Rat Poison Alternative Cuts Clots; Approach to Benefit Millions

August 31, 2009 by Editor · Leave a Comment
Filed under: Drug 

Warfarin users now undergo monthly blood tests to make sure they get the correct amount of the drug, since levels in the body react to numerous other medicines, alcohol and food ranging from beef to broccoli. Too little increases the risk of deadly clots, while too much triggers bleeding. Researchers said they have looked for something better for the past five decades, and have only now found something they agree is superior.

The change stems from findings of the largest study ever conducted in atrial fibrillation, an erratic heartbeat that predisposes patients to strokes and early death. It showed Boehringer Ingelheim Gmbhs Pradaxa is easier to take and offers either a 34 percent reduction in stroke or 20 percent fewer episodes of bleeding, depending on the dose. The drug is the first in a wave of new treatments doctors say will overhaul care for more than 7 million people worldwide.

“Its becoming a new era in stroke prevention and warfarin will be dead,” said Freek Verheugt, professor at the University Medical Center in Nijmegen, the Netherlands, in an interview. Pradaxa “raises the bar. The lack of bleeding was remarkable.”

The study of 18,113 patients, dubbed RE-LY, found the risk of bleeding in the brain, one of the most feared complications of warfarin, was reduced 69 percent to 74 percent in the Pradaxa group. Patients getting the drug also had fewer cases of life- threatening bleeding. The benefits came without signs of liver damage, a side effect that doomed AstraZeneca Plcs similar treatment Exanta.

Superior Results

The research, simultaneously published in the New England Journal of Medicine, was originally designed show Pradaxa was equal to warfarin. The superior results may affect the way millions of people are treated, researchers said.

“When this is available, we are going to turn to it in droves,” Chris Cannon, a cardiologist with Brigham and Womens Hospital in Boston, said in an interview, predicting the change will occur quickly. “This is a huge change and probably is the beginning of a total revolution. Having something that is easier is a game changer to begin with, but to have something thats better on efficacy and safety and easier is almost unbelievable.”

Additional studies are needed to make sure the drug is also effective in other patients, such as those with mechanical heart valves and a history of blood clots, doctors said.

Regulatory Approval

Closely held Boehringer of Ingelheim, Germany, plans to file for regulatory approval of the drug, which would be given as a pill twice daily based on weight, and expects to be able to sell Pradaxa by the end of next year, Chief Executive Officer Andreas Barner said in a telephone interview.

“If I had been asked to predict the most favorable result possible for this study, I couldnt have imagined showing such a result,” Barner said. “This is really good news for patients. This is really a once-in-a-lifetime thing.”

Pradaxa and Xarelto, a rival from Bayer AG and Johnson & Johnson, are both approved in some European countries. The U.S. Food and Drug Administration failed to clear Xarelto earlier this year for patients undergoing hip and knee replacement surgery, though the companies plan to submit additional data in the next few months to back the application. A study in patients with atrial fibrillation is expected next year.

New Drugs

Merck & Co. also is working on a rival to Pradaxa known as betrixaban that it licensed from Portola Pharmaceuticals Inc. in July. The drug is in the second of three stages of testing. Tokyo drugmaker Daiichi-Sankyo Co. also has a similar product in late-stage testing.

“Fortunately there are several other drugs coming along as well,” Cannon said. “Were all really looking forward to having rivaroxiban as an option as well,” he said, using the chemical name for Xarelto.

The number of patients with atrial fibrillation getting treatment may double because the new pills are so much easier to take, doctors said. More than half of the patients currently choose not to take warfarin because of the difficulty with using it or doctors concerns about the potential bleeding risks.

Cost will be an issue when it comes to the new medications, as they are expected to have price tags dramatically higher than warfarin.

