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FDA okays drug to prevent stroke, heart attack in diabetics
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The American Heart Association (AHA) estimates that one person every 45 seconds will experience a stroke in 2005.

In the Philippines, the National Nutrition and Health Survey reports that close to 900,000 Filipinos already show symptoms of stroke. The risk is higher for Filipino males aged 20 years old and above, with one out of four victims not surviving an attack.

Common independent risk factors for heart disease include high cholesterol, high blood pressure, family history, age over 55, smoking, diabetes, obesity and stress. Stroke is more prevalent in adults at the age of 65 and older, and the incidence of stroke continues to rise as age increases.

The national nutrition survey conducted in 2003 by the Food and Nutrition Research Institute – Department of Science and Technology (FNRI-DoST) revealed that several out of 100 Filipino adults aged 20 and above are suffering from impaired glucose levels and diabetes, which are risk factors for future cardiovascular disease. It is expected that the majority of people with diabetes – roughly 65 percent – will suffer a heart attack or stroke, a rate that is up to four times higher than in adults without diabetes.

According to the American Diabetes Association recommended treatment guidelines, adults with type 2 diabetes should be considered for statin therapy regardless of their low density lipoprotein (LDL) or bad cholesterol.

Based on the findings of the Collaborative Atorvastatin Diabetes Study (CARDS) — a landmark trial of more than 2,800 patients with type 2 diabetes, near normal cholesterol, and at least one other risk factor, such as high blood pressure or smoking — patients on the cholesterol-lowering medicine atorvastatin calcium experienced nearly 50 percent fewer strokes than those on placebo. The CARDS trial was stopped nearly two years earlier than planned by the study’s Steering Committee because of the strong benefits found among patients who took the medicine.

Following this development, the US Food and Drug Administration (FDA) has approved atorvastatin calcium to reduce the risk of stroke and heart attack in people with type 2 diabetes without evidence of heart disease but with other risk factors. Atorvastatin calcium also received approval to reduce the risk of stroke in people without evidence of heart disease but with multiple risk factors other than diabetes.

The additional approval of Atorvastatin calcium to reduce the risk of stroke in patients with multiple risk factors reflects findings from The Anglo-Scandinavian Cardiac Outcomes Trial: Lipid-Lowering Arm (ASCOTLLA) another landmark trial which was likewise halted nearly two years earlier than planned. The trial found that atorvastatin calcium reduced the relative risk of stroke by 26 percent compared to placebo.

The study involved more than 10,300 people with normal or borderline cholesterol levels and no prior history of heart disease, but with controlled high blood pressure and at least three other risk factors for heart disease, such as family history, age over 55, smoking, diabetes and obesity.

"Patients with multiple risk factors, including diabetes, face a greater threat of heart attack and stroke, so reducing their risk is critical," said David Waters, M.D., F.A.C.C., Chief of Cardiology, San Francisco General Hospital, San Francisco, CA. "The idea that we can reduce the risk of heart attack and stroke even in this high-risk population with a medicine like atorvastatin calcium is important."

The 2004 update to guidelines issued by the National Cholesterol Education Program in the US confirms the added benefit of prescribing cholesterol-lowering medication like atorvastatin calcium, along with diet modification and exercise, to patients at risk for cardiovascular disease.

Since the introduction of atorvastatin calcium eight years ago, its safety and efficacy have been supported through an extensive clinical trial program with more than 400 ongoing and completed trials involving more than 80,000 patients. It is the most prescribed cholesterol-lowering therapy in the world with over 100 million patient years of experience.

Atorvastatin calcium may only be bought with a doctor’s prescription. Patients are advised to see their doctors before taking any prescription medicine. It is not for those with liver problems so doctors are encouraged to do blood tests to check liver function before and during treatment. It is also not for women who are nursing, pregnant, or may be pregnant. The most common side effects, which tend to be mild and often go away, are gas, constipation, stomach pain, and heartburn. Any unusual muscle pain or weakness could be a sign of serious muscular side effects.

Atorvastatin calcium is used in patients with multiple risk factors for heart disease to reduce the risk of heart attack or stroke and, along with a low-fat diet, to lower cholesterol.

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