2011 in Review: Rivaroxaban, Sapien, Mark Midei, Conflicts of Interest, and Much More

Here’s a completely personal review of the past year in cardiology. Please write a comment if you strongly agree, disagree, or think something is missing. Drug of the Year: Rivaroxaban (Xarelto)– Despite a highly negative review from FDA reviewers, rivaroxaban gained FDA approval for the coveted stroke prevention in AF indication. The drug was approved…

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J&J Submits NDA for ACS Indication for Rivaroxaban (Xarelto)

Based on the promising results of the recently published ATLAS ACS 2 TIMI 51 trial, Johnson & Johnson has submitted a supplemental new drug application to the FDA for the approval of rivaroxaban (Xarelto) to reduce the risk of thrombotic cardiovascular events in ACS patients. Following a succession of failed trials, ATLAS was the first…

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No Mortality Benefit Found For Low-Molecular-Weight Heparin in Acutely Ill Patients

Although venous thromboembolism (VTE) is a serious problem for acutely ill patients in the hospital, a new study published in the New England Journal of Medicine failed to find any improvement in mortality associated with thromboprophylaxis. Ajay Kakkar and the LIFENOX investigators randomized 8307 acutely ill patients to enoxaparin or placebo for 10 days. All…

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Nissen and Topol Clash Over Genetics and Personalized Medicine

Steve Nissen and Eric Topol, former colleagues and collaborators, have staked out opposite positions on the future of medicine. Topol has been a leading advocate for genomics and personalized medicine, while Nissen has now publicly questioned whether the enthusiasm for these technologies has outpaced their value in medicine today. In an editorial in JAMA, Nissen writes…

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Clopidogrel Testing Comes Under Fire

The phenomenon of clopidogrel resistance has been much discussed, but no consensus has emerged about the best, or any, response to the problem. Now a review published in JAMA finds no clinically relevant relationship between the CYP2C19 genotype  and cardiovascular events. Michael Holmes and colleagues performed a meta-analysis of 32 studies involving CYP 2C19 genotyping and more than 42,000 patients. In…

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Study Finds Role For New Troponin Test in Diagnosis of MI

A new study from Germany provides evidence that a new high-sensitive troponin I (hsTnI) assay may improve and speed the early diagnosis of acute MI. In an article published in JAMA, Till Keller and colleagues report on 1818 patients with acute chest pain in whom numerous biomarker tests were conducted at admission and at 3 and 6…

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Study Finds MR Superior to SPECT, But Clinical Role Is “Uncertain”

Authors of a new study published online in the Lancet state that multiparametric cardiovascular magnetic resonance (CMR) is superior to single-photon emission computed tomography (SPECT) in patients with suspected coronary heart disease (CHD). But at least one expert states that the future role of the technique in clinical practice remains “uncertain.” John Greenwood and colleagues compared…

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Ray of Light for the Physician Payment Sunshine Act

The Physician Payment Sunshine Act (PPSA) may shed even more light on payments to physicians than previously expected. PPSA is the part of the health care reform act that will require pharmaceutical and device companies to report their payments to physicians and other healthcare workers and organizations. However, many observers thought a major loophole of PPSA…

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Study Examines Changes in Resting Heart Rate Over Time

Although resting heart rate (RHR) has been long known to be associated with cardiovascular risk, change in RHR over time has not been well studied. A new paper from Norway published in JAMA demonstrates that an increase in RHR over 10 years helps predict the risk of all-cause and ischemic heart disease (IHD) death. Javaid Nauman…

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22 Years Later, Study Shows Life-Prolonging Effect of Antihypertensive Therapy

After more than 20 years the benefits of antihypertensive therapy are still evident, according to a new paper published in JAMA. John Kostis and colleagues performed a 22-year followup study on patients enrolled between 1985 and 1988 in the Systolic Hypertension in the Elderly Program (SHEP) trial. In 1991 SHEP found that low-dose chlorthalidone in 4,736 elderly…

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ALTITUDE Study of Aliskiren Terminated Early by Novartis

Novartis announced today the early termination of the ALTITUDE trial, which was testing the effect of the direct renin inhibitor aliskiren (Rasilez, Tekturna) in type 2 diabetics at high risk for cardiovascular and renal events. The action was based on the recommendation of the independent Data Monitoring Committee (DMC), after it found an increased risk for…

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More Uncertainty About Vitamin D Supplements

