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From the FDA

Cholesterol Drugs Could Go Over the Counter

Less than one half of Americans who could benefit from cholesterol-lowering drugs take them. The majority on medication are at high risk for heart disease, while people with moderate risks typically do not medicate. To expand access to these drugs, several companies are currently seeking approval to sell them over the counter.

Specifically, drug makers want regulatory approval to sell these drugs in small doses without a prescription. Precedent for over the counter sales exists in Britain, where health officials recently approved the drug Zocor for sale without a prescription. British patients will ask a pharmacist for the drug and answer questions to determine whether it is appropriate.

While a decision in the FDA in the United States is months away, a change in regulations could have both positive and negative impacts. Over the counter cholesterol drugs could help reduce the nation's biggest health problem, heart disease, if more people access medication. Some fear, however, increased accessibility will mean people will see their doctors less frequently and ignore other health risks, such as high blood pressure, smoking, and diabetes. The companies will urge consumers of medication sold without prescription to get follow up tests of their cholesterol levels.

http://www.cnn.com/

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Anticoagulation News

Awareness of Stroke Signs Lacking

Because strokes are now more treatable than ever with early detection, it is imperative that people understand how to recognize the signs and symptoms. A recent study conducted by the Centers for Disease Control and Prevention (CDC), however, found that many Americans lack the knowledge necessary to detect stroke symptoms and seek rapid medical treatment.

The five major warning signs of a stroke are:

• Sudden confusion, trouble speaking, or understanding
• Sudden numbness or weakness of the face, arm, or leg, especially on one side of the body
• Sudden trouble seeing in one or both eyes
• Sudden trouble walking, dizziness, or loss of balance or coordination
• Sudden, severe headache with no known cause

Overall, recognizing the five major stroke warning signs and being aware that sudden chest pain was not a stroke sign. (but a sign of a heart attack) was low at 19.6%. In addition, fewer than 18% of people were both aware of all the correct stroke signs and reported they would first call 911 if they thought someone was having a stroke or a heart attack.

Factors that put someone at risk of stroke are:

• Uncontrolled high blood pressure
• History of mini-stroke (known medically as a transient ischemic attack, or TIA)
• Atrial fibrillation, the most common heart rhythm problem
• Diabetes
• History of stroke or heart attack

CDC analyzed 2001 data from the Behavioral Risk Factor Surveillance System (BRFSS) in 17 states and the U.S. Virgin Islands. Education campaigns are needed to increase public awareness of stroke signs and the necessity of calling 911 when persons are suffering a possible stroke. The five major warning signs for stroke are sudden confusion or trouble speaking or understanding; sudden numbness or weakness, particularly on one side of the body; sudden vision trouble; dizziness or trouble walking; and sudden severe headache with no apparent cause.

Stroke is the third leading cause of death in the United States and a major cause of disabilities among adults. Since 1900, the number of stroke deaths has declined, and substantial advances have been made in the diagnosis and treatment of ischemic stroke during the previous decade. The proportion of deaths that occur before patients are transported to hospitals, however, has increased to nearly half of all stroke deaths.

http://my.webmd.com/

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Readers Comments

Diabetes Linked to Alzheimer's Disease

Question: "My father has had Diabetes for years, and I've noticed an increase in new conditions that make him worse. Is there a link between diabetes and other diseases?

A new study shows that people with diabetes may experience increased risks for developing Alzheimer's disease. Diabetes mellitus has been associated with several other disorders, including cognitive impairment. Few studies, however, have examined a possible link between diabetes mellitus and Alzheimer's disease. Diabetes mellitus is a common condition, affecting about 20 percent of people older than 65 years.

In the new study, researchers evaluated the association between diabetes mellitus and risk of Alzheimer's disease and change in cognitive functioning in 824 Catholic nuns, priests, and brothers older than 55 years who underwent annual clinical evaluations. The participants were followed for up to nine years; 127 (15.4%) had diabetes mellitus.

During an average of 5.5 years of observation, 151 participants developed Alzheimer's disease, of whom 31 had diabetes. Among those with diabetes mellitus, there was a 65 percent increase in risk of developing Alzheimer's disease, compared to those without diabetes mellitus. Participants with diabetes mellitus also had lower levels of cognition and had more memory problems.

http://www.theglobeandmail.com/

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New Treatment

New Drug Fights Prostate Cancer

The US Food and Drug Administration approved a new drug that can increase survival among patients with advanced prostate cancer. The drug is Taxotere from Aventis Pharmaceuticals. For prostate cancer, the drug is given along with the steroid prednisone. The treatment offers a new option to men who have not responded to hormone treatment. Taxotere works by inhibiting tubulin, a protein cancer cells need in order to multiply.

