FDA PANEL RECOMMENDS DIABETES DRUG.

Byline: Lauren Neergaard Associated Press

Holding out the possibility that many thousands of diabetics could reduce or even stop their insulin shots, the government's scientific advisers recommended approval Wednesday of the first drug to attack the underlying cause of diabetes' most common form.

Parke Davis' Rezulin ``is a truly novel approach,'' said the Food and Drug Administration's Dr. Solomon Sobel before a panel of FDA advisers voted unanimously to support the drug.

It puts doctors ``in the realm of treating Type II diabetes in a more fundamental way,'' he said.

Rezulin, known chemically as troglitazone, somehow resensitizes the body to insulin, a hormone that converts blood sugar into energy.

Researchers believe it stimulates a gene to produce more insulin-controlled proteins that in turn remove this blood sugar, or glucose, from the bloodstream - essentially giving insulin more opportunity to do its job.

That makes Rezulin the only drug to attack the cause of Type II diabetes - the gradual loss of natural insulin's ability to work - and as a bonus, decrease the body's production of glucose.

``Rezulin is not a drug that just has people taking less insulin,'' said Parke Davis researcher Dr. Randall Whitcomb. Also, ``this is a drug that improves glycemic control.''

Some 16 million Americans have diabetes, although only half are diagnosed. Type I diabetes typically strikes children, who cannot produce any insulin and need daily shots of the hormone to survive. Rezulin should never be used by them.

But the vast majority of diabetics have Type II, also called adult-onset or non-insulin dependent, diabetes. With this form, the pancreas produces more and more insulin but the body gradually stops reacting to it, letting blