Abbott and AstraZeneca announced today that they were discontinuing their collaboration for the development of Certriad, the combination of rosuvastatin and fenofibric acid. The companies received a Complete Response Letter from the FDA earlier this year, and said “the resulting regulatory delay and the commercial attractiveness of the product in the U.S. market.”
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In the ADVANCE-3 trial 5,407 hip replacement patients were randomized to receive thromboprophylaxis with either the new oral factor Xa inhibitor apixaban or enoxaparin. The rate of DVT, nonfatal PE, or death from any cause was 1.4% in the apixaban group compared to 3.9% in the enoxaparin group (RR 0.36, CI 0.22-0.54, P<0.001), thereby demonstrating both [...]
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Editor’s Note: This following guest post by Dr. Micah Eimer is reprinted with permission from CardioExchange. Dr. Eimer is a cardiologist in the northern suburbs of Chicago. Say Hello to Your New Drug Rep? by Micah Eimer, MD Most of the doctors I know have, at one time or another, responded to a web-based “survey”. While I have tried not [...]
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Editor’s Note: This following guest post by Dr. Roy Poses is reprinted with permission from Health Care Renewal. In the post, Poses finds severe faults with an American Journal of Cardiology review article on beta blockers. Digging further, he finds evidence that the article may only be the tip of a much larger iceberg. You can [...]
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A focused update on the guidelines for the management of atrial fibrillation has been released by the ACC, AHA, and HRS. Most notably, the new guidelines incorporate recent data from clinical trials evaluating dronedarone, clopidogrel, strict rate control, and catheter ablation. Here are the major highlights of the document:
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Editor’s Note: The following article is reprinted with permission from ProPublica, the “independent, non-profit newsroom that produces investigative journalism in the public interest.” This is a new installment in the ongoing investigation titled “Dollars for Doctors.” For more information and resources about the investigation, including a tool to look up drug company money paid to physicians, [...]
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Starting next month Medpage Today and ACC’s CardioSource will collaborate to offer detailed, in-depth coverage of more than 15 cardiovascular and cardiovascular-related medical meetings worldwide. The joint project, which will be called “On the Scene,” will be prominently displayed on each website and will be widely distributed via email newsletters to ACC members and cardiologists and [...]
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Medtronic announced today that it had received FDA approval for its Arctic Front® Cardiac CryoAblation Catheter system for the treatment of refractory paroxysmal AF.
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Updated, Friday December 17, 1 PM– Despite widespread expectations of an easy approval, the FDA has issued a complete response letter to AstraZeneca for Brilinta (ticagrelor). According to a press release from the company, the FDA has asked for additional analyses of the PLATO data, but did not request any additional studies. AstraZeneca said it [...]
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From 1997 to 2007, the death rate from heart disease declined 27.8% and the death rate from stroke declined 44.8%. But inpatient cardiovascular operations and procedures increased during the same period by 27%, and heart disease and stroke cost $286 billion in 2007, more than any other diagnostic group. These are some of the most [...]
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A 52-year old woman with atypical chest pain ended up with a heart transplant after a CT angiogram to “reassure” her sparked a devastating sequence of events. Following a false-positive CT angiogram, the patient underwent coronary angiography and suffered a dissection of the left main coronary artery, followed by emergency CABG, subsequent graft failure, and [...]
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Mark Midei’s lawyer responded to the sensational reports earlier this week about his client’s relationship to Abbot. In defending his client he gave a preview of Midei’s defense. According to a story by Tricia Bishop in the Baltimore Sun, “it was business as usual for the medical profession.” “All of these events were legal; they were [...]
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Highly recommended weekend reading: in his Bad Science column in the UK’s Guardian, Ben Goldacre, the physician and best-selling author and columnist, brutally dissects NMT Medical, the troubled medical company that makes closure devices that have had a poor record in the clinical trial arena. CardioBrief readers will likely recall the company’s vicious assault on Peter [...]
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Editor’s Note: This is a substantially updated version of a previously published story. It includes new commentary from David Hillis, Rick Lange, and myself. Additional update, December 11, 2010: The PROTECT II press release appears to be a very clear violation of the Ingelfinger Rule. Although companies are obligated to release the top line results [...]
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Chronic lower respiratory disease (CLRD) has replaced stroke as the third leading cause of death in the United States, according to preliminary 2008 statistics published by the CDC’s National Center for Health Statistics. In 2008, there were 133,750 deaths from stroke compared to 141,075 deaths from CLRD. Although the stroke rate has been declining for many [...]
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A new meta-analysis has found that postmenopausal women taking aromatase inhibitors (AIs) instead of tamoxifen to treat breast cancer appear to be at increased risk for cardiovascular complications. The results were presented at the San Antonio Breast Cancer Symposium.
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The US Department of Justice announced today that Kos Pharmaceuticals, a subsidiary of Abbott Laboratories, will pay $41 million dollars to resolve liability for paying kickbacks and engaging in other illegal activities in marketing Advicor and Niaspan. The Justice Department said that the company offered and paid “illegal kickbacks in the form of money, free [...]
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Following rejections earlier this year of two previous anti-obesity drugs, the FDA’s Endocrinologic and Metabolic Drugs advisory committee recommended approval for Contrave, the combination of sustained release forumulations of naltrexone and buproprion from Orexigen Therapeutics.
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This story has been substantially updated. Click here to read the updated story. The PROTECT II study has been stopped early. The trial had been comparing the Impella circulatory support device to the intra-aortic balloon (IAB) in high risk PCI patients. The trial was terminated after an interim analysis by the Data and Safety Monitoring [...]
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A group of Duke students protested the excessive compensation given to some top Duke officials, including cardiologist Victor Dzau, who is the Chancellor for Health Affairs at the University. In response to the protest, one noted advocate for health care reform says that Dzau has enriched himself even further through service on four separate corporate [...]
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A new analysis finds that long-term aspirin use reduces deaths from several common cancers. Previous studies had only shown a convincing benefit in colorectal cancer. In the new meta-analysis, appearing online in the Lancet, Peter Rothwell and colleagues combined data from more than 25,000 patients enrolled in long-term randomized trials of aspirin. They showed that patients [...]
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[Updated] Mark Midei, the interventional cardiologist who has been accused of implanting hundreds of unnecessary stents at St. Joseph Medical Center in Maryland, was congratulated by Abbott Labs for implanting 30 stents in one day. ”I heard thru the grapevine that you had a truly outstanding day with Xience in the labs on Friday, perhaps setting [...]
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AstraZeneca’s ticagrelor (Brilique) gained European approval this morning. In most EU countries, however, ticagrelor will not be available for the second months, “due to pricing and reimbursement negotiations,” according to the company. Click here for previous coverage of ticagrelor on CardioBrief.
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In the EINSTEIN-DVT noninferiority study, 3449 patients with acute DVT were randomized to receive open label oral rivaroxaban or conventional therapy with enoxaparin followed by warfarin or acenocoumarol for 3, 6, or 12 months. The rate of recurrent VTE, the primary efficacy outcome, was lower with rivaroxaban treatment than with enoxaparin treatment, successfully demonstrating noninferiority for [...]
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