Although many experts believe that vitamin D deficiency may play a significant role in cardiovascular disease, there is little evidence to support the use of vitamin D supplements for the prevention of cardiovascular disease. In a narrative review published in Annals of Internal Medicine, Cora McGreevy and David Williams write that the few available studies…

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FDA Adds New Warnings to Dronedarone (Multaq) Label

In an updated  safety communication the FDA announced it was adding new warnings  to the dronedarone (Multaq, Sanofi) label. Based on results from the PALLAS trial, which was discontinued early due to safety concerns, the drug label will now warn: Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be…

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Letter From Jail: A Cautionary Tale

CardioBrief reprints a letter from a friend in jail. Are there lessons to be learned from it?

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The Good, the Bad, and the Ugly: AHA Releases Update of Heart and Stroke Statistics

Once again, statistics on the cardiovascular health of the United States portray a complicated picture of improvement and decline. On the one hand, deaths from cardiovascular disease continue to decline. On the other hand, ominous trends, many stemming from the increase in obesity, suggest that the good news may not last much longer. The full…

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Investigation in Poldermans Case Expands to Leiden University Medical Center

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The investigation in the Dutch scientific misconduct case has now spread to the Leiden University Medical Center, according to media reports in the Netherlands. The case first came to public attention last month when the Erasmus Medical Center in Rotterdam fired  prominent cardiovascular researcher Don Poldermans. (Click here for previous CardioBrief coverage of the case.) A spokesman for…

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Study Examines New-Onset Atrial Fibrillation After TAVI

The broad enthusiasm for TAVI (transcatheter aortic valve implantation) as it enters the marketplace has been partially offset by concerns about an increased risk of stroke associated with the procedure. The role of one major cause of stroke, atrial fibrillation (AF), has not been the subject of close scrutiny. Now a new study from Quebec published…

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Meta-analysis Finds No Danger for PCI Performed at Centers Without Surgical Backup

On-site surgical backup for PCI has long been mandated by guidelines, though its necessity in the modern era has been questioned, and the most recent PCI guidelines published last month lack a specific recommendation about surgical backup. Now a large new meta-analysis published in JAMA suggests that the PCI performed without surgical backup may be safe….

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Large Analysis Confirms Safety of ADHD Medications

The cardiovascular safety of ADHD (attention-deficit/hyperactivity disorder) drugs has been uncertain. Now a large new study published online in JAMA provides reassurance that the drugs are safe. Laurel Habel and colleagues analyzed data from more than 440,000 adults, including 150,359 users of ADHD medications and matched nonusers and found “no evidence of an increased risk…

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From the Archives: Understanding Risk: Tricky Business

Note to readers: The attached article (click on the image to download the PDF) about understanding risk was originally published in the Harvard Health Letter in 1994. I recently stumbled across it in my archives and thought some readers here might enjoy it. Although it is directed at a consumer and not a professional audience,…

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FDA Advisory Panel Votes Against Implantable CardioMEMS HF Pressure Measurement System

Members of the FDA Circulatory System Devices Panel today recommended against approval of the implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the risks….

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Oops, She Did It Again! FDA Disinvites Another Advisor

Today an FDA advisory panel will meet to review the safety of oral contraceptives that contain drospirenone. One person who will not be voting on the panel is Sidney Wolfe, the well known consumer advocate and pharma critic. Wolfe was originally listed as a panel member, but then, only 2 days before the meeting, he was removed from…

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CV Risk of Prostate Cancer Therapy Underappreciated

Androgen suppression therapy (AST) for prostate cancer may be a serious risk factor for cardiovascular (CV) disease, according to a Viewpoint published online in Heart. The scope of the problem is widely underappreciated and is rarely considered in clinical practice, write Liam Bourke and colleagues. The subject was also the topic of a 2010 scientific statement from the…

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FDA Undertakes Safety Review of Dabigatran (Pradaxa)

The FDA announced today that it was initiating a safety review of  dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug. Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The FDA said it was “working to determine whether the reports…

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Change in Fitness More Important Than BMI Over Time

Experts have been debating the relative role of obesity and fitness in cardiovascular risk. Now a new report from the Aerobics Center Longitudinal Study published in Circulation finds that maintaining or improving fitness significantly lowers CV risk irrespective of changes in BMI. Duck-chul Lee and colleagues followed 14,435 men for 11.4 years. Compared with people whose…

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