CardioExchange Archive

October 18th, 2012

FDA Panel Recommends Approval of Mipomersen for Homozygous Familial Hypercholesterolemia

Larry Husten, PHD

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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October 18th, 2012

FDA Reviewers Recommend Approval of Lomitapide for Homozygous Familial Hypercholesterolemia

Larry Husten, PHD

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 on Wednesday 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 […]

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October 16th, 2012

FDA Review Raises Safety Concerns About Mipomersen

Larry Husten, PHD

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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October 16th, 2012

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

Larry Husten, PHD

The FDA said on Monday that it had identified a transplant patient with Aspergillus fumigatus infection who received cardioplegia solution during surgery. The solution was manufactured by the New England Compounding Center (NECC), which has been at the center of a broad investigation after the deaths of at least 15 patients from fungal meningitis due to contaminated vials […]

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October 15th, 2012

FDA Reviewers Raise No New Red Flags Over Lomitapide

Larry Husten, PHD

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. It’s intended for use as an adjunct to a […]

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October 12th, 2012

Free Cardiac And Spine Surgery For Walmart Employees At Six Hospitals

Larry Husten, PHD

Starting next year 1.1 million U.S. Walmart employees and their dependents will be eligible for free heart, spine, and transplant surgery at six 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” program, which […]

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October 10th, 2012

Chocolate and Nobel Prizes Linked

Larry Husten, PHD

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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October 10th, 2012

Danish Study Gives a Boost to Hormone Replacement Therapy ‘Timing Hypothesis’

Larry Husten, PHD

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 study from Denmark published in BMJ lends strong support to […]

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October 9th, 2012

PCI Utilization Lower in States with Public Reporting of Outcomes

Larry Husten, PHD

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 […]

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October 9th, 2012

Erasmus Medical Center Releases Final Report on Cardiovascular Research Scandal

Larry Husten, PHD

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 Medical Center 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 numerous […]

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