Cardiovascular Diseases

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.

Not surprisingly, the treatment costs associated with ACS and its various comorbidities are astoundingly high.

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 has decided not to approve acute heart failure drug serelaxin (Novartis).

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.

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.

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.

Greater dietary fiber intake is significantly associated with lower risk of first stroke, according to a recent study published in Stroke.

Thanks to consumer education efforts on heart disease and hypertension, self-reported hypertension and use of antihypertensive medications has increased in the United States according to the Centers for Disease Control and Prevention (CDC).

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.

In patients with heart failure with preserved ejection fraction, long-term treatment with spironolactone improved left ventricular diastolic function, but didn’t affect maximal exercise capacity, patient symptoms, or quality of life (QoL), according to a recent study in JAMA.

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).

In a recently published observational registry study, researchers have demonstrated that the utilizatio of evidence-based therapies in patients experiencing ST-elevation myocardial infarction is on the rise.

Safety information regarding varenicline will be added to the Warnings and Precautions section of the label and to the patient Medication Guide because smoking cessation aid varenicline may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.

Angiotensin receptor blockers do not increase the risk of developing cancer in patients using the medications, FDA announced recently after a safety review.

FDA is assessing new information indicating an association between birth control pills containing the progestin hormone drospirenone and an increased risk of deep vein thrombosis and pulmonary embolus.

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.

Nearly 20% of young adults in the United States may have high blood pressure, according to an analysis of the NIH-funded National Longitudinal Study of Adolescent Health (Add Health) published online May 23 in Epidemiology.

An investigational fixed-dose therapy showed promising results in lowering blood pressure compared with study comparators, according to the results of three phase 3 studies presented at the 26th annual American Society of Hypertension (ASH) Scientific Meeting and Exposition in New York.

There is no safe therapeutic window of time for using NSAIDs in patients with prior myocardial infarction. Even short-term treatment with most NSAIDs appears associated with increased risk of death and recurrent MI. In general, NSAIDs should be limited from a cardiovascular safety point of view, according to a study published in Circulation.

The American Heart Association recently released its updated cardiovascular disease prevention guidelines for women. The guidelines emphasize practical medical advice that works in the "real world" rather than on findings primarily observed in clinical research.

In patients with chronic low back pain with comorbidities such as hypertension, diabetes, and cardiovascular disease, extended-release oxymorphone (Opana ER, Endo Pharmaceuticals) may be a safe and effective alternative, according to a study presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.

New molecular entity: Azilsartan medoxomil tablets are selective AT1 subtype angiotensin receptor antagonists that were approved by FDA to lower blood pressure.

Dalteparin was not better than unfractionated heparin for the prevention of deep vein thrombosis among critically ill patients, according to an international study published in the New England Journal of Medicine.

There are several advanced therapies in addition to blood thinners that physicians should consider when managing patients with deep vein thrombosis, according to a new scientific statement from the American Heart Association.

Clopidogrel hypersensitivity, which affects 6% of patients, can be successfully treated using short-course corticosteroids and antihistamines without interrupting drug therapy, reported researchers at Jefferson Medical College in Philadelphia.

Combining angiotensin-converting-enzyme inhibitors with angiotensin-receptor blockers is associated with increased risk of adverse renal outcomes, according to a recent study published in the Canadian Medical Association Journal.