Health News, Wellness, and Medical Information

April 29, 2010

Early EKG Seems to Improve Odds After Heart Attack

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Researchers report that people with chest pain who are given an electrocardiogram by paramedics before reaching the hospital don’t wait as long to receive treatment to open their arteries.

They often were able to bypass the emergency room and go directly to the cardiac catheterization laboratory for treatment with what’s commonly known as an angioplasty, the study found.

They were treated 60 minutes, on average, after reaching the hospital, compared with 91 minutes for people who did not have an EKG before arriving at the hospital. The findings were published in the January issue of Catheterization and Cardiovascular Interventions.

Research has shown that rapid angioplasty treatment reduces the chances of dying within the next year.

For the study, the researchers examined medical records for cardiac patients taken to three hospitals in Southeast Michigan from 2003 to 2008. When EKGs were done outside of a hospital, data were transmitted to the hospital before patients arrived so doctors could prepare.

Of those who did not have an EKG done before arrival, 2 percent (seven of 241 patients) died in the hospital. None of the 108 patients who were given pre-arrival EKGs died in the hospital, the study reported.

SOURCE: Wiley-Blackwell

April 24, 2010

Discovery Links Genes to Pancreatic Cancer

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Researchers have identified four regions of the human genome that predict a heightened risk of pancreatic cancer as a result of what they describe as the biggest-ever sweep of the genome for genes related to the disease.

Though some of the locations had been linked to other cancers, the discovery of others apparently surprised the researchers.

“This lets us go places we had never thought of before,” said senior study author Dr. Stephen Chanock, chief of the laboratory of translational genomics at the U.S. National Cancer Institute.

However, he cautioned that though the regions “are conclusively associated with the risk of developing pancreatic cancer, it doesn’t mean if you have a variation in that region you’re going to get pancreatic cancer.”

It simply means risk is increased, and, more than likely, environmental factors would have to come into play to complete the picture, he explained.

The findings were reported online Jan. 24 in Nature Genetics.

Pancreatic cancer has an extremely grim prognosis, with only 5 percent of people still alive five years after detection.

“Pancreatic cancer is often diagnosed at a very late stage, and that’s partly due to anatomical location,” Chanock said. “The disease can fester and grow for extended periods of time before it impinges on a vital structure that produces symptoms, and we have not developed sufficiently good ways to identify people at risk with tests.”

Smoking, a history of diabetes and weight problems all can contribute to risk, as can a family history of the disease, although family clusters account for less than 5 percent to 10 percent of all pancreatic cancers, he added.

But only recently have scientists begun to unravel the myriad genetic factors that might trigger the disease.

After analyzing genes in close to 4,000 people with pancreatic cancer and an equivalent number of people without the disease, the investigators identified three genetic regions associated with a greater risk for the cancer.

Combined with previous work, the discovery gives scientists four particular areas of interest in understanding the disease.

The first genetic location plays an important role in ABO blood types, something scientists had suspected even before the genetic connection was made.

The second location is in a region of chromosome 5 that harbors a gene important for telomeres, structures at the end of chromosomes that get shorter each time a cell divides.

“The telomerase gene has already been identified in lung cancer, brain cancer, skin cancer and leukemia, and it’s associated with a rare lung disease and blood disorders,” Chanock said. “This seems to be pointing toward a ’soft spot’ in the human genome — that there’s something about genetic variation in that region that can predispose toward a number of different diseases.”

The question now is why someone with this predisposition would develop lung cancer rather than skin cancer, and that’s where environmental cues probably come into play, Chanock said.

The other two regions — on chromosomes 1 and 13 — are “enigmatic,” Chanock said. “They are new places we’d never thought of in pancreatic or any type of cancer.”

Dr. Michael Hall, director of the gastrointestinal cancer risk assessment program at Fox Chase Cancer Center in Philadelphia, described the study as “a monumental effort to gather this many samples.”

“The findings were very consistent and, I think, very believable,” Hall said. “The next question becomes what do you do with that information. Once this starts to get meshed together with what other people have found, the impact is going to be greater.”

And as Chanock explained, researchers now are faced with the laborious task of making sense of the findings and figuring out how to use them to reduce risk.

“It’s more complicated than just using markers to predict risk,” Chanock said. “Some work together, some work against each other. It will take more studies to move toward risk profiles that will help us to figure who’s at greater or lesser risk for pancreatic cancer and who might need certain types of tests or to visit their doctor more frequently, or who would be candidates for a trial of chemoprevention.”