In clinical trials, men receiving Taxotere and prednisone survived two-and-a-half months longer than patients treated with Novantrone and prednisone, an existing cancer-slowing drug. The most common adverse events reported were nausea, hair loss, and bone marrow suppression. Fluid retention and tingling sensations in the extremities also occurred in some patients. This drug is also approved for treatment of breast and lung cancer.

http://www.aventisoncology.com/

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Life Style

Fast Food Inflames Blood Vessels

Results from a new study demonstrate that consuming large quantities of fast food can have immediate, adverse health effects. Specifically, eating a large fast food breakfast can trigger a temporary but large inflammatory response in the blood vessels. Although these effects are short-term, researchers suggest the long-term effects of routinely consuming fast food could include increased risks for heart attack and stroke.

Chronic inflammation is key in the development of the artery disease arteriosclerosis, a hardening and narrowing of the arteries that can lead to heart attack and stroke. The concern is that, over time, repeated inflammatory responses could lead to chronic inflammation in the blood vessels.

The study, conducted by the State University of New York at Buffalo, included nine healthy, normal-weight adults who were fed a breakfast of one Egg McMuffin, a Sausage McMuffin and two servings of hash browns from McDonald's. The meal included 910 calories, 81 grams of carbohydrates, 51 grams of fat and 32 grams of protein.

Although this study examined large portion sizes, researchers state that it is the content of the food, not the quantity, which caused the adverse reaction. The metabolism of fat could be responsible for the rapid inflammation. Chronic inflammation is key in the development of the artery disease arteriosclerosis, a hardening and narrowing of the arteries that can lead to heart attack and stroke. Researchers stressed that fast food can be part of a balanced diet and healthy lifestyle when consumed in moderation.

http://www.reuters.co.uk/

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Tech Talk

New Bacteria Killer Shows Promise

Phase II clinical trials show a new antibiotic's great promise for killing resistant bacteria in skin and soft tissue infections. The drug, called dalbavancin, has shown thus far to be an improved alternative to vancomycin, the most widely-used and one of the few treatments available to patients infected with the most difficult-to-treat strains of Staphylococcus.

Research has also shown that the drug kills bacteria, rather than just inhibiting its growth. Dalbavancin may also help reduce the length of hospital stays by decreasing the need for intravenous lines that increase the risk of local and bloodstream infection. In studies to date, dalbavancin appears to be one of the most potent antibiotics in its and has not shown significant dose-limiting side effects.

The antibiotic was developed by Vicuron Pharmaceuticals, a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients in North America and major countries in Europe. The company expects to seek FDA approval within the year.

http://www.forbes.com/healthcare/

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Fitness Watch

Study Shows Cigars' Health Risks

As cigar smoking grows increasingly popular, the health risks of this habit are becoming better understood. Recent study findings, published in the American Journal of Hypertension, showed that smoking only one cigar can harden the heart's arteries for hours afterwards. Although some might consider cigars a safe alternative to cigarette smoking, cigars actually contribute significantly to cardiovascular disease.

A study of 12 healthy men who smoked cigarettes and cigars found that shortly after smoking a cigar, the men showed evidence of greater stiffness in the aorta, the main artery carrying blood from the heart to the rest of the body. The degree of stiffness in large arteries is key in how well the heart's main pumping chamber can work and blood can flow. Because this study only assessed the short-term effects of cigar smoking, researchers were not able to draw concrete conclusions about long-term health effects.

Nationally, it's estimated that 10-12 million people smoke cigars. The incidence of cigar smoking almost doubled between 1993 and 1996.

http://www.jointogether.org

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Product of the Month

My Allergy Home Test

Allergies can strike your family any time of the year. It's frustrating and can be expensive with constant trips to the doctor.Save time and money by testing at home with My Allergy Test, the world's first at-home allergy test, cleared by the FDA and clinically proven to be accurate.

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Physicians and health care providers will want to visit our professional site at www.pointofcaretest.com for a comprehensive selection of CLIA waived point of care testing devices and products.

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Copyright ©2003 QAS, Inc. All rights reserved. The information provided in this Newsletter and on the Hometestmed site is intended for your general knowledge only and is not a substitute for professional medical advice or treatment for specific medical conditions.