Pradaxas Price

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Astrazeneca Drug Shrinks Heart Attacks More Than Sanofi Competitor

August 31, 2009 by Philbert Ross · Leave a Comment
Filed under: Heart 

Brilintas potency didnt cause more episodes of serious bleeding, a common complication seen with drugs that ward off heart conditions by preventing blood clots from developing, the research showed. The findings position Brilinta to rival Plavix, the second-biggest selling medicine in the world with almost $10 billion in annual revenue, for millions of patients suffering from heart attacks or severe chest pain.

About 1.3 million Americans are hospitalized each year with heart attacks and chest pain known as acute coronary syndromes. While aspirin and Plavix have lowered their subsequent health risks, cardiovascular disease remains the leading cause of death worldwide. Death from any cause was also significantly lower in patients taking Brilinta, according to the results of the study known as Plato.

“I think this will become the new standard of care,” said Douglas Weaver, a cardiologist at Henry Ford Hospital in Detroit and a past president of the American College of Cardiology, in an interview. “Its more rapid, more effective and it appears to be safer” than Plavix and another competitor, Effient, from Eli Lilly & Co. of Indianapolis and Daiichi Sankyo Co. of Japan. “I dont think they could have done much better than they did in this trial.”

North America

The study included more than 18,000 patients in 43 countries. Those in North America may have done worse on Brilinta, a finding researchers couldnt explain. That raised questions among analysts about future sales in the U.S.

“The North American market is such a big issue in terms of sales,” said Michael Leacock, an analyst at Royal Bank of Scotland in London. “This North American subgroup leaves a little more room for debate.”

While analyst estimates are sure to rise for Brilintas sales, it might not be enough to make the companys shares more attractive, Leacock said in an interview. AstraZeneca faces lower-priced competition on products that generate 62 percent of sales by 2014.

“It certainly seems to be a more competitive product than we would have expected,” Leacock said. “The consensus is already at $1 billion a year. Even if you add another $1 billion to AstraZenecas sales in 2013, Im not sure it makes a large difference to the investment case for AstraZeneca.”

AstraZeneca shares have gained 1.2 percent this year, compared with a 2.1 percent increase in the 17-member Bloomberg Europe Pharmaceutical Index. Sanofi, which is set to lose patent protection on Plavix in 2011, has risen 6.1 percent.

Eagerly Anticipated

The trial, funded by London-based AstraZeneca, was one of the most eagerly anticipated findings presented at the European Society of Cardiology meeting in Barcelona this week. It was simultaneously published in the New England Journal of Medicine yesterday. The researchers reported an unexpected 22 percent reduction in the overall risk of early death from any cause.

Seeking Approval

The U.K. drugmaker plans to file for approval of Brilinta in the fourth quarter in Europe and the U.S. and hopes to begin selling it next year, said Gunnar Olsson, AstraZenecas head of cardiovascular therapy.

Brilinta, Plavix and Effient all work by preventing platelets from clumping together in the blood to form clots. Plavix and Effient, which was approved this year in Europe and the U.S., last for the life of the platelet, or about a week, and are given once a day. Brilinta needs to be taken twice daily, and patients are likely to comply with that regimen, said David Snow, AstraZenecas vice president of cardiovascular global marketing.

“Youve had a heart attack,” Snow said in an interview in Barcelona. “Youre certainly going to be motivated to avoid another one.”

About 30 percent of patients dont respond well to Plavix. Brilintas effects wear off in a few days, making surgery easier for patients who need it.

Huge Conundrum

One in 10 patients rushed to the hospital with chest pain or heart attacks actually need by-pass surgery, said Christopher Cannon, a cardiologist at Brigham and Womens Hospital in Boston. If they are given Plavix or Effient, they must wait five days before getting the surgery, he said.

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Flu Season: How Several Shots?

August 31, 2009 by Johnson Anders · Leave a Comment
Filed under: Vaccine 

Some possibilities:

-One shot: Older adults currently arent on the priority list to get swine flu vaccine but they should get the seasonal vaccine, which is available.

-Two shots: Theres a potential for the regular vaccine in one arm and the swine flu vaccine in the other, if that one requires just one dose.

