NIH Trial Of Lifestyle Intervention For Type 2 Diabetes Stopped For Futility After 11 Years

The NIH today announced the early termination of a large randomized trial testing a lifestyle intervention approach to weight loss in type 2 diabetics. More than 5,000 patients with type 2 diabetes were randomized to participate in an intensive lifestyle intervention program or a traditional program of diabetes support and education in Look AHEAD (Action…

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FDA Panel Recommends Approval Of Mipomersen For Familial Hypercholesterolemia

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee gave a weak endorsement to mipomersen, an antisense oligonucleotide inhibitor manufactured by Genzyme, for use in homozygous familial hypercholesterolemia (FH). With its relatively close 9-6 vote, and with its comments, the committee expressed concerns about both the efficacy and safety of the drug, but ultimately the severity of…

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FDA Reviewers Recommend Approval For Lomitapide For Homozygous Familial Hypercholesterolemia

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 to recommend approval of Aegerion Pharmaceuticals’ cholesterol-lowering drug lomitapide for use in patients with homozygous familial hypercholesterolemia (FH). The lopsided vote does not completely reflect the views of many of the panel members, who expressed considerable concern  that the drug might be used in lower…

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FDA Review Raises Safety Concerns About Mipomersen

An FDA review raises a number of potentially significant safety concerns about the cholesterol-lowering drug mipomersen. The review appears ahead of a Thursday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to evaluate Genzyme’s new drug application (NDA) for use of the drug as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce…

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FDA Warns About Fungal Meningitis In Transplant Patient Who Received NECC Cardioplegia Solution

Update (October 16): On Tuesday the FDA revised its initial report and said that only one transplant patient who had received the NECC cardioplegia solution had developed fungal meningitis.  The FDA said on Monday that it had identified two transplant patients with Aspergillus fumigatus infection who received cardioplegia solution during surgery. The solution was manufactured by the…

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FDA Reviewers Raise No New Red Flags Over Lomitapide

FDA reviewers have raised no new concerns about lomitapide ahead of a Wednesday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee.  The FDA today released briefing documents that evaluate the new drug application (NDA) for lomitapide capsules, the microsomal triglyceride transfer protein (MTP) inhibitor from  Aegerion Pharmaceuticals for use as an adjunct to a low-fat diet and…

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Chocolate And Nobel Prizes Linked In Study

You don’t have to be a genius to like chocolate, but geniuses are more likely to eat lots of chocolate, at least according to a new paper published in the august New England Journal of Medicine. Franz Messerli reports a highly significant correlation between a nation’s per capita chocolate consumption and the rate at which its…

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Danish Study Gives A Boost To Hormone Replacement Therapy Timing Hypothesis

Hormone replacement therapy (HRT) suffered a sharp blow a decade ago when the Women’s Health Initiative failed to show any cardiovascular benefit in women taking HRT. Despite the setback, many researchers theorized that HRT might still be beneficial in women who start HRT close to menopause. Now a new study from Denmark published in BMJ lends…

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Observational Study Links Common Household Chemical To Cardiovascular Disease

High levels of a manmade chemical widely used in common household products and detectable in more than 98% of people may increase the risk of cardiovascular (CV) disease and peripheral arterial disease (PAD), according to a study published in Archives of Internal Medicine. (The study was published online in September and will appear in this week’s print…

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UK Study Casts Doubts On Value Of Type 2 Diabetes Screening

The dramatic growth in type 2 diabetes has resulted in increased interest in screening programs. Now a new study published in the Lancet raises concerns that screening programs may not result in long-term improvement in outcomes. In the ADDITION-Cambridge study, investigators in the UK randomized general practices to either screening or no screening.  The practices allocated to…

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What Is The Benefit Of Adding CRP To Risk Factor Assessment?

In recent years controversy has swirled around the role of inflammation in cardiovascular disease and the relative worth of measuring novel risk factors like CRP. Now, in a new paper published in the New England Journal of Medicine, researchers from the Emerging Risk Factors Collaboration provide detailed calculations that estimate the benefits of adding two of…

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Registry Study Raises Questions About Cardioprotective Effect Of Beta Blockers

Although beta-blockers have been a cornerstone of therapy for patients with coronary artery disease for more than a generation, a new study published in JAMA suggests that that in the modern era beta blockers may not improve outcomes. Sriapl Bangalore and colleagues analyzed data from 44,708 patients enrolled in the Reduction of Atherothrombosis for Continued…

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Another One Bites the Dust: Diovan Patent Expires But Generic Valsartan Is MIA

