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A cheap drug that can stop bleeding in recently injured accident patients could potentially save the lives of tens of thousands worldwide, a new study says.

Researchers studied the effects of tranexamic acid, or TXA, in more than 10,000 adult trauma patients in 40 countries who received the drug within 8 hours of being injured. They compared those patients’ outcomes to more than 10,000 accident victims who got a placebo treatment. The study was published online Tuesday in the medical journal Lancet.

Doctors found that patients who got TXA had a 15 percent lower chance of dying from a hemorrhage than those who didn’t get it. They also had a 10 percent lower chance of dying from any other cause, including organ failure and a head injury, versus patients who didn’t receive TXA. The study was paid for by the British government.

The drug is commonly used in wealthy countries during elective surgeries to stop bleeding, but isn’t prescribed for accident victims.

TXA is off-patent and manufactured generically by many companies. It costs about 3 pounds ($4.50) per gram, and a typical dose is two grams. It is usually given via an injection and would be relatively easy to introduce, even in poor countries, experts said.

“This is one of the cheapest ways ever to save a life,” said Ian Roberts, a professor of epidemiology at the London School of Hygiene and Tropical Medicine and one of the study’s main investigators.

Previous tests of the drug regarded its use in elective surgeries, such as heart operations, but this was the first study to test the drug on accident victims.

Doctors were worried it might increase side effects such as blood clots in the heart and lungs, strokes, or heart attacks. There was no evidence of that in the Lancet study, though the authors said it was possible they might have missed some of these incidents.

For people between 5 and 45, accidents are the second leading cause of death worldwide after AIDS, and about 600,000 injured patients bleed to death every year. Nearly 6 million people die of injuries every year, more than AIDS, malaria and tuberculosis combined.

Roberts and colleagues estimated that if TXA were readily available, between 70,000 and 100,000 lives a year could be saved. Though the drug wasn’t tested in children, he said it would almost certainly work in them as well.

Etienne Krug, director of violence and injury prevention and disability at the World Health Organization, said the drug would likely have the biggest impact in developing countries such as China and India, where 90 percent of injury-related deaths occur.

“People often have a fatalistic attitude about accidents and think nothing can be done to save people,” he said. “But this study shows that isn’t true.”

Experts said rolling out TXA could save as many lives as other measures such as making seatbelts compulsory or strengthening drunk-driving laws.

The drug also could save thousands of people in the West.

“This is not just something for developing countries,” said Dr. Karim Brohi, who works at one of London’s busiest emergency rooms at Barts and the London School of Medicine and University of London-Queen Mary. “We could probably use tranexamic acid on a daily basis.”

Last week, Roberts and colleagues submitted an application to WHO to include TXA on its List of Essential Medicines, which is used by many developing countries as a shopping list for drugs. Once drugs are on WHO’s list, other U.N. agencies such as UNICEF often buy the drug for poor countries.

“In many developing countries, emergency departments are like war zones, even when there’s no war,” Roberts said. “If (TXA) is available, a lot of those deaths could be avoided.”

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Technorati Tags: accident victim, cheap drug, drug, placebo treatment

Some of the world’s most popular blood pressure pills may slightly increase your risk of getting cancer, but doctors say it’s too soon to ditch the drugs, according to new research.

In an analysis of five previous studies following about 60,000 patients, experts found a link between people taking medicines known as angiotensin-receptor blockers, or ARBs, and cancer. The drugs are taken by millions of people worldwide for conditions like high blood pressure, heart problems and diabetic kidney disease.

In the analysis, researchers found that people who took the drugs had about a 1 percent higher risk of getting cancer than people who weren’t on the drugs. This included a whole range of cancers — prostate, breast and a noticable spike in lung cancer.

About 85 percent of those people were on telmisartan, sold as Micardis, made by Boehringer Ingelheim Corp. There was no difference in the rate of cancer deaths in people on the drugs compared to those not on them.

The study was published Monday in the medical journal, Lancet Oncology. No funding was provided for the study, but Dr. Ilke Sipahi, the study’s lead author, has received past payments from drug makers Pfizer Inc., AstraZeneca PLC and Ranbaxy Pharmaceuticals Inc., which all make blood pressure drugs. Other authors reported similar grants from other pharmaceuticals.

