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 as a late-breaking clinical trial as part of Renal Week in San Diego, and published simultaneously in the New England Journal of Medicine. The trial randomized 4038 diabetic patients with CKD and anemia to darbepoetin alfa (target hemoglobin level of about 13 g/dl) or placebo (with rescue darbepoetin alfa when hemoglobin dropped below 9 g/dl).
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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 be interested to learn that some of the major results were released by Amgen in their third-quarter conference call on October 21. Here is the relevant paragraph from the company’s press release:
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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 treated with clopidogrel, or when a patient has diabetes.
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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 committee website.
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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 women.) On the other hand, women who do have an MI have achieved larger larger gains in mortality than men.
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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 to the announcement, “to pursue his research into the biology of apolipoprotein E in heart disease and Alzheimer’s disease.”
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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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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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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 in high risk patients who are unable to take ACE inhibitors. Boehringer Ingelheim announced the new indication this morning, as well as approval of aNDA for Twynsta, the combination of telmisartan and amlodipine for the treatment of hypertension alone or in combination with other agents.
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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 not especially surprising, but it has not been examined previously in a large sample, according to the authors. The growing population of elderly people taking warfarin means this is a potential problem of increasing urgency.
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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 not sufficient to estimate the size of the effect, however.
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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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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 glucose, cholesterol, and hypertension increased broadly, although the most impressive changes occurred in glucose control. By the end of the study more than half the patients had HbA(1c) levels lower than 7%, compared to only 43% who had controlled cholesterol and 39% who had controlled hypertension.
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