Cardiovascular Diseases

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FDA declined to approve Merck’s claim that its cholesterol-lowering drugs Zetia and Vytorin reduce the risk of heart attacks and strokes in patients with coronary heart disease.

An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug omalizumab (Xolair, Genentech) than in those who were not treated with omalizumab. As a result, FDA has added information about these potential risks to the drug label.

Unhydrogenated, unsaturated vegetable oils, such as canola oil, can have health advantages when included in as part of a low-glycemic index (GI) diet in people with type 2 diabetes, according to research presented at American Diabetes Association Scientific Sessions in San Francisco, and published in Diabetes Care.

FDA approved dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals) for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

Results of 5 phase 3 studies evaluating evolocumab (AMG 145), an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood, were presented at the American College of Cardiology’s 63rd Annual Scientific Session (ACC.14), in Washington, D.C

Implementation of a pharmacy service that provides dosing, monitoring, education, and ensured safe transition from the inpatient to the outpatient setting is associated with improved patient satisfaction with overall care and with care related to anticoagulation management, according to a study published in the Annals of Pharmacotherapy.

Guideline-directed medical therapy for heart failure (HF) is highly cost-effective and able to produce significant health gains for individuals with mild to moderate disease, according a study published April 2 in the Journal of the American College of Cardiology.

FDA has issued a second complete response letter regarding a supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Janssen) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (ACS).

A 56-week phase 3 data for orphan drug lomitapide are consistent with 26-week data, showing that the drug significantly reduced low density lipoprotein cholesterol levels in patients with homozygous familial hypercholesterolemia, according to the drug?s manufacturer Aegerion Pharmaceuticals.