Archives for July 2011

US Senate Unanimously Endorses Campaign Against Atrial Fibrillation

On a day when Americans watched nervously as its government sought to contend with unprecedented turmoil and peril in the economic and political life of the country, the US Senate put aside all divisions and partisan politics to act decisively and unanimously to express support for “promoting increased awareness, diagnosis and treatment of atrial fibrillation.”…

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Controversial IOM Report Highly Critical of 510(k) Process

The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The…

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AstraZeneca Sets Premium Price for Ticagrelor (Brilinta)

[Updated with statement from AstraZeneca]– AstraZeneca will be charging a premium price for its new antiplatelet drug Brilinta (ticagrelor). Bernstein analyst Timothy Anderson reports that the daily treatment cost for the drug will be $7.24 on a wholesaler acquisition cost (WAC) basis, which is approximately 20% higher than the daily cost of $6.08 for clopidogrel (Plavix)…

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Mixed Results For New Implantable Device For the Treatment of Resistant Hypertension

A phase III pivotal trial has yielded mixed results for an experimental implantable device that uses baroreflex activation therapy (BAT) to treat resistant hypertension. The paper on the Rheos Pivotal Trial by John Bisognano and colleagues has been published online in the Journal of the American College of Cardiology. 265 patients with resistant hypertension had…

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Study Finds Differences in Heritability of Coronary and Cerebrovascular Disease

Although a family history of coronary or cerebrovascular disease usually receives equal weight when assessing risk, a new study suggests that family history may play a more important role in MI and ACS than in stroke or TIA. In a paper published in Circulation: Cardiovascular Genetics, Amitava Banerjee and colleagues report the results of a…

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Adding HbA1c Measurements Improves CV Risk Prediction in Diabetics

Current risk prediction models classify diabetes as equivalent to established CV disease.  Now, a new report from the Women’s Health Study and the Physician’s Health Study II suggests that adding HbA1c measurements to the model can improve risk prediction and lead to downward classification of some diabetics. In a paper published in Archives of Internal…

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APPRAISE-2 Dashes Hope of Adding Anticoagulant to Antiplatelet Therapy in ACS

The factor Xa inhibitor apixaban (under joint development by Bristol Myers Squibb and Pfizer as Eliquis) has been the subject of intense interest in recent years, showing great promise for thromboprophylaxis after surgery and for stroke prevention in AF. Some pundits now believe apixaban will become the anticoagulant of choice for the AF indication, although…

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Less May Be More, But Stents Are Neither Good Nor Bad

A few days ago the distinguished healthcare writer Shannon Brownlee wrote a provocative blog post  about the overuse of stents. A key piece of evidence that she used was a paper co-authored by Grace Lin and Rita Redberg in which focus groups of cardiologists cheerfully admitted that they would give stents to hypothetical patients who were, according…

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FDA and EMA Issue Updates on Dronedarone, Varenicline, and Pioglitazone

The FDA has issued an update on dronedarone (Multaq, Sanofi Aventis) and the European Medicines Agency (EMA) has provided updates on its reviews of dronedarone and 2 other drugs which also have been the subject of recent controversies: pioglitazone (Actos and other names, Takeda) and varenicline (Champix, Pfizer): The FDA and dronedarone– The FDA issued a…

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Sapien Transcatheter Heart Valve Receives Strong Support from FDA Advisory Panel

(Updated to include the FDA’s brief summary of the panel)–The FDA Circulatory Systems Devices Panel has given a strong vote of support in favor of the Sapien Transcatheter Heart Valve (THV)  for use in patients with inoperable severe aortic stenosis and with no co-morbidities precluding benefit from correction of the aortic stenosis. By  large majorities,…

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AstraZeneca: Ticagrelor (Brilinta) Gains FDA Approval

The FDA has approved ticagrelor (Brilinta, AstraZeneca). In a press release, the FDA said that the drug was approved to reduce cardiovascular death and MI in patients with acute coronary syndromes (ACS). The drug’s label will include a boxed warning about bleeding risks and, of considerable significance in light of the enormous amount of discussion…

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Study Suggests Possibility that CETP Inhibitors May Improve Glycemic Control

A new analysis of the ILLUMINATE trial raises the possibility that CETP inhibitors like torcetrapib may have the unexpected beneficial effect of improving glycemic control in addition to their intended effect of raising HDL cholesterol. Development of torceptrapib was halted several years ago following the early termination of the large ILLUMINATE trial due to an…

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FDA Releases Briefing Documents for Advisory Panel on the Edwards Sapien Transcatheter Aortic Valve Implant