SOURCES: Stephen Chanock, M.D., chief, laboratory of translational genomics, U.S. National Cancer Institute, Bethesda, Md.; Michael Hall, M.D., director, gastrointestinal cancer risk assessment program, Fox Chase Cancer Center, Philadelphia

April 21, 2010

FDA Approves First Percutaneous Heart Valve

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The U.S. Food and Drug Administration today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.

Conduits are surgically implanted valves used to treat congenital heart defects of the pulmonary valve. Patients with congenital heart defects have narrowed, leaky, or missing pulmonary valves that impede the proper flow of blood from the heart’s right ventricle to the pulmonary artery, which then sends the blood on to the lungs for oxygenation. Conduits can have a limited lifespan and often require replacement. The Melody is intended to provide another option to conduit replacement.

“The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition,” said Jeffrey Shuren, J.D., M.D., director of the FDA’s Center for Devices and Radiological Health. “Congenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients.”

Like other valves, the Melody does not cure the heart condition and over time, the Melody may wear and require replacement. However, it is implanted without open heart surgery, can prop open the poorly functioning conduit, and can keep blood flowing in the proper direction because of the tissue valve in the Melody. These characteristics will allow a patient’s conduit to function longer than usual, which can delay the need for more invasive open-heart surgery.

Approval of the Melody valve should be especially beneficial to pediatric patients with right-sided valvular heart disease who may face several surgeries over their lifetimes.

Clinical studies of 99 participants in the United States and 68 participants in Europe showed that the device improved function of the heart, and the majority of participants have noted improvements in their clinical symptoms. The device showed similar, limited durability compared with existing alternative treatments; 21 percent of U.S. participants experienced a stent fracture, a rate consistent with stent fractures reported for the bare metal stents presently used to treat congenital heart defects of the pulmonary valve.

As a condition of the FDA’s approval, the system’s manufacturer, Medtronic Inc. of Minneapolis, will conduct two post-approval studies to assess long-term risks and benefits as well as to evaluate the physician specialization needed to perform the implantation procedure, also called generalizability. One study will continue to follow 150 participants from the initial clinical trial for five years, and the second study will enroll more than 100 new participants to be evaluated over five years, in order to evaluate and assess the training program. Safety and benefit assessments will be part of both studies. The FDA also requires that Medtronic maintain a database of Melody recipients.

The FDA approved the Melody under the Humanitarian Device Exemption (HDE) program, which supports the development of medical devices intended to benefit patients in the treatment or diagnosis of diseases or conditions affecting fewer than 4,000 people in the United States per year. Under an HDE, the FDA can approve a device for limited use if there is a reasonable assurance that the device is safe and if the probable benefit to health outweighs the risk of injury or illness. Such products can only be used at medical institutions with an overseeing Institutional Review Board.

Manufacturers of most HDE devices are prohibited from selling their device for an amount that exceeds the costs of research and development, fabrication and distribution of the device. However, this prohibition does not apply to an agency-specified number of Melody devices sold each year and intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients, due to a provision in the Pediatric medical Device Safety and Improvement Act of 2007.

April 20, 2010

FDA Approves New Treatment for Type 2 Diabetes

Filed under: FDA — admin @ 1:57 am

The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.

Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone.

Insulin is a hormone that helps prevent sugar (glucose) from building up in the blood. People with type 2 diabetes have difficulty making and using insulin. Victoza is in a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists that help the pancreas make more insulin after eating a meal.

“Diabetes is a leading cause of death and disability, with more than 1.5 million new cases diagnosed annually,” said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Controlling blood sugar levels is very important to preventing or reducing the long term complications of diabetes, and Victoza offers certain patients with type 2 diabetes a treatment option for controlling their blood glucose levels.”

In five clinical trials involving more than 3,900 people, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Victoza should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Victoza should be used with caution in people with a history of pancreatitis.

The most common side effects observed with Victoza were headache, nausea, and diarrhea. Other side effects included allergic-like reactions such as hives.

Victoza was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. FDA approved Victoza, however, with several post-marketing requirements under the Food and Drug Administration Amendments Act (FDAAA) to ensure that the company will conduct studies to provide additional information on the safety of this product.

In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of Victoza in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the United States over the next 15 years.

