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FDA Approves Eliquis to Reduce the Risk of Stroke, Blood Clots in Patients with Non-Valvular Atrial Fibrillation

Posted 31 Dec 2012 by Drugs.com

December 28, 2012 – The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. Atrial fibrillation, one of the most common types of abnormal heart rhythm, is an abnormal, irregular, and rapid beating of the heart in which the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body. “Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk ... Read more

New Anti-Clotting Drug Bests Warfarin, Study Says

Posted 1 Oct 2012 by Drugs.com

MONDAY, Oct. 1 – A new anti-clotting drug called apixaban was better than warfarin at preventing stroke in patients with the heart rhythm disorder atrial fibrillation, a new study found. Data from more than 18,000 patients also found that apixaban was safer overall than warfarin, and tended to cause less bleeding in the skull in patients who faced the highest risk of bleeding. The findings suggest that the current risk scoring systems for tailoring anti-clotting (anticoagulant) treatment to individual patients may be less relevant when using apixaban for patients with atrial fibrillation who have at least one risk factor for stroke, according to the Duke University Medical Center researchers. "The benefits of apixaban are preserved, regardless of the risk score used and regardless of the patient risk category," study author and cardiologist Dr. Renato Lopes said in a Duke news release. ... Read more

More Patients With Irregular Heartbeat Recognize Stroke Risk: Survey

Posted 9 Sep 2012 by Drugs.com

FRIDAY, Sept. 7 – Patients with atrial fibrillation – a heart rhythm disorder – are increasingly aware of the link between their condition and the increased risk of stroke, according to a recent survey. Atrial fibrillation is a quivering or irregular heartbeat that affects about 2.7 million people in the United States. A 2011 survey of more than 500 people with atrial fibrillation found that half of them were unaware they had a fivefold increased risk of suffering a stroke. But the more recent American Heart Association/American Stroke Association 2012 poll of 500 people with atrial fibrillation found that 64 percent knew about this level of increased stroke risk. The improved awareness "is a great step in the right direction," association spokesperson Dr. Patrick Ellinor, associate professor at Harvard Medical School and a cardiologist at Massachusetts General Hospital in Boston, ... Read more

Related support groups: Prevention of Thromboembolism in Atrial Fibrillation

Irregular Heartbeat May Pose Higher Stroke Risk for Women Than Men

Posted 31 Aug 2012 by Drugs.com

FRIDAY, Aug. 31 – Women older than 75 who have a heart rhythm disorder called atrial fibrillation are 20 percent more likely to have a stroke than men in the same age group with atrial fibrillation, according to a large new study. However, researchers said the findings suggest that being a woman should not be included as an independent risk factor for stroke or blood clots, either in guidelines for treatment or risk assessment of patients with atrial fibrillation, because the difference doesn't hold for women younger than 75. The study included more than 87,000 atrial fibrillation patients in Denmark. Of those patients, more than 51 percent were female. After one year of follow-up, female patients younger than 75 did not have an increased risk of stroke, but those over age 75 had a 20 percent increased risk, the investigators found. The study was presented Sunday at the European ... Read more

Heart Rhythm Disorder May Raise Older Women's Stroke Risk

Posted 2 Jun 2012 by Drugs.com

FRIDAY, June 1 – Women with a heart rhythm disorder called atrial fibrillation are slightly more likely to suffer a stroke than men with the condition, according to a new study. The finding suggests that doctors need to consider patients' sex when making decisions about treatment, the researchers said. Atrial fibrillation raises the risk of blood clots and stroke, and people with the condition are sometimes prescribed anti-clotting drugs. "In borderline situations, in which a decision about whether to give anticoagulation treatment weighs in the balance, we suggest that female sex should probably tip the scale towards initiating treatment," the researchers from Karolinska Institute in Sweden and University of Birmingham in England wrote in the report published online May 31 in BMJ. The study included more than 100,000 atrial fibrillation patients in Sweden who were followed for an ... Read more