Although the patent on valsartan (Diovan, Novartis) expired last Friday, a generic version of the popular antihypertensive drug has yet to make it to market. By contrast, a generic version of Diovan HCT, the combination of valsartan and hydrochlorothiazide, was recently launched by generic drugmaker Mylan. As reported on Pharmalot, Ranbaxy, the embattled generic drugmaker, holds…

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Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation (AF). The drug is already approved in Europe for the prevention of venous thromboembolic events (VTE) following hip or knee replacement surgery. The drug has not yet been approved in the United States. Here…

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Screening For AAA Comes Under Renewed Scrutiny And Criticism

A 2007 Medicare initiative to increase AAA (abdominal aortic aneurysm) screening in appropriate patients failed to prevent AAA rupture or reduce all-cause mortality, according to a new study published in Archives of Internal Medicine. The larger implications of the study are unclear, but two accompanying papers, an invited commentary and a perspective, emphasize the darker side of…

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Meta-Analysis Links Stress At Work And Heart Disease

A new study published in the Lancet provides the best evidence yet that work-related stress and, in particular, job strain– “the combination of high job demands and low control at work”– plays a small but important role in causing heart disease. In order to address the limitations of previous studies on this topic, including a…

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A Manhattan Project To End The Obesity Epidemic

A newly launched nonprofit organization, the Nutrition Science Initiative, will try to find an answer to the question,  “What should we eat to be healthy?” NuSI is nothing if not ambitious: its goal is to seek “the end of fad diets and high obesity rates.” The founders of the organization, called NuSI (pronounced “new see”) for short, are Gary Taubes…

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Antihypertensive Use Among Pregnant Women on the Rise

Growing numbers of pregnant women are taking antihypertensive drugs that may harm themselves or their babies, according to a new study published in Hypertension. Brian Bateman and colleagues analyzed Medicaid data from more than 1.1 million pregnant women. Overall, 4.4% of the women received antihypertensive medications at some point during their pregnancy. From 2000 to 2007…

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News Briefs: Cholesterol Trends, AHA Late-Breakers, FDA Updates On Rivaroxaban And Heartware HVAD

Cholesterol Trends The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in US adults. Here is their summary of the key findings: …cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported…

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Unrecognized MI: More Prevalent And Dangerous Than Previously Suspected

Unrecognized myocardial infarction (UMI) is more prevalent, and is associated with a worse prognosis, than may be generally understood, according to a new study published in JAMA. Studying an elderly (67-93 years of age) population in Iceland, Erik Schelbert and colleagues used ECG and cardiac magnetic resonance (CMR) to detect UMI. CMR was more effective than…

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Danish Survey Finds Clopidogrel Less Effective In Diabetics

A large nationwide survey of MI survivors in Denmark provides new information about the efficacy of antiplatelet therapy with clopdiogrel in patients with diabetes. In a paper published in JAMA, Charlotte Andersson reports on 58,851 MI patients, 12% of whom had diabetes and 60% of whom received clopidogrel. As expected, diabetics had a worse outcome than nondiabetics: the…

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CDC: 35 Million Americans Have Uncontrolled Hypertension

According to the Centers for Disease Control, new data from the National Health and Nutrition Examination Survey (NHANES) shows: 30.4% of US adults (about 66.9 million people) have hypertension. 53.5% have uncontrolled hypertension (about 35.8 million people). 39.4% with uncontrolled hypertension (about 14.1 million) are unaware that they have hypertension. 89.4% with uncontrolled hypertension have a “usual source…

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First Detailed Look At Why Aliskiren Failed To Gain ALTITUDE

Last December the once-promising direct renin inhibitor aliskiren (Rasilez, Tekturna) suffered a fatal setback with the early termination of the ALTITUDE trial. The trial was stopped when the Data Monitoring Committee (DMC) found an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after 18-24 months. At the ESC in Munich ALTITUDE investigator Hans-Henrik…

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NHLBI Announces 7000 Patient Trial Testing Inflammation Hypothesis

The National Heart, Lung, and Blood Institute (NHLBI) has announced the launch of a large  clinical trial testing the inflammation hypothesis. Paul Ridker is the principal investigator of the trial, which will be known as  the Cardiovascular Inflammation Reduction Trial (CIRT). CIRT will enroll 7,000 patients who are stable following a heart attack but are at high…

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Cardiovascular Risk Prediction: Two More Studies, Little Progress

Two studies published in JAMA provide new data — and, perhaps, some additional clarity — about using additional markers to help improve risk prediction for coronary heart disease (CHD) and cardiovascular disease (CVD). In one study, Joseph Yeboah and colleagues used data from 1330 intermediate-risk participants in the Multi-Ethnic Study of Atherosclerosis (MESA)  to analyze the prognostic value of…

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