HealthDay
Top Stories for the Week of June 30, 2008
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FDA Approvals |
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Industry Highlights |
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New 5-in-1 Vaccine May Reduce Number of Pediatric Shots |
Parkinson's Drugs Again Linked to Compulsive Disorders |
Novel Treatments Ease Migraine PainIt's easier to use and produces fewer blood clots, studies find |
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WEDNESDAY, June 25 —A new anti-clotting drug that could be one of the long-sought alternatives to commonly used blood thinners has performed well in hip and knee replacement patients, physicians report. The drug, rivaroxaban, was more effective at reducing potentially fatal blood clots than heparin, with no increase in side effects, according to studies by three research teams reporting this week in the New England Journal of Medicine and The Lancet. "It was superior to low molecular weight heparin, one of the two most common prophylaxis modalities in the United States," said Dr. William Geerts, a professor of medicine at the University of Toronto, and a member of a team that tested rivaroxaban after hip replacement surgery. Prophylaxis in this case means prevention of blood clots. Heparin is commonly used in hospitals because it is easier to manage than Coumadin (warfarin), which requires frequent blood tests for close control. The new drug, rivaroxaban, is an easily swallowed pill that does not require constant monitoring. In the international trial of 4,541 people who had hip surgery, 1.1 percent of those given rivaroxaban suffered problems such as deep-vein blockage or pulmonary embolism, compared to 3.7 percent of those given enoxaparin, a widely used form of heparin. The incidence of major bleeding was similar in both groups -- six of 2,209 for rivaroxaban, and two of 2,224 for enoxaparin. In the knee replacement study, which included 2,531 patients, 9.6 percent of them given rivaroxaban experienced problems such as deep-vein thrombosis, compared to 18.9 percent of those who got enoxaparin. The third study, done in England, followed 2,509 people who had hip replacement surgery for more than a month after they left the hospital. Only 2 percent of those taking rivaroxaban suffered problems during that time, compared to 9.3 percent of those getting daily injections of heparin. All three studies were funded by Bayer, which plans to market the drug rivaroxaban as Xarelto. It already has competition from another anti-clotting drug known as dabigatran, which the pharmaceutical company Boehringer Ingelheim has permission to market in Europe and has approval to start marketing in Canada later this month, Geerts said. The brand name of that pill is Pradaxa. The potential bigger market for both new anti-clotting drugs is for out-of-hospital use. An estimated 2 million Americans now take -- or are supposed to take -- Coumadin because of atrial fibrillation, the abnormal heartbeat that can cause formation of life-threatening blood clots, said Dr. Richard C. Becker, a professor of medicine at Duke University Medical Center, who co-wrote an accompanying editorial in the New England Journal of Medicine. Bayer is moving toward marketing rivaroxaban for those people, he said. "These trials are part of a very large program," he said. "There are four large trials in orthopedic surgery and also large programs in atrial fibrillation. There are also programs for patients with acute coronary syndrome. In all, there will be close to 50,000 patients in randomized clinical trials." Both new anti-clotting pills will be an improvement for many people now taking Coumadin, Geerts said. Because of the frequent testing required for Coumadin, many people who are told to take the medication don't follow instructions, he said. "This will likely translate to a larger proportion of people who should be on prophylaxis actually getting it," he said. But the fact that frequent tests aren't required for the new anti-clotting agents is a challenge to physicians, Geerts said. Lab tests are proof-positive that someone is taking their medicine, he said. "As physicians, we have to think of new strategies to make sure people are compliant," he added. More information Learn more about anticoagulant drugs from the American Heart Association.