-Three shots: The swine flu vaccine might require two doses three weeks apart, plus the regular vaccine.

-Four shots: Theres even this possibility for some children. Youngsters under 9 who are getting their first-ever regular flu vaccination need two doses of it.

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Exercise Beats Angioplasty For Some Heart Patients

August 31, 2009 by Johnson Anders · Leave a Comment
Filed under: Heart 

Studies have shown heart patients benefit from exercise, and some have even shown it works better than surgical procedures. At a meeting of the European Society of Cardiology on Sunday, several experts said doctors should focus more on persuading their patients to exercise rather than simply doing angioplasties.

Angioplasty is the top treatment for people having a heart attack or hospitalized with worsening symptoms. It involves using a tiny balloon to flatten a blockage and propping the heart artery open with a mesh tube called a stent. Most angioplasties are done on a nonemergency basis, to relieve chest pain caused by clogged arteries cutting off the hearts blood supply.

“Its difficult to convince people to exercise instead of having an angioplasty, but it works,” said Rainer Hambrecht of Klinikum Links der Weser in Bremen, Germany.

Hambrecht published a study in 2004 that found that nearly 90 percent of heart patients who rode bikes regularly were free of heart problems one year after they started their exercise regimen. Among patients who had an angioplasty instead, only 70 percent were problem-free after a year.

Hambrecht is now conducting a similar trial, which he expects to confirm his initial findings: that for some heart patients, exercise is more effective than a surgical procedure.

Other experts agreed that would likely be the case.

An angioplasty “only opens up one vessel blockage,” said Dr. Christopher Cannon, an associate professor of medicine at Harvard University and spokesman for the American College of Cardiology. He was not linked to Hambrechts research. “Exercise does a lot more than fixing one little problem.”

Among other benefits, exercise lowers bad cholesterol while raising good cholesterol, helps the body process sugar better, improves the lining of the blood vessels and gets rid of waste material faster. Exercise also lowers blood pressure and prevents plaque buildup in the arteries.

Previous research has estimated one third of heart disease and stroke could be prevented if patients did two-and-a-half hours of brisk walking every week. In the U.S., that would mean 280,000 fewer heart-related deaths every year.

Joep Perk, a professor of health sciences at Swedens Kalmar University and spokesman for the European Society of Cardiology, said two thirds of heart patients in line for an angioplasty could probably get better benefits by regularly working up a sweat.

Experts say less than 20 percent of heart patients get the recommended amount of exercise – about 30 minutes of moderate activity five times a week.

Perk said doctors who performed angioplasties on their patients without asking them to change their lifestyles were ignoring the fundamental problem. “It would be like getting rid of the most troubled rust spots on a car without doing anything to stop more rust from appearing tomorrow.”

“Most patients want the quick fix,” Cannon said. Exercise may improve patients hearts better than an angioplasty, but it may also take months or even longer for patients to feel the benefits. “Its a lot easier to get your artery fixed than it is to exercise every day.”

—-

On the Net:

http://www.escardio.org

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Astrazenecas Brilinta Safely Cuts Heart Risks, Fatality In Study

August 30, 2009 by Editor · Leave a Comment
Filed under: Heart 

Brilintas potency didnt cause more episodes of serious bleeding, a common complication seen with drugs that ward off heart conditions by preventing blood clots from developing, the research showed. The findings position Brilinta to rival Plavix, the second-biggest selling medicine in the world with almost $10 billion in annual revenue, for millions of patients suffering from heart attacks or severe chest pain.

About 1.3 million Americans are hospitalized each year with heart attacks and chest pain known as acute coronary syndromes. While aspirin and Plavix have lowered their subsequent health risks, cardiovascular disease remains the leading cause of death worldwide. Death from any cause was also significantly lower in patients taking Brilinta, according to the results of the study known as Plato.

