Archive for February, 2010

Uninsured Trauma Patients More Likely to Die: Study

Thursday, February 25th, 2010

Americans without health insurance are more likely to die after admission to the hospital with trauma injuries than those who are insured, new research suggests.

“After admission to a hospital, trauma patients can have worse outcomes based on insurance status,” the study authors wrote. “This concerning finding warrants more rigorous investigation to determine why such variation in mortality would exist in a system where equivalent care is not only expected but mandated by law.”

Dr. Heather Rosen, from Children’s Hospital Boston and Harvard Medical School, and colleagues analyzed statistics from the National Trauma Data Bank, which has tracked 2.7 million trauma patients admitted to over 900 U.S. trauma centers. The researchers looked at 687,091 adult patients admitted between 2002 and 2006.

Uninsured patients were more likely to die than insured patients even when researchers tried to adjust the statistics to eliminate the influence of factors such as gender, age and race that might throw off the results.

“Treatment often is initiated before payer status is recognized; thus, this provokes the question of whether differences exist in processes of care during the hospital stay,” the study authors wrote. “We can only speculate as to the mechanism of the disparities we have exposed; the true causes are still unclear. Although the lack of insurance may not be the only explanation for the disparity in trauma mortality, the accidental costs of being uninsured in the United States today may be too high to continue to overlook.”

Public Health Advisory: Updated Safety Information about a drug interaction between Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC)

Thursday, February 18th, 2010

The U.S. Food and Drug Administration (FDA) has new data showing that omeprazole (Prilosec/Prilosec OTC)—a medicine used to reduce stomach acid—reduces the anti-blood clotting effect of clopidogrel (Plavix) by almost half when these two medicines are taken by the same patient. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. This effect is called a drug interaction and it occurs because omeprazole blocks the conversion of clopidogrel into its active form.

Since clopidogrel can cause bleeding in the stomach, medications like omeprazole may be used in combination to reduce the production of stomach acid, and prevent stomach bleeding. Omeprazole is available by prescription and as an over-the-counter (OTC) medication to treat frequent heartburn

FDA wants to emphasize the following information for patients using clopidogrel:
Patients using clopidogrel should consult with their healthcare provider if they are currently taking or considering taking omeprazole, including Prilosec OTC.
Both clopidogrel and omeprazole can provide significant benefits to patients, and patients should always consult with their healthcare professional before starting or stopping any medication.
It is very important that patients talk with their healthcare professional about any over-the-counter (OTC) drugs they are taking before starting or while using clopidogrel

Patients who use clopidogrel and need a medication to reduce stomach acid can use antacids (such as Maalox or Mylanta) and most acid reducers, such as Zantac (ranitidine), Pepcid (famotidine), or Axid (nizatidine) because the FDA does not believe that these medicines will interfere with the anti-clotting activity of clopidogrel. However, Tagamet and Tagamet HB (cimetidine) should not be used. Ranitidine and famotidine are available by prescription and OTC and antacids are available OTC.

The manufacturers of clopidogrel have agreed to look at other possible drug interactions with clopidogrel. In the meantime, the clopidogrel label will be updated with new warnings on omeprazole and other drugs that could interact with clopidogrel in the same way. When more information becomes available, FDA will communicate any additional recommendations or conclusions on the use of clopidogrel.

U.S. Scores a ‘D’ on Preterm Birth Report Card

Thursday, February 11th, 2010

The United States is doing a poor job of reducing preterm births, according to a new report, which found Mississippi, Alabama and Louisiana have especially high numbers of early, life-threatening deliveries.

Vermont and New Hampshire were the only states with a preterm birth rate under 10 percent, while in Louisiana, Alabama and Mississippi, the premature birth rate ranged from 16.5 to 18.3 percent.

Each year, the March of Dimes ranks each state according to its rate of premature births — babies born before 37 weeks of gestation. Preterm births contribute to infant mortality and can put children at risk for lifelong problems, including cerebral palsy and developmental disabilities.

The U.S. premature birth rate was 12.7 percent in 2007 (the year the birth data was collected), nearly twice the goal of 7.6 percent set by the federal government’s Healthy People 2010 campaign.

In the March of Dimes report, states were graded on how closely they came to meeting the preterm birth objective. No state earned an “‘A” and Vermont was the only state to earn a “B” grade. All the rest earned grades ranging from “C” to “F” and the nation overall earned a “D” grade.

Still, it wasn’t all bad news. Seven states — Arizona, Indiana, Missouri, Idaho, Massachusetts, Utah and Wisconsin — improved their grade year over year. However, Ohio’s and Oklahoma’s grades dropped.

“This year, we found a slight reduction in the rate of preterm birth,” said Jennifer Howse, March of Dimes president. “Overall, that’s encouraging. But as any good epidemiologist will tell you, one year does not a trend make.”

