Rivaroxaban Meets Primary Endpoint in ATLAS ACS TIMI 51

Bayer AG announced today that the ATLAS ACS TIMI 51 trial of rivaroxaban (Xarelto, Bayer and Johnson and Johnson) in patients with acute coronary syndrome (ACS) had met its primary efficacy endpoint, “showing a statistically significant reduction in the rate of events for the primary composite endpoint of cardiovascular death, myocardial infarction and stroke in…

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Meta-Analysis Explores Real World CV Risk of NSAIDs

A new meta-analysis sheds additional light on the cardiovascular risk of NSAIDs as used in the real world, including low doses of the most popular drugs, over short periods, and in low-risk populations. In a paper published online in PLoS Medicine, Patricia McGettigan and David Henry analyzed data from 30 case-control studies including 184,946 CV events and…

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Study Finds Noncardiac Sources of Positive Troponin T Tests

Cardiac troponin T (cTnT) is not always cardiac specific and in some cases may lead to a false-positive diagnosis of cardiac injury, according to a study in the Journal of the American College of Cardiology. The study was prompted by a case seen by a senior clinician at the Mayo Clinic in which a patient, who…

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Easy Come, Easy Go? ESC To Review Dronedarone’s Role in AF Guidelines

caution drive slowly sign

Just over a year after speeding with unprecedented haste into the European Society of Cardiology’s atrial fibrillation guidelines with a class 1 recommendation, the role  of dronedarone (Multaq, Sanofi) in the treatment of AF will be reconsidered. Responding to an announcement last week from the European Medicines Agency (EMA), the ESC again announced that it…

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The Pen Is Mightier Than the Scold

Pharma journalist Matt Herper, who’s generally quite savvy about these issues, argues on his Forbes blog that little things like free meals and modest speaking fees don’t really influence doctors. He says that as a journalist he avoids quoting physicians who receive tens or hundreds of thousand of dollars from industry, but small payments don’t bother him. Pharma…

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Experience Counts in Carotid Artery Stenting

According to a new study published in JAMA,  experience really does count when it comes to carotid artery stenting(CAS). And that may be a big problem, since the explosive growth in the procedure after gaining FDA approval in 2004 means that most current operators do not have substantial experience with the procedure. Brahmajee Nallamothu and colleagues…

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Statins for Primary Prevention: the Debate Continues

Several leading cardiologists have taken issue with the assertion made by Rita Redberg and the editors of Archives of Internal Medicine that using statins for primary prevention is an example “of the widespread use of medications with known adverse effects despite the absence of data for patient benefit for these indications.” In a research letter published in…

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Former NEJM Editor Criticizes Publication and Peer Review of ARISTOTLE Trial

Editor’s note: The following guest post is reprinted with permission from the blog of Alison Bass. Bass is the author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, and was a longtime medical and science writer for The Boston Globe. New heart medication study was too flawed for publication, former journal…

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Rivaroxaban (Xarelto) Gets Positive Recommendation for AF and DVT in Europe

The European Committee for Medicinal Products for Human Use (CHMP) has recommended that rivaroxaban (Xarelto) be approved for the prevention of stroke and systemic embolism in AF and also for the treatment of DVT and prevention of recurrent DVT and PE following acute DVT, according to Bayer HealthCare, which is developing the drug in conjunction…

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Dronedarone (Multaq) Gets Another Drubbing in Europe

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended new restriction on dronedarone (Multaq), Sanofi’s embattled and controversial antiarrhythmic drug. CHMP says that dronedarone should only be used for maintaining sinus rhythm in patients with paroxysmal or persistent AF after successful cardioversion. CHMP said that it was recommending that dronedarone…

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Diet Drugs Get a New Slim Chance at Approval

Contrave, the investigational diet pill combination of naltrexone and bupropion, has been granted a possible new lease on life by the FDA. In January of this year the FDA issued a complete response letter to Orexigen, the drug’s sponsor. Now Orexigen says that it has received guidance from the FDA that could lead to approval…

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More Data But No Answers About Platelet Function Testing

The RECLOSE 2–ACS (Responsiveness to Clopidogrel and Stent Thrombosis 2–ACS) trial from Italy provides new information about platelet reactivity but doesn’t answer any of the key questions about the possible role of platelet function testing in clinical practice. In a paper published in JAMA, Guido Parodi and colleagues report on 1,789 ACS patients who underwent PCI and…

