Study finds many patients shun free heart drugs (AP)

ORLANDO, Fla. � Give people free prescription drugs and many of them still won't bother to take their medicine.

Doctors were stunned to see that happen in a major study involving heart attack survivors. The patients were offered well-established drugs to prevent a recurrence of heart trouble, including cholesterol-lowering statins and medicines that slow the heart and help it pump more effectively.

"My God, we gave these people the medicines for free and only half took it," said one of the study's authors, Dr. Elliott Antman of Harvard-affiliated Brigham and Women's Hospital in Boston.

In fact, the researchers couldn't even give the stuff away: They had trouble just signing up patients to take part in the study.

Nevertheless, Aetna, the insurance company that footed the bill, thinks this approach will save money in the long run and plans to start offering certain heart drugs free to some patients. In the study, patients offered medicines at no cost suffered fewer heart problems and saved $500 on average over roughly a year.

It is no secret many Americans don't follow their doctors' instructions. In one survey, one-third said they didn't fill a prescription or used less medicine than they should because of cost. The researchers in this study wanted to see what would happen if they took cost out of the equation.

The results were disheartening.

"Adherence in America is miserable," lamented Dr. Eric Peterson of Duke University, who had no role in the study. He noted that only 10 percent of the patients were taking all the medicines they should one year after a heart attack.

The study was led by Dr. Niteesh Choudhry of Brigham and Women's, who presented the findings Monday at an American Heart Association conference in Florida. They also were published online by The New England Journal of Medicine.

The study did not examine why people didn't take their medications. But doctors know that some forget. Most of these drugs mean three pills a day or more, for the rest of a patient's life. Also, some of these medicines carry side effects such as fatigue, lightheadedness, muscle pains, cough, even sexual difficulties for men.

Still, heart attack survivors like Joan Ferraro, 53, of Freehold, N.J., said they can't imagine not taking prescribed medicines, though she sometimes forgets her pills over a weekend.

"Why would you want to go through something like that again? It was the most horrific experience of my life. I would never want another one," she said.

The study enrolled 5,855 Aetna members who had a drug plan as part of their benefits and were going home from the hospital after a heart attack. They were 53 years old on average, and three-fourths were men.

The researchers had hoped to recruit 7,500 patients but scaled back when so few signed on.

Preventive medicines were offered free to 2,845 patients and prescribed with the usual copayments for the rest. Copays for these drugs run around $50 a month.

Roughly a year later, the share of patients who filled their prescriptions ranged from 36 percent to 49 percent in the copay group, depending on the drug, and was only 4 to 6 percentage points higher in the group that had no copays.

Providing these medicines for free had a "distressingly modest" effect on patients' willingness to take them, Dr. Lee Goldman of Columbia University and Dr. Arnold Epstein of the Harvard School of Public Health wrote in an editorial in the medical journal.

The Commonwealth Fund, a foundation devoted to improving the health care system, helped pay for the study, and some of authors consult for insurance companies.

In the study, the total number of heart attacks, strokes, cases of chest pain or heart failure and other such problems was significantly lower in the group offered free medicine.

That meant that an additional 2 of every 100 people were spared such problems because they were offered free medicines. Doctors suspect the difference between the groups would have been greater if more people had actually filled their prescriptions.

Costs dropped 26 percent for patients in the free drug group compared with the others, partly because of fewer doctor visits, lab tests and hospitalizations.

After about a year, total medical costs for the insurer, including follow-ups, hospitalizations and doctor's appointments, averaged $69,997 for those with the usual coverage and $64,726 for those offered free medicines. That was not considered a significant difference statistically, but insurers looking at the bottom line would still view it as worthwhile.

Dr. Lonny Reisman, an author of the study and chief medical officer for Aetna, said the company plans to offer some of these drugs free or with a reduced copay to some heart attack survivors and is considering doing do so for other chronic conditions such as diabetes and chronic lung disease.

The study may persuade other insurers to do the same, Goldman and Epstein said.

