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A new blood thinner called dabigatran etexilate may be just as effective in preventing dangerous venous clots as an old standby, warfarin, but much easier for doctors and patients to manage, a new study finds.

Dabigatran is marketed as Pradax in Canada and Pradaxa in Europe; it is not yet approved for use in the United States.

The new study, published early online Dec. 6 by the New England Journal of Medicine, follows on the heels of two other promising reports presented at the American Heart Association meeting in Orlando, Fla., last month. Those studies found that dabigatran appeared safe and effective in preventing blood clots when patients were treated for acute coronary syndrome, a cluster of symptoms that might indicate a heart attack; it was also found superior to warfarin in preventing strokes in patients with the irregular heartbeat known as atrial fibrillation.

In the new trial, warfarin and dabigatran seemed to perform equally well in helping patients with potentially dangerous clots in their veins avoid a subsequent clot or death over the next six months.

But it is in its ease of use that the newer drug appears to outshine warfarin, the authors of this latest study say.

Doctors have for years been looking for a safe alternative to warfarin, which is notoriously difficult to manage.

“For patients and health-care providers, dabigatran is a far more convenient drug than warfarin because it has no known interactions with foods and minimal interactions with other drugs and therefore does not require routine blood-coagulation testing,” wrote the international team of researchers led by Dr. Sam Schulman of McMaster University and the Henderson Research Center in Hamilton, Ontario, Canada.

In the prospective trial, which was funded by dabigatran’s maker, Boehringer Ingelheim, nearly 1,300 patients who had experienced a venous thromboembolism (VTE) received 150 milligrams of dabigatran in pill form twice a day. Another group of almost 1,300 patients was given warfarin, adjusted in dose to suit their particular needs.

Six months after the therapies began, 30 patients on dabigatran experienced another VTE compared to 27 patients on warfarin, for a 0.4 percent difference in risk, the authors report. Side effects such as major or minor bleeding were similar between the two groups, with slightly more bleeding events occurring in those on warfarin.

Based on the results, the authors conclude that, “a fixed dose of dabigatran is as effective as warfarin, has a safety profile that is similar to that of warfarin, and does not require laboratory monitoring.”

Those optimistic findings echo those from the American Heart Association meeting in November. That study involved more than 1,800 patients in 24 countries with acute coronary syndrome — a cluster of symptoms that might indicate a heart attack. Patients received one of four doses of dabigatran or a placebo on top of aspirin and the blood thinner Plavix.

The study found dabigatran safe in preventing blood clots in these heart patients. Researchers also saw reductions in mortality, nonfatal heart attack and stroke, although the trial was not specifically designed to look at efficacy.

“Dabigatran seems to be safe on top of dual antiplatelet therapy [meaning aspirin and Plavix],” study author Dr. Jonas Oldgren, chief physician in the department of cardiology at Uppsala University Hospital in Uppsala, Sweden, said at the time. “It has already been shown to have superior efficacy compared with warfarin.”

And another trial, also presented at the AHA meeting, demonstrated that dabigatran outperformed warfarin in preventing strokes in patients with atrial fibrillation.

“Dabigatran appears to be superior to warfarin in terms of safety and more effective as well. This is the first alternative to warfarin that could signal a changing of the guard,” Dr. Bernard Gersh, a professor of medicine at the Mayo Clinic College of Medicine in Rochester, Minn, said during the heart association conference. “I think there are still questions that need to be answered, but it’s fair to say that warfarin has been around for many, many years and everybody hates warfarin. Patients hate warfarin. Doctors hate warfarin. It’s not the most convenient drug, but it’s effective and it is cheap.”

“It’s premature to say that a drug like dabigatran will take the place of warfarin,” Gersh added. “There will be a lot of discussion about cost and convenience. It’s a twice-daily dose and there are some questions about a possible higher rate of heart attack. I don’t think this is truly resolved yet, but I think we can say that for the first time we have seen a drug that certainly has the potential to be an alternative to warfarin, and maybe even superior.”

