The European Society of Cardiology (ESC) prefers Brilinta (Brilique in Europe), a new blood thinner manufactured by AstraZeneca, over Bristol-Myers Squibb and Sanofi-Aventisâ€™ best seller, <"http://www.yourlawyer.com/topics/overview/Plavix-Cerebral-Gastrointestinal-Bleeding-Hemorrhaging-Lawsuit-Lawyer">Plavix.
The ESC recommended Brilique over Plavix, in its revised treatment guidelines, for patients suffering form acute coronary syndromes who are at a moderate-to-high risk for heart attack or stroke and for patients after bypass surgery, said FiercePharma. The change could be a godsend to AstraZeneca when Plavix will lose its patent status in 2012 and will be available in generic form, noted FiercePharma.
The recommendations come on the heels of Bristol-Myers Squibb and Sanofi-Aventisâ€™ release of additional analyses of the Plato study, which compared Brilique/Brilinta to Plavix in over 18,000 patients. Trial data revealed that Brilique/Brilinta was linked to less fatalities in patients who underwent heart-bypass surgery, according to FiercePharma.
A researcher at the Uppsala Clinical Research Center, Chrisyoph Varenhorst said, “These data may help to further understand the factors that contribute to the ability of [Brilique/Brilinta] to provide superior outcomes over [Plavix] in ACS patients, including when a surgical intervention like [coronary artery bypass graft] is required,”.
The ESC said its new recommendations were based on a review of Brilique data, including data from the Plato Study, supporting the drug makerâ€™s application for approval of the medication. One study in particular, cited 54 ACS patients who were treated with Brilique instead of Plavix for one year, one atherothrombotic event was prevented while 91 patients had one cardiovascular death prevented, both with no major bleeding increases, according to the ECS.
As weâ€™ve reported, Plavix is the subject of lawsuits alleging its makers failed to adequately research the medication or warn about the risks which could increase the likelihood of serious and potentially life-threatening complications. Recently, dozens of Plavix injury lawsuits were centralized in New Jersey and transferred to Superior Court Judge Jessica R. Mayer in Middlesex.
Recent studies lend support to plaintiffsâ€™ allegations. For example, one study conducted by the U.S. Centers for Disease Control (CDC) that compared the blood thinner, Wafarin, with combination Plavix-aspirin therapy found the risk of hemorrhaging in people treated with the Plavix combo was significantly higher than previously believed. Another study published in the New England Journal of Medicine found that patients taking Plavix are 12 times likelier to suffer recurrent ulcers and gastrointestinal bleeding than those who received a combination of aspirin and a heartburn pill.
Many lawsuits were filed after a black-box warningâ€”the U.S. Food & Drug Administrationâ€™s strongest safety warningâ€”was added to Plavixâ€™s label in March 2010. The black box warned of â€œdiminished effectivenessâ€ in patients who metabolize the drug poorly. Doctors were to counsel these patients that Plavix will cause them to bruise and bleed more easily, and that it will take longer than usual to stop bleeding.