Roadblock for diabetes

Blood glucose abnormalities 8211; known as pre-diabetes 8211; indicate that a person may soon develop diabetes. Which makes him/her a good candidate for Rosiglitazone.

Diet and exercise are the only current means of preventing progression to Type 2 diabetes.

8220;I think it will change treatment practices if it stands up,8221; said Dr Andrew Drexler, director of the Gonda Diabetes Center at the University of California, Los Angeles. Drexler was not involved in the study.

Some physicians, such as Dr Stuart Weiss of the New York University School of Medicine, have begun giving Rosiglitazone to pre-diabetic patients.

WHY A DRUG?

The results with Rosiglitazone, which costs as much as 170 per month, are comparable to those achieved with intensive programmes to modify diet and increase exercise. But experts say few physicians or patients are willing to invest the time and effort necessary for that.

In the United States, an estimated 18 million people have Type 2 diabetes. The number has been growing so rapidly that the Centers for Disease Control and Prevention have declared diabetes an epidemic.

Worldwide, 220 million people have diabetes, most of whom later develop heart disease, kidney disease, blindness or nerve damage, often leading to amputation of limbs.

8220;Getting people on drugs early is a very important thing,8221; said Weiss. The complications of diabetes, such as heart and kidney disease, 8220;occur even before the diabetes is diagnosed8230; We need to be much more aggressive and get in sooner.8221;

8220;Anything we can do to prevent it will have huge public health implications,8221; said Dr Vivian Fonseca of the Tulane University Health Sciences Center.

HOW IT WORKS

Unlike Type 1 diabetes, in which the pancreas stops producing insulin completely, Type 2 diabetes occurs when the pancreas loses part of its ability to produce insulin and the body8217;s cells lose part or all of their ability to use insulin to remove glucose from the bloodstream for use by cells.

Rosiglitazone, sold by GlaxoSmithKline under the brand name Avandia, increases the sensitivity of cells to insulin.

Earlier studies on treating diabetes had suggested that Rosiglitazone and a second drug, Ramipril, might also halt progression to diabetes.

Ramipril, which is sold by King Pharmaceuticals Inc. and Wyeth under the brand name Altace, increases production of insulin.

THE STUDY

Previous studies have shown that between 29 percent and 59 percent of such pre-diabetic patients will progress to diabetes within three years.

The current study, led by Dr Hertzel Gerstein of McMaster University in Canada, enrolled 5,269 people with pre-diabetes in 21 countries.

The subjects received daily doses of either Rosiglitazone, Ramipril, a placebo or both drugs.

Gerstein reported that 10.6 per cent of the 2,365 people who received Rosiglitazone, progressed to diabetes, compared to the 25 per cent of the 2,634 given a placebo.

The results suggest, Gerstein said, that for every 1,000 people given Rosiglitazone, 144 cases of diabetes will be delayed or prevented.

AND THE PITFALLS

One important side effect of the drug during the three-year study was an increase in congestive heart failure, although the absolute number of cases was low and physicians managed it successfully. Fourteen of those receiving the drug developed congestive heart failure, compared with two of those receiving placebo.

The condition occurs due to a buildup of fluids in some patients. Weiss noted that this can be controlled or prevented by counseling patients to reduce the amount of salt in their diet.

A WORD OF CAUTION

Dr Al Powers, director of the diabetes research and training center at the Vanderbilt University, has cautioned against hasty prescribing of the drug.

8220;People with pre-diabetes don8217;t technically have a disease8230; and not all develop diabetes,8221; he said. 8220;You are causing a serious disease in some with the drug.8221;

He also pointed out that intensive lifestyle modification, involving dieting and increased exercise, is just as effective, reducing progression to diabetes by 58 per cent in a 2002 study. 8220;And it has an outstanding safety profile,8221; he said.