Howse said she was concerned that the recession, including job losses and loss of medical benefits, could reverse the trend when the birth statistics from 2008 and 2009 are analyzed. “I think we’re moving in the right direction, but I am worried we are going to see slippage,” Howse said.

The states that improved did so by targeting three key risk factors for premature birth: smoking during pregnancy, lack of health insurance for pregnant women, and elective inductions or cesarean sections done during the “late pre-term,” or between 34 to 36 weeks’ gestation. The March of Dimes recommends babies not be delivered by elective C-section or induction before 39 weeks.

Lack of health insurance keeps some women from getting prenatal care, which means health conditions that could affect the pregnancy, such as underlying infections, obesity, poor nutrition, diabetes, high blood pressure and periodontal disease, are less likely to be caught and treated.

About 33 states and the District of Columbia reduced the number of women of childbearing age who smoke; 21 states and Washington, D.C. insured more women year over year; while 27 states, Washington, D.C. and Puerto Rico lowered the late pre-term birth rate.

Though the target areas are important, Howse said physicians still don’t know all of the reasons why babies are born prematurely.

“We probably understand roughly half the risks that are associated with preterm birth, but the other half are very poorly understood from a biological standpoint,” Howse said

Dr. Harold Perl, a senior neonatologist at Hackensack University Medical Center in Hackensack, N.J., said that physicians in the United States are very skilled at taking care of premature babies after they are born, but more emphasis needs to be placed on preventing premature births in the first place.

“Overall, it’s a very important point that the March of Dimes is making,” Perl said. “We have to look not only at how well we take care of our premature babies, but what we can do to prevent mothers from having premature babies.”

The report didn’t explore some significant geographic variations in causes for preterm birth factors that need to be considered when designing education or intervention programs, Perl said. New Jersey and Missouri, for example, had roughly the same rate of premature births, 12.7 percent and 12.5 respectively.

But in Missouri, about 28.4 percent of expectant mothers smoked, ranking it among the states with the highest maternal smoking rates, compared to 12.8 percent in New Jersey, ranking it among the lowest.

In New Jersey, a key reason for premature births is the number of twins, triplets and higher-order multiples being born as a result of in vitro fertilization procedures, Perl said. Twins are delivered on average, at about 35 weeks, triplets at 33 weeks, and quadruplets at 29 weeks, according to the American College of Obstetricians and Gynecologists.

Perl recommends fertility doctors follow American Society for Reproductive Medicine guidelines that call for implanting no more than two embryos at a time for women under 35, and no more than three for women with poorer chances of becoming pregnant.

About 540,000 babies are born prematurely in the United States each year, costing more than $26 billion in additional health care costs.

It’s one of the reasons that the United States is ranked 30th in infant mortality, behind most other developed nations, according to a U.S. National Center for Health Statistics report issued earlier this month. Premature births have risen 36 percent since 1984, according to the report.

Alternative to Warfarin May Cut Risk of Bleeding

Wednesday, February 3rd, 2010

The anti-clotting drug dabigatran etexilate (Pradaxa) may be more effective and safer than warfarin at preventing clots and stroke in patients with atrial fibrillation, a new Swedish study has found.

Warfarin is effective in preventing blood clots that can cause stroke in patients with atrial fibrillation (abnormal heart rhythm) and other diseases, but the drug has a narrow therapeutic range in which it prevents strokes but doesn’t cause bleeding, according to the researchers. This means that effective warfarin treatment requires regular laboratory monitoring to ensure warfarin levels remain in the range that lowers the risk of stroke without increasing the risk of bleeding.

This study included 18,113 atrial fibrillation patients in 44 countries who were randomly selected to receive either oral treatment with standard warfarin (6,022 patients) or dabigatran etexilate at either 110 milligrams (6,015 patients) or 150 milligrams (6,076 patients).

After one to three years of follow-up, 1.69 percent of patients in the warfarin group suffered a stroke or serious clot per year, compared with 1.53 percent and 1.11 percent of patients taking 110-milligram and 150-milligram doses of dabigatran etexilate, respectively, the study authors, from University Hospital in Uppsala, found.

Rates per year of major bleeding were 3.36 percent in the warfarin group and 2.71 percent and 3.11 percent for patients taking 110-milligram and 150-milligram doses of dabigatran etexilate, respectively.

The study was scheduled to be presented Sunday at the American Heart Association’s annual meeting in Orlando, Fla.

The patients in the study were an average age of 72 and included some who’d suffered a prior stroke (13 percent), patients with high blood pressure (79 percent), those who’d never taken an oral anti-clotting drug for more than two months (50.4 percent), and those who weren’t using an oral anti-clotting drug when they enrolled in the study (34 percent).

Dabigatran etexilate is approved for use in Canada and Europe but not in the United States.