Is the Time Right for a Preprint Archive for Clinical Trials?

Here’s a great idea: a preprint archive for clinical trials. Taking inspiration from the well-established use of preprint archives in physics, math, and other scholarly areas, Martin Fenner, a cancer researcher, proposes the establishment of a preprint archive for clinical trial research papers. Fenner points out that “the results of clinical trials are rarely first…

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Meta-Analysis Lends More Support to Compression-Only CPR

There’s new evidence supporting the movement away from traditional bystander CPR in favor of chest-compression-only CPR. In a paper appearing online in the Lancet, Michael Hüpfl, Harald F Selig, and Peter Nagele report the results of two separate meta-analyses. In the first meta-analysis, the investigators combined data from 3 randomized trials comparing compression-only CPR to standard CPR…

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Trick or TREAT? FDA Staff Highly Critical of Aranesp Trial

Update: 6:00 PM: The FDA has posted the roster for Monday’s meeting. Committee members include Henry Black, Jonathan Halperin, Judith Hochman, Sanjay Kaul, Mori Krantz, and Darren McGuire. The questions for the committee will not be posted before the meeting. An FDA official told CardioBrief that the FDA is not required to post questions. Halloween…

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Guest Post: Big Pharma Knows Your Private Health Matters

(Editor’s note: The following post is written by Dr. John Mandrola, an electrophysiologist in Louisville, KY. Mandrola is also the author of his own blog, Dr John M, where this post originally appeared.) by Dr. John Mandrola He was here for routine follow-up. He has atrial fibrillation. He is, and has been well controlled on…

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Transfusions and Cardiac Surgery: “A Major Concern

One new study in JAMA demonstrates very wide differences among hospitals in the use of transfusions during cardiac surgery. A second study finds no differences in outcome based on transfusions. Two editorialists write that “continued inappropriate transfusions among hospitals is a major concern.”…

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Heart Failure and Resource Use at the End of the Road

Two studies of heart failure populations — one conducted in the U.S. and one in Canada —  shed light on patterns of resource use in the last 6 months of life. Both studies appear in the Archives of Internal Medicine….

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Obesity: Good News and Bad News

Two new trials and accompanying editorials published online in JAMA offer hope that lifestyle interventions can result in significant weight loss. The bad news: The results are fairly modest, and it is difficult to obtain reimbursement for lifestyle interventions….

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Guest Post: “Why I Won’t Blog About Heart Failure for US News & World Report”

Editor’s note: The following guest post is by Mary Knudson, who 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 Hospital, she is the co-author of the highly praised book,…

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The Plot Thickens in the Case of the Exploding ICD

The plot thickens: The case report of an “exploding” ICD, originally published and then withdrawn in the journal Europace, continues to provoke comment and controversy. On Friday evening, Westby Fisher, the electrophysiologist and blogger who first drew attention to the Europace report, met with officials from Biotronik and later summarized the meeting on his blog. The…

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Abbott withdraws obesity drug Meridia (sibutramine) from US market

Abbott Laboratories has voluntarily withdrawn its obesity drug sibutramine (Meridia) from the US market after the FDA concluded that the drug’s very modest benefits did not outweigh the risk of MI and stroke associated with the drug. The drug was pulled from the European market earlier this year. Here’s a link to the FDA Communication: Drug…

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The Case of the Exploding ICD, the Disappearing Journal Article, and a Defensive Blogger

The story so far: The official ESC journal Europace publishes an online case report by Dr. Martin Hudec about the extremely rare and spectacular failure of a recently implanted Biotronik 340 VR-T ICD in a 46-year-old man. The battery of the device apparently overheated, causing the device to malfunction and leading to severe internal burning. On Wednesday, October…

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Briefs: Rolofyline Fails, Genome Studies Pool Data

Rolofylline Fails in Heart-Failure Trial In a report in the New England Journal of Medicine, Massie and colleagues randomized 2033 patients hospitalized with acute heart failure and impaired renal function to receive intravenous roloflylline or placebo. Earlier studies had suggested that the use of an adenosine A1-receptor antagonist might be beneficial in this patient population….

