ABBOTT PARK, Ill., Nov. 14 /PRNewswire-FirstCall/ -- In response to data on the FIELD trial being presented at a late-breaking session of the American Heart Association annual meeting and published in The Lancet, Abbott issued the following statement:
The FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) study was conducted to determine whether early intervention with fenofibrate could prevent cardiovascular events in patients with type 2 diabetes. FIELD is the largest prospective study examining the effects of a cholesterol-lowering medication on cardiovascular outcomes in an exclusively diabetic population. Patients with type 2 diabetes are at three to four-fold risk for developing cardiovascular disease versus people without diabetes.
"FIELD provides important learnings on the role of early intervention with fenofibrate," said Dr. Anthony Keech, University of Sydney, Australia, and FIELD primary investigator. "Type 2 diabetes affects nearly 20 million Americans placing them at high risk for cardiovascular disease. The results of FIELD will add to the growing body of knowledge of how best to manage cardiovascular risks within this patient population."
About FIELD
The FIELD study is endorsed by the National Heart Foundation of Australia, Diabetes Australia, the New Zealand Society for the Study of Diabetes and the Finnish Diabetes Association. The FIELD study was conducted at 63 sites in Australia, Finland and New Zealand and was coordinated independently of the sponsors by the National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia. Fournier Pharma of Dijon, France, is the main sponsor of FIELD and supplier of the fenofibrate and matching placebo medication. Fenofibrate was discovered and developed by Fournier Pharma and is approved for use in nearly 80 countries worldwide, registered as Lipanthyl(R) and Lipidil(R) in most areas outside of the United States. Fournier Pharma was acquired by the Belgian company Solvay in 2005.
Indication and Important Safety Information - TriCor (fenofibrate) tablets
Fenofibrate, marketed by Abbott as TriCor in the United States, is used in addition to appropriate diet to treat adults with high cholesterol and/or mixed dyslipidemia with or without elevated triglycerides (TG), after results of lifestyle changes are unsuccessful. TriCor reduces elevated LDL cholesterol ("bad" cholesterol), total cholesterol, TGs and apolipoprotein B, and increases HDL cholesterol ("good" cholesterol).
TriCor, in addition to appropriate diet, is also used to treat adults with high TGs. Excessive body weight, drinking alcohol, diseases such as diabetes and hypothyroidism, and various drugs can contribute to high TG levels and these should be assessed by a doctor before a patient takes TriCor.
TriCor tablets are not for everyone. TriCor should not be taken by people with serious liver, kidney or gallbladder disease, or by those who may be allergic or sensitive to the drug.
The combined use of TriCor and statin drugs is not advised since it may produce potentially serious side effects that could lead to acute renal failure. Therefore, it is important for a health care professional to determine if the benefits of the combined use of these drugs are likely to outweigh the increased risks of the drug combination.
TriCor tablets may cause changes in laboratory reports, especially in liver chemistry results. Regular periodic liver tests should be performed while patients are taking TriCor. Patients should contact their doctors if they feel pain in the stomach area while taking TriCor, as this can be a sign of gallstones or inflammation of the pancreas. TriCor may cause muscle pain or serious muscle disease, allergic type reactions and possible changes in blood chemistry. If patients experience unexpected muscle pain, tenderness or weakness while taking TriCor, a health care provider should be contacted immediately.
Patients should notify their doctor if they are taking any other drugs while taking TriCor including any other cholesterol-lowering medications. TriCor may have an effect on drugs that help prevent blood clotting, such as the blood thinner warfarin sodium tablets, USP, and doctors should monitor blood-clotting tests more frequently.
Patients should tell their doctors about any side effects they experience, including breathing problems, back pain and headaches.
For more information about TriCor (fenofibrate) Tablets, including full prescribing information, please visit http://www.TriCortablets.com .
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 60,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com .
AbbottCONTACT: Media, Laureen Cassidy, +1-847-938-7743 or +1-847-772-1987(onsite), or Ilke Arici, +1-847-938-8551 or +1-847-269-7419 (onsite), orFinancial Community, Lawrence Peepo, +1-847-935-6722, all of Abbott
Company News On-Call: http://www.prnewswire.com/comp/110328.html/
