CHICAGO (Reuters) - Johnson & Johnson's blood clot preventer Xarelto proved as effective as and safer than standard treatments against blood clots of the lung in a big study, possibly paving the way for it to become the eventual preferred treatment for the third most common cause of deaths in hospitals.
Researchers and J&J officials on Monday said the 4,833-patient study showed Xarelto was as effective as customary dual therapy -- injections of the clot-buster heparin given about the same time as the blood-thinning pill warfarin -- for treating the clots and preventing new lung clots or dangerous clots in the legs that can break free and cause lung clots. The vast majority of patients were treated for more than six months.
The largest clinical trial ever conducted among lung-clot patients also showed that those taking Xarelto, also known by its chemical name rivaroxaban, experienced only half the number of major bleeding incidents, largely brain hemorrhages, as patients receiving the heparin/warfarin combination.
Brain bleeding is one of the most worrisome side effects of warfarin, the active ingredient of rat poison that has been a mainstay anti-coagulant for more than half a century.
"Rivaroxaban is just as good as standard treatment for pulmonary embolism -- these data are pretty convincing -- and this is an oral-only approach, which makes it very simple," said Dr. Harry Buller, a professor of vascular medicine at the Academic Medical Center in Amsterdam, who led the trial.
In the J&J-sponsored trial, 10.3 percent of patients taking Xarelto had major or minor bleeding, compared with 11.4 percent of those taking heparin and warfarin, Buller said. He said 1.1 percent of patients taking Xarelto experienced major bleeding, versus 2.2 percent on standard dual therapy.
Buller presented the trial results on Monday at the annual scientific sessions of the American College of Cardiology in Chicago.
"Xarelto has the potential to become the new standard of care," Paul Burton, cardiovascular medical leader at J&J's Janssen division, said in an interview. "It may offer the opportunity for a single drug that doesn't require monitoring to be used in acute and long-term treatment of pulmonary embolism."
Based on the favorable findings, J&J said it plans in the second quarter to ask U.S. regulators to approve Xarelto for lung clots and leg clots.
Morningstar analyst Damien Conover said the new indications, if approved, could eventually bring an additional $250 million to $500 million in annual revenue for Xarelto. He said that would pale, however, in comparison with expected sales of the medicine for patients with atrial fibrillation.
Lung clots develop in an estimated 600,000 Americans a year and kill as many as 100,000 of them. By blocking vital blood vessels, they often kill within less than an hour after symptoms develop. Because immobility is a major cause of lung clots, hospitalized patients are at particular risk of developing them.
Xarelto, which J&J developed in partnership with German drugmaker Bayer AG, is already approved to reduce the risk of blood clots in the legs and lungs of people who have had knee or hip replacement surgery. It is also approved to prevent strokes among people with irregular heartbeats, called atrial fibrillation.
Xarelto, like Eliquis from Bristol-Myers Squibb Co and Pfizer Inc, works by blocking a protein called Factor Xa involved in the clotting process. Neither of the new drugs carries the onerous demands of warfarin, such as the need for regular blood monitoring and strict avoidance of some foods.
"The reason people look for alternatives (to warfarin) is that it's a nightmare to give," Buller said. "Rivaroxaban makes things easier for everybody -- patients and physicians."
Although Eliquis is approved in Europe to prevent blood clots after hip and knee replacements, it is not approved to treat lung clots. It is awaiting U.S. approval to prevent strokes in atrial fibrillation patients, by far the biggest commercial opportunity for the new crop of blood clot preventers.
Monday, March 26, 2012
Sunday, March 25, 2012
Raisins and soy may ward off high blood pressure
By Jean-Louis Santini, AFP
Eating raisins and soy appears to help ward off high blood pressure, a key risk factor in heart disease, according to two studies presented at a major US cardiology conference on Sunday.
Munching on a handful of raisins three times a day helped people with slightly elevated blood pressure lower their numbers after several weeks, said one of the studies presented at the American College of Cardiology conference.
The randomized clinical trial -- believed to be the first formal measurement of raisins' benefits on blood pressure -- involved 46 people with a condition known as pre-hypertension.
That means their blood pressure ranged from 120 over 80 millimeters of mercury (mm Hg) to 139 millimeters of mercury over 89 mm Hg, or just higher than normal.
Compared to people who snacked on cookies or crackers, the raisin-eating group saw significant drops in blood pressure, in some cases lowering the top number, or systolic pressure, by 10.2, or seven percent over the 12-week study.
Researchers are not sure exactly why the raisins work so well, but they think it may have to do with the high level of potassium in the shriveled, dried grapes.
"Raisins are packed with potassium, which is known to lower blood pressure," said lead investigator Harold Bays, medical director of Louisville Metabolic and Atherosclerosis Research Center.
"They are also a good source of antioxidant dietary fiber that may favorably alter the biochemistry of blood vessels, causing them to be less stiff, which in turn, may reduce blood pressure."
