Third Time Is the Charm: FDA Panel Finally Backs an Obesity Pill

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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PROTECT II Study of Impella Stopped Early for Futility

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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Questions Raised About Compensation and Conflicts at Duke

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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Meta-Analysis: Daily Aspirin Reduces Cancer Deaths

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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Senate Report on Mark Midei and Abbott: 30 Stents in 1 Day, Pig Roasts, and More

[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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Ticagrelor (Brilique) gains European approval

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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Rivaroxaban Found Safe and Effective for DVT

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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The Possible Return of the Missing Case Report of the Exploding ICD

The missing case report of an “exploding” ICD may be back. Two months ago I recounted the strange series of events following the initial online publication of a case report in Europace about an extremely rare and spectacular failure of a Biotronik ICD. The battery of the device apparently overheated, causing the device to malfunction…

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Vanity Fair Article Eviscerates Globalization of Clinical Trials

The globalization of the pharmaceutical industry, and in particular the outsourcing of clinical trials to “sick Russians, homeless Poles, and slum-dwelling Chinese,” is brought to light and critically assaulted in “Deadly Medicine,” an article in Vanity Fair by Donald L. Barlett and James B. Steele. CardioBrief readers are probably familiar with this topic, but the full magnitude of…

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Heart Failure Death Statistics: Don’t believe what you read on the internet

Editor’s note: The following guest post by Mary Knudson originally appeared on her blog, Heart Sense: A Blog About Heart Failure. Knudson worked for 17 years as a medical writer for The Baltimore Sun and currently teaches science and medical writing at Johns Hopkins University. Along with Edward Kasper, clinical chief of cardiology at Johns Hopkins…

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New Performance Measures for Peripheral Artery Disease Issued

Performance measures to improve the diagnosis and treatment of peripheral artery disease (PAD) in adults have been published for the first time. The document was produced by the ACC, the AHA, and several other medical organizations. Here are a few key details of the performance measures:…

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Study Finds No Link Between Cancer and Antihypertensives, Except for ARB-ACE Inhibitor Combo

A new meta-analysis has found no evidence of a large cancer risk for most common antihypertensive agents, but did find strong evidence, largely based on one trial, for at least a 10% increase in cancer risk with the rarely used angiotensin-converting-enzyme (ACE) inhibitor and angiotensin-receptor blocker (ARB) combination. In a paper in the Lancet Oncology, Sripal Bangalore…

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MARINE: New Fish Oil Pill Slashes High Triglycerides

A new prescription-grade formulation of ethyl-EPA, an omega-3 fatty acid, significantly lowers triglycerides but doesn’t increase LDL. These were the top line results of the MARINE trial released on Monday by Amarin Corporation, which is developing the drug, now known as AMR101. MARINE randomized 229 patients with triglyceride levels of 500 mg/dl or greater to…

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Greek Study Offers Reassurance About Statin Usage in Patients with Abnormal Liver Tests

Among the 1600 patients randomized in the GREACE (Greek Atorvastatin and Coronary Heart Disease Evaluation) study, 437 had moderately abnormal liver tests at baseline suggesting non-alcoholic fatty liver disease (NAFLD). In a post-hoc analysis of this subset of patients published in the Lancet, the GREACE Study Collaborative Group reported a dramatic 68% reduction in the rate…

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Guest Post: Of Drug Talks, Deception, and Denial

This guest post by Roy Poses, MD, is reprinted with permission from Health Care Renewal. by Roy M. Poses, MD A month ago, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the…

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SHARP: A Tale of Two Press Releases

Two press releases were issued about the SHARP trial : one from Merck, the much-maligned and criticized manufacturer of Vytorin (the combination of ezetimibe and simvastatin), and one from the group running the trial, the highly-respected Clinical Trials Service Unit (CTSU) at Oxford. Here’s the surprise: compared to the Oxford press reelease, the Merck release…

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SHARP Shows Benefit for Vytorin in Chronic Kidney Disease

The long-awaited SHARP study has turned up positive results for Vytorin (ezetimibe and simvastatin) in a population of patients with chronic kidney disease. Results of SHARP (Study of Heart and Renal Protection) were presented on Saturday at the American Society of Nephrology meeting in Denver and were scheduled to be posted online on the trial’s website….

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APPRAISE-2 Apixaban in ACS Study Discontinued Due to Increased Bleeding

Bristol-Myers Squibb announced on Thursday evening the discontinuation of APPRAISE-2 (Apixaban for Prevention of Acute Ischemic Events – 2), a phase 3 trial comparing apixaban to placebo in patients with acute coronary syndrome. The decision was based on a recommendation from the Data Monitoring Committee based on “a clinically important increase in bleeding among patients…

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AHA 2010 Is History

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Will This Be the HDL Decade? REVEAL Revealed, Mixed Results for Apo-A1

For a long time HDL has been called the “good cholesterol.” Are we now entering the HDL decade? Two HDL-related trials were presented today at the AHA, and an array of additional trials are planned or underway, prompting the  lead investigator of one of those trials, Chris Cannon, to speculate that this decade may be…

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Anacetrapib: “knock-your-socks-off effect on HDL and a jaw-dropping effect on LDL”

Following the failure of torcetrapib in 2006 the future of CETP inhibitors appeared quite troubled. Now, with the results of  DEFINE (Determining the Efficacy and Tolerability of CETP Inhibition with Anacetrapib), presented at the AHA in Chicago and published online simultaneously in the New England Journal of Medicine, the future for this novel class of…

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CardioExchange at the AHA: A New Voice Emerges

Some of you may be aware that my “day job” for the last year has been with the Massachusetts Medical Society, publishers of NEJM. I’ve been working with the great people at MMS helping develop and publish CardioExchange, a social media website for cardiovascular healthcare professionals. Now that may sound silly to many of you…

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BASKET-PROVE Examines Stents for Large Vessels

The BASKET investigators continue their investigator-led exploration of stents in the real world. In BASKET-PROVE they sought to test the hypothesis derived from observations in earlier trials that drug-eluting stents in large vessles might cause only a marginal reduction in revascularizations and might have an increased risk for late stent thrombosis. The results of BASKET-PROVE…

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GRAVITAS: No Benefit for Clopidogrel Dosing Based on Platelet Function Test

The GRAVITAS (Gauging Responsiveness With A VerifyNow Assay– Impact on Thrombosis and Safety) trial enrolled 2,214 patients with high residual platelet reactivty, as assessed by the VerifyNow P2Y12 Test measured 12 to 24 hours after the procedure. (The manufacturer of the test, Accumetrics, sponsored the trial.) Patients in the trial were randomized to either high dose clopidogrel…

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Blast Off! ROCKET AF Hits Chicago

ROCKET AF hit the AHA on Monday morning. Results of ROCKET AF (Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared With Warfarin in Patients with Nonvalvular Atrial Fibrillation) had been the topic of intense speculation and interest. The trial showed that the experimental factor Xa inhibitor rivaroxaban was as effective as warfarin…

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