Halloween trick: don’t TREAT diabetes with ESAs

Scary Pumpking

In the first adequately powered trial of an erythropoiesis-stimulating agent (ESA), darbepoetin alfa (Aranesp, Amgen) failed to reduce major clinical events and was associated with an increased risk of stroke in a population of type 2 diabetics with chronic kidney disease. The much-anticipated TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) was presented by Marc Pfeffer…

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AstraZeneca update on ticagrelor (Brilinta) raises questions about reduced efficacy with high dose aspirin

Last August the results of PLATO raised hopes that ticagrelor could join clopidogrel and prasugrel in the antiplatelet armamentarium. On Thursday, in the course of its quarterly update, the drug’s manufacturer, AstraZeneca, raised an issue that may dampen somewhat the positive news from the summer….

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Halloween to arrive early this year with presentation of TREAT

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Trick or Treat? On Friday night, only hours before Halloween, the much-anticipated TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) will be presented by Marc Pfeffer as a late-breaking clinical trial as part of Renal Week in San Diego. CardioBrief will have full coverage of the trial at 8:40 PM. However, CardioBrief readers may…

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Study suggests statins may prevent flu deaths

People on statins are less likely to die of the flu, according to a new observational study to be presented on Friday in Philadelphia at the Annual Meeting of the Infectious Diseases Society of America. Meredith Vandermeer (Oregon Public Health Division) and colleagues studied 2,921 patients hospitalized with lab-confirmed influenza, 26% of whom were taking statins….

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UK’s NICE allows limited use of prasugrel

The UK’s National Institute for Health and Clinical Excellence (NICE) has recommended prasugrel (Efient) for use in the National Health Service, but only under limited conditions. Specifically, the guidance document specified that prasugrel should only be used during PCI for ACS only when emergent PCI is required for a STEMI, for stent thrombosis in patients…

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Review article highlights differences between European and North American STEMI guidelines

Differences between recently published updated STEMI guidelines from the ACC/AHA and the ESC are partly the result of conflicting interpretations of the data, according to a review article in the American Heart Journal by Deepak Thomas and Robert Giugliano. Other differences may be due to the availability of new data between the publications, though on…

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Medicare advisory committee delivers mixed review for AF catheter ablation

Catheter ablation for atrial fibrillation received mixed reviews from MedCAC (the Medicare Evidence Development and Coverage Advisory Committee), according to a report in the Gray Sheet. The advisory committee met on October 21 to “discuss the adequacy of the available evidence for the use of catheter ablative techniques to treat patients with atrial fibrillation,” according to the…

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Senator queries NIH about Ballantyne and other NIH grantees who took Vytorin money

Following the detailed disclosure of the vast sums of money spent on academic institutions and individual physicians for Vytorin CME and consulting, Senator Grassley is now raising additional concerns about conflicts of interest involving 5 physicians who were also recipients of NIH grants. In his letter to Francis Collins, the new NIH director, Grassley highlighted…

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Women and MI: increasing incidence but improved survival

Two new studies provide important new details about the complex situation regarding women and MI. On the one hand, middle-aged women over the last 20 years have developed an increased risk of MI. (The trend for men of the same age has been improving, by contrast, though men still have a higher absolute risk than…

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FDA advisory committee to review primary prevention indication for Crestor (rosuvastatin)

On December 15 the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will evaluate AstraZeneca’s application for a primary prevention indication for rosuvastatin (Crestor). The application is based on the results of JUPITER. Click here for the FDA announcement….

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Duke cardiologist to be new president of Gladstone Institutes

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Roberts Sanders “Sandy” Williams will be the next president of the Gladstone Institutes, the Institutes announced yesterday. Sanders, a Duke Univeristy cardiologist, most recently served as the senior vice chancellor for academic affairs at Duke University Medical Center. Williams succeeds the Gladstone’s founding director and president, Robert Mahley, who is stepping down after 30 years, according…

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Lancet: liraglutide shows considerable promise in weight loss trial

Can liraglutide go where rimonabant couldn’t? Can it safely and effectively help to mitigate the effects of the obesity and metabolic syndrome pandemic? Results of a new trial with liraglutide may well help restart speculation and refuel the rumor mill. But the chief limitations to liraglutide are the current absence of robust long term data…

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Betsy Nabel to leave NHLBI to become president of the Brigham

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Elizabeth Nabel will be the next president of Brigham and Women’s Hospital, the hospital has announced. Nabel will leave her position as director of the NHLBI and assume her new position on January 1, 2010. She succeeds Gary Gottlieb, who will become the CEO and president of Partners HealthCare….

