Study New heart pill may rival Plavix
Sun, 04 Nov 2007 18:59:33 GMT
By MARILYNN MARCHIONE, AP Medical Writer
ORLANDO, Fla. - A new blood thinner proved better than Plavix, one of the world's top-selling drugs, at preventing heart problems after procedures to open clogged arteries, doctors reported Sunday. But the new drug also raised the risk of serious bleeding.
People given the experimental drug, prasugrel, were nearly 20 percent less likely to suffer one of the problems in a combined measure — heart attack, stroke or heart-related death — than those given Plavix, a drug that millions of Americans take to prevent blood clots that cause these events.
However, for each heart-related death that prasugrel prevented, compared to Plavix, almost one additional bleeding death occurred.
"There is a price to pay" for greater effectiveness, Dr. Deepak Bhatt, a Cleveland Clinic cardiologist, wrote in an editorial accompanying the results, which were published online by The New England Journal of Medicine and presented at an American Heart Association conference in Florida.
Still, many doctors said that on balance, the new drug comes out ahead, and offers great promise as a more potent alternative to Plavix, which costs $4 a day and does not work for many patients.
"I'm encouraged by the results" and think prasugrel should win Food and Drug Administration approval because it so dramatically cuts non-fatal heart attacks, said the Cleveland Clinic's Dr. Steven Nissen, a frequent government adviser.
Doctors can sort out who might most benefit from it, such as diabetics, and who might face too much bleeding risk to use it, like the elderly, people who previously had strokes and those with kidney problems, he said.
Doctors also were waiting for prasugrel's makers to clarify why they stopped two small studies of it a week ago. They said it was due to dosing problems but did not explain.
Prasugrel is being developed by Indianapolis-based Eli Lilly and Co. and a Japanese firm, Daiichi Sankyo Co. It could be a hugely important drug, and the study has been one of the most-watched tests of a novel heart medication in recent years.
Like Plavix, prasugrel prevents blood components called platelets from sticking together and forming a clot. Anti-platelet drugs are advised for most people with stents — tiny mesh tubes that keep arteries open after balloon angioplasty, an artery-clearing procedure that more than a million Americans have each year.
Plavix, sold by Sanofi-Aventis SA and Bristol-Myers Squibb Co., has been the most effective drug of this type. More than 70 million people have taken it since it went on sale a decade ago.
Plavix had 18.6 million prescriptions and nearly $3 billion in U.S. sales last year, according to IMS Health, a healthcare information firm. Worldwide sales were nearly $6 billion.
The study comparing it to prasugrel involved 13,608 patients from 30 countries and was led by Dr. Elliott Antman at Harvard Medical School and Brigham and Women's Hospital in Boston. Prasugrel's makers paid for the study; many of the researchers work or consult for them.
Study participants were having angioplasty due to heart attacks or blockages causing sudden or worsening chest pain, and were randomly assigned to one drug or the other for six to 15 months.
The results: about 12 percent of people taking Plavix but only 10 percent on prasugrel suffered heart attacks, strokes or heart-related deaths — a 20 percent reduction in risk. Only 1.1 percent on the new drug developed blood clots in stents versus 2.4 percent on Plavix — a 52 percent lower risk. Prasugrel also worked faster than Plavix and showed more effectiveness at the first checkpoint — three days.
However, major bleeding occurred in 2.4 percent of those on prasugrel versus 1.8 percent of those on Plavix. This included brain or gastrointestinal bleeding, or after falls. Fatal bleeding was uncommon, but four times more frequent with the new drug.
Results hinted that some people might be in greater danger — those who had a previous stroke, were elderly, or weighed less than 132 pounds.
These signs are why prasugrel's makers suspended two small studies a week ago to see whether such patients should be included in the study or should get a lower dose, said Dr. Anthony Ware of Eli Lilly.
"It was a precaution ... because of a risk of a safety problem rather than an actual one," he said.
Lilly will conduct another big study of prasugrel in people not having angioplasty but on medications because they are at risk of having a heart attack, Ware said.
That 10,000-person study will be led by Dr. E. Magnus Ohman at Duke University Medical Center.
In the study reported on Sunday, "the benefit clearly outweighs the risk" for most patients, Ohman said.
Bhatt of Cleveland Clinic noted that even aspirin — which is widely recommended to prevent clots and was prescribed to all patients in this study — carries a risk of bleeding.
Dr. Spencer King, a heart specialist at Piedmont Hospital in Atlanta and spokesman for the American College of Cardiology, was on the safety monitoring committee for the study. He said prasugrel would be "a little bit of a tough sell" to doctors who are comfortable with using Plavix, but that competition could give patients drugs more closely matched to their needs.
"We've had one size fits all ... now we'll have two choices," King said.
Dr. Harlan Krumholz, a Yale University cardiologist with no role in the study, noted that "in absolute numbers, for every 1,000 people you treat, you'd save a lot more heart events than you'd cause bleeds," because heart problems are more common.