A handful of about 60 raisins contains a gram of fiber and 212 milligrams of potassium. Raisins are often recommended as part of a high-fiber, low-fat diet to reduce blood pressure.
A second study on soy showed that daily intake of foods like tofu, peanuts and green tea helped lower blood pressure in more than 5,100 white and African American people aged 18-30.
The study began in 1985 and was based on self-reported data about the food the participants ate.
Those who consumed about 2.5 or more milligrams of isoflavones, a key component in soy, per day had significantly lower systolic blood pressure -- an average of 5.5 mmHg lower -- than those who ate less than 0.33 mg per day.
That daily level should not be hard for most people to reach -- a glass of soy milk contains about 22 mg of isoflavones, or nearly 10 times the amount needed to see an effect, according to the research.
"Our results strongly suggest a blood pressure benefit for moderate amounts of dietary isoflavone intake in young black and white adults," said Safiya Richardson, a graduating medical student at Columbia University's College of Physicians and Surgeons and the study's lead investigator.
"Our study is the first to show a benefit in African Americans, who have a higher incidence of high blood pressure, with an earlier onset and more severe end-organ damage."
Eating soy could be a way for people with slightly elevated blood pressure to avoid progressing to high blood pressure, and potentially ward off the need to take medications, she added.
"Any dietary or lifestyle modification people can easily make that doesn't require a daily medication is exciting, especially considering recent figures estimating that only about one third of American hypertensives have their blood pressure under control."
Soy and the isoflavones it contains work by boosting enzymes that create nitric oxide, which in turns helps to widen blood vessels and reduce blood pressure.
"Based on our results and those of previous studies, we would encourage the average adult to consider including moderate amounts of soy products in a healthy, well-balanced diet to reduce the chances of developing high blood pressure," Richardson said.
Eating raisins and soy appears to help ward off high blood pressure, a key risk factor in heart disease, according to two studies presented at a major US cardiology conference on Sunday.
Munching on a handful of raisins three times a day helped people with slightly elevated blood pressure lower their numbers after several weeks, said one of the studies presented at the American College of Cardiology conference.
The randomized clinical trial -- believed to be the first formal measurement of raisins' benefits on blood pressure -- involved 46 people with a condition known as pre-hypertension.
That means their blood pressure ranged from 120 over 80 millimeters of mercury (mm Hg) to 139 millimeters of mercury over 89 mm Hg, or just higher than normal.
Compared to people who snacked on cookies or crackers, the raisin-eating group saw significant drops in blood pressure, in some cases lowering the top number, or systolic pressure, by 10.2, or seven percent over the 12-week study.
Researchers are not sure exactly why the raisins work so well, but they think it may have to do with the high level of potassium in the shriveled, dried grapes.
"Raisins are packed with potassium, which is known to lower blood pressure," said lead investigator Harold Bays, medical director of Louisville Metabolic and Atherosclerosis Research Center.
"They are also a good source of antioxidant dietary fiber that may favorably alter the biochemistry of blood vessels, causing them to be less stiff, which in turn, may reduce blood pressure."
A handful of about 60 raisins contains a gram of fiber and 212 milligrams of potassium. Raisins are often recommended as part of a high-fiber, low-fat diet to reduce blood pressure.
A second study on soy showed that daily intake of foods like tofu, peanuts and green tea helped lower blood pressure in more than 5,100 white and African American people aged 18-30.
The study began in 1985 and was based on self-reported data about the food the participants ate.
Those who consumed about 2.5 or more milligrams of isoflavones, a key component in soy, per day had significantly lower systolic blood pressure -- an average of 5.5 mmHg lower -- than those who ate less than 0.33 mg per day.
That daily level should not be hard for most people to reach -- a glass of soy milk contains about 22 mg of isoflavones, or nearly 10 times the amount needed to see an effect, according to the research.
"Our results strongly suggest a blood pressure benefit for moderate amounts of dietary isoflavone intake in young black and white adults," said Safiya Richardson, a graduating medical student at Columbia University's College of Physicians and Surgeons and the study's lead investigator.
"Our study is the first to show a benefit in African Americans, who have a higher incidence of high blood pressure, with an earlier onset and more severe end-organ damage."
Eating soy could be a way for people with slightly elevated blood pressure to avoid progressing to high blood pressure, and potentially ward off the need to take medications, she added.
"Any dietary or lifestyle modification people can easily make that doesn't require a daily medication is exciting, especially considering recent figures estimating that only about one third of American hypertensives have their blood pressure under control."
Soy and the isoflavones it contains work by boosting enzymes that create nitric oxide, which in turns helps to widen blood vessels and reduce blood pressure.
"Based on our results and those of previous studies, we would encourage the average adult to consider including moderate amounts of soy products in a healthy, well-balanced diet to reduce the chances of developing high blood pressure," Richardson said.
