CardioExchange Archive

November 29th, 2012

Following Earlier Recall, Ranbaxy Halts Manufacturing of Atorvastatin

Larry Husten, PHD

Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012, the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the […]

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November 28th, 2012

Statins and Exercise: Independently Beneficial, Even Better in Combination

Larry Husten, PHD

It’s no secret that statins and exercise are good for people with dyslipidemia. Now a study published in the Lancet offers fresh evidence suggesting that the two may be independently beneficial, and that the two together may yield greater benefits than either alone. U.S. researchers analyzed data from 10,043 people with dyslipidemia treated at either of two Veterans Affairs […]

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November 5th, 2012

Early Look: New Methods to Enhance Cholesterol Efflux

Larry Husten, PHD

Although clinical trials of HDL-boosting CETP inhibitors have so far failed to produce positive results, many other avenues of HDL-related research remain active. Conference attendees got a glimpse of the very early phases of two intriguing lines of research in this area on Monday. Apoliporotein A-I is thought to be the key HDL component that removes […]

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November 5th, 2012

Dalcetrapib: Another HDL-Raising CETP Inhibitor Bites the Dust

Larry Husten, PHD

Another HDL-raising CETP inhibitor has failed to demonstrate cardiovascular benefit in a large clinical trial. With the presentation of the dal-OUTCOMES trial at the American Heart Association in Los Angeles and simultaneous publication in the New England Journal of Medicine, dalcetrapib joins torceptrapib on the list of once-promising CETP inhibitors. In dal-OUTCOMES, 15,871 patients with a recent […]

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October 31st, 2012

PCSK9 Inhibitor Enhances Cholesterol-Lowering Effect of Atorvastatin

Larry Husten, PHD

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 […]

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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 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 3rd, 2012

CRP and Cholesterol Emerge as Equally Strong Predictors of Cardiovascular Risk

Paul Ridker, MD, MPH

Paul Ridker discusses findings from the Emerging Risk Factors Collaboration showing that C-reactive protein provides incremental risk information comparable to that of total cholesterol and HDL cholesterol.

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