PCSK9 Inhibitor Enhances Cholesterol-Lowering Effect Of Atorvastatin

When added to low-dose atorvastatin a much-discussed new monoclonal antibody to PCSK9 significantly lowers cholesterol more effectively than atorvastatin alone, according to a phase 2 study published in the New England Journal of Medicine. Earlier this year, in March, the findings of three phase 1 trials demonstrating the cholesterol-lowering effects of the drug in healthy volunteers and…

Click here to continue reading…

The Research Agrees: Smoking Is Really Bad For You

stop smoking copy

Four new studies offer powerful evidence of the dangers of smoking and the health benefits of quitting or not being exposed to secondhand smoke. Smoking in the UK– Between 1996 amd 2001 the Million Women Study started following more than one million women aged 50 to 65 years of age. In  a report published in…

Click here to continue reading…

L.A. Confidential: Preview Of AHA Scientific Sessions 2012

AHA 2012

The American Heart Association scientific sessions, which start next weekend in Los Angeles, will be bigger than ever, with 853 separate sessions– 111 more than last year– and 27 late-breaking clinical trials– 6 more than last year. Elliott Antman, chair of the scientific sessions program committee, provided a preview of some of the highlights of this…

Click here to continue reading…

Research And Denial At St Jude Medical

Research and development is the cornerstone of medical progress, but sometimes R&D turns into its evil twin brother, research and denial. Yesterday I reported on the the RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial presented at the TCT meeting in Miami. The trial missed its primary…

Click here to continue reading…

TCT: Two PFO Closure Trials Miss Primary Endpoints

Two trials presented today at the TCT meeting in Miami testing the benefits of PFO closure in patients with cryptogenic stroke have failed to convincingly demonstrate any significant  benefit for the controversial procedure. The RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial randomized 980 patients  to PFO closure…

Click here to continue reading…

Atrial Fibrillation: Radiofrequency Catheter Ablation And Antiarrhythmic Drug Therapy Compared

A trial comparing radiofrequency catheter ablation (RFA) to antiarrhythmic drug therapy (AAD) as initial therapy for atrial fibrillation (AF) found no difference in the overall burden of AF between the groups. But the trial also turned up evidence supporting the use of RFA as an initial treatment strategy in some patients. In a paper published…

Click here to continue reading…

TCT: Impressive Survival Benefit For TAVR In Inoperable Patients At 3 Years

At the TCT meeting in Miami  Murat Tuzcu presented the latest findings from the PARTNER B trial comparing transcatheter aortic valve replacement (TAVR) with standard therapy in patients who are not considered eligible for surgical valve replacement. At three years the mortality advantage continued to grow for TAVR over standard therapy in patients who are…

Click here to continue reading…

Setback For Trial Studying Dabigatran After Mechanical Valve Surgery

Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for a newer oral anticoagulant has suffered a setback. Last year Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase…

Click here to continue reading…

High Rate Of Warfarin Discontinuation Observed In Study

One of the many potential problems with warfarin-based anticoagulant therapy is the poor rate of adherence and persistence among patients who are prescribed the drug. Now a new observational study published in Archives of Internal Medicine raises the possibility that the problem may be even worse than many may have previously suspected, as discontinuation rates in clinical…

Click here to continue reading…

Jeffrey Moses Accused Of Cocaine Use And Domestic Violence (Updated)

Moses

Update– December 21, 2012:The New York Post has substantially disavowed significant portions of an October 22 news story about Jeffrey Moses. The story contained allegations that the well-known interventional cardiologist had tested positive for cocaine but was allowed to continue performing procedures at New York-Presbyterian Hospital. Now, the Post says, allegations of cocaine use were “subsequently proven to be conclusively false…

Click here to continue reading…

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…

Click here to continue reading…

FDA Approves The Sapien Transcatheter Heart Valve For High Risk Patients

sapien

The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were not…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

Don Poldermans And The Dutch Research Scandal

The publication last week of the final report from the Erasmus Medical Center on the Don Poldermans research scandal in the Netherlands ends the first and most explosive chapter of an ugly episode of scientific misconduct. But there are still many important questions regarding scientific integrity and the culture of medical research raised by the case. And…

Click here to continue reading…

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…

Click here to continue reading…

Free Cardiac And Spine Surgery For Walmart Employees At Six Hospitals

Walmart

Starting next year 1.1 million US Walmart employees and their dependents will be eligible for free heart, spine, and transplant surgery at 6 highly regarded health care organizations. Walmart employees will have no out-of-pocket costs, including travel, lodging and food for the patient and a caregiver. On Thursday the company announced that its “Centers of Excellence”…

Click here to continue reading…

Chocolate And Nobel Prizes Linked In Study

Nobel Chocolate Coins

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…

Click here to continue reading…

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…

Click here to continue reading…

PCI Utilization Lower In States With Public Reporting Of Outcomes

In patients with acute MI, utilization of percutaneous coronary intervention (PCI) is lower in states that publicly report outcomes data, according to a new study published in JAMA. Despite the difference in utilization, however, there was no difference in mortality between reporting and nonreporting states. Karen Joynt and colleagues used Medicare data to analyze PCI utilization and mortality…

Click here to continue reading…

Erasmus Medical Center Releases Final Report On Cardiovascular Research Scandal

Poldermans

After an extensive investigation, a large medical center in the Netherlands has confirmed earlier charges of research misconduct against a prominent cardiovascular researcher. On Tuesday, Erasmus MC in Rotterdam released a final report on the scientific integrity of trials conducted by Don Poldermans, a well-known and highly prolific Dutch cardiovascular researcher. The final report contains…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…