Thursday, March 22, 2012
Smoking deaths triple over decade: tobacco report
LONDON (Reuters) - Tobacco-related deaths have nearly tripled in the past decade and big tobacco firms are undermining public efforts that could save millions, a report led by the health campaign group the World Lung Foundation (WLF) said on Wednesday.
In the report, marking the tenth anniversary of its first Tobacco Atlas, the WLF and the American Cancer Society said if current trends continue, a billion people will die from tobacco use and exposure this century - one person every six seconds.
Tobacco has killed 50 million people in the last 10 years, and tobacco is responsible for more than 15 percent of all male deaths and 7 percent of female deaths, the new Tobacco Atlas report found. (www.tobaccoatlas.org)
In China, tobacco is already the number one killer - causing 1.2 million deaths a year - and that number is expected to rise to 3.5 million a year by 2030, the report said.
That is part of a broader shift, with smoking rates in the developed world declining but numbers growing in poorer regions, said Michael Eriksen, one of the report's authors and director of the Institute of Public Health at Georgia State University.
"If we don't act, the projections for the future are even more morbid. And the burden of death caused by tobacco is increasingly one of the developing world, particularly Asia, the Middle East and Africa," he said in an interview.
Almost 80 percent of people who die from tobacco-related illnesses now come from low- and middle-income countries. In Turkey, 38 percent of male deaths are from smoking-related illnesses, though smoking also remains the biggest killer of American women too.
WLF's chief executive Peter Baldini accused the tobacco industry of thriving on ignorance about the true effect of smoking and "misinformation to subvert health policies that could save millions".
The report said the industry had stepped up its fight against anti-tobacco policies, launching legal challenges and seeking to delay or stop the introduction of plain packaging, legislation banning smoking in public places, advertising bans and health warnings on packets.
The world's six biggest tobacco firms made $35.1 billion in profits in 2010 - equal to the combined earnings of Coca-Cola, Microsoft and McDonald's, the report said.
Smoking causes lung cancer as well as several other chronic pulmonary diseases and is a major risk factor in heart disease, the world's number one killer.
More than 170 countries have signed up to a World Health Organization-led convention committing them to cut smoking rates, limiting exposure to second-hand smoke, and curbing tobacco advertising and promotion.
WHO director general Margaret Chan said thanks in part to that convention, 1.1 billion people have in the past two years become covered by at least one measure designed to curb tobacco use. She added, however, that the battle was far from over and urged more countries to fight the industry.
"We must never allow the tobacco industry to get the upper hand," she said in a foreword to the report. "Tobacco is a killer. It should not be advertised, subsidized or glamorized."
(Reporting by Kate Kelland; Editing by Ben Harding)
In the report, marking the tenth anniversary of its first Tobacco Atlas, the WLF and the American Cancer Society said if current trends continue, a billion people will die from tobacco use and exposure this century - one person every six seconds.
Tobacco has killed 50 million people in the last 10 years, and tobacco is responsible for more than 15 percent of all male deaths and 7 percent of female deaths, the new Tobacco Atlas report found. (www.tobaccoatlas.org)
In China, tobacco is already the number one killer - causing 1.2 million deaths a year - and that number is expected to rise to 3.5 million a year by 2030, the report said.
That is part of a broader shift, with smoking rates in the developed world declining but numbers growing in poorer regions, said Michael Eriksen, one of the report's authors and director of the Institute of Public Health at Georgia State University.
"If we don't act, the projections for the future are even more morbid. And the burden of death caused by tobacco is increasingly one of the developing world, particularly Asia, the Middle East and Africa," he said in an interview.
Almost 80 percent of people who die from tobacco-related illnesses now come from low- and middle-income countries. In Turkey, 38 percent of male deaths are from smoking-related illnesses, though smoking also remains the biggest killer of American women too.
WLF's chief executive Peter Baldini accused the tobacco industry of thriving on ignorance about the true effect of smoking and "misinformation to subvert health policies that could save millions".
The report said the industry had stepped up its fight against anti-tobacco policies, launching legal challenges and seeking to delay or stop the introduction of plain packaging, legislation banning smoking in public places, advertising bans and health warnings on packets.
The world's six biggest tobacco firms made $35.1 billion in profits in 2010 - equal to the combined earnings of Coca-Cola, Microsoft and McDonald's, the report said.
Smoking causes lung cancer as well as several other chronic pulmonary diseases and is a major risk factor in heart disease, the world's number one killer.
More than 170 countries have signed up to a World Health Organization-led convention committing them to cut smoking rates, limiting exposure to second-hand smoke, and curbing tobacco advertising and promotion.
WHO director general Margaret Chan said thanks in part to that convention, 1.1 billion people have in the past two years become covered by at least one measure designed to curb tobacco use. She added, however, that the battle was far from over and urged more countries to fight the industry.
"We must never allow the tobacco industry to get the upper hand," she said in a foreword to the report. "Tobacco is a killer. It should not be advertised, subsidized or glamorized."
(Reporting by Kate Kelland; Editing by Ben Harding)
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