New Blood Thinner May Lower Chances of Clots in High-Risk Heart Patients: FDA

Posted 21 May 2012 by Drugs.com

MONDAY, May 21 – The new blood thinner Xarelto appears to lower the chances of potentially fatal blood clots in high-risk heart patients, a U.S. Food and Drug Administration review has found. The review came in briefing documents that were filed Monday in advance of an FDA advisory panel meeting Wednesday, at which the panel is to vote on whether to recommend approval of Xarelto for treating people with acute coronary syndrome (a group of conditions brought on by sudden reduced blood flow to the heart). The FDA is not required to follow the advice of its expert panels, but the agency typically does. A final decision is expected by the end of June, according to the documents. Xarelto (rivaroxaban) is one of a new class of blood thinners that have been developed to overcome some of the problems that exist with the standard treatment, warfarin (Coumadin), which requires constant dose ... Read more

Irregular Heartbeat Poses Greater Stroke Risk for Women Than Men

Posted 8 May 2012 by Drugs.com

TUESDAY, May 8 – Older women with the irregular heartbeat known as atrial fibrillation face a 14 percent greater risk of stroke than men with the same condition, Canadian researchers report. The raised risk remained higher even when women were taking the blood-thinner warfarin (Coumadin) to prevent stroke, the study authors noted. "Previously, there was a common belief that women were undertreated, and this was the cause for the higher risk of stroke," said lead researcher Dr. Louise Pilote, director of the division of general internal medicine at McGill University and McGill University Health Center in Montreal. "Our current paper shows that this is not the situation and, compared to men, women have higher risk for stroke regardless of warfarin prescriptions," she said. "This study should alert doctors treating patients with atrial fibrillation that women, especially older women, have ... Read more

Stopping Blood Thinners Raises Stroke Risk for Patients With Irregular Heartbeat

Posted 25 Apr 2012 by Drugs.com

WEDNESDAY, April 25 – When patients with atrial fibrillation stop taking anti-clotting drugs, their stroke risk goes up quickly, new research finds. That risk increases about the same whether they are taking warfarin or a newer, more expensive drug, Xarelto (rivaroxaban). Atrial fibrillation is an abnormal heart rhythm in which the upper chambers of the heart quiver or flutter instead of contracting correctly, raising the risk of stroke fivefold. Patients are often put on anti-clotting drugs to ward off stroke. But some people need to temporarily stop taking anti-clotting drugs before surgery or other medical procedures to prevent excess bleeding, while other patients permanently stop taking anti-clotting drugs because of side effects, researchers said. Researchers analyzed data from a previous trial including more than 14,000 patients with atrial fibrillation. In that trial, ... Read more

Warfarin Helps Cut Stroke Risk, Researchers Report

Posted 27 Mar 2012 by Drugs.com

TUESDAY, March 27 – The anti-clotting drug warfarin reduces stroke risk in patients with a heart rhythm disorder called atrial fibrillation, research shows. In atrial fibrillation – the most common type of irregular heartbeat – the heart's upper chambers don't pump blood properly, allowing clots to form that can cause a stroke. Cleveland Clinic researchers led by Dr. Shikhar Agarwal examined data from more than 32,000 people who took part in eight studies that compared warfarin (Coumadin) with newer anti-clotting medications. The investigators found that stroke risk was higher among women, the elderly, patients who had a previous stroke or mini-stroke (also known as a transient ischemic attack) and patients who had never taken anti-clotting drugs called vitamin K antagonists. The study was released online March 26 in advance of publication in an upcoming print issue of the Archives ... Read more

New Anti-Clotting Drug May Cut Brain Bleeding Risk: Study

Posted 2 Feb 2012 by Drugs.com

THURSDAY, Feb. 2 – A new medication that helps prevent strokes in people with the abnormal heart rhythm disorder known as atrial fibrillation poses less risk of bleeding in the brain than a commonly used drug, research comparing rivaroxaban (Xarelto) and warfarin suggests. Anti-clotting medications, also called blood-thinners or anticoagulants, include warfarin (Coumadin) and aspirin, among others. In patients with atrial fibrillation, these drugs can reduce the risk of ischemic stroke, which occurs when a vessel becomes clogged by a blood clot. But the drugs can also cause excessive bleeding because they make it harder for blood to clot. In a new study, researchers led by Dr. Graeme Hankey, a neurologist at the Royal Perth Hospital and University of Western Australia, followed more than 14,000 people who took anti-clotting drugs for a median of two years. Of those patients, 136 had ... Read more

