Walking With the American Heart Association: Valerie Bertinelli and Chester Cheetah

American Heart Association Heart Walk With Valerie Bertinelli

A few weeks ago Chester Cheetah, the official mascot for Frito Lay’s Cheetos, played an official part in  the American Heart Association’s Dallas Heart Walk. Yoni Freedhoff, on his Weighty Matters blog, pretty much says what needs to be said about this disgraceful association between Frito Lay and the AHA. This weekend I received a press kit…

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Subcutaneous ICD Gains FDA Approval

The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) system from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and  therefore  does not need to be guided with x-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage…

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FDA Sets New Decision Date For Eliquis (Apixaban)

The FDA will decide the fate of apixaban (Eliquis) by March 17, 2013. The new Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug’s manufacturers, Pfizer and BristolMyers Squibb. The new drug application (NDA) for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was…

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Merck Returns To Cardiome All Rights To Atrial Fibrillation Drug Vernakalant

Merck and Cardiome announced today that Merck was returning to Cardiome all marketing and development rights for the atrial fibrillation (AF) drug vernakalant. An intravenous formulation of vernakalant is marketed in Europe as Brinavess. It has not been approved in the United States, though it received a positive recommendation from the FDA’s Cardiovascular and Renal…

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AHA Urges More Education And Support For ICD Patients

Despite, and perhaps sometimes because of, their life-saving benefits, ICDs are associated with a host of complex psychosocial problems, but clinicians and caregivers receive little training to deal with these problems. In response to these concerns, the American Heart Association (AHA) has published a scientific statement in Circulation to provide a “comprehensive review of what is and…

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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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Novartis Announces Top Line Results For Phase 3 Trial Of New Acute Heart Failure Drug

Novartis announced preliminary results from the RELAX-AHF trial, a phase 3 study of a novel drug, RLX030 (serelaxin), for patients hospitalized with acute heart failure. The company said the trial met one of its two primary endpoints in reducing dyspnea. Novartis also reported a reduction in all cause mortality at 6 months. However, it should be…

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“Dramatic” Increase In Bleeding Accompanies Addition Of Oral Anticoagulant Therapy In ACS

The newer oral anticoagulants may help reduce ischemic events after an acute coronary syndrome (ACS), but only at the cost of a “dramatic” increase in bleeding complications, according to a new meta-analysis published in the Archives of Internal Medicine. Hungarian researchers performed a systematic review and meta-analysis of seven trials in which 31,286 ACS patients were randomized to…

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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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Studies Examine Less Burdensome Dual Antiplatelet Regimens

Two new studies published in the Journal of the American College of Cardiology offer hope but not, yet, compelling evidence to support less burdensome requirements for dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation. In the first study, Spanish investigators followed 1,622 consecutive patients who received a drug-eluting stent (DES) for one year. They found…

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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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International Cardiology Groups Push For Aggressive Public Health Goals

Cardiovascular disease is the largest cause of death in the world and accounts for almost half of all deaths from non-communicable diseases (NCDs). Earlier this year, in response to a high-level UN meeting on NCDs in 2011, the World Health Assembly set a global target  to reduce premature NCD mortality by 25% by the year 2025. Now The…

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News Flash! Company Issues Incredibly Boring Press Release

Last week Abiomed issued a press release (reprinted below) that was about as dull as a press release can get. The main news of the press release was that the PROTECT II study testing the company’s Impella 2.5  circulatory support device had been published online in Circulation. The press release provides no details or information about…

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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

NuSI slide

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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Study Predicts Renal Denervation Will Be Cost Effective In Resistant Hypertension

Renal denervation (RDN) for resistant hypertension may be cost-effective and may provide long-term clinical benefits, according to a new analysis published in the Journal of the American College of Cardiology. Benjamin Geisler and colleagues developed a model to predict the impact of the Medtronic Symplicity RDN system in patients with resistant hypertension. Over 10 years,…

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More Evidence That Omega-3 Supplements Don’t Work

Once again researchers have failed to find any clinical benefit for omega-3 supplements. In a new meta-analysis and systematic review published in JAMA, Evangelos Rizos and colleagues analyzed 20 randomized controlled trials including  68,680 patients and found no significant effect on any of the endpoints: all-cause mortality: relative risk (RR) 0.96, CI 0.91 – 1.02 cardiac…

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Updated Rhythm Device Guidelines Clarify And Expand CRT Criteria

A newly released update of 2008 guidelines for device-based therapy of cardiac arrhythmias contains some much-needed clarification about indications for cardiac resynchronization therapy (CRT). The document was developed jointly by the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society. Highlights of the documents include: The Class 1 recommendation for CRT…

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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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Plagiarism Of Hypertension Article In Korean Journal Results In Retraction

In response to evidence of plagiarism in a review article in the Korean Circulation Journal, the article has now been retracted by the journal. Here is the notice: On July 31, 2011, Korean Circulation Journal (KCJ) published a review article by Park et al.1)regarding the J-curve in hypertension and coronary artery diseases. However, a possibility of plagiarism has…

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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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ESC Trials: The Best And The Worst

Two trials presented at the ESC this year– WOEST and IABP-SHOCK II— are great examples of the way medicine is supposed to work. Another trial, FAME 2, is an example of so many of the things that can go wrong. WOEST and IABP-SHOCK II are remarkably similar. Both trials tested conventional wisdom and found it lacking. WOEST…

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