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Study Finds No Evidence for Clopidogrel-Omeprazole Interaction

A large clinical trial has found no evidence that omeprazole interferes with the cardiovascular efficacy of clopidogrel. COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial) randomized 3873 patients eligible for dual antiplatelet therapy to receive aspirin, clopidogrel, and either omeprazole or placebo. The COGENT investigators had planned to enroll 5000 patients, but the trial…

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Briefs: Genetic Expression Testing, Compression-Only CPR Gains Support

Gene Expression Test Brings Modest Improvement to Patient Classification A gene expression test can improve the prediction of CAD but may not be clinically useful, according to results of the Personalized Risk Evaluation and Diagnosis in the Coronary Tree (PREDICT) study published in theAnnals of Internal Medicine. The PREDICT investigators, led by Eric Topol, evaluated a…

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Briefs: Sleep and Obesity, Closure Device Recommendation, Hypertension in Blacks

Study Finds Deep Ties Between Sleep and Weight Loss A good night’s sleep might be a key to losing weight. In a crossover study among 10 overweight people, Arlet Nedeltcheva and colleagues compared the effects of 2 weeks of dieting with 8.5 or 5.5 hours of sleep each night. They found that during the sleep…

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Guest Post: A Case of Exuberance About a Subgroup in a Clinical Trial

Editor’s note: This post by Harlan Krumholz is republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to join the site. by Harlan Krumholz In many clinical trials, researchers investigate whether an overall effect of an intervention is consistent…

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Novartis pays $422 million to settle DOJ lawsuit

Novartis has agreed to pay $422 million to settle a US Department of Justice and whistleblower lawsuit. Although many of the allegations against the company concerned the off-label promotion of the epilepsy drug Trileptal, key additional portions of the lawsuit involved the company’s cardiovascular products, including Diovan (valsartan) as well as Tekturna (aliskiren) and Exforge…

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Avandia, Meridia… now it’s Aranesp’s turn before the FDA

The FDA Death Panel Cardiovascular and Renal Drugs Advisory Committee will consider the fate of darbepoetin alfa (Aranesp) on October 18. Having failed to impose the death penalty on rosiglitazone (Avandia) and Meridia (sibutramine) in recent months, it appears likely the committee will not recommend withdrawal of the drug, though in the absence of any…

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Guest post: My Life as a Mom

Editor’s note: The following guest post is completely off-topic and, further, completely divergent from the cynical, skeptical, and occasional misanthropic perspective usually on display here. It is written by new mom Patricia Moreno, one of the most gifted fitness instructors on the face of the earth. My Life as a Mom My daughter Olivia is…

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Guest post: news you can use: sex and your defibrillator

Editor’s Note: The following post was written by Westby G. Fisher, an electrophysiologist at NorthShore University HealthSystem in Evanston, IL and the author of Dr Wes, a popular blog about cardiology, the internet, and anything else that catches his imagination. Have a defibrillator and feel like getting frisky? For the first time that I can…

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Carotid endarterectomy still beneficial at 10 years

Carotid endarterectomy (CEA) in asymptomatic patients under 75 years of age reduces the long-term risk of stroke, according to 10-year results from the Asymptomatic Carotid Surgery Trial (ACST), published in the Lancet. The ACST investigators randomized 3120 asymptomatic patients to immediate CEA or to indefinite deferral of CEA. At 5 years, CEA had been performed…

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TCT Briefs: EES versus SES; Peripheral DES

Two more short items from the TCT meeting, reprinted courtesy of CardioExchange:…

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TCT briefs: Xience V outperforms Taxus at 2 years, ACC to co-sponsor TCT 2011

In addition to the PARTNER trial, newsworthy events from TCT on Thursday include the presentation of two trials showing the long-term superiority of the Xience V over Taxus and the surprising announcement that the ACC would be a co-sponsor of TCT 2011….

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FDA keeps Avandia on market, re-adjudicates RECORD, halts TIDE; EMA suspends Avandia marketing

The FDA announced today that it would not remove rosiglitazone (Avandia) from the market but that it would impose severe new restrictions on its use. It also put on “full clinical hold” the controversial TIDE trial. The FDA is also requiring GSK to “commission an independent re-adjudication of the RECORD study.” The new REMS will require…

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NEJM: fondaparinux effective in superficial-vein thrombosis

In a randomized, double-blind trial, 3002 patients with acute, symptomatic superficial-vein thrombosis in the legs, but without DVT or symptomatic PE, received either fondparinux (2.5 mg) or placebo for 45 days. The primary efficacy endpoint– a composite of all cause death, symptomatic PE or DVT, symptomatic extension to the saphenofemoral junction, or symptomatic recurrence of…

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