“I think this will become the new standard of care,” said Douglas Weaver, a cardiologist at Henry Ford Hospital in Detroit and a past president of the American College of Cardiology, in an interview. “Its more rapid, more effective and it appears to be safer” than Plavix and another competitor, Effient, from Eli Lilly & Co. and Daiichi Sankyo Co. “I dont think they could have done much better than they did in this trial.”

The trial, funded by London-based AstraZeneca, included 18,624 patients and was one of the most eagerly anticipated findings presented at the European Society of Cardiology meeting in Barcelona this week. It was simultaneously published in the New England Journal of Medicine.

Sales Estimate

Sachin Jain, an analyst at Bank of America Merrill Lynch in London, forecast $500 million in sales by 2015 in an Aug. 17 note to investors, and said he may raise his estimate to $1.3 billion if the drug has a meaningful benefit without serious side effects.

AstraZeneca needs Brilinta to help replace sales lost to generic competition for its best-selling drugs, as products including Seroquel that now account for about 62 percent of the companys revenue will face lower-priced competition by 2014. The Brilinta findings may not be enough to replace the lost sales, wrote Kevin Wilson, an analyst at Citigroup Inc. in London, in an Aug. 19 note to investors.

“Brilinta peak upside sales of $4 billion would be expected to be reached more than five years post-launch, once physicians become comfortable with how to get the best out of the product,” he wrote. “Even exceptional Brilinta success is not enough,” given the time it would take for doctors to embrace it, he said.

Seeking Approval

AstraZeneca plans to file for approval of Brilinta in the fourth quarter and hopes to begin selling it next year, said Gunnar Olsson, the companys head of cardiovascular therapy.

Brilinta, Plavix and Effient all work by preventing platelets from clumping together in the blood to form clots. Plavix and Effient, which was approved this year in Europe and the U.S., last for the life of the platelet, or about a week, and are given once a day. Brilinta needs to be taken twice daily. About 30 percent of patients dont respond well to Plavix. Brilintas effects wear off in a few days, making surgery easier for patients who need it.

Huge Conundrum

“Its a huge conundrum, a headache for doctors, hospitals and patients,” he said in a telephone interview. “This opens the door. Its a neat differentiating factor that could open up treatment options.”

In the study, 9.8 percent of patients taking Brilinta for a year after being treated for a heart attack or worsening chest pain suffered another heart attack or stroke, or died from vascular disease, compared with 11.7 percent of those given Plavix. Overall, 4.5 percent of Brilinta patients died from any cause, significantly fewer than the 5.9 percent of Plavix patients who died.

The rates of major bleeding were similar between the two groups, occurring in 11.6 percent of those on Brilinta and 11.2 percent of those on Plavix. Fatal bleeding in the brain was more frequent in those given Brilinta, while fatal bleeding in other areas was more common with Plavix. Brilinta was linked to more serious bleeding in the brain and stomach of patients who didnt undergo bypass surgery, the study found.

Safety Monitoring

In an accompanying comment in the New England Journal, Albert Schoemig of the German Heart Centre in Munich wrote that the safety of Brilinta, also known as ticagrelor, needs to be tracked closely.

“The whole story concerning the adverse effects of ticagrelor may require evaluation in a much larger number of patients, something that may be beyond the capacity of a randomized trial,” Schoemig wrote. “We should carefully monitor patients receiving this drug to establish the overall impact of its side effects.”

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Boehringers Pradaxa Is Safe, Effective Alternative to Warfarin

August 30, 2009 by Johnson Anders · Leave a Comment
Filed under: Drug 

Pradaxa prevented more strokes and damaging clots than warfarin without increasing the risk of major bleeding when given at a high dose, according to the results of a trial known as RE-LY. A lower dose of the experimental drug was as effective as warfarin with less bleeding in the study presented today at the European Society of Cardiology meeting in Barcelona.

Almost 4 percent of people aged 60 and older have atrial fibrillation, including about 7 million in the U.S. and Europe, and the number is increasing, doctors said. Treatment is with warfarin, which interacts with a long list of food and drugs and requires frequent blood tests to ensure patients take the right dose. Pradaxa would be given as a pill twice daily based on weight and doesnt require laboratory monitoring, researchers said.