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Novel Treatments Ease Migraine PainBoth call for stimulation of nerve centers related to pain |
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THURSDAY, June 26 —Technology may ease migraine and headache pain, two new studies suggest. "What this tells us is that there are non-medical, non-drug treatments that are effective," said Dr. Stephen Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, who was a co-author on both papers. One paper found that stimulating the back of the head at the beginning of a migraine attack with a handheld magnetic device significantly reduced pain levels. The second approach involved stimulating the occipital nerve at the back of the head with an implanted device. This technique would target more "high-end" patients, those who don't respond to other therapies. The magnetic device would be aimed at more "garden variety" headaches, Silberstein said. Millions of Americans suffer from migraines or other forms of chronic headaches. Many don't respond to standard medications, leading some researchers away from conventional drug therapies to explore other options. "We're going in a lot of different directions," confirmed Dr. Michael Palm, an assistant professor of neuroscience, experimental therapeutics and internal medicine at Texas A&M Health Science Center College of Medicine and director of the Parkinson's Program and the Headache Program at the Texas Brain and Spine Institute in Bryan. "We're still trying to find the mechanisms." The studies are to be presented this week at the American Headache Society annual meeting, in Boston. The transcranial magnetic stimulation (TMS) device, about the size of a hairdryer, is held to the back of the head at the first sign of a migraine aura. Pressing a button twice sends two brief magnetic pulses into the brain. Those pulses, scientists believe, basically short-circuit the abnormal electrical activity that causes or contributes to the migraine. Previous research had studied a similar, table-top device when administered by health-care professionals. This is the first study to look at patients administering TMS to themselves. One hundred sixty-four outpatients, aged 16 to 68, were randomly selected to receive either the TMS device or a "sham" device. They recorded pain levels and symptoms in an electronic diary. After two hours, 39 percent in the TMS group were pain-free, compared with 22 percent in the sham group. For the second study, 28 patients were implanted with an adjustable neurostimulator, 16 were implanted with a neurostimulator that could not be adjusted, and 17 patients received standard medication therapy with no implant. In occipital nerve stimulation, an electrode is implanted near the occipital nerve in an outpatient procedure. That device sends electrical impulses into the central nerve system that are thought to block the perception of pain in the brain. "It stimulates the occipital nerve in an attempt to turn off the pain," Silberstein explained. Close to 40 percent of patients in the first group had a positive response, meaning at least a 50 percent reduction in the number of days each month they suffered headaches, or a reduction in pain intensity of three points or more on a specific pain scale. Only 6 percent in the second group, and none in the control group had a positive response. "This group is typically hard to treat," Palm said. "Electrical stimulation sounds like it resulted in improvements in a significant number of people. It's no more invasive than spinal cord stimulation." Silberstein added: "These patients were, by definition, the worst of the worst and that is why this is so important. These are patients who give up hope." Now more studies need to be conducted before seeking approval from the U.S. Food and Drug Administration. More information The American Headache Society has more on migraines and other types of headaches.
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Parkinson's Drugs Again Linked to Compulsive DisordersImpulsive gambling, shopping, sex and binge eating common among patients, study shows |
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WEDNESDAY, June 25 —People taking dopamine agonists to treat Parkinson's disease are at risk for impulse-control disorders such as compulsive gambling, buying and sexual behavior, University of Pennsylvania researchers report. In fact, people taking these particular medications are three times more likely to engage in these behaviors compared with Parkinson's patients not taking these drugs. The connection is not entirely new. "Impulse-control disorders are relatively common in Parkinson's disease," said lead researcher Dr. Daniel Weintraub, an assistant professor of psychiatry. "In almost 14 percent of treated Parkinson's disease, patients had at least one of the four impulse-control disorders." Of the 14 percent, about a third had more than one impulse-control disorder, Weintraub said. The findings were to be presented Wednesday at the Movement Disorder Society's 12th International Congress of Parkinson's Disease and Movement Disorders, in Chicago. Most research on compulsive behaviors in Parkinson's disease is focused on gambling, Weintraub said. "We found that the other three impulse-control disorders occurred as commonly as compulsive gambling," he noted. In the study, Weintraub's team looked at these compulsive behaviors in 3,090 patients taking dopamine agonists for Parkinson's disease and Parkinson's patients not taking these drugs. The researchers followed the patients for six months. Weintraub's team found a twofold to