Experimental Drug Might Beat Aspirin in Preventing Repeat Strokes: Study

Posted 1 Feb 2012 by Drugs.com

WEDNESDAY, Feb. 1 – An investigational drug called apixaban (Eliquis) appears to be better than aspirin at preventing blood clots in certain patients who have already suffered a stroke or so-called "mini-stroke" due to an abnormal heart rhythm, according to the results of a new study. For patients with the dangerous irregular heart rhythm known as atrial fibrillation who can't tolerate the standard drug treatment, daily apixaban seems to be more effective at warding off a stroke or blood clot than aspirin, the study found. The study was funded by Bristol-Myers Squibb and Pfizer, which are developing apixaban. The findings were slated for presentation Wednesday at the American Stroke Association's annual conference in New Orleans. For the study, a team of researchers from Canada and Germany, led by Dr. Hans-Christoph Diener of the University Hospital Essen, tracked nearly 5,600 atrial ... Read more

FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm

Posted 4 Nov 2011 by Drugs.com

SILVER SPRING, Md., Nov. 4, 2011 /PRNewswire-USNewswire/ – The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation). Atrial fibrillation occurs in more than 2 million Americans and is one of the most common types of abnormal heart rhythm. In atrial fibrillation, the beating of the heart's two upper heart chambers (atria) is irregular and poorly coordinated. This leads to blood pooling in these chambers, resulting in blood clots. Non-valvular atrial fibrillation refers to atrial fibrillation in patients who do not have significant problems in their heart valves. "Atrial fibrillation can lead to the formation of blood clots, which can travel to the brain, blocking blood flow and causing a disabling stroke," said Norman Stockbridge, M.D., ... Read more

Xarelto Approved to Prevent Stroke in People With Abnormal Heartbeat

Posted 4 Nov 2011 by Drugs.com

FRIDAY, Nov. 4 – The anti-clotting drug Xarelto (rivaroxaban) has been approved by the U.S. Food and Drug Administration to prevent stroke in people with atrial fibrillation, a common form of irregular heartbeat. More than 2 million Americans have atrial fibrillation, in which the heart's two upper chambers beat irregularly, the FDA said in a news release. The condition can lead to the formation of a blood clot, which can travel to the brain and cause a stroke. The new drug was approved for cases in which the atrial fibrillation is unrelated to the performance of the heart's valves. Xarelto's safety and effectiveness were compared to those of another anti-clotting drug, warfarin, in clinical studies involving some 14,000 patients. Xerelto was deemed similar to warfarin in its ability to prevent stroke, the FDA said. As with other anti-clotting drugs, Xarelto has the ability to cause ... Read more

Related support groups: Xarelto, Prevention of Thromboembolism in Atrial Fibrillation

Many With Irregular Heartbeat Unaware of Raised Stroke Risk

Posted 23 Sep 2011 by Drugs.com

FRIDAY, Sept. 23 – Half of the 2.7 million Americans affected by an irregular heartbeat, known as atrial fibrillation, deny or do not know they are at greater risk for stroke, according to a new survey from the American Heart Association (AHA). "While there's a lot known about atrial fibrillation, there's a lot unknown as well," Dr. Mark Estes III, professor of medicine at Tufts University School of Medicine in Boston, said in a news release from the heart association. "The American Heart Association's goal for atrial fibrillation is to bridge those knowledge gaps through research and education. By helping people better understand their risks, we can impact treatment and prevention of atrial fibrillation and atrial fibrillation-related strokes." The AHA surveyed 502 people living with atrial fibrillation. Despite being the third-leading cause of death in the United States (behind heart ... Read more

FDA Advisers Review Clot Drug

Posted 8 Sep 2011 by Drugs.com

WASHINGTON, September 8, 2011 – A new anticlotting drug that had been seen as a blockbuster comes under scrutiny by a panel of outside advisers to the Food and Drug Administration Thursday, two days after a negative review by FDA staff. Johnson & Johnson and partner Bayer Healthcare of Germany are seeking U.S. approval of Xarelto for preventing strokes in patients with a common irregular heart rhythm called atrial fibrillation. The FDA approved the drug in July for a much smaller patient pool, patients getting knee and hip replacements, a group at heightened risk of dangerous blood clots. Even that approval followed a delay of roughly two years due to FDA concerns about internal bleeding risk. A 388-page report by FDA staff reviewers, released Tuesday, recommended against approving Xarelto for use in patients with atrial fibrillation, in which the heart's upper chambers quiver ... Read more

Related support groups: Xarelto, Prevention of Thromboembolism in Atrial Fibrillation

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