggesting that resistance arose separately.

"I think we don't know yet how remarkable something like this will be. I think it is another commentary on how our antibiotic resistance is evolving. This could be a problem in the future if we run out of more options than we have now," Park said.

Another expert, who was not involved in the treatment of either patient, agreed that the cases are important warnings to other physicians.

"These bacteria were multidrug-resistant, and two separate events occurred," said Dr. Stuart Levy, director of the center of adaptation genetics and drug resistance at Tufts University School of Medicine in Boston. "It shows this could be occurring elsewhere, and alerts you that the drug of last resort, vancomycin, is clearly losing its power."

Levy stressed the importance of the findings. "Infectious disease specialists need to know this could be cropping up and may be a reason for the failure of treatment," he said.

SOURCES: Connie Park, infectious disease fellow, Montefiore Medical Center, New York City; Elizabeth Scott, Ph.D., co-director, Center for Hygiene and Health in Home and Community, Simmons College in Boston; Stuart Levy, M.D., director, Center of Adaptation Genetics and Drug Resistance, Tufts University School of Medicine, Boston; Feb. 27, 2014, New England Journal of Medicine

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Are Kids Born to Older Dads at Risk for Mental Health Woes?: MedlinePlus

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Are Kids Born to Older Dads at Risk for Mental Health Woes?

Large Swedish study found higher rates of autism, ADHD and other disorders, but expert says the risk is small

Wednesday, February 26, 2014

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WEDNESDAY, Feb. 26, 2014 (HealthDay News) -- Children born to older fathers are at higher risk for various psychiatric and learning problems than once thought, a large new study suggests.

Among more than 2 million children born in Sweden, researchers found that those born to fathers aged 45 and older were more prone to problems such as autism, attention-deficit/hyperactivity disorder (ADHD), bipolar disorder, schizophrenia, attempted suicide and drug abuse. Other problems include poor grades in school and low IQ scores.

"We were shocked by the findings," lead researcher Brian D'Onofrio, an associate professor in the department of psychological and brain sciences at Indiana University, said in a university news release. "The specific associations with paternal age were much, much larger than in previous studies."

D'Onofrio, however, doesn't want people to think that all or even most children of older fathers will have these problems.

"We are not saying that all children born to older fathers will have psychiatric or educational problems," D'Onofrio said in an interview.

"Rather, the study found that advancing paternal age at childbearing is associated with greater risk for serious problems," he said. "As such, the study adds to a growing body of research that suggests families, doctors and society as a whole must consider both the pros and cons of delaying childbearing."

While the new study uncovered an association between older fathers and increased risk of mental health and learning problems in their children, it didn't prove cause-and-effect.

And a child behavioral specialist not involved with the study said the findings should be kept in perspective because the actual risk of having a child with any of these problems is small.

The new report was published in the Feb. 26 online edition of JAMA Psychiatry.

For the study, D'Onofrio and colleagues collected data on about 2.6 million children born in Sweden from 1973 to 2001.

Compared with a child born to a 24-year-old father, a child born to a 45-year-old father was 3.5 times more likely to have autism and 13 times more likely to have ADHD, the study found.

In addition, children born to 45-year-old fathers were twice as likely to have a psychotic disorder, 25 times more likely to have bipolar disorder and about 2.5 times more likely to have suicidal behavior or a drug abuse problem, the authors noted.

Over the past 40 years, the average age when men and women start a family has been increasing. In the United States, the average age for mothers having their first baby has gone up about four years, from 21.5 to 25.4 years old, the news release noted. For men the average increase is three years.

An expert not involved with the study said parents shouldn't overreact to the findings.

"There have been studies before that have shown an association between advanced parental age and developmental problems, particularly autism," said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at the Steven and Alexandra Cohen Children's Medical Center of New York.

"Parents need to remember that many of the conditions the researchers looked at are very uncommon, and even if you double the risk, the likelihood is you are not going to have a child affected with any of these conditions," he said.

