Very Little New Light Shed on the Archives Meditation Paper Fiasco

Update, June 30-– Jann Ingmire, the director of media relations for JAMA and the Archives Journals, sent the following clarification late this afternoon: “The authors submitted the additional data in a letter just prior to publication.  That letter was submitted by the authors in response to a request for changes from the NIH program director (not the…

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New Concerns Raised About Withdrawn Archives Meditation Paper

I don’t know why Archives of Internal Medicine stopped the publication of a paper only moments before its scheduled debut (see my previous post for the details). But a news story on the study (published despite the withdrawal of the paper, and provoking further questions about gullible journalists) provides firm evidence that the study’s authors are…

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Archives Decides At Last Minute Not to Publish a Scheduled Paper

Here’s something I’ve never seen: 12 minutes before the scheduled publication of a paper the journal publishing the paper announced that it had “made the decision not to publish” the paper. Here’s what happened: Last Thursday the JAMA/Archives media team issued a press package to  accredited media about several articles scheduled for publication in Archives…

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Asprin Dosage in US May Explain Disparity in Ticagrelor Results in PLATO

Although the PLATO trial succeeded in demonstrating the overall superiority of ticagrelor (Brilinta, AstraZeneca) to clopidogrel in more than 18,000 ACS patients worldwide, approval of the drug in the US has been delayed because of ticagrelor’s lack of effect in the prespecified subgroup of patients from North America. Now, two  analyses of the trial, presented…

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Diabetes Growth Termed a Rising Global Hazard

In 2008 347 million people in the world had diabetes, more than twice the 153 million in 1980, according to estimates contained in a report in the Lancet from the Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group. The papers appears in conjunction with the annual meeting of the American Diabetes Association. Throughout  the world diabetes…

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Limited Benefit Found for Early Aggressive Management of Diabetes

In the ADDITION-Europe trial, 3055 patients without diabetes were randomized to either routine care or screening followed by intensive treatment of multiple risk factors. The results were presented at the American Diabetes Association meeting and published online in the Lancet, After five years, cardiovascular risk factors– HbA1c, lipids, and blood pressure– were “slightly but significantly…

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FDA Recommends More Conservative Dosing of ESAs

The FDA today said that it was recommending more conservative dosing of ESAs (erythropoiesis-stimulating agents) in patients with chronic kidney disease (CKD). The possible beneficial effects of the drugs to decrease the need for transfusions in CKD patients should be weighed against the increased risk of cardiovascular events, the FDA said. ESA therapy should be…

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Pundits Declare Victory in Anticoagulant Contest But It’s Not Over Yet

The pundits and analysts have called it: apixaban (Eliquis), the oral, direct factor Xa inhibitor being jointly developed by BMS and Pfizer, is the winner. Dabigatran (Pradaxa) and rivaroxaban (Xarelto) will fight for the remainder of the market. Yesterday’s announcement of the topline results from ARISTOTLE indicates a clear victory for the drug, say the experts….

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Apixaban (Eliquis) Meets Primary Endpoint in ARISTOTLE

Pfizer and Bristol-Myers Squibb said today that their new oral direct Factor Xa drug apixaban, which will be marketed under the brand name of Eliquis, had met the primary endpoint of the ARISTOTLE study. The Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE) study was designed to compare the factor Xa inhibitor…

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JAMA: Skeptical Perspectives on Consumer Cardiac Tests and Vitamin D

Two commentaries published in JAMA offer skeptical perspectives on the roles of direct-to-consumer (DTC) cardiac tests and vitamin D in cardiovascular health. In the first commentary, Kimberly Lovett and Bryan Liang write that DTC screening tests “likely pose more risk than benefit to patients,” and point out that for companies selling these tests there is no…

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Meta-Analysis Examines Risk of Diabetes Associated with Statins

Although the cardiovascular benefits of statin therapy are well-characterized, recent studies have raised concerns that intensive statin therapy increases the risk of developing type 2 diabetes. Now, a new meta-analysis published in JAMA provides a more precise estimate of the risk of diabetes associated with statin therapy and also weighs that risk against the cardiovascular…

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Study Finds Critical Delay in Most MI Patients Transferred for Primary PCI

MI patients who arrive at hospitals unable to perform primary PCI need to be promptly transferred to another hospital in order to receive the full benefits of reperfusion. Unfortunately, these patients often have prolonged door-to-balloon times. A key element in the delay is the time spent at the first hospital, referred to as the door-in…

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FDA Says Varenicline (Chantix) May Increase Risk of CV Events