Half of all patients in intensive care units around the world have infections, and more than 70 percent are being given antibiotics — a trend that could help more drug-resistant superbugs emerge, researchers reported on Tuesday.

Patients who had infections were more likely to die, especially of bloodborne infections known as sepsis, the survey of more than 13,000 patients found. They also spent more time in the ICU at greater expense to hospitals and patients.

But one of the biggest concerns was the widespread use of antibiotics in patients who were not infected — a practice that has been shown to lead to antibiotic resistance, when germs defy common drugs.

“Importantly, the incidence of sepsis is increasing, as is the number of consequent infection-related deaths,” Dr. Jean-Louis Vincent of Erasme University Hospital in Brussels, Belgium and colleagues wrote in the Journal of the American Medical Association.

For the study, Vincent’s team surveyed 13,796 adults in 1,300 intensive care units in 75 countries on one day — May 8, 2007.

The analysis took some time and revealed that 51 percent of the patients had infections and 71 percent were receiving antibiotics, either as treatment or to prevent infection.

In 64 percent of cases, the lungs were infected, and infections of the abdomen and bloodstream were also common.

The most common bacteria was Staphylococcus aureus, but E. coli and a family of bacteria called Pseudomonas were also common.

“Infection and related sepsis are the leading cause of death in noncardiac ICUs, with mortality rates that reach 60 percent and account for approximately 40 percent of total ICU expenditures,” the researchers wrote.

TROUBLING TRENDS

Dr. Steven Opal of Brown University in Rhode Island and Dr. Thierry Calandra of Vaudois Hospital Center in Lausanne, Switzerland, who were not involved in the study, saw several troubling trends.

For instance, a type of bacteria known as gram-negative now account for 63 percent of infections. “This is not a favorable trend, because resistance among gram-negative bacteria is increasing and the number of therapeutic alternatives to treat these infections is diminishing,” they wrote in a commentary.

The heavy use of antibiotics in ICUs can make such units into epicenters for bacteria to mutate into drug-resistant forms and to spread, they added.

But critical care doctors have little choice, they noted.

“Early intervention with appropriate antibiotics is lifesaving in patients with severe infection, yet the profligate use of antimicrobial agents contributes to progressive antimicrobial resistance,” they wrote.

Doctors are penalized if they fail to treat with an antibiotic, but little happens if they over-treat patients.

And few good tests are available to tell if a patient is really infected or just carrying a germ. “With few alternatives available, it is understandable why intensivists opt for liberal antibiotic use and rely heavily on these therapeutic agents to carry patients through critical illness to recovery,” Opal and Calandra wrote.

Without some “radical” new technology, such as vaccines or immunotherapy, there is little hope for the situation to improve, they added.

Psychological therapy may be much more effective at making people happy than getting a raise or winning a lottery prize, suggests an English study.

Researchers analyzed data on thousands of people who provided information about their mental well-being and found that the increase in happiness from a $1,329 course of therapy was so significant that it would take a pay raise of more than $41,542 to achieve an equal boost in well-being.

That suggests that therapy could be as much as 32 times more cost-effective at improving well-being than simply getting more money, the researchers said.

The study was published online Nov. 18 in the journal Health Economics, Policy and Law.

“We have shown that psychological therapy could be much more cost effective than financial compensation at alleviating psychological distress,” said study author Chris Boyce, of the University of Warwick. “This is not only important in courts of law, where huge financial rewards are the default way in which pain and suffering are compensated, but has wider implications for public health and well-being.”

“Often the importance of money for improving our well-being and bringing greater happiness is vastly over-valued in our societies,” Boyce explained. “The benefits of having good mental health, on the other hand, are often not fully appreciated and people do not realize the powerful effect that psychological therapy, such as non-directive counseling, can have on improving our well-being.”

Skiers and snowboarders who don’t wear helmets are more likely to suffer a head injury and lose consciousness than those who do wear helmets, a new U.S. study has found.

The researchers analyzed the medical records of skiers and snowboarders treated at nine hospital emergency departments in Colorado, New York and Vermont between July 2002 and July 2004.