The FDA has posted the briefing documents for the much-anticipated meeting on Wednesday of the Circulatory Systems Devices Panel for the Edwards Sapien transcatheter heart valve system in patients with severe aortic stenosis who are not eligible for surgical valve replacement, as studied in the PARTNER B trial. Overall the FDA documents suggest that the…

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The Mark Midei Cases: Patient A

The document containing the final decision of the Maryland State Board of Physicians revoking the medical license of Mark Midei includes extensive details about 5 cases (Patients A-E) reviewed by the Administrative Law Judge (ALJ), along with expert testimony about the cases by Midei himself, William O’Neill, Midei’s expert witness, and Matthews Chacko, the state’s expert…

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Maryland Revokes Mark Midei’s Medical License

Mark Midei’s license to practice medicine has been revoked by the Maryland Board of Physicians. In its Final Decision and Order the Maryland Board found that Midei was guilty of unprofessional conduct, willfully making a false report, gross overutilization of health care services, violating the standard of quality care, and failure to keep adequate medical records. The Maryland board…

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Therapeutic Hypothermia Network Benefits Cardiac Arrest Patients

Previous studies have shown that therapeutic hypothermia (TH) improves outcomes in patients who have an out-of-hospital cardiac arrest (OHCA). In a new paper published in Circulation, Michael Mooney and colleagues report on their experience with 140 OHCA patients in Minnesota who received treatment within a regional network of care that transfers OHCA patients to a…

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Study Finds Sodium-Potassium Ratio Strongly Tied to Mortality and CV Disease

The separate roles of sodium and potassium in cardiovascular disease have been extensively observed in epidemiologic studies. Now a study published in Archives of Internal Medicine examines their joint effect. Quanhe Yang and colleagues analyzed data from 12,267 adults participating in the 3rd National Health and Nutrition Examination Survey. As expected, they found that higher…

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OAT Trial Had Little Impact on Clinical Practice

Once again a study finds that  cardiologists don’t always pay attention to the literature and guidelines. In 2006 the Occluded Artery Trial (OAT) showed no benefit for routine PCI in patients with persistently occluded infarct-related arteries identified at least one day after a MI. But the study appeared to have minimal impact on clinical practice,…

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Guest Post: “Creepy” invasion of pharma into patient-targeted social media space

Editor’s Note: Recently I wrote about why patients should be subject to the same critical scrutiny as anyone else when their views about medical and scientific topics are presented in news coverage of medical stories. One aspect of the subject that I didn’t consider is that those patient views may well have been influenced by…

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ESC Congress in Paris: Hot Lines and Clinical Trial Updates

Here are the Hot Line sessions and Clinical Trial Updates scheduled for the ESC Congress 2011 in Paris:…

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Guest Post: Multaq’s Off Again, On Again, Then Off Again Ride

CardioBrief welcomes this guest post, reprinted with permission, from Dr. Westby Fisher, an electrophysiologist practicing at NorthShore University HealthSystem in Evanston, Illinois, and a Clinical Associate Professor of Medicine at University of Chicago’s Pritzker School of Medicine. This piece originally appeared on his blog, Dr. Wes. Today was another tough day for Sanofi’s dronedarone antiarrhythmic…

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Dronedarone (Multaq) Study for Permanent AF Stopped Early

The PALLAS trial of dronedarone (Multaq) for permanent AF has been stopped early, according to a press release (below) issued by Sanofi. PALLAS (Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy) was a double-blind, placebo-controlled, phase IIIb trial comparing dronedarone to placebo in patients with permanent AF. The company said the…

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ASCEND-HF: No Harm or Benefit with Nesiritide

With the publication of the final results of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Trial) in the New England Journal of Medicine, the once intense controversy over the use– or misuse– of the drug nesiritide in patients with acute decompensated heart failure has finally been resolved. The results,…

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Lower Sudden Cardiac Death Rates Observed in Women With Healthy Lifestyles

It probably won’t come as a big surprise, but a new study finds that women who live a healthy lifestyle have a lower risk of sudden cardiac death (SCD). In a paper published in JAMA, Stephanie Chiuve and colleagues analyzed data from 81,722 women enrolled in the Nurses’ Health Study. They used 4 factors to…

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Comment: ACC Circling the Wagons, Once Again

Once again the ACC is circling the wagons. In response to a paper in JAMA finding that about half of all nonacute PCI procedures may be inappropriate, the ACC released a statement assuring everyone that there’s nothing to be concerned about and that all the experts and officials are hard at work mending whatever slight…

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