The FDA said that the anti-smoking drug varenicline (Chantix) may increase the risk of cardiovascular events in people who already have cardiovascular disease. The new information will be added to the drug’s label and Medication Guide for patients. The FDA does not recommend that people with cardiovascular disease discontinue taking varenicline, but says that physicians…

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FDA Says Pioglitazone Use Is Linked to Bladder Cancer

The FDA has issued a safety announcement stating that the use of pioglitazone (Actos) for more than 1 year may be  associated with increased risk for bladder cancer. The FDA announcement follows last week’s suspension of the drug in France and Germany by regulatory authorities in those countries. The FDA said that pioglitazone should not be used in patients…

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NEJM: FDA Officials Explain the New Simvastatin Label

(Updated with comments from Joe Ross and Steve Nissen)– In a perspective published in the New England Journal of Medicine, two FDA officials, Amy Egan and Eric Colman, explain in some detail the recent changes made by the FDA regarding simvastatin. They note that in the SEARCH trial myopathy developed in 52 (0.9%) patients in the…

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Twice a Stent Pioneer, J&J Abandons the Stent Market

Johnson & Johnson, the company which pioneered the original stent market in the 1990s and the drug-eluting stent market in the 2000s, is abandoning the stent market. On both occasions the company completely revolutionized the field of interventional cardiology, and on both occasions the company spectacularly lost its leading position and failed to build a…

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CRT for HF Patients With Moderately Prolonged QRS Interval: Unethical?

Approximately 40% of cardiac resynchronization therapy (CRT) devices are implanted in patients with QRS intervals below 150 msecs, but a meta-analysis published in Archives in Internal Medicine finds that these patients may not benefit from the device. Ilke Sipahi and colleagues performed a meta-analysis that included 5 CRT clinical trials (COMPANION, CARE-HF, REVERSE, MADIT-CRT, RAFT)…

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Increased Mortality Found in MI Patients During Ambulance Diversion

MI patients treated who are diverted to other emergency departments (EDs) while their local EDs are closed have an increased risk of death, according to a new study published in JAMA. Yu-Chu Shen and Renee Hsia analyzed data from 4 California counties of all Medicare patients with MI who were admitted to the hospital between…

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A New Biomarker From the Lungs

A new study raises the possibility that a protein produced in the lungs may improve the prediction of cardiovascular disease. In a paper in the European Journal of Cardiology, John Hill and colleagues report on their research with surfactant protein-D (SP-D), which is produced in the lungs and whose levels are increased in the general…

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Pioglitazone (Actos) Suspended in France Over Cancer Concerns

Update–June 10: Following the example of France, Germany has also suspended the use of pioglitazone. Click here for the announcement (in German). Sales of the popular diabetes drug pioglitazone (Actos, Takeda) have been suspended in France after a study carried out by the French health insurance fund (CNAM)  found that the drug may increase the…

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SHARP Results Published in Lancet

The main results of SHARP (Study of Heart and Renal Protection) have now been published in the Lancet, following their preliminary presentation last November at the American Society of Nephrology meeting. The results are also posted online on the trial’s website. In brief, SHARP randomized 9270 patients with chronic kidney disease (one-third of whom were on…

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FDA Recommends Limiting Usage of High Dose Simvastatin

The FDA today recommended significant limitations in the use of high dose (80 mg) simvastatin because of the increased risk of myopathy. The FDA said the 80 mg dose of simvastatin should be used only in people who have been taking the high dose for at least one year and have had no evidence of…

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FDA Sets July 20 Date for Advisory Panel on Sapien Transcatheter Aortic Valve

An FDA advisory panel will review the premarket approval (PMA) application for the Sapien transcatheter aortic valve on July 20, the device’s manufacturer, Edwards, has announced. The application is based on results from the PARTNER B trial, which compared the Sapien valve to optimal medical therapy in patients with severe aortic stenosis who were not eligible…

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ProPublica Investigates Heart Check America

Editor’s Note: The following post is reprinted with permission from ProPublica. Body Imaging Business Pushes Scans Many Don’t Need — Including Me by Marshall Allen, ProPublica, June 7, 2011, 5 a.m. The telemarketer called in February with an unusual offer: free heart scans for me and my wife, an $800 value, from a company called…

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Smoking Found To Be Potent Risk Factor for Symptomatic PAD

The latest report on the 40,000 women enrolled in the Women’s Health Study provides further demonstration that smoking is “a potent risk factor for symptomatic PAD.” The paper by David Conen and colleagues has been published in Annals of Internal Medicine. Here are the age-adjusted incidence rates per 1000 person-years of follow-up:…

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