“Were in an epidemic of atrial fibrillation, and its very difficult for patients to monitor their warfarin levels,” Alfred Bove, chief of cardiology at Temple University in Philadelphia and president of the American College of Cardiology, said in an interview. “This drug takes some of that away and is a major breakthrough for patients with atrial fibrillation.”

The research, simultaneously published in the New England Journal of Medicine, is the largest trial ever conducted in patients with atrial fibrillation and was originally designed show Pradaxa was equal to warfarin. The superior results may affect the way millions of them are treated, researchers said.

Game-Changer

The study of 18,113 patients found 1.11 percent of those on the high dose of Pradaxa had a stroke or clot known as an embolism within two years, compared with 1.53 percent of low dose patients and 1.69 percent of warfarin patients. Major bleeding occurred in 3.11 percent of high dose patients, 2.71 percent of low dose patients and 3.36 percent of warfarin users.

Strokes caused by bleeding in the brain were significantly less common in patients getting either dose of Pradaxa.

“In my view, this is an absolute game-changer,” said researcher Michael Ezekowitz, vice president of the Lankenau Institute for Medical Research and the Heart Center in Wynnewood, Pennsylvania. “I was amazed by the results,” he said in an interview.

Boehringer plans to file for regulatory approval of the drug as rapidly as possible, and expects to be able to sell the drug by the end of next year, Chief Executive Officer Andreas Barner said in a telephone interview.

Real Breakthrough

“Overall, this trial looks like the rare event of a real breakthrough,” he said. “For stroke prevention, I do believe there will be a clear move toward Pradaxa because the efficacy and safety results are so compelling. I am convinced that Pradaxa is the new gold standard.”

Merck & Co. also is working on a rival to Pradaxa known as betrixaban that it licensed from Portola Pharmaceuticals Inc. in July. The drug is in the second of three stages of testing.

Potential Questions

One big issue with the use of Pradaxa will be its price, said Clyde Yancy, medical director at Baylor Heart and Vascular Institute in Dallas, Texas, and president of the American Heart Association. While warfarin is available as an inexpensive generic medication, the cost of testing and dose adjustment can cost anywhere from $50 to $500 a month, he said.

There are other potential questions with Pradaxa, Yancy said in an interview. Heart attacks, though rare, occurred more often in patients getting Pradaxa in the study, as did abdominal pain and nausea, the study showed.

“Weve learned in cardiovascular medicine not to ignore these signs,” even when they arent large or fully understood, he said. “I would anticipate the Food and Drug Administration would come forward with a somewhat restrictive labeling,” targeting the drug for the higher risk patients while doctors get more comfortable with using the medicine, he said.

Still, only about half of patients with atrial fibrillation consistently stick with the medication, he said. The positive results seen in RE-LY have generated some sense of relief and enthusiasm, he said.

“Patients have wanted something easier to take for atrial fibrillation, and this may be it,” he said. “Sparing patients the agony of weekly tests – thats worth it.”

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Sanofis Experimental Clot Drug Shows Guarantee In Heart Patients

August 30, 2009 by Aleccia Yule · Leave a Comment
Filed under: Drug 

Patients given Sanofis otamixaban were 40 percent less likely to have a second heart attack, need an emergency procedure to open clogged arteries or die than those given heparin and Schering-Plough Corp.s Integrilin. The study, from the second of three phases needed for approval, was presented at the European Society of Cardiology meeting in Barcelona today.

While heparin and Integrilin have been used for years to prevent clots that cause complications in patients undergoing procedures to clear clogged arteries, its difficult to get the right dose and patients must be closely monitored. If otamixaban proves effective in larger clinical trials, it may also compete against other blood thinners, including Sanofis Lovenox, the Medicines Co.s Angiomax and GlaxoSmithKline Plcs Arixtra.