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Online:

Heart Association: http://www.americanheart.org

New England Journal: http://www.nejm.org

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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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Free drugs can help prevent repeat heart attacks (AP)

ORLANDO, Fla. � A study finds that offering people free medicines after a heart attack can help cut the chances they will suffer another one. It also saves them about $500 for health care over the next year without raising costs for insurers.

However, doctors were shocked that only about half of these patients filled their prescriptions even though they got them for free.

Insurance company Aetna says it soon will start offering certain heart medicines such as cholesterol-lowering statin drugs for free or with a reduced copay to some heart attack survivors because of these results. Aetna helped sponsor the study,

The research was discussed Monday at an American Heart Association conference in Florida.

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Online:

Heart Association: http://www.americanheart.org

New England Journal: http://www.nejm.org

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Group predicts 522M could have diabetes by 2030 (AP)

GENEVA � The International Diabetes Federation predicts that one in 10 adults could have diabetes by 2030, according to their latest statistics. In a report issued on Monday, the advocacy group estimated that 522 million people would have diabetes in the next two decades, based on things like aging and demographic changes.

The figure includes both types of diabetes. The group expects the number of cases to jump by 90 percent even in Africa, where infectious diseases have previously been the top killer. Without including the impact of increasing obesity, the International Diabetes Federation said its figures were conservative.

According to the World Health Organization, there are about 346 million people worldwide with diabetes, with more than 80 percent of deaths occurring in developing countries. The agency projects diabetes deaths will double by 2030 and said the International Diabetes Federation's prediction was possible.

"It's a credible figure," said Gojka Roglic, head of WHO's diabetes unit. "But whether or not it's correct, we can't say."

Roglic said the projected future rise in diabetes cases was because of aging rather than the obesity epidemic. Most cases of diabetes are Type 2, the kind that mainly hits people in middle age, and is linked to weight gain and a sedentary lifestyle.

Roglic said a substantial number of future diabetes cases were preventable. "It's worrying because these people will have an illness which is serious, debilitating, and shortens their lives," she said. "But it doesn't have to happen if we take the right interventions."

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Online:

http://www.idf.org

http://www.who.int

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Study: New drug cuts deaths after heart attack (AP)

ORLANDO, Fla. � People recovering from a heart attack or severe chest pain are much less likely to suffer another heart-related problem or to die from one if they take a new blood-thinning drug along with standard anti-clotting medicines, a large study finds.

But this benefit had a cost: a greater risk of serious bleeding, usually in the digestive tract.

Still, some doctors said the drug, Xarelto, could become a new standard of care for up to a million Americans hospitalized each year for these conditions. A low dose of the drug substantially cut the risk of dying of any cause during the study.

"Mortality trumps everything," so a drug that improves survival is a win, said Dr. Paul Armstrong of the University of Alberta in Edmonton, Alberta, Canada.

He had no role in the study, discussed Sunday at an American Heart Association conference in Florida and published online by the New England Journal of Medicine. The study was sponsored by the drug's makers � Johnson & Johnson and Bayer Healthcare � and some researchers work or consult for the companies.

Xarelto is approved now at higher doses for preventing strokes in people with a common heart rhythm problem and for preventing blood clots after joint surgeries. It works in a different way than aspirin and older blood thinners do.

Dr. C. Michael Gibson of Harvard Medical School led a study testing it in 15,500 patients around the world who were leaving the hospital after a heart attack or severe chest pain from clogged arteries.

All were prescribed aspirin and an older blood thinner. One-third also received a low dose of Xarelto, and one-third got a higher dose. After about a year on average, nearly 11 percent of those on just the usual medicines had suffered a heart attack, heart-related death or a stroke versus less than 9 percent of those on either dose of Xarelto.

The lower dose proved better and safer. Fewer than 3 percent of those getting Xarelto died of any cause during the study, compared with 4.5 percent of those getting just the usual medicines. That translates to a 32 percent lower risk with Xarelto.