Other studies have shown that women who are older when they first have children also run the risk of having kids with similar problems, such as autism, Adesman said.

Although the reasons for this risk are not known, Adesman said that when a female child is born she has all the eggs she will ever have and it's possible that older eggs are more prone to genetic changes as women delay childbirth. The same may also be true of the sperm that older men produce, he said.

"Age seems to have some adverse impact in terms of increasing the risk of children having developmental problems. But age is just one of many factors that couples need to consider when planning a family," Adesman said.

Although these problems were found to happen more often with older dads, there is no specific age when the risk starts to increase, the researchers noted.

SOURCES: Brian D'Onofrio, Ph.D., associate professor, department of psychological and brain sciences, Indiana University, Bloomington, Ind.; Andrew Adesman, M.D., chief, developmental and behavioral pediatrics, Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, N.Y.; Feb. 26, 2014, news release, Indiana University; Feb. 26, 2014, JAMA Psychiatry, online

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Teens Who Indoor Tan Often Take Other Health Risks: Survey: MedlinePlus

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Teens Who Indoor Tan Often Take Other Health Risks: Survey

CDC study tied practice to binge drinking, drug use and extreme weight control measures

Wednesday, February 26, 2014

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WEDNESDAY, Feb. 26, 2014 (HealthDay News) -- American teens who indulge in indoor tanning -- long linked to skin cancer risk -- are also more likely to adopt other bad habits, a new federal survey of high school students finds.

"We saw that indoor tanning is associated with a number of other risky behaviors, such as illegal drug use, binge drinking and smoking," said study lead author Gery Guy Jr.

"We also found that teens who tan indoors are likely to be very concerned about their appearance," Guy added. "That sometimes leads to positive behaviors, like engaging in sports and eating healthy foods. But it also leads to unhealthy behaviors, such as steroid use or extreme weight control."

Guy is a health economist in the division of cancer prevention and control with the National Center for Chronic Disease Prevention and Health Promotion, part of the U.S. Centers for Disease Control and Prevention. The study findings appear online Feb. 26 in JAMA Dermatology.

The study authors noted that between 1994 and 2006, the overall incidence of non-melanoma skin cancer in the United States doubled. Among American teens, melanoma has become one of the most frequently diagnosed cancers.

Previous research suggests that melanoma risk rises by nearly 60 percent among those who use indoor tanning facilities before the age of 35. The World Health Organization has classified indoor tanning booths as cancer-causing devices. And the CDC recommends that people of all ages refrain from the practice to prevent cancer and premature aging.

To gain insight into current tanning habits among teens, the CDC analyzed data drawn from the Youth Risk Behavior Surveys, which every year are administered to a national sample representing roughly 15.5 million American high school students.

The new study focused on the responses of nearly 26,000 students, starting as young as 14, who had responded to questions about indoor tanning in 2009 and 2011.

Despite strong public health warnings regarding the dangers of indoor tanning, the practice remains popular, the research revealed.

Overall, a little more than 13 percent of the high school students said they had tanned indoors in 2011. Of these, more than half said they did so 10 or more times over the previous year.

But when broken down by gender, the situation looked different. Indoor tanning among all girls seemed to be on a downward trend, dipping from about 26 percent in 2009 to about 21 percent in 2011. However, nearly a third of females aged 18 and up said they visited tanning beds in 2011, as did more than 29 percent of white girls.

For males, indoor tanning was most popular among those 18 and up, and also among white boys, the results showed.

Regional differences were also noted. For example, about 27 percent of those surveyed in the South said they tanned indoors, compared with about 17 percent in the West.

Those who tanned indoors were more likely to engage in some healthy practices that might be classified as appearance related, such as playing sports and eating more fruits and vegetables.

On the other hand, teens who tanned indoors were also more likely to engage in many problematic behaviors.

Among indoor tanners, boys were more likely to take steroids without a prescription, smoke or attempt suicide. Girls were more likely to take illegal drugs, or have multiple sexual partners. And both boys and girls were more likely to maintain unhealthy weight-control habits or binge drink, the study found.

