Halloween trick: don’t TREAT diabetes with ESAs 3

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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AstraZeneca update on ticagrelor (Brilinta) raises questions about reduced efficacy with high dose aspirin 3

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 Reply

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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Study suggests statins may prevent flu deaths 1

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. The researchers found that older patients and patients with cardiovascular disease had an increased risk of death, while patients on statins enjoyed a protective effect.
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UK’s NICE allows limited use of prasugrel 1

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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Review article highlights differences between European and North American STEMI guidelines Reply

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 most major issues the guidelines are in accord.
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Medicare advisory committee delivers mixed review for AF catheter ablation 2

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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Senator queries NIH about Ballantyne and other NIH grantees who took Vytorin money 2

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 the case of Baylor’s Christie Ballantyne. The letter states that Ballantyne
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Women and MI: increasing incidence but improved survival Reply

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

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 Reply

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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Lancet: liraglutide shows considerable promise in weight loss trial 1

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 and the fact that because it is a peptide it can only be given as an injection.

According to a new study from Europe appearing in the Lancet, liraglutide is more effective than both placebo and orlistat in reducing weight and improving risk factors. The startling results prompted George Bray, in an accompanying comment, to  say of liraglutide and other  GLP-1 analogs that he is “optimistic that their promise for the treatment of obesity will be fulfilled.”

Arne Astrup and colleagues reported on 564 overweight subjects who were randomized to either open-label orlistat, placebo, or one of four doses of liraglutide. At 20 weeks weight loss was significantly greater in all of the liraglutide dose groups than in the placebo or orlistat groups.

Mean weight loss (kg) % of pts w/ >5% weight loss
Liraglutide 1.2 mg 4.8 52.1
Liraglutide 1.8 mg 5.5 53.3
Liraglutide 2.4 mg 6.3 60.8
Liraglutide 3.0 mg 7.2 76.1
Orlistat 120 mg 4.1 44.2
Placebo 2,8 29.6

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

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 advisory panel failed to recommend the agent in July. Here are links to our earlier coverage:
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Hospitals getting with the guidelines are not getting with aldosterone antagonism Reply

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 2

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 composite primary endpoint of CV death, nonfatal MI, or nonfatal stroke.
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Telmisartan gets FDA approval for CV prevention in ACE inhibitor-intolerant patients Reply

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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More allegations about ENHANCE fiasco laid out in Vytorin lawsuit complaint 3

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 investigators and consultants.

One potentially explosive new development: the document includes many details based on testimony from several insiders within Schering-Plough, though for now these confidential witnesses remain anonymous, and they have not been deposed or cross-examined by opposing attorneys.

A spokesman for Schering-Plough sent the following response to CardioBrief:

There is nothing new in this filing.  These allegations have been made and responded to before.  We are confident the company will ultimately be vindicated.

Click here for links to the complaint and other resources…

Study raises concerns about trauma treatment in growing population on warfarin Reply

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

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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Meta-analysis suggests statins may help fight infections Reply

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 infections.
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10 years after, Columbia heart surgery study still causing problems Reply

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 drug trial’s design, management and oversight” but found no evidence that patients were harmed and concluded “that there was no need to provide the patients with additional information about the study.”

Now, however, the US Office of Human Research Protections has determined that “at least some of the subjects appear to have suffered harms that were a function of the design and procedures of the study.” OHRP is “demanding that Columbia track down the patients and their families, and acknowledge that they never were informed about the ‘true nature’ of the drug study, the risks they faced or the consequences of their participation.”
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Study finds increased use of glucose lowering treatments at the expense of statins and antihypertensives Reply

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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