Clinical and Industry News II

HIV Drugs Don’t Increase Heart Risk Fears that the drugs used to treat people infected with HIV cause an increased risk of heart attack and stroke appear to be unfounded, at least over the short term, researchers report. While it is possible there is a long-term risk, it is overwhelmed by the benefits of drug treatment, says study author Dr. Samuel A. Bozzette, director of health research at the San Diego Veterans Affairs Medical Center. If you look at the total risk of death or heart attack, people will still be enormously better off with treatment, Bozzette says. The fears have been aroused because the antiretroviral drugs given to HIV-infected people raise blood levels of cholesterol, increase resistance to insulin and increase body fat. Bozzette and his colleagues did a study of the nearly 37,000 patients treated for HIV infection at Veterans Affairs health-care centers between 1993 and 2001. They found a major drop 75 percent in overall mortality, because the people were not dying of AIDS. However, they also found the incidence of heart attacks and stroke and deaths caused by them stayed level, or even decreased slightly. There was no increased risk of cardiovascular events associated with any of the multitude of drugs given to treat HIV infection, the report says. Is it possible that there will be some increase in risk? Bozzette asks. Yes, because the metabolic effects that produce the risk are real. But this study shows that the benefits of therapy utterly overwhelm any possible increase in risk. It's even possible the antiretroviral drugs might protect the arteries, Bozzette adds. HIV is directly toxic to the blood vessels, so treating HIV reduces blood vessel injury, he says. The story is far from over, because the people in the study were treated for a relatively short time and cardiovascular risk plays out over the course of decades, says Dr. Daniel R. Kuritzkes, director of AIDS research at Brigham and Women's Hospital in Boston. Just last week, a Scandinavian speaker at an international meeting in Boston described a study that reported a 26 percent increase in cardiovascular events in HIV-infected persons treated for longer periods at 11 centers in the Europe an increase that appears to increase with the length of treatment, Kuritzkes says. However, it is something that physicians have to keep in mind, Kuritzkes says, because drug treatment has been so effective. Because patients are living so much longer, we need to be attuned to the long-term risks and accept therapies that minimize those risks, he says. Younger Heart Patients Face Grim Prognosis One of every three people diagnosed with coronary artery disease before age 40 dies within 15 years, says new research. For those with diabetes, the death rate was nearly two out of three. Their mortality rate is so dramatic, says study author Dr. Joe Miller III, an assistant professor of preventative cardiology at Emory University School of Medicine in Atlanta. A third of them were dead at follow-up. It’s a little shocking. For the study Miller and his colleagues analyzed the medical records of 843 heart patients under age 40 listed in the Emory Cardiac Database. All of the patients had at least one documented coronary artery blockage between 1975 and 1985. The mean age at diagnosis for men was 36; for women, it was 35. By age 50, nearly one-third of the patients had died. Two-thirds of those who had diabetes were dead. The death rate was highest among those who had suffered a prior heart attack or had been diagnosed with heart failure. Smoking also dramatically increased the chance of dying. Heart patients who continue to smoke had a six times greater chance of dying than those who didn't smoke. Those who quit smoking fared better. Former smokers’ risk was about the same as those who'd never smoked. It really shows how bad smoking is for people, Miller says. Even if you treat diabetes aggressively, if you lower cholesterol and treat blood pressure aggressively, if you continue to smoke, your risk does not go down. Dr. Daniel Fisher, a cardiologist at New York University Medical Center in New York City, says he's not surprised by the findings. He believes the incidence of early death from heart disease is going to continue to rise with the epidemic of obesity. We are going to see a shift away from heart disease being thought of as only a disease of older people, he adds. Diagnoses for coronary artery blockages are still somewhat unusual in younger adults. Most studies estimate only about 3 percent of people treated for blockages are under age 40, Dr. Lloyd Klein notes. It must be noted, however, that those patients who come to medical attention owing to symptomatic disease may well represent the tip of the iceberg, Klein said. The prevalence of the disease has been grossly underestimated, he adds. In a recent study of transplanted hearts, researchers found more than half of the teenagers involved had the beginnings of coronary artery disease; one in six teenagers had coronary lesions. Doctors aren’t sure why some people develop blockages so young, while others have similar lifestyles but don’t need treatment until old age. It’s almost certainly some combination of genetics and lifestyle, Fisher says. The study also found heart patients treated by surgical techniques such as angioplasty fared better than those treated by drugs alone. However, Fisher notes that new and better medicines, such as cholesterol-lowering statins, have been developed since the 1970s and 1980s, when these patients were seen. HRT Shown to Pose Greater Risks for Diabetic Women Hormone replacement therapy poses added risks for women with diabetes because it can increase their risk of heart disease, new research shows. Reported by Danish scientists, the research shows that HRT, which is taken by millions of women to relieve the symptoms of the menopause, does not protect against heart disease and can be particularly dangerous for diabetics. In a study of more than 13,000 nurses in Denmark, they found that women who were diabetics and taking HRT had four times the risk of suffering from heart disease, and were nine times more likely to have a heart attack, than other diabetics. Women with diabetes who use hormone replacement therapy are at an increased risk of deaths from all causes and ischemic heart disease, Ellen Lok-kegaard, of Hvidovre University Hospital in Denmark, said. She believes heart problems account for the diabetics’ raised risk of dying from any causes in the study. The results of the study are consistent with the findings of a trial by The Women’s Health Initiative which was halted after it showed HRT can raise the risk of heart disease, stroke and breast cancer in women. Earlier this year, the U.S. Food and Drug Administration strengthened warning labels