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Significant Declines Observed in Cardiovascular Procedures Performed in Hospitals

downward-trend

More evidence is starting to emerge that the overall volume of cardiovascular procedures in US hospitals is in decline. The trend should come as no surprise to those who have been following news about cardiovascular medicine in recent years, as the field has been repeatedly struck by debate, scandal and controversy related to the potential…

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FDA Approves Watson Pharmaceuticals Generic Lovenox (Enoxaparin)

The FDA has granted approval to Amphastar’s generic version of Lovenox (enoxaparin sodium), Watson Pharmaceuticals has announced. The low molecular weight heparin will be sold by Watson under an arrangement with Amphastar. In July 2010 the FDA approved the first generic version of enoxaparin, manufactured by Sandoz and marketed in the US by Momenta, after a…

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Study Identifies Slow Spots in Transfer of Primary PCI Patients

In recent years great progress has been made in speeding the delivery of primary PCI to STEMI patients, but lingering problems remain, especially involving the transfer of patients from centers without primary PCI capability. Now a new study published in Circulation helps identify the precise causes for delays with these patients. Michael Miedema and colleagues…

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Xanthelasmata Identified as Independent CV Risk Factor

A large new study from Denmark finds that xanthelasmata (raised yellow patches around the eyelids) but not arcus cornae (white or grey rings around the cornea) is an independent risk factor for cardiovascular disease. In a paper in BMJ, Mette Christoffersen and colleagues report on 12,745 adults in Copenhagen without cardiovascular disease at baseline who were followed…

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Meta-Analysis Finds Reduction in Stent Thrombosis with Everolimus-Eluting Stents

Stent thrombosis and other complications are less likely to occur when an everolimus-eluting stent (EES) is used, according to a large new meta-analysis appearing in the Journal of the American College of Cardiology. Usman Baber and colleagues analyzed data from 13 trials that included 17,101 patients who were randomized to either an EES or a non-EES….

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Study Sheds Light on Consequences of Bicuspid Aortic Valve

Although bicuspid aortic valve  (BAV)is the most frequently occurring congenital heart defect, little is known about the long-term prognosis of people with BAV. Now a new study published in JAMA shows that although the overall rate of aortic complications remains low in people with BAV, their risk is nevertheless about 8 times greater than the…

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HHS Announces Initiative to Prevent One Million Heart Attacks and Strokes

The US Department of Health and Human Services (HHS) is launching a campaign to prevent one million heart attacks and strokes in the next 5 years. The announcement was published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) and in a perspective published in the New England Journal of Medicine by Thomas Frieden, the director…

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Study Finds Risks and Costs Associated with Infection After Device Implantation

A large new study has found significant risks and costs associated with infections following the implantation of CIEDs (cardiovascular implantable electronic devices, including ICDs, CRT/Ds, and pacemakers). In a paper published in Archives of Internal Medicine, Muhammad Sohail and colleagues analyzed Medicare data from more than 200,000 patients admitted for CIED implantation, replacement, or revision in 2007,…

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Global Monitor: Early Signs of Possible Problems with ICD Leads, Dabigatran

Reports from Ireland and New Zealand may herald new concerns about the Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa). A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that  15% of 212 patients who received Riata leads had an insulation breach on…

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The Rivaroxaban FDA Panel and Large Pragmatic Trials

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data…

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Live Blog– FDA Advisory Panel on Rivaroxaban (Xarelto)

Click here for a brief summary and commentary on the FDA panel hearing. Panel Adjourns! Good night everyone. 4:58– Lincoff asks if anyone thinks the transitioning study should be done pre-approval? Everyone seems ok with a post-marketing study. 4:55– Nissen wants to see the drug tested in a BID regimen. Papdemetriou wants a post-marketing study on transitioning….

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Stenting Worse Than Medical Therapy for Intracranial Stenosis

In recent years stenting for intracranial arterial stenosis has become widespread. Now, however, a trial testing the procedure has been terminated early, raising serious questions about both the safety and efficacy of the technique. In the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial, which has now been published…

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FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)

FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers…

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