CardioExchange Archive

November 3rd, 2011

FDA Advisory Committee Recommends Approval of Vytorin for Pre-Dialysis CKD Patients

Larry Husten, PHD

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Wednesday strongly supported the combination of ezetimibe and simvastatin (Vytorin, Merck) to prevent cardiovascular events in pre-dialysis chronic kidney disease (CKD) patients. But the panel voted against recommending Vytorin for patients with end-stage renal disease on dialysis. The votes were 16-0 in favor of the pre-dialysis […]

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November 1st, 2011

No Increased Risk for CV Events with ADHD Drugs, Large Study Finds

Larry Husten, PHD

A large new study may help lay to rest concerns that the widely prescribed ADHD drugs may increase the risk for cardiovascular (CV) events. In a study funded by the Agency for Healthcare Research and Quality and the FDA and published in the New England Journal of Medicine, William Cooper and colleagues analyzed data from 1.2 million […]

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October 31st, 2011

FDA Gives Favorable Review to SHARP Ahead of Vytorin Advisory Panel

Larry Husten, PHD

In preparation for Wednesday’s meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, an FDA reviewer has generally endorsed the positive interpretation of the SHARP trial of Vytorin (ezetimibe and simvastatin) in chronic kidney disease (CKD). Based on the results of SHARP (Study of Heart and Renal Protection), Merck is seeking an expansion of its […]

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October 26th, 2011

Danish Study Clarifies VTE Risk Associated with Newer Progestogens in Oral Contraceptives

Larry Husten, PHD

A large new study from Denmark provides the best evidence yet that third-generation oral contraceptives (OCs) containing drospirenone, desogestrel, or gestodene (sometimes used to treat dysmenorrhea) are associated with twice the risk for venous thromboembolism (VTE) as second-generation OCs containing levonorgestrel. In a paper published in BMJ,  Øjvind Lidegaard and colleagues analyzed data from national registries containing more […]

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October 24th, 2011

New Study Proposes Possible Causative Role for HPV in Atherosclerosis

Larry Husten, PHD

Human papillomavirus (HPV) may play a role in the development of cardiovascular disease (CVD) in women, according to a new study published in the Journal of the American College of Cardiology. Hus-Ko Kuo and Ken Fujise speculated that HPV may be a risk factor for CVD because it inactivates the tumor-suppressor protein p53, which plays a regulatory […]

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October 24th, 2011

Midlife Obesity Increases Risk for CHD Mortality

Larry Husten, PHD

Obesity in early adulthood doubles the risk of coronary heart disease (CHD) mortality, but this association is eliminated after midlife BMI is factored into the equation, according to a report in Archives of Internal Medicine. Linsay Gray and colleagues utilized data from the Harvard Alumni Health Study, which included nearly 19,000 men who were undergraduates between 1916 […]

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October 20th, 2011

CDC and AHA Tussle Over Just How Bad the Salt Problem Really Is

Larry Husten, PHD

No matter how you slice it, a lot of people in the U.S. consume too much sodium. But the CDC and the American Heart Association (AHA) disagree about just how bad the salt problem really is. U.S. guidelines currently recommend that everyone keep their daily sodium intake below 2300 mg, but a large subpopulation, including people aged […]

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October 20th, 2011

EMA’s CHMP Finds No Cancer Link for ARBs

Larry Husten, PHD

Following the lead of the FDA earlier this year, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has completed a safety review of angiotensin II receptor antagonists (ARBs) and found no evidence of any increased risk of cancer associated with the drugs. The FDA and EMA safety reviews were initially prompted by a meta-analysis […]

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October 19th, 2011

First-Trimester Hypertension, Not ACE Inhibitors, Linked to Birth Defects

Larry Husten, PHD

Although the teratogenic properties of ACE inhibitors in the second and third trimesters of pregnancy are well-documented, the effects of their use in the first trimester have been unclear. Now a study suggests that hypertension itself, rather than ACE inhibitors or other antihypertensive drugs, is the likely cause of an increased risk for birth defects […]

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October 17th, 2011

National Lipid Association Responds to Coverage of Its Statement on Biomarkers

Christopher Seymour, MBA

Editor’s Note: This contribution from Christopher R. Seymour, Executive Director of the National Lipid Association, is a response to Larry Husten’s October 13 blog post titled “National Lipid Association Expert Panel Has Many Deep Ties to Industry.” On behalf of the National Lipid Association (NLA), I want to address your inquiry regarding the paper titled “Clinical […]

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