They found that:
More collisions with fixed objects occurred in the Northeast
Loss of consciousness was more likely to occur among terrain park users
Patients in Colorado were less likely to lose consciousness
Loss of consciousness was less likely among those who wore helmets than among those who did not

The findings are reported in the fall issue of Wilderness and Environmental Medicine.

The authors noted that traumatic brain injury accounts for 50 to 88 percent of skiing and snowboarding fatalities. They expressed hope that their findings would strengthen the case for the use of helmets in these winter sports.

Obesity is a major risk factor for left atrial enlargement, which increases the risk of atrial fibrillation, stroke and death, a new study shows.

Atrial fibrillation is the most common type of arrhythmia (an irregular heart rhythm or heartbeat).

Researchers analyzed data on 1,212 men and women, aged 25 to 74, in Germany who were followed for 10 years. The study authors concluded that obesity and hypertension cause structural and functional changes in the heart and are independent predictors of left atrial enlargement (LAE).

The highest incidence of LAE after 10 years was seen in obese people — 31.6 percent compared to baseline prevalence of 10 percent among all study participants.

The findings, published in the Nov. 17 issue of the Journal of the American College of Cardiology, confirm the strong association between obesity and LAE reported in previous research. Some of those studies found that excess weight may affect left atrial size at an early age, potentially predisposing young obese people to future heart problems.

The authors of the new study said early assessment and intervention, especially among younger obese patients, is crucial to prevent the premature onset of cardiac remodeling — changes in heart size, shape and function — caused by LAE.

But they noted that it isn’t clear how much weight management or moderate weight loss can improve LAE. Further research is needed.

To keep colds at bay during the chilliest months of the year, exercise just might be the key.

David Nieman, a representative of the American College of Sports Medicine, says that studies have shown that people who exercise at least 45 minutes four or more days a week take 25 to 50 percent less time off from work because of illness.

“This reduction in illness far exceeds anything a drug or pill can offer,” Nieman said in a news release from the sports medicine group. “All it takes is a pair of walking shoes to help prevent becoming one of the thousands predicted to suffer from the common cold this winter.”

But what if you’re already under the weather? Should you try to get some exercise? Nieman suggests:
If a cold is only in your head and has not reached your chest, feel free to exercise.
Don’t overexert yourself. That means no running: Just take a walk. Studies have not shown that moderate exercise is bad if you have a cold.
If you have symptoms beyond the sniffles, stay in bed. This advice holds if a cold has traveled to your chest, if you have severe aches and pains and if you’re running a fever. Swollen glands spell trouble, too.
Take it slow when recovering from anything but a mild bout of illness. Take a couple of weeks off from exercise before you start workouts again.

Nieman has one more bit of advice: Exercise before you get your flu shot because research has shown that moderate-level physical activity will boost your immunity in the long run.

imple measures such as starting a walking group or creating pedestrian-friendly routes can encourage people to walk more, a new study has found.

At a multicultural housing site in Seattle, researchers implemented and evaluated several interventions meant to increase residents’ walking, including sponsoring walking groups, improving walking routes, offering information about walking options and advocating for pedestrian safety.

After the measures were implemented, self-reported walking among walking group members increased from 65 minutes to 108 minutes a day, according to the study published online Nov. 4 in the American Journal of Public Health.

“The built environment influences opportunities for physical activity through access to trails, parks, recreation centers and walkable streets, as does the social environment, such as having opportunities to walk with others,” the researchers wrote.

Community design should take into account ways to encourage walking, the study authors noted, and interventions to change people’s behavioral habits need to be considered.

World Trade Center rescue workers can add another illness to the list of health problems that may have resulted from exposure to Ground Zero toxins and the ensuing mental anguish of the tragedy — gastroesophageal reflux disease (GERD).

A new study shows that 41 percent of World Trade Center responders have GERD, twice that of the general population. GERD is a condition in which the lower esophageal sphincter doesn’t function properly, allowing the stomach’s contents to rise up into the esophagus, causing a burning sensation in the chest or throat.

