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.
[BLOG] The acute coronary syndrome pipeline: Novel therapies targeting unmet needs in niche patient populations
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
ACC: Bivalirudin associated with reductions in cardiac death, major bleeding in STEMI patients undergoing PCI
Compared to a combination of heparin and a glycoprotein (GP) IIb/IIIa inhibitor, use of bivalirudin (Angiomax) is associated with significant absolute reductions in risk for cardiac death and major non-coronary artery bypass graft (CABG) bleeding, according to data presented at the American College of Cardiology 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.