In animal studies, Victoza caused tumors of the thyroid gland in rats and mice. Some of these tumors were cancers, which were significantly increased in rats who received excessive doses that were 8-times higher than what humans would receive.

It is not known if Victoza could cause thyroid tumors or a very rare type of thyroid cancer called medullary thyroid cancer in people. For this reason, Victoza should not be used as the first-line treatment for diabetes until additional studies are completed that support expanded use. Also, Victoza should not be used in people already at risk for medullary thyroid cancer, such as those who have medullary thyroid cancer in the family or those with a rare genetic condition known as Multiple Endocrine Neoplasia syndrome type 2.

To ensure the safe and effective use of this product, Victoza was approved with a Risk Evaluation and Mitigation Strategy consisting of a Medication Guide and a Communication Plan to help patients and providers understand the risks of Victoza and to ensure that the benefits of the drug outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid cancer.

Victoza is manufactured by Novo Nordisk of Bagsvaerd, Denmark.

March 29, 2010

Living With a Smoker Puts Kids at Risk for Emphysema

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- Children who are around smokers face a higher risk of early emphysema when they become nonsmoking adults, perhaps because their lungs never totally recovered from secondhand smoke exposure, new research suggests.

Researchers reached their conclusions after conducting CT scans on 1,781 non-smokers from six communities in the United States. About half of them grew up in homes with at least one smoker.

“We were able to detect a difference on CT scans between the lungs of participants who lived with a smoker as a child and those who did not,” Gina Lovasi, an assistant professor of epidemiology at Columbia University’s Mailman School of Public Health, said in a university news release. “Some known harmful effects of tobacco smoke are short-term, and this new research suggests that effects of tobacco smoke on the lungs may also persist for decades.”

The researchers didn’t find a link between childhood exposure to tobacco smoke and lung function. “However, emphysema may be a more sensitive measure of damage compared with lung function in this relatively healthy cohort,” Lovasi noted.

The findings are published in the December issue of the American Journal of Epidemiology.

March 27, 2010

Menu labels spur diners to trim calories

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Restaurant menus that include calorie information do seem to encourage diners to exercise some restraint, a new study suggests.

What’s more, researchers found, menus that give added information — namely, the number of calories the average adult should get in a day — could prove even more effective at curbing appetites.

The findings, reported in the American Journal of Public Health, give some weight to the growing movement to require restaurant chains to place calorie information on their menus and menu boards.

In 2008, New York City became the first U.S. city to mandate such changes at fast-food and coffee chains. That law became a model for California and other U.S. states and cities that have since implemented or are considering similar measures.

And soon the federal government may be stepping in; provisions for menu labeling are part of the healthcare reform legislation currently before Congress.

The intention is to help combat the nation’s obesity problem by raising consumer awareness of just how many calories lurk in their burgers, sandwiches, fries and desserts.

But questions have been raised about the effectiveness of menu labeling.

In October, an independent study of New York’s law concluded that menu labeling had done nothing to change consumer habits in the city’s low-income neighborhoods. Shortly thereafter, the city’s health department released preliminary data from a larger study suggesting that New Yorkers had, in fact, started buying fewer calories at 9 of 13 fast- food and coffee chains included in the research.

For the current study, Yale University researchers tested the effects of menus that provide not only calorie content, but also a line stating that the average adult should get about 2,000 calories a day.

The researchers randomly assigned 303 adults to order from one of three menus: one with no calorie labeling; one with calorie information; and one with calorie content, plus a label with the 2,000- calorie recommendation.

Overall, the study found, diners in the two calorie-label groups ate 14 percent fewer calories at the meal than those who had ordered from the label-free menus.

And when study participants later reported on their food intake for the remainder of the day, the researchers found that those who had seen the 2,000-calorie recommendation downed fewer calories — an average of 250 fewer than those in the other two groups.

The setting was experimental, and not “real world,” but that allowed the researchers to show cause-and-effect, noted Christina Roberto, a doctoral candidate at Yale who led the study. “We can say that is the menu labeling having the effects” on calorie intake, she told Reuters Health.

Moreover, Roberto said, the findings highlight the potential impact of a simple line stating the number of calories a person should get each day. “That turned out to be really important,” said Roberto, noting that the information helps people put their single meal in the context of a whole day.

“By putting that ‘anchor’ in,” she said, “you can maximize the effectiveness of menu labeling.”

Roberto noted that the current healthcare reform bills would have restaurants include the daily-calorie recommendation on menus.

February 25, 2010

Depression may up risk of a leaky bladder in women

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Older women who suffer from major depression are at greater risk of developing urinary incontinence than women of the same age who are not depressed, new research shows.

Since urinary incontinence and depression often occur together in women, Dr. Jennifer Melville from the University of Washington in Seattle and colleagues set out to determine if a causal relationship exists between the two conditions.

Previous studies demonstrated a high rate of depression among women being treated for urinary incontinence but none had examined whether one condition led to the other.

Melville’s team hypothesized that because the brain chemical serotonin plays a role in both depression and bladder function, the physiological changes brought on by one illness may set the stage for the other.

“We thought maybe we’d see it both ways. In some people because of chemical changes in the body, depression could lead to incontinence but in others, the cause would run the other way because of the psychologic reaction to incontinence,” Melville told Reuters Health in a telephone interview.

They scoured data gathered over six years in the ongoing Health and Retirement Study of the financial and physical health of recent retirees in 70,000 households.

The investigators conducted two analyses. In the first, women who entered study with depression were examined to see if urinary incontinence developed. The second analysis looked at women who entered the study with urinary incontinence to see if depression was reported at follow-up.

In this sample of nearly 6,000 women with an average age of 59 years, “we just saw the one pathway, very strong, leading from depression to incontinence and in fact incontinence not leading to depression,” Melville said.

The unambiguous results of the study were not expected, she admitted. “We were surprised at was how one-sided the effect looked.”

Doctors can use the findings in the current study “to counsel women with depression about a potentially increased risk for development of urinary incontinence or what to do if incontinence symptoms begin to emerge,” Melville and her colleagues write in the American Journal of Obstetrics and Gynecology.

The loss of bladder control may take a large toll emotionally because of the impact it can have on daily life, they note in their report. Many people feel humiliated and helpless about their condition and restrict social and work activities as a result.

The findings, Melville and colleagues add, also highlight “the importance of addressing depression urgently as a public health priority,” because of the effect it may have on other biological functions.

February 20, 2010

Ginkgo Won’t Prevent Heart Attack, Stroke in Elderly

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Among people aged 75 and older, the herbal supplement Ginkgo biloba does not prevent heart attacks, stroke or death, a new study finds.

There is some evidence that the popular herbal remedy might help prevent the leg-circulation problem known as peripheral artery disease, however.

Ginkgo contains nutrients called flavonoids, which are also found in fruits, vegetables, dark chocolate and red wine, and are believed to offer some protection against cardiovascular events, the researchers say. The supplement, which is popular in the United States and Europe, has been touted to improve memory, and to prevent dementia, heart disease and stroke.

However, “ginkgo had no benefit in preventing heart attack or stroke,” said study lead researcher Dr. Lewis H. Kuller, distinguished university professor of public health and professor of epidemiology at the University of Pittsburgh.

“But, surprising to us, was that the results were consistent with the observations in Europe that ginkgo appeared to have some benefit in preventing peripheral vascular disease,” he said.

This could be due to flavonoids acting as both antioxidants and also causing blood vessels to expand, Kuller said.

The report was released online Nov. 24 in advance of publication in an upcoming print issue of the journal Circulation. Last year the same University of Pittsburgh team reported that ginkgo biloba had no effect on preventing dementia.

For their latest study, Kuller’s group randomly assigned 3,069 patients to 120 milligrams of highly purified ginkgo biloba or placebo, twice a day as part of the Ginkgo Evaluation of Memory Study.

Over the six years of the trial, 385 participants died, 164 had heart attacks, 151 had strokes, 73 had mini-strokes (”transient ischemic attacks”) and 207 had chest pain, the researchers found.

There was no significant difference between those taking ginkgo or placebo for any of these outcomes, Kuller said.

However, among the 35 people who were treated for peripheral artery disease, 23 received placebo and 12 were taking ginkgo — a statistically significance difference, the researchers noted.

About 8 million Americans have peripheral artery disease, which typically affects the arteries in the pelvis and legs. Symptoms include cramping and pain or tiredness in the hip muscles and legs when walking or climbing stairs, although not everyone who has PAD is symptomatic. The pain usually subsides during rest.

“This study demonstrated that there were absolutely no benefits of ginkgo biloba in reducing cardiovascular events such as heart attack or stroke or in reducing death due to cardiovascular disease,” said Dr. Gregg A. Fonarow, a professor of cardiovascular medicine at the University of California, Los Angeles.

