PHARMACY

Study: Combined lipid, blood pressure therapies don’t reduce diabetes patients’ cardiovascular risk

BY Alaric DeArment

NEW YORK Diabetes patients combining drugs to control blood fat and blood pressure may remain at risk for heart attacks and other heart disease, according to a study presented in Atlanta on Sunday.

In the Action to Control Cardiovascular Risk in Diabetes, or ACCORD trial, a 10,251-patient study sponsored by the National Institutes of Health, researchers at 77 medical centers in the United States and Canada studied Type 2 diabetes patients ages 40 to 79 years considered to be at high risk of cardiovascular problems, taking one of three strategies for lowering the risk of cardiovascular problems: control of blood sugar, control of blood pressure and control of blood lipids.

 

They found that giving diabetes patients a fibrate and a statin did not reduce the combined risk of heart attack, stroke or death from cardiovascular disease more than a statin alone. Results of the study were presented at the American College of Cardiology’s 59th annual scientific session and will appear in the April 29 issue of the New England Journal of Medicine.

 

 

“ACCORD provides important evidence to help guide treatment recommendations for adults with Type 2 diabetes who have had a heart attack or stroke or who are otherwise at especially high risk for cardiovascular disease,” National Heart, Lung and Blood Institute acting director Susan Shurin said in a statement. “This information provides guidance to avoid unnecessarily increasing treatment that provides limited benefit and potentially increases the risk of adverse effects.”

 

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Late-stage clinical trial of Avastin fails to meet expectations, Genentech says

BY Alaric DeArment

SOUTH SAN FRANCISCO, Calif. A late-stage clinical trial of a Genentech drug for men with late-stage prostate cancer has failed, the biotech company announced Friday.

Genentech, part of Swiss drug maker Roche, announced that a phase 3 trial of Avastin (bevacizumab) combined with prednisone and the chemotherapy drug docetaxel did not extend the amount of time that patients survived, compared with chemotherapy and prednisone alone.

The drug already has approval from the Food and Drug Administration for treating tumors and cancers of the lungs, colon, rectum, breasts, kidneys and brain.

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Abbott’s submits supplemental approval application for Lupron Depot to FDA

BY Alaric DeArment

ABBOTT PARK, Ill. Abbott is hoping that the Food and Drug Administration will approve one of its drugs as a treatment for advanced prostate cancer.

The Chicago-based drug maker announced Thursday that the FDA accepted its supplemental approval application for Lupron Depot (leuprolide acetate) in the 45-mg strength. The drug, an injectable, works by suppressing production of testosterone for six months. It is currently available in 7.5-mg, 22.5-mg and 30-mg formulations that work for one, three and four months.

“For many patients with advanced prostate cancer, Lupron Depot is an important treatment option because it can help manage the symptoms of their disease,” Abbott VP global pharmaceutical development Eugene Sun said in a statement. “Abbott is seeking approval for a new six-month formulation to provide greater convenience and dosing flexibility to physicians and patients who could benefit form this medication.”

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