on all women's HRT products to take into account the findings of that study. Lokkegaard said little attention has been focused on subgroups of women, such as diabetics, who may or may not benefit from using HRT. Heart Disease Care Varies Widely Across Europe Many doctors are failing to use heart disease guidelines designed to help save the lives of millions of patients, European cardiologists said. A significant proportion of doctors rarely use them, the European Society of Cardiology said as it presented the latest figures showing how the quality of heart care and the chances of survival can be a lottery across Europe. Heart disease claims the lives of more than four million Europeans every year and accounts for two in five of all deaths in people under the age of 74. The chances of dying vary significantly from country to country because of different diets, rates of smoking and obesity and standards of medical care. Prevention and treatment guidelines have been developed to help doctors combat the epidemic but the society said survey findings showed wide differences in the way guidelines are implemented. For example, only a fifth of doctors in France and Poland adhered to heart disease risk assessment guidelines compared to one third of doctors in Germany and Italy and three quarters of doctors in Spain and the UK. Research has shown this is due to a variety of factors, most significantly a lack of support at Government level, no financial incentive and budget constraints, the society said. The survey of 39,000 patients in 34 countries shows that only about 40% of patients who have a heart attack receive aspirin before reaching the hospital. Professor David Wood, from Charing Cross Hospital, London, and chairman of the Euro Heart Survey committee, told reporters that cardiovascular drugs were still often prescribed at lower doses than those shown to be effective in clinical trials. More than half of patients have poorly controlled blood pressure, Wood said. He added that smoking is becoming more common among patients with coronary heart disease and more patients are likely to be obese. Rates of coronary revascularization also varied widely. In France and Germany, over 1,200 procedures were done per million inhabitants compared with rates of 400 to 800 per million in the UK and Spain and even lower rates in Central European countries such as Hungary. The findings confirm that heart disease death rates are highest among the Eastern and Central European countries and that within Western Europe, the UK, Ireland and Finland have the highest mortality. The differences are striking: in Russia, the death rate from heart disease for men and women aged 35 to 74 is eight times higher than in France, while the rate in Ireland is twice that of Italy. The standardized mortality rates are lowest in Mediterranean countries such as France, Israel and Spain (less than three per 1,000 inhabitants) and highest in Eastern European countries such as Romania, Russia and the Ukraine (over eight per 1,000). New, Unique Heart-Rhythm Mutation Identified A variety of gene mutations can cause irregular heartbeats, so the discovery of one more may not seem like a big deal. But scientists have found that the mutation to blame for an irregular heartbeat in one family leads to life-threatening cardiac disease through a completely different mechanism than previously identified gene mutations. The discovery could help scientists better understand the complexities of heart rhythms and, perhaps, eventually lead to new treatments for irregular heartbeats. Dr. Vann Bennett explained that the French family with the mutation had a hereditary type of irregular heart rhythm that had caused sudden death in several family members. The family has a type of irregular heartbeat, or arrhythmia, known as long QT arrhythmia. There are about seven or eight varieties of this type of arrhythmia, according to Bennett, who is at Duke University Medical Center in Durham, North Carolina. What makes the mutation that causes the French family's irregular heartbeat different is that it involves a completely different type of gene than other mutations that have been linked to long QT arrhythmia, Bennett said. The Duke researcher explained that the other abnormalities are present in genes that involve ion channels. But the mutation in the French family does not involve an ion channel gene, Bennett said. Instead, this gene is involved in organizing ion channels, he explained. The gene contains the blueprints for building a protein called ankyrin-B. This protein seems to help anchor ion transporters to the membranes of cells. This is the next level of complexity, Bennett said. No one understands exactly how ion channels are organized, he said, adding that knowing that this particular gene is involved may help scientists get a better idea of how ion channels work. Mobile Phones Used to Monitor Heart Patients Doctors have successfully used mobile phones to monitor the blood pressure and heart rate of people with high blood pressure and give them almost instant advice, according to a pilot study in Austria. Doctors at Graz’s University Medical School joined forces with the Austrian Research Center (ARC) and the mobile telephone company, mobilkom Austria, in the study involving 25 patients with high blood pressure. Friedrich M. Fruwald, professor of cardiology at Graz, said that the study showed that monitoring chronically ill patients using mobile phones was technically feasible and also safe. The advantage is that doctors get information immediately. In the past, a patient with high blood pressure might go to the doctor every six months. It was only then that their doctor would see that blood pressure had been too high at certain times. Thanks to constant transfers of data by mobile phones, the doctor knows what is going on at once, Fruwald said. Patients monitored key values, such as their blood pressure, pulse or bodyweight, on a regular basis at home. They then entered the figures on a mobile phone using special software developed by ARC. The software allowed doctors to define the upper and lower limit of particular values for each patient. The information was sent to an ARC server in Graz and the hospital accessed the data using a computer with an Internet connection. We were able, for example, to monitor patients who were suffering from heart problems when they took beta blockers. We could observe whether the weight was stable and their heart rate went down, Fruwald said. The monitoring unit also warned doctors to intervene if a patient’s values were too high or low. Doctors were notified by a text message or an e-mail. Doctors then call the patients at home, check whether the data is correct and then prescribe medication, Fruwald said.

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