“Individuals interested in maintaining cardiovascular health should stick to interventions that have been proven to be beneficial, including not smoking, engaging in regular exercise, and maintaining healthy weight, blood pressure and cholesterol levels rather than taking herbal supplements,” Fonarow said.

Mark Blumenthal, founder and executive director of the American Botanical Council, an independent non-profit educational organization, pointed to the study’s more positive outcome.

“I believe it is important to emphasize that the results of this current exploratory trial do not in any manner reduce or negate the existing positive results of ginkgo biloba as an effective treatment in peripheral artery disease patients, which has been evaluated, confirmed, and approved by government regulatory drug authorities in leading Western European countries like Germany and France,” he said.

In addition, Blumenthal said, the trial showed that ginkgo biloba was safe and well-tolerated.

February 15, 2010

Graduated Driver’s Licensing Saves Lives: Study

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Three-stage graduated licensing for teens and other new drivers prevents injuries and saves lives, say U.S. researchers who analyzed five years of crash data from six states — Illinois, Indiana, Michigan, Minnesota, Ohio and Wisconsin.

More than 300 lives could have been saved if all of these states had added new, evidence-based modifications to their graduated driver’s licensing (GDL) programs, study leader Dr. Timothy Corden, an associate professor of pediatrics at the Medical College of Wisconsin, and colleagues reported in a university news release.

The study authors also concluded that more than 21,400 traffic injuries could have been prevented if all these states had instituted at least five of seven components recommended by the Insurance Institute for Highway Safety:
Minimum age of 16 years for obtaining a learner’s permit.
A waiting period of at least six months after obtaining a learner’s permit before applying for an intermediate-phase license.
At least 30 hours of supervised driving.
Minimum age of 16.5 years for entering the intermediate phase.
No unsupervised driving at night after 10 p.m. during the intermediate phase.
No unsupervised driving during the intermediate phase with more than one passenger younger than 20.
Minimum age of 17 for a full license.

“Our study lends support for states moving to include more of the best-practice components included within the Insurance Institute for Highway Safety recommendations for state GDL regulations,” the researchers said. “This could be viewed as a ‘policy treatment prescription’ capable of keeping teenagers alive and families intact.”

While some politicians may be reluctant to revise GDL laws, parents are generally supportive of GDL programs and play an important role in the development of successful GDL policies, the researchers said.

February 9, 2010

Herbal supplements may raise blood lead levels

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Some herbal supplements may boost the levels of lead in the blood of women, new research shows.

Among 12,807 men and women age 20 and older, Dr. Catherine Buettner, at Beth Israel Deaconess Medical Center in Boston, Massachusetts, and colleagues found blood lead levels about 10 percent higher in women, but not men, who used specific herbal supplements.

When they examined herbal supplement use among women of reproductive age (age 16 to 45 years old), “the relationship with lead levels was even stronger, with lead levels 20 percent higher overall, and up to 40 percent higher among users of select herbal supplements compared to non-users,” they report in the Journal of General Internal Medicine.

Lead accumulates in the body over time and may pass from a woman’s placenta and breast milk to developing fetuses and infants. The U.S. Food and Drug Administration does not specify safe lead limits, or even routinely test for this toxin in herbal supplements.

Buettner’s team found that women using Ayurvedic or traditional Chinese medicine herbs had lead levels 24 percent higher than non-users, while those using St. John’s wort and “other” herbs had lead levels 23 percent and 21 percent higher, respectively, than non-users.

When combined with prior studies hinting at excess lead in specific supplements, the evidence strongly suggests use of specific herbal supplements may result in higher lead levels among women, Buettner said.

In the current study, Buettner was reassured to find “no evidence of lead toxicity,” she told Reuters Health in an email.

The researchers point out that the use of some herbal supplements among study participants was low, which limited the power to detect associations among specific herbal supplements.

They also emphasize that the current study does not prove that herbal supplements cause higher lead levels. They urge further studies to analyze how other lead exposures, calcium intake, or use of other dietary supplements alter lead levels.

Dr. Adriane Fugh-Berman, at Georgetown University Medical Center in Washington, D.C. concurs in an editorial on the study, and also cautions, “let us not use too broad a brush to tar all herbal products.”

Specific analyses of specific herbal products or the blood of users, Fugh-Berman writes, should be used to establish products containing problematic amounts of lead.

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