“The risk for the individual patient is modest,” said Sipahi, associate director of heart failure and transplantation at University Hospitals Case Medical Center in Cleveland. “However, when you look at it from the population level, millions and millions of people are on these drugs and it can cause a lot of excess cancer worldwide.”

Sipahi and colleagues calculated that one extra cancer case will occur for every 105 people taking the medications for about four years. He said there wasn’t enough information to know if this increased cancer risk disappears once people stop taking the medications.

The maker of the most-used drug in the study, Boehringer Ingelheim, disputed the findings and said Micardis is one of the best-researched drugs worldwide. The company claimed in a statement that it had “internal safety data” contradicting the Lancet study. According to studies run by the pharmaceutical, there was no link between increased cancer risk and Micardis.

Sipahi warned patients not to stop taking their drugs, and recommended they consult their doctor if they were concerned.

Since completing the analysis, Sipahi said he now thinks twice about whether to prescribe the drugs. But he said many heart patients couldn’t take other drugs because of their side effects and they should continue taking ARBs since their chances of dying from heart failure outweighed their chances of getting cancer.

Scientists aren’t sure why ARBs might raise the possibility of developing cancer, though some animal studies suggest the medications help produce new blood vessels, which would speed tumor growth.

In an accompanying commentary in the Lancet Oncology, Steven Nissen, a cardiologist at the Cleveland Clinic, described the study as “disturbing and provocative.” He called for regulatory agencies to order drug makers to submit more data on their products and to promptly report their findings.

Michael Thun, vice-president emeritus of epidemiology and surveillance at the American Cancer Society, said the study underlined how hard it is to pick up potentially dangerous side effects in drugs once they are on the market. He was not connected to the study.

Because cancer can take decades to develop, Thun said it’s impossible to know if a new drug can cause cancer in the future before it goes on sale. “There’s a tension between making drugs available in a timely way and detecting some cancer effect in the long term that you didn’t expect,” he said.

Thun also added it would be important to determine if it was a single drug linked to cancer, like Micardis, or if the entire class of drugs was implicated.

Popularity: 7% [?]

Technorati Tags: blood pressure drugs, blood pressure pills, cancer risk, heart problems, Micardis

Other people’s smoke is bad for your lungs and bad for your heart, and new research suggests it could be bad for your mental health, too.

Researchers found that non-smokers exposed to a lot of secondhand smoke were 50 percent more likely to suffer from psychological distress than those not exposed to other people’s smoke.

And their risk of being admitted to a psychiatric hospital over the next six years was nearly tripled (it was almost quadrupled for smokers).

So-called “passive smoking” is very common, Dr. Mark Hamer of University College London in the UK and colleagues note in the Archives of General Psychiatry. One US study found evidence of secondhand smoke in 60 percent of non-smokers.

Studies measuring the nicotine byproduct cotinine have made it possible to precisely measure secondhand smoke exposure and its health effects, they add, but there is “very limited information” on how other people’s smoke might affect mental health.

To investigate, Hamer and his colleagues studied 5,560 non-smoking adults and 2,595 smoking adults, none of whom had a history of mental illness. The study subjects answered questions about psychological distress and admissions to psychiatric hospitals were tracked for six years.

Exposure to secondhand smoke among non-smokers was determined using saliva levels of cotinine, which is formed when nicotine is broken down in the body and is an established marker of nicotine exposure.

A total of 14.5 percent of study subjects reported psychological distress. According to the investigators, the higher a person’s secondhand smoke exposure, the greater their risk of psychological distress, while the risk was highest for people who were themselves smokers.

People with high exposure to secondhand smoke (those with the highest cotinine levels) who didn’t actually smoke themselves were 62 percent more likely to report psychological distress than those unexposed to secondhand smoke, while the risk for smokers was 2.45 times greater.

During follow-up, which averaged about six years, 41 people were admitted to psychiatric hospitals. The risk of hospitalization was 2.8 times greater for secondhand smokers compared to people not exposed to secondhand smoke, while it was 3.7 times greater for smokers.

The effects were stronger for never-smokers than for ex-smokers, Hamer noted; the fact that former smokers were able to quit could suggest they were intrinsically less vulnerable to the effects of nicotine.

Studies like the current one can’t prove that something caused something else, Hamer said in an interview. However, he added, the link remained even after he and his colleagues accounted for social status, alcohol intake and other factors that could influence both the risk of mental health problems and the likelihood of being exposed to secondhand smoke. “We did see pretty robust associations that remained after those adjustments,” he said.

Moreover, Hamer and colleagues note that animal studies have hinted that tobacco may depress a person’s mood and some human studies have also suggested a potential link between smoking and depression. “Taken together, therefore, our data are consistent with other emerging evidence to suggest a causal role of nicotine exposure in mental health,” the investigators conclude.

SOURCE: http://archpsyc.ama-assn.org/cgi/content/full/2010.76

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Technorati Tags: cotinine, mental health, mental health problems, psychological distress, Secondhand smoke

The safety of a popular drug for seizures took another hit Wednesday when researchers pinned a handful of major birth defects on the medication.

Earlier research had shown that taking Depakote (valproate) during pregnancy might lower the baby’s IQ and lead to deformities in up to one in ten cases. (See Reuters Health story April 16, 2009.)

Scientists have long known about one of these malformations, called spina bifida, in which the fetus’ spinal column doesn’t close properly. But it was unclear whether the drug was linked to other birth defects, such as heart problems or extra short limbs.

Writing in the New England Journal of Medicine, European researchers report an increased risk of six different birth defects in babies whose mothers took Depakote during their first trimester of pregnancy.

The odds of spina bifida, for instance, were more than 12 times higher in these babies compared to those whose mothers didn’t take epilepsy drugs. Abnormal skull development, cleft palate, holes in the heart’s walls, extra fingers or toes, smaller limbs, and urinary problems were also more frequent in the Depakote group, with odds increased up to seven times.

And five of these defects appeared to be specific to Depakote compared with other epilepsy drugs.

Still, the researchers note, the actual frequency of specific birth defects were relatively small, all ranging below one percent. That compares to an overall rate of all birth defects of about 2 percent in the general population.

“I would say valproate is a poor first choice for pregnant women with epilepsy,” said Dr. Kimford J. Meador, a seizure disorder expert at Emory University in Atlanta, who wasn’t involved in the study.

Since last summer, U.S. guidelines have recommended against using Depakote in pregnancy, but Meador said it was still widely used across the country.

Although a few women with epilepsy may only respond to Depakote, often there are alternatives. “If a drug doesn’t work on a woman, you can try another,” said Meador. But fixing malformations is more of a challenge.

Depakote is also approved by the US Food and Drug Administration for the treatment of psychiatric conditions such as bipolar disorder. For women taking the drug, Meador said they should start considering switching medication before they think about having kids.

“By the time they find out they are pregnant, it’s probably too late,” he said.

SOURCE: NEJM/New England Journal of Medicine, June 9, 2010. http://www.nejm.org

Popularity: 7% [?]

Technorati Tags: birth defects, Depakote, epilepsy drugs, heart problems, using Depakote in pregnancy

The diabetes drug Metformin and the anti-obesity drug AICAR may help treat hepatitis C infections, although much more study is needed, British researchers report.

Researchers at the University of Leeds found that Metformin and AICAR can prevent the hepatitis C virus from replicating in the body.

“We’re very excited about these findings. These drugs are already on the market, and whilst substantial clinical trials still need to take place before they can be used to treat hepatitis C infection, we think it could be an enormous step forward in the battle against the virus,” Mark Harris, a professor in the Faculty of Biological Sciences, said in a news release from the university.

Metformin and AICAR stimulate an enzyme called AMP kinase (AMPK), which regulates energy within cells. The hepatitis C virus needs to suppress AMPK to replicate. By stimulating the enzyme, metformin and AICAR halt hepatitis C replication and enable cells to clear the infection, according to Harris and colleagues.

They’ve applied for a patent on the discovery and will soon begin a small-scale clinical trial with the University of Nottingham.

Hepatitis C virus, which damages the liver, affects about 3 percent of the world’s population. Only about 40 percent of people with hepatitis C fully recover, while many patients develop cirrhosis and liver cancer.

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Technorati Tags: diabetes drug, hepatitis C infection, Metformin, treat hepatitis C