“There is intense interest in finding a more effective, reliable and safe replacement for heparin,” said Marc Sabatine, the lead researcher and a cardiologist at Brigham and Womens Hospital in Boston. “With otamixaban, we can use a weight-based dose and patients fall right into the target range. Its much more convenient to give.”

Otamixaban is given intravenously and inhibits a key enzyme needed for blood to clot. A previous study found the drug was effective in lower-risk patients undergoing a planned procedure to clear the heart arteries. The new trial involved a higher risk group of patients undergoing the procedure known as angioplasty. Both trials were funded by Paris-based Sanofi.

$1 Billion Drug

If the drug proves safe and effective in larger studies, it could eventually generate $1 billion to $1.5 billion in annual sales, Alexandra Hauber, an analyst at J.P. Morgan, said in an Aug. 21 note to investors. The earliest it could be available is 2012, she said.

“Due to the limited disclosure provided by Sanofi in the agent, we believe that it is not yet on the radar screen of investors,” she said, describing the study as a potential “upside surprise” for the company.

The lowest two doses of the drug were insufficient to keep the arteries clear in the study, while the highest level raised bleeding rates, Sabatine said in a telephone interview. While the main goal was to find the best dose for larger trials, the heart risks after a week were significantly lower in patients getting a moderate dose of otamixaban, without increasing the risks of serious bleeding, he said.

Intermediate Dose

Patients getting the intermediate dose also had a 46 percent reduction in death and heart attack rates, and the benefit lasted through the full six months of the study.

“We achieved our goal of figuring out what is the right dose range for a big, phase 3 trial to definitively establish the drugs benefit,” he said. “This may not only replace heparin, it could simplify treatment.”

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Study Shows Experimental Drug Cuts Stroke Risk

August 30, 2009 by Philbert Ross · Leave a Comment
Filed under: Drug 

Patients taking the new drug dabigatran etexilate, made by German pharmaceutical Boehringer Ingelheim, also were slightly more likely to have heart attacks or stomach pain, according to the research presented at the European Society of Cardiology meeting in Barcelona.

Patients with irregular heartbeats are up to 17 times more likely to have a stroke than healthy people.

About one-sixth of all strokes occur in patients with irregular heartbeats who also have other risk factors such as smoking or obesity. In the United States, there are about 2 million people with such a condition.

Until now most such patients have been given warfarin, which has been around since the 1950s and has side effects including bleeding risks and requires lifestyle changes such as dietary restrictions.

Doctors hope the new drug can help improve treatment for patients, who must be monitored continuously if they are put on warfarin and avoid alcohol and foods such as spinach and cranberries.

The new research on dabigatran – which has not yet been approved by any drug regulatory agency – was compiled after doctors monitored more than 18,000 patients with irregular heartbeats, or atrial fibrillation, worldwide for about two years starting in 2005. The patients took either dabigatran or warfarin, at varying doses.

On warfarin a patients risk of stroke drops dramatically to about 0.38 percent per year, according to the study, also published online in the New England Journal of Medicine. Warfarin has invited complications, however, because it is difficult to dose and may be confusing for patients to take, doctors have said.

On dabigatran, that risk is slashed even further to about 0.10 percent per year, the study says.

“It is certainly a big step forward,” said Dr. Fausto Pinto, director of the Cardiovascular Institute at the University of Lisbon, Portugal, and program chairman of the European Society of Cardiology.

Dabigatran “probably will replace warfarin,” as it is easier for both doctors and patients to use, said Pinto, who was not involved in the study.

Last year, the market for anti-clotting drugs was about $13.6 billion globally.

Getting approval for dabigatran could take years after Boehringer Ingelheim submits data to regulatory agencies.

“Patients have wanted something easier to take for their atrial fibrillation for years, and this may be it,” Yancy said. “Thats why this may be a game-changer.”