"Of course the emergence of risky behavior during adolescence is not a surprise," Guy said. "But as this study shows that many risky behaviors are associated with each other, it highlights the importance of taking comprehensive approaches to indoor tanning prevention."

That means "trying to incorporate our specific concerns about indoor tanning into more general messaging about many of these other risky behaviors as well," Guy explained.

Dr. Darrell Rigel, a clinical professor of dermatology at New York University Medical Center in New York City, said that approach has promise.

"But it's a challenge," Rigel said. "Clearly there is no such thing as a safe tan. And the more you do it at a younger age the worse it is for your health over time. It's very analogous to cigarette smoking. But most teens feel they are immortal, and that nothing bad is going to happen to them. Unfortunately, it will."

The new study "just reinforces the fact that despite everything we've tried -- and we've tried all sorts of different messages over the years -- we still haven't hit on the right approach," Rigel said. "But I totally agree that putting anti-tanning messages into a broader context makes sense."

SOURCES: Gery P. Guy Jr., Ph.D., health economist, division of cancer prevention and control, National Center for Chronic Disease Prevention and Health Promotion, U.S. Centers for Disease Control and Prevention; Darrell Rigel, M.D., clinical professor, dermatology, New York University Medical Center, New York City; Feb. 26, 2014, JAMA Dermatology, online

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Quick Vision Test May Help Spot Concussions on Sidelines: MedlinePlus

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Quick Vision Test May Help Spot Concussions on Sidelines

Combined with two other simple screenings, all cases of head injury were caught, researchers report

Wednesday, February 26, 2014

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WEDNESDAY, Feb. 26, 2014 (HealthDay News) -- A simple vision test given on the sidelines can help identify athletes who've suffered a concussion, a new study finds.

Researchers found that the test -- known as the King-Devick, or K-D -- was able to detect 79 percent of concussions among college athletes who were followed over a season. When the results were combined with those of two other screening tests, all of the concussions were caught.

The findings were released Wednesday by the American Academy of Neurology (AAN), ahead of its annual meeting this spring.

Experts said the study bolsters evidence that the K-D is a reliable way to help spot athletes' head injuries -- though the test, by itself, is not enough.

"People have been looking for quick, on-the-field screening tests," said Steven Broglio, an athletic trainer and director of the NeuroSport Research Laboratory at the University of Michigan in Ann Arbor.

The new findings suggest the K-D is "one option," said Broglio, who was not involved in the study. "But it's not definitive, and you wouldn't want to rely on this alone," he added.

The K-D takes a minute or two, and it can be given by an athletic trainer, coach or even a parent right on the sidelines. It requires test-takers to read a few rows of single-digit numbers that are unevenly spaced, as quickly and accurately as possible. If they are slower to finish than they were on their "baseline" test -- taken before the season starts -- that's a potential sign of a concussion.

There are other sideline screening tests already in use, including ones that test balance and short-term memory.

But the K-D test "fills a gap" by looking for vision-related problems, explained study co-author Dr. Steven Galleta, chair of neurology at NYU Langone Medical Center in New York City.

Concussions can cause a wide range of symptoms that are often subtle at first. Symptoms like worsening headache, dizziness, nausea, fatigue and confusion might not become obvious until hours after the knock to the head. Plus, even when athletes are suffering immediate problems, they might not tell anyone.

"Some athletes don't recognize the symptoms, and some try to hide them because they want to stay in the game," Galleta said.

A number of professional groups, such as the AAN and National Athletic Trainers' Association, say that athletes who've potentially suffered a concussion should be taken out of the game or practice immediately.

For the new study, Galleta and his colleagues followed 217 athletes at the University of Florida -- including male football players, and female lacrosse and soccer players.

At the start of the season, they all took the K-D, as well as two other sideline screening tests: the BESS, which measures balance; and the SAC, which measures abilities such as short-term memory (asking the athlete to memorize and recall five words) and "orientation" (asking the player to name the day, month and year).