threefold increased risk for these four compulsive behaviors among those taking dopamine agonists. In addition, patients taking levodopa were also prone to impulse-control disorders, Weintraub said. Higher doses of levodopa or dopamine agonists increase the risk of developing and impulse-control disorder, he said. "Doctors and patients should be aware that development of one or more impulse-control disorders is a potential risk factor for Parkinson's patients that are treated with a dopamine agonist," Weintraub said. In addition, younger patients and those taking levodopa and patients with a family history of similar behaviors may be at higher risk of developing impulse-control disorders, Weintraub said. Since people taking higher doses of these drugs are more susceptible to impulse-control disorders, doctors should prescribe only the highest dose needed to control Parkinson's symptoms, Weintraub advised. Michael W. Jakowec, an assistant professor of neurology at the University of Southern California, said that "these compulsive disorders reflect clinical challenges faced in the treatment of Parkinson's disease, especially in the context of dopamine-replacement strategies." While dopamine is necessary for control of the aspects of motor control, it also plays an important role in other regions of the brain, particularly those involved in reward systems, Jakowec explained. "There are a number of behaviors we are subject to that are a balance between reward-reinforcement-aversion," Jakowec said. "A dysfunction in the reward system can lead to an imbalance such that compulsive behaviors emerge." It is very similar to drug addiction, where drug dependence is reflected in dopamine dysfunction, Jakowec said. "So, it is not surprising that there are behavior similarities between these disorders," Jakowec said. "What we learn in Parkinson's disease with respect to non-motor features of the disorders will also impact similar behaviors in other disorders including drug addiction and compulsive disorders." More information For more about Parkinson's disease, visit the National Institute of Neurological Disorders and Stroke.
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New 5-in-1 Vaccine May Reduce Number of Pediatric ShotsBy as many as one-third MONDAY, June 23 —The U.S. Food and Drug Administration has approved Sanofi Pasteur's Pentacel combination vaccine for children, the company said Monday. Approved as a four-dose series at 2, 4, 6 and 15 to 18 months of age, it protects against diphtheria, tetanus, whooping cough (pertussis), polio, and influenza type B. Use of the vaccine could reduce the number of injections children get before they are 18 months old by as many as one-third -- from 23 shots to 16, Sanofi said in a statement. The vaccine was clinically tested among more than 5,000 children. Adverse reactions included injection site redness, swelling, fever, fussiness, and crying. The vaccine should not be administered to infants who developed Guillain-Barré syndrome after a prior tetanus vaccine, or if a serious adverse reaction was noted after a prior whooping cough vaccine, the company said. More information The FDA has more information about this approval. |
Device Helps Spinal Patients Breathe Without VentilatorHelps control diaphragm WEDNESDAY, June 18 —The NeuRx DPS RA/4 Respiratory Stimulation System has been approved by the U.S. Food and Drug Administration to help paralysis patients breathe for at least four hours without a ventilator. The implanted device uses four electrodes to stimulate the diaphragm, which contracts when a person breathes. People with paralysis stemming from severe spinal cord injuries can lose the ability to control this muscle, requiring full-time connection to a ventilator machine. "While the NeuRx RA/4 does not cure paralysis of the diaphragm, allowing patients to be free from a mechanical ventilator for at least four hours a day may enhance their quality of life," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a statement. The device is manufactured by Synapse Biomedical of Cleveland, Ohio. More information To learn more about the respiratory system, visit the American Medical Association. |
Cymbalta Approved for FibromyalgiaAffects about 5 million Americans WEDNESDAY, May 21 —Eli Lilly said Monday that its antidepressant Cymbalta (duloxetine) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia, a chronic disorder with symptoms including widespread muscle pain and tenderness. The condition affects about 2 percent of the American population, or about 5 million people, mostly women. While its cause is unknown and there is no known cure, it's believed it may be related to a combination of changes in brain and spinal cord chemistry, genetic factors, and stress, the company said in a statement. Cymbalta affects production of two naturally occurring brain substances, serotonin and norepinephrine. In addition to affecting mood, it's believed these substances are part of the body's natural pain-surpressing system, Lilly said. In a pair of three-month trials involving 874 people with fibromyalgia, Cymbalta significantly reduced pain levels, compared with a non-medicinal placebo, the company said. Common adverse reactions included nausea, dry mouth, constipation, decreased appetite, and sleepiness. Cymbalta also is approved to treat major depressive disorder and generalized anxiety disorder, and a form of nerve pain in diabetics, all in adults 18 and older. More information To learn more about this drug, visit the FDA's Center for Drug Evaluation and Research. |
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