Cost also keeps many people from taking Plavix now. Prasugrel's makers have not said what it would cost, but "if they start competing on price, it could be a boon for the health care system," Krumholz said.
___On the Net:
Heart Association: http://www.americanheart.org
New England Journal: http://www.nejm.org
Democrats seek better care for veterans
Sun, 04 Nov 2007 08:38:47 GMT
By MATTHEW DALY, Associated Press Writer
WASHINGTON - A Democratic senator on Saturday accused President Bush of "hollow talk" in support of U.S. troops returning from Iraq and Afghanistan, and said the Bush administration has not done nearly enough to provide veterans with the care they need.
Sen. Patty Murray, D-Wash., said, "The president can call on Democrats to follow him in lockstep all he wants, but when it comes to caring for our veterans, we are not about to start taking advice from George Bush."
Bush scolded Democrats on Thursday for combining spending bills for defense and veterans programs with one for labor, health and education matters. Republicans consider the bill bloated.
The president also lamented that his emergency spending request for the wars in Iraq and Afghanistan still languishes.
Murray, delivering the Democrats' weekly radio address, accused Bush of underfunding the Veterans Affairs Department and said thousands of troops returning from Iraq and Afghanistan are "stuck in a bureaucratic nightmare" and aren't getting the health care they need.
The senator said the number of uninsured veterans has skyrocketed in recent years. The administration also lost the personal data of millions of veterans and failed to correct shoddy outpatient treatment and poor living conditions at Walter Reed Army Medical Center in Washington, she said.
Murray, the fourth-ranking Democratic senator, defended a Democratic bill that pays for veterans programs and other priorities such as education and medical research.
The bill provides thousands of new case workers to help reduce delays for treatment, improves conditions at Walter Reed and other facilities and invests in new ways to treat ailments such as post-traumatic stress disorder, she said.
Death rate for Afghan kids drops
Sun, 04 Nov 2007 18:22:30 GMT
By JASON STRAZIUSO, Associated Press Writer
KABUL, Afghanistan - Six years after the Taliban's ouster, medical care in Afghanistan has improved such that nearly 90,000 children who would have died before age 5 in 2001 will survive this year, Afghan President Hamid Karzai said Sunday.
Saddled for years with one of the world's worst records on child health, Afghanistan has seen access to health care rise dramatically since the U.S.-led invasion.
Thousands of health clinics have been built across the country, and the Afghan government and aid agencies have trained tens of thousands of doctors, vaccinators and health volunteers who now reach into some of the country's most remote areas.
Access to health care for Afghans has jumped from 8 percent of the population in the 1990s to close to 85 percent today, thanks in large part to efforts by USAID, the World Bank and the European Commission.
The under-5 child mortality rate in Afghanistan has declined from an estimated 257 deaths per 1,000 live births in 2001 to about 191 per 1,000 in 2006, a 25-percent drop, the Ministry of Public Health said, relying on a new study from Johns Hopkins University.
"This is certainly very positive news," said the U.N. spokesman in Afghanistan, Adrian Edwards. "To come from such low life expectancy to see this improvement does appear to be an indication that the work on the health sector here is beginning to pay off."
President Hamid Karzai, surrounded by smiling Afghan children at a news conference in Kabul, thanked aid organizations and health workers for their work. He said 89,000 children will be saved each year because of the improved health care.
Still, Afghanistan faces severe problems. Even with the improvements, almost one in five Afghan children will die before age 5, translating into 250,000 childhood deaths a year, mostly from malnutrition, diarrhea, tuberculosis and malaria, said Health Minister Mohammad Amin Fatimi.
Childhood immunizations have risen dramatically, but Afghan infants make up the bulk of the country's high child mortality rate, said Tariq Ihsan of Save the Children.
"Many newborns are dying because they don't have access to immediate health care. I think that's a real challenge for Afghanistan. They need to ask, 'Are we saving enough newborns?'" Ihsan said.
Still, deaths of Afghan children who don't reach their first birthday have dropped from 165 per 1,000 in 2001 to 129 per 1,000 today, a drop of some 22 percent, Edwards said.
Afghanistan's child mortality rate, from birth to age 5, has been among the world's worst. Before recent improvements, only Sierra Leone, with 283 child deaths per 1,000 live births, Angola with 260 and Niger at 259 ranked below Afghanistan's 257, UNICEF said in a 2006 report.
By comparison, the United States has eight under-5 child deaths per 1,000 births. Singapore and Iceland, with three childhood deaths per 1,000, topped the rankings.
USAID has spent $309 million since 2002 to improve health services in 13 of Afghanistan's northern provinces, said Julie Fossler, a spokeswoman for USAID.
More than 670 clinics have been constructed and 10,000 health care workers trained there, and more than 7 million children have been vaccinated for polio, according to USAID information.
The UNICEF report noted that, like Afghanistan, most of the countries with the worst child mortality rates have suffered from armed conflict.