"Our study group has been going for 27 years and we've not seen that" magnitude of benefit from a drug like this, said Dr. Eugene Braunwald of Harvard-affiliated Brigham and Women's Hospital, the study's chairman.

To prevent a single heart-related death, heart attack or stroke, only 56 people would need to be treated for two years with a low dose of the drug, Gibson said.

However, serious bleeding was nearly four times more common with Xarelto, including bleeding in the head, a potentially disabling side effect. Fatal bleeding was no greater with Xarelto, though.

"There's a trade-off" between thinning the blood to prevent clots and raising the risk of bleeding, said Dr. Roger Blumenthal, preventive cardiology chief at Johns Hopkins Medical Center.

Cost is another issue. Usual care for these patients is changing with newer drugs that have come on the market since this study started. One � ticagrelor, sold as Brilinta in the U.S. and other brands elsewhere � also proved beneficial for similar patients taking just aspirin instead of pricier additional medicines used in the Xarelto study.

Xarelto's makers will seek approval to sell it for people like those in this study by the end of the year, a Johnson & Johnson spokesman said. A price has not been set, but the higher doses sold now for other purposes run more than $7 a day.

The good results with Xarelto contrast with the disappointing ones from an experimental blood thinner by Merck & Co., vorapaxar.

The drug flopped in a key late-stage study aimed at preventing heart attacks, strokes and other problems in people similar to those in the study of Xarelto � hospitalized for a heart attack or severe chest pain from clogged arteries.

Vorapaxar gave no significant benefit when added to standard medicines in a study of 13,000 patients around the world. It also raised the risk of serious bleeding.

Merck's senior vice president of cardiovascular research, Dr. Michael Mendelsohn, said results due out early next year from another large study testing vorapaxar in different types of patients will tell more about the drug's potential.

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Online:

Heart Association: http://www.americanheart.org

New England Journal: http://www.nejm.org

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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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Doctors: Test all kids for cholesterol by age 11 (AP)

CHICAGO � Every child should be tested for high cholesterol as early as age 9 � surprising new advice from a government panel that suggests screening kids in grade school for a problem more common in middle age.

The idea will come as a shock to most parents. And it's certain to stir debate.

The doctors on the expert panel that announced the new guidelines Friday concede there is little proof that testing now will prevent heart attacks decades later. But many doctors say waiting might be too late for children who have hidden risks.

Fat deposits form in the heart arteries in childhood but don't usually harden them and cause symptoms until later in life. The panel urges cholesterol screening between ages 9 and 11 � before puberty, when cholesterol temporarily dips � and again between ages 17 and 21.

The panel also suggests diabetes screening every two years starting as early as 9 for children who are overweight and have other risks for Type 2 diabetes, including family history.

The new guidelines are from an expert panel appointed by the National Heart, Lung and Blood Institute and endorsed by the American Academy of Pediatrics.

Some facts everyone agrees on:

� By the fourth grade, 10 to 13 percent of U.S. children have high cholesterol, defined as a score of 200 or more.

� Half of children with high cholesterol will also have it as adults, raising their risk of heart disease.

� One third of U.S. children and teens are obese or overweight, which makes high cholesterol and diabetes more likely.

Until now, cholesterol testing has only been done for kids with a known family history of early heart disease or inherited high cholesterol, or with risk factors such as obesity, diabetes or high blood pressure. That approach misses about 30 percent of kids with high cholesterol.

"If we screen at age 20, it may be already too late," said one of the guideline panel members, Dr. Elaine Urbina, director of preventive cardiology at Cincinnati Children's Hospital Medical Center. "To me, it's not controversial at all. We should have been doing this for years."

Elizabeth Duruz didn't want to take that chance. Her 10-year-old daughter, Joscelyn Benninghoff, has been on cholesterol-lowering medicines since she was 5 because high cholesterol runs in her family. They live in Cincinnati.

"We decided when she was 5 that we would get her screened early on. She tested really high" despite being active and not overweight, Duruz said. "We're doing what we need to do for her now, and that gives me hope that she'll be healthy."