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On the Net:

http://www.escardio.org

http://www.nejm.org

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New Drug Shrinks Risks For Heart Patients

August 30, 2009 by Philbert Ross · Leave a Comment
Filed under: Drug 

Researchers followed 18,624 patients worldwide from 2006 to 2008. About half the patients were taking clopidogrel, also known as Plavix, while the other half were taking an experimental drug called ticagrelor, or Brilinta, made by AstraZeneca PLC.

Those on Brilinta had a 4.5 percent chance of dying, versus a 5.9 percent death risk for patients on Plavix, the worlds second-best selling medication made by Sanofi-Aventis and Bristol-Myers Squibb.

Doctors also found Brilinta was safer for patients since they were less likely to have bleeding problems, one of Plavixs known side effects. Ticagrelor had its own adverse effects, including breathing and heart rhythm abnormalities.

The study results were announced Sunday at the European Society of Cardiology meeting in Barcelona, and also published online in the New England Journal of Medicine. The research was paid for by AstraZeneca.

For years, Plavix has been the standard anti-clotting treatment, though another drug, Prasugrel, made by Eli Lilly, became available earlier this year. Heart patients often take blood thinners like Plavix to avoid more serious problems in the future.

Brilinta is not yet on the market. If drug regulatory agencies eventually approve it, some experts predict it will be a best-seller. “It will become the new standard of care,” said Dr. Douglas Weaver, immediate past president of the American College of Cardiology.

“Its more effective (than Plavix) and appears to be even safer,” said Weaver, who was not linked to the study.

Still, drug regulatory agencies typically take years to approve new drugs.

Not everyone was as optimistic about Brilinta being able to crowd out the available blood thinners.

“It means we will have a third option and the practitioner will have to make a very thoughtful decision about which of the three options is best for a given patient,” said Dr. Clyde Yancy, medical director of the Baylor Heart and Vascular Institute in Dallas and president of the American Heart Association.

Yancy said more information was needed on how the drug works to understand its side effects. “We dont want to change things overnight,” he said. “(But) this is another option.”

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http://www.escardio.org

http://www.nejm.org

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The Key to Bacterial Resistance May Be Your Stomach, Study Says

August 28, 2009 by Philbert Ross · Leave a Comment
Filed under: Drug 

Bacteria that fails to respond to standard treatments have been a growing concern since 2006, when methicillin-resistant Staphylococcus aureus, or MRSA, killed more people in the U.S. than HIV/AIDS, the report noted. The study by Harvard Medical School geneticist George Church found a plethora of genes in DNA from saliva and fecal samples that allowed resistance to antibiotics when added to the E. coli bacteria.

The report, published today in the journal Science, suggests that more research must be done on this newly discovered cluster to determine whether it is somehow adding to the difficulty of treating drug-resistant germs, said Stuart Levy, director for the Center for Adaptation Genetics and Drug Resistance at Tufts University in Boston.

“Now the question is why are they there, and what are they doing?” Levy, referring to the gut-based bacteria, said today in a telephone interview. “Were these there in cavemen, or are they fairly new and coming from somewhere else?” The paper doesnt say, said Levy, who wasnt involved in the research.

Initially, researchers were studying the resistance of soil bacteria to antibiotics and wanted to see if the soil was more dangerous than the human mouth, Church said.

“There was a lot more resistance in the uncultured bacteria,” said Church, in an Aug. 26 telephone interview from his Boston office.

New Technique

The scientists used multiple drugs at the same time to see if there was resistance. Usually, researchers examine one drug at a time, Church said. The new method of discovering antibiotic resistance may make it easier to diagnose a doctors guess that a germ is drug-resistant.

“Were getting closer to a time where you can just sequence all kinds of things and immediately know what organisms are involved,” Church said. That would be faster than the current method of guessing and checking.

While antibiotic use may not create resistant bacteria, it does make it easier for drug-resistant bugs to spread by wiping out susceptible germs, said Levy. Thats why its important to use antibiotics as theyre prescribed, without stockpiling or stopping treatment early. It would be interesting to see what happens to these gut bacteria when a person is given antibiotics, he said.

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