FDA Warns About Severe Liver Injury Associated with Multaq (Dronedarone)

The FDA has released a safety communication (reprinted below) about severe liver injury associated with Multaq (dronedarone). The  communication confirms and provides additional details about the 2 liver transplant cases that were first reported here on CardioBrief. (Click here for the response from Sanofi-Aventis to the CardioBrief report.) The FDA said that information about the risk…

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Sanofi-Aventis Provides More Details About Multaq Letter

A Sanofi-Aventis spokesperson has confirmed CardioBrief’s story yesterday and has provided further details and clarifications about the Dear Doctor letter. Here is the Sanofi statement:…

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Sanofi-Aventis To Inform Doctors About Liver Transplants in 2 Patients Taking Multaq (Dronedarone)

Sanofi-Aventis is about to send a “Dear Doctor” letter to physicians informing them of two cases of fulminant hepatic failure/necrosis resulting in liver transplanation in two patients taking Multaq (dronedarone), CardioBrief has learned. The two patients were women in their 70’s with no other apparent causes of liver injury or known elevations of liver function…

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Merck’s Thrombin Receptor Antagonist Suffers Major Setback

Merck’s thrombin receptor antagonist, vorapaxar, has suffered a major setback in its clinical trial program. In one trial, TRACER, the study drug is being discontinued and the trial will be closed out. The second trial, TRA-2P TIMI 50, is being curtailed but not stopped. The actions were based on recommendations from the combined Data and…

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Why Do Military Doctors Have Stricter Rules Than Other Doctors?

Jason Layne Davis, a US Army cardiologist, has pleaded guilty to accepting nearly $5,000 from Guidant. Last year Guidant paid $600,000 to settle claims that it had illegally paid Davis so that he would use the company’s devices at Madigan Army Hospital. Accepting a payment from an illegal source is a misdemeanor punishable by up…

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Researchers Shed New Light on HDL Cholesterol

Two papers published in the New England Journal of Medicine shed new light on the important but often mysterious role of HDL cholesterol in cardiovascular disease. In the first paper, researchers at the University of Pennsylvania studied 1,000 healthy volunteers and patients with coronary artery disease and observed a strong inverse relationship between cholesterol efflux from macrophages (a…

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Large Meta-Analysis Explores Cardiovascular Safety of NSAIDs

A large network meta-analysis has found “little evidence” to suggest that any of the commonly used NSAIDs or COX 2 inhibitors are safe in terms of cardiovascular risk. In a paper published in BMJ, Sven Trelle and colleagues analyzed data from 31 trials in which patients receiving an NSAID were compared to another NSAID or…

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Candesartan Beats Losartan in Swedish HF Registry

The Swedish Heart Failure Registry followed more than 5,000 patients treated with the angiotensin II receptor blockers (ARBs) candsartan or losartan between 2000 and 2009. According to a paper published in JAMA, survival at one year was 90% in the candesartan group compared to 83% in the losartan group. Five-year survival was 61% and 44%. After…

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World’s First Drug Eluting Bioresorbable Stent Gains CE Mark Approval

Abbott announced today that it had received CE Mark approval for Absorb, its bioresorbable vascular scaffold (BVS) device.  The device props a narrowed coronary artery open but then dissolves within 2 years, leaving the patient without a permanent implant. One hope for the device is that it will allow stent patients to safely discontinue dual antiplatelet…

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ACC and HRS Downplay Data From Their Own Registry

[Updated]– A study in JAMA earlier this week received a lot of attention when it reported that 22.5% of ICD implantations in the US did not have a firm basis in evidence. The study was derived from a very large dataset taken from the NCDR ICD registry, which was established by the American College of…

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Bevacizumab in Breast Cancer Linked to Increase in Heart Failure Risk

A meta-analysis in the Journal of Clinical Oncology suggests that bevacizumab (Avastin) significantly raises the risk for heart failure when given to patients with breast cancer. Toni Choueiri and colleagues analyzed data from 3,784 patients and found a significant increase in the incidence of heart failure among those taking bevacizumab compared with those taking placebo…

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Study Finds Mixed Long-Term Results for AF Catheter Ablation

Long-term results after catheter ablation for AF are decidedly mixed, according to the longest study yet to follow patients after the procedure. In a report in the Journal of the American College of Cardiology, Rukshen Weerasooriya and colleagues followed 100 patients treated at a French hospital for 5 years. After a single procedure, the rates of arrhythmia-free survival…

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J&J Submits Application for Rivaroxaban for Stroke Prevention in AF

Johnson & Johnson announced today that it had submitted a new drug application to the FDA for rivaroxaban for the prevention of stroke and systemic embolism in AF patients. The submission is largely based on the recently reported ROCKET AF trial. J&J also said the company had submitted its response to the FDA’s request for…

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JAMA Study Finds 22.5% of ICDs Implanted Without Evidence Base

A paper in JAMA from a very large registry reports that a substantial proportion of ICD implantations are not supported by a firm evidence base. Sana Al-Khatib and colleagues examined data from the National Cardiovascular Data Registry (NCDR) including 117,707 patients who received ICDs between January 1, 2006 and June 30, 2009 and found that…

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PLATO CABG Substudy Raises Hope and Questions

The much-anticipated CABG substudy from the PLATO (Platelet Inhibition and Patient Outcomes) trialcomparing ticagrelor to clopidogrel in ACS patients has been published online in JACC. About 10% of the 18,624 patients enrolled in  PLATO underwent CABG. The substudy reports on the 1,261 who received the study drug within 7 days prior to their surgery. The study protocol…

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Guest Post: Medicare: The MasterCard That Keeps On Giving

Editor’s Note: This following guest post by Dr. Shanti Bansai is reprinted with permission from CardioExchange. Medicare: The MasterCard That Keeps On Giving by Shanti Bansal, MD In the cardiac catheterization lab one Tuesday morning, I encountered a situation that made me reflect on a bit of 18th-century British history. At that time, the British government was overburdened…

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Abbott and AstraZeneca End Efforts to Develop Certriad (Rosuvastatin/Fenofibric Acid)

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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Apixaban Beats Enoxaparin for Thromboprophylaxis After Hip Replacement

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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Guest Post: Survey or Advertisement?

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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Guest Post: Another Highly Dubious Article in the American Journal of Cardiology

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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Dronedarone, Rate Control, and Catheter Ablation Incorporated in Updated AF Guidelines

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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ProPublica: Med Schools Flunk at Keeping Faculty Off Pharma Speaking Circuit

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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CardioSource and Medpage Today Will Collaborate to Provide News Coverage of Major CV Meetings

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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FDA Approves Cryoballoon Ablation Treatment for Paroxysmal AF

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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FDA Delays Approval of Brilinta (Ticagrelor)

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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