Dr. Roger Blumenthal, who is preventive cardiology chief at Johns Hopkins Medical Center and had no role in the guidelines, said he thinks his 12-year-old son should be tested because he has a cousin with very high "bad" cholesterol who needed heart bypass surgery for clogged arteries in his 40s.

"I'm very supportive" of universal screening, he said. "The knowledge of their cholesterol numbers as well as their blood sugar levels can be very helpful for the physicians and their families about which patients are headed toward diabetes."

Dr. William Cooper, a pediatrics and preventive medicine professor at Vanderbilt University, said expanding the testing guidelines "would seem to me to make sense."

But he added: "One of the risks would be that we would be treating more kids, potentially, and we don't know yet the implications of what we're treating. Are we treating a number or are we treating a risk factor?"

That's the reason a different group of government advisers, the U.S. Preventive Services Task Force, concluded in 2007 that not enough is known about the possible benefits and risks to recommend for or against cholesterol screening for children and teens.

One of its leaders, Dr. Michael LeFevre, a family medicine specialist at the University of Missouri, said that for the task force to declare screening beneficial there must be evidence that treatment improves health, such as preventing heart attacks, rather than just nudging down a number � the cholesterol score.

"Some of the argument is that we need to treat children when they're 14 or 15 to keep them from having a heart attack when they're 50, and that's a pretty long lag time," he said.

The guidelines say that cholesterol drugs likely would be recommended for less than 1 percent of kids tested, and they shouldn't be used in children younger than 10 unless they have severe problems.

"We'll also continue to encourage parents and children to make positive lifestyle choices to prevent risk factors from occurring," steps such as diet and exercise, said Dr. Gordan Tomaselli, president of the American Heart Association. The group praised the guidelines and will host a presentation on them Sunday at its annual conference in Florida.

Cholesterol tests cost around $80 and usually are covered by health insurance. Several of the 14 doctors on the guidelines panel have received consulting fees or have had other financial ties to makers of cholesterol medicines.

Typically, cholesterol drugs are used indefinitely but they are generally safe, said Dr. Sarah Blumenschein, director of preventive cardiology at Children's Medical Center in Dallas, who had no role in the guidelines but supports them.

"You have to start early. It's much easier to change children's behavior when they're 5 or 10 or 12" than when they're older, she said.

The guidelines also say doctors should:

� Take yearly blood pressure measurements for children starting at age 3.

� Start routine anti-smoking advice when kids are ages 5 to 9, and counsel parents of infants not to smoke in the home.

� Review infants' family history of obesity and start tracking body mass index, or BMI, a measure of obesity, at age 2.

The panel also suggests using more frank terms for kids who are overweight and obese than some government agencies have used in the past. Children whose BMI is in the 85th to 95th percentile should be called overweight, not "at risk for overweight," and kids whose BMI is in the 95th percentile or higher should be called obese, not "overweight � even kids as young as age 2, the panel said.

"Some might feel that `obese' is an unacceptable term for children and parents," so doctors should "use descriptive terminology that is appropriate for each child and family," the guidelines recommend.

They were released online Friday by the journal Pediatrics.

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Marchione reported from Milwaukee and can be followed at http://twitter.com/MMarchioneAP

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Online:

Guidelines: http://tinyurl.com/7csojas

NHLBI panel: http://www.nhlbi.nih.gov/guidelines/cvd_ped/index.htm

Cholesterol info: http://tinyurl.com/23dtxvo

and http://www.nhlbi.nih.gov/health/public/heart/index.htm(hash)chol

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Panel: Every child should get a cholesterol test (AP)

CHICAGO � Doctors are recommending that every child be tested for high cholesterol by around age 10 to prevent heart disease later in life.

The advice is in new guidelines from an expert panel appointed by the federal government. These experts say that current testing of children with a family history of heart disease is missing too many kids, and more are at risk because of the rising obesity epidemic.

Doctors say that children should be tested before puberty because cholesterol dips during that time of hormone change and rises later.

The guidelines were released Friday by the journal Pediatrics.

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