The likelihood of having GERD was linked to mental health disorders, including post-traumatic stress disorder and depression. The more extensive the mental health issues, the more likely patients were to have GERD.

About 47 percent of those diagnosed with one mental health disorder also had GERD. About 64 percent of those who had two mental health disorders had GERD, while the rates of GERD rose to 70 percent and 72 percent for those who had three or four mental health disorders, respectively.

“These patients were exposed to a very complex trauma — both psychological and physical,” explained senior study author Dr. Benjamin Luft, a professor of medicine at State University of New York at Stony Brook and director of the Long Island World Trade Center Medical Monitoring and Treatment Program. “Unless you treat both of these things at the same time, they tend to exacerbate one another. It’s the close interaction between mind and the body. The physical may impact you psychologically, and the psychological may impact you physically.”

The study was scheduled to be presented Monday at the American College of Gastroenterology’s annual meeting in San Diego.

Previous research has found that people with mental health issues tend to have more reflux disease or other gastrointestinal disturbances, said Dr. David A. Johnson, past president of the American College of Gastroenterology.

Research has shown that people who are stressed are more sensitive to discomfort of gastric acid in the esophagus. Studies in animals have shown that over time, stress can weaken the ability of the esophagus to withstand acid reflux. Other research has shown that people who don’t sleep well are more bothered by acid reflux. The lack of sleep lowers the “sensory threshold” for pain.

“The study offers a very interesting and potentially very meaningful observation,” Johnson said. “We do know that stress does have a relationship to GERD.”

Researchers looked at records of 697 World Trade Center rescue, recovery and clean-up workers who were examined in 2005 and 2007 as part of the World Trade Center Medical Monitoring and Treatment program, which follows and treats several thousand Ground Zero workers, many of whom have suffered persistent mental health and respiratory ailments.

“It’s not as readily apparent as to why they would have a gastrointestinal problem,” Luft said. “Though as a result of being there, when you are exposed to a tremendous amount of dust, a lot of what goes into your mouth, nose and lungs is also swallowed and can enter the gastrointestinal tract as well.”

One explanation for some of the respiratory ailments is that the dust at Ground Zero was extremely alkaline, or acidic, and may have damaged the lining of the mucosal membranes. Something similar could have happened to the membranes of the gastrointestinal tract, Luft said.

The study also found that smoking and obesity, known risk factors for GERD, did not increase the risk of GERD, while spending a lot of time at Ground Zero did.

In a second study to be presented at the meeting, researchers found that active-duty military who were exposed to infectious gastroenteritis were more likely to have “functional gastrointestinal disorders,” including diarrhea, irritable bowel syndrome, functional constipation and dyspepsia (indigestion).

Infectious gastroenteritis is caused by viruses, bacteria or parasites.

Researchers used electronic medical records from the Defense Medical Surveillance System to identify 31,866 cases of gastrointestinal disease among active-duty personnel between 1999 and 2007. For some, the gastrointestinal disturbances were long-lasting. About 29 percent of active duty personnel were still being treated for gastrointestinal disorders two years after diagnosis.

New research suggests that sperm, not just semen, can transmit the virus that causes AIDS to immune cells in the body and, in fact, sperm may play a major role in transmission.

Scientists already know that men infected with HIV, the virus that causes AIDS, can spread the disease through their semen, the fluid that carries sperm. But it hasn’t been clear what role sperm itself plays, especially considering that men who don’t produce sperm, such as those who have had vasectomies, can transmit the virus.

In a new study, published in the Oct. 26 online edition and the Nov. 23 print issue of the Journal of Experimental Medicine, researchers found that the virus attaches to the surface of sperm and can be transmitted to immune cells.

Immune cells known as dendritic cells appear to be vulnerable, the study authors explained. The researchers, led by Ana Ceballos of the University of Buenos Aires in Argentina, think the virus gets to these cells by passing through tiny abrasions in the vagina or anus or perhaps through another method.

The researchers said that a slightly acid environment, which they likened to that in the vagina after sexual intercourse, boosts the likelihood of infection of these cells.