Over one season, 30 athletes were diagnosed with a concussion. And when the researchers looked at their sideline test results, 79 percent showed slower times on the K-D, compared with their pre-season performance. Adding the SAC and BESS results improved the detection rate to 100 percent.

Part of the appeal of the K-D is its simplicity; it can be used by "laypeople," including coaches and parents, Galleta noted. That raises the question of whether it can be used in high school and youth sports -- where there is often no athletic trainer or other health professional on the sidelines.

Studies are currently testing the K-D's usefulness for kids as young as 6, said Dr. Laura Balcer, a professor of neurology at NYU Langone who also worked on the study.

But regardless of what the K-D or other screening test shows on the sidelines, Balcer said there is "no substitute" for parents' judgment. If they notice any potential signs of concussion after a game or practice, they should take their child to the doctor immediately, she said.

"Parents know their kids best," Broglio agreed. "If you notice a change in their behavior, it's probably worth it to have them evaluated."

According to the U.S. Centers for Disease Control and Prevention, more than 173,000 U.S. children and teens land in the ER each year because of a concussion suffered during sports or recreational activities, like bike riding.

But the overall number -- including kids not seen in the ER -- is probably much larger: the CDC estimates that across age groups, up to 3.8 million Americans sustain a sports-related concussion each year.

In general, experts say kids with concussions should be symptom-free and get a doctor's OK before returning to sports. The biggest concern is that, if they sustain another knock to the head while they are still recovering from the first concussion, they could suffer so-called second-impact syndrome -- which can cause potentially fatal bleeding inside the skull and brain swelling.

The data and conclusions of research presented at meetings should be viewed as preliminary until published in a peer-reviewed journal.

SOURCES: Laura Balcer, M.D., professor, vice chair, neurology, and Steven Galleta, M.D., professor, chair, neurology, NYU Langone Medical Center, New York City; Steven Broglio, Ph.D., ATC, director, NeuroSport Research Laboratory, University of Michigan, Ann Arbor; American Academy of Neurology, news release, Feb. 26, 2014

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Kids' Body Image Shaped by Parents, Expert Says: MedlinePlus

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Kids' Body Image Shaped by Parents, Expert Says

Doctor offers tips for helping children develop healthy eating habits, self-image

By Robert Preidt

Wednesday, February 26, 2014

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WEDNESDAY, Feb. 26, 2014 (HealthDay News) -- Parents play a crucial role in helping children develop a positive body image and healthy eating habits, an expert says.

"Sometimes we parents forgot how important our words, thoughts, and feelings are in the lives of our kids," Dr. Aaron Krasner, director of the adolescent transitional living program at Silver Hill Hospital in New Canaan, Conn., said in a news release.

"'We make the weather in our homes,' a wiser-than-me parent once told me," Krasner added. "I think it's true -- especially when it comes to eating behaviors and body image. As parents, we must be mindful of our own relationship with our bodies, how we eat, and the potential impact on our kids."

He noted that 80 percent of 10-year-old children are afraid of being fat, according to the National Eating Disorders Association.

To mark National Eating Disorders Week (Feb. 23 to March 1), Krasner outlined the following ways that parents can help their children:

Don't criticize yourself or others about weight or shape in front of youngsters.
Don't make negative comments about food, such as "I can't eat potatoes because they're carbs." Instead, teach children the importance of good nutrition and exercise without mentioning weight.
Praise children on their talents and achievements.
Explain to youngsters that weight gain and changes in body shape are a natural part of the growing process.
Talk to children about what they see in the media and remind them of things such as that only 5 percent of American women have the so-called "ideal" body type portrayed in ads.

"At the end of the day, parents are the most influential role models in a child's life, so be mindful of your words and actions. They may be listening when you least expect it," Krasner said.

SOURCE: Aaron Krasner, M.D., director, adolescent transitional living program, Silver Hill Hospital, New Canaan, Conn., news release, February 2014

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