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FDA turns down King’s NDA for CorVue (binodenoson)

The FDA has issued a completed response letter in response to King Pharmaceuticals NDA for CorVue (binodenoson). The company has not disclosed the content of the letter. Binodenoson is a pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) cardiac imaging. The FDA response is not entirely unexpected, as the FDA’s cardiorenal…

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Hospitals getting with the guidelines are not getting with aldosterone antagonism

Only a third of heart failure patients who have a guideline-based indication for an aldosterone antagonist are actually receiving one, according to a new study appearing in JAMA. Ironically, the observational analysis  of 43,625 heart failure patients took place in  241 hospitals participating in the Get With The Guidelines–HF quality improvement registry….

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Medco launches 14,000 patient head-to-head observational comparison of clopidogrel and prasugrel

Medco announced today that it is launching a large head-to-head prospective, observational study comparing clopidogrel (Plavix) and prasugrel (Effient) in more than 14,000 patients. The study, GeCCO (Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study), is designed to assess whether clopidogrel given to patients who are CYP2C19 extensive metabolizers is noninferior to prasugrel on the…

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Telmisartan gets FDA approval for CV prevention in ACE inhibitor-intolerant patients

Update: October 23– Boehringer Ingelheim announced in a press release that CHMP had issued a positive opinion for telmisartan as the first treatment in its class to reduce the risk of cardiovascular morbidity in high CV risk patients. Telmisartan (Micardis) has received FDA approval for the prevention of MI, stroke, or death from cardiovascular causes…

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More allegations about ENHANCE fiasco laid out in Vytorin lawsuit complaint

A 200+ page complaint filed in the Schering-Plough/ENHANCE lawsuit provides the closest glimpse yet of the inner workings and details of the ENHANCE trial fiasco, at least from the perspective of the company’s critics. The lengthy document provides a detailed chronology of the trial’s history and the interactions of the company and the trial’s academic…

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Study raises concerns about trauma treatment in growing population on warfarin

A large observational study raises concerns that the growing population of patients on warfarin is more likely to die because of trauma. The new study, which included 36,000 warfarin users among 1.2 million people in the National Trauma Databank, was presented at the 2009 Clinical Congress of the American College of Surgeons. The finding is…

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Crestor gains pediatric FH indication from FDA

AstraZeneca announced today that Crestor (rosuvastatin) had received FDA approval for pediatric patients with heterozygous familial hypercholesterolemia….

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IOM report: smoking bans cut heart attacks in smokers and nonsmokers

The Institute of Medicine has released a report, Secondhand Smoke Exposure and Cardiovascular Effects: Making Sense of the Evidence, that provides strong evidence to support the effectiveness of smoking bans. The report found strong evidence that exposure to secondhand smoke increases the risk of coronary heart disease among both men and women. The existing data was…

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Meta-analysis suggests statins may help fight infections

Statins may help prevent and fight infections, according to a systematic review and meta-analysis appearing in Archives of Internal Medicine. The researcher found that patients with infections taking statins had a better outcome, including an improved chance of survival, than patients not taking statins. Statin use was similarly associated with a significant beneficial reduction in preventing…

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Brave new world: ZEN trial to test DES for ED

Writers for the late night talk shows are already sharpening their pencils. Medtronic today announced the initiation of a study called ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-Optimal Response to PDE5 Inhibitors)….

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10 years after, Columbia heart surgery study still causing problems

A study that started in 1999 and ended in 2001 is still causing problems for Columbia University Medical Center, according to a detailed investigation by Jeanne Lenzer and Shannon Brownlee in the Huffington Post. Lenzer and Brownlee report that Columbia has performed three separate internal reviews of the study which “raised serious questions about the…

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Study finds increased use of glucose lowering treatments at the expense of statins and antihypertensives

Physicians have the wrong priorities when treating patients with diabetes, according to a research letter  in the Archives of Internal Medicine. Mann et al looked at data from diabetics participating in the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2006. During the course of the study period the use of medications to treat…

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