Diabetes News for January 30, 2000

Diabetes This Week News
Vitamin E May Not Help The Heart
Antioxidant Depletion Linked To Complications
Active Women Have 50% Less Risk Of Stroke
Altace Reviewed For New Applications
Bayer Sues Can-Am: Trademark Infringement

Vitamin E May Not Help The Heart

People with heart disease who take vitamin E do not lower their risk of heart attack, stroke, or heart disease related death, according to research reported in the January 20th issue of The New England Journal of Medicine.

In a study just concluded, people aged 55 and older with heart disease, diabetes or one other risk factor for heart disease who took 400 international units of natural vitamin E daily for 4 to 6 years were no less likely to have a heart attack, stroke, or die from heart disease than people taking a sugar pill or placebo. The study had 9,000 participants randomly assigned to either the vitamin E group or the placebo group.

Does this mean vitamin E is not helpful to the heart? While vitamin E did not prevent heart attacks or strokes in the participants in this study, it may help younger people without heart disease. And other research suggests that consuming vitamin E and making lifestyle adjustments such as a healthier diet and more exercise does provide benefit. It may also have benefits when taken in combination with other antioxidants. It is important to note that vitamin E is not harmful, but it also is not potent enough to counteract smoking, poor eating habits and a sedentary lifestyle.

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Antioxidant Depletion Linked To Diabetic Complications

What causes the complications of diabetes? The full answer is under consideration, but major clinical trials have determined high blood sugars is a primary culprit. It is also likely that oxidative stress caused by the high blood sugars is involved in the formation of complications.

A study by Duke University Medical Center investigated the relationship between antioxidant depletion, glucose control, and the development of chronic complications in 50 participants with Type 2 diabetes. The participants were of similar age, matched for body weight and were treated with sulfonylureas but not insulin. They were screened and assigned to two groups based on the presence or absence of proteinuria, a sign of kidney disease. The study also had a control group without diabetes who were age-matched and weight-matched with the other two groups.

Plasma glucose and fructosamine levels, indicators of blood sugar control, were higher in the two groups of participants with diabetes versus the control group. The control group had the highest antioxidant levels, the group with diabetes but no proteinuria had the next highest, and the group with diabetes and proteinuria had the lowest antioxidant levels.

One measure of antioxidant level called TEAC in the control group was 2.7+/-0.45, versus 1.7+/-0.5 (P < .001) in the participants with diabetes without proteinuria. In addition, the TEAC measured in participants with proteinuria, who also had other diabetic complications, was lower (1.4+/-0.5, P < .001) than the TEAC in patients without urinary protein.

The study reported in the journal Metabolism in November of 1999 showed that a depletion of the total antioxidant capacity is linked with a higher incidence of diabetic complications.

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Active Women Have 50% Less Risk Of Stroke

Women over 50 can reduce their risk of dying from a stroke by as much as 50% through regular physical activity according to a 10 year study reported in the January issue of the journal Stroke: Journal of the American Heart Association.

Why does exercise have this effect? Previous studies suggest that activity helps regulate body weight, blood pressure and cholesterol, which all effect the progression of a stroke. Physical activity may provide protection against death from stroke by ameliorating the deposit of plaque in the arteries, enhancing electric stability in the heart, or helping to dissolve blood clots. Physical activity also helps control diabetes and raises HDL.

To investigate the effect of exercise on middle-aged and older women, lead author Dr. Hanne Ellekjaer of the National Institute of Public Health in Verdal, Norway, and colleagues analyzed data from 14,000 women through self-administered questionnaires. The women, who were free of stroke at the outset of the study, reported on their physical activity and health conditions which placed them at risk for stroke, such as diabetes, heart disease, illness, high blood pressure medication and smoking. A physical exam provided data on height, weight, blood pressure and pulse rate.

The results showed that the risk of dying from stroke declined as physical activity increased so that the most active women had approximately 50% lower risk of death from stroke across all age groups.

The conclusion of the study is that physical activity should be part of a prevention program against stroke in women.

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Altace Reviewed For New Applications

Altace, an ACE inhibitor, was recently reported to have more applications than just the treatment of high blood pressure and congestive heart failure, the functions it was origonally developed for. The finding that Altace is effective in more ways than originally thought came from a landmark study called HOPE (Heart Outcomes Prevention Evaluation), and was reported in The New England Journal of Medicine January 20 of this year.

King Pharmaceuticals, Inc., the developer of Altace, has now submitted a supplemental drug application to the FDA to request approval for new applications for Altace. The applications requested are for the prevention of myocardial infarction and stroke, for revascularization procedures, and to prevent heart failure in patients at risk for such cardiovascular events.

In the HOPE study, Altace also demonstrated the ability to significantly reduce the occurrence of diabetes, diabetic microvascular complications, and nephropathy. However, these benefits are not being applied for from the FDA.

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Bayer Sues Can-Am For Trademark Infringement

Bayer Corporation has filed a lawsuit against Selfcare, Inc., Inverness Medical, Inc., and Can-Am Care Corporation charging the defendants with trademark and trade dress infringement and unfair competition.

The charges arise from Can-Am's use of Bayer's trademarks and closely imitative packaging design on their packaging and advertisements. These ads promote the use of Can-Am's Excel GE test strips with Bayer's Glucometer Elite blood glucose monitors and Bayer believes that this is likely to confuse or mislead consumers into believing Can-Am's test strips are associated with Bayer.