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FDA Gives Favorable Review to SHARP Ahead of Vytorin Advisory Panel (31 Oct 2011)

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…

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Belgian Study Supports Use of FFR to Guide Therapy in Intermediate LAD Lesions (28 Oct 2011)

A study published in JACC: Cardiovascular Interventions suggests that fractional flow reserve (FFR) may be safely used to guide treatment in patients with an intermediate left anterior descending coronary artery (LAD) stenosis. Olivier Muller and colleagues report on 730 patients at a single center in Belgium who had a 30% to 70% stenosis in the proximal…

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FDA Advisory Panel Votes 8-2 Against Approval of Medtronic AF Ablation System (28 Oct 2011)

An FDA advisory panel has recommended against approval of Medtronic’s Ablation Frontiers Cardiac Ablation System for the treatment of symptomatic, drug refractory, persistent atrial fibrillation (AF) or longstanding persistent AF of up to four years in duration. In an 8-2 vote, members of the Circulatory System Devices Panel said that the risks of the device outweighed…

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Danish Study Clarifies VTE Risk Associated with Newer Progestogens in Oral Contraceptives (26 Oct 2011)

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…

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Genetic and Clinical Factors Linked to Stent Thrombosis (25 Oct 2011)

French researchers have identified several genetic and clinical factors independently tied to early stent thrombosis. Writing in the Journal of the American Medical Association, Guillaume Cayla and colleagues report on their case-control study comparing 123 patients with definite early stent thrombosis with 246 matched controls without stent thrombosis. The researchers found three genes with variants…

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New Study Proposes Possible Causative Role for HPV in Atherosclerosis (24 Oct 2011)

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…

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Midlife Obesity Increases Risk for CHD Mortality (24 Oct 2011)

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…

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CDC and AHA Tussle Over Just How Bad the Salt Problem Really Is (20 Oct 2011)

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…

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EMA’s CHMP Finds No Cancer Link for ARBs (20 Oct 2011)

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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U.K. Registry Tracks Long-Term TAVI Outcomes (19 Oct 2011)

The excitement over transcatheter aortic valve implantation (TAVI) has been tempered by the absence of long-term outcomes data and concerns that the procedure may not live up to its initial promise in real-world settings. Now a report from the U.K. TAVI Registry, which keeps track of every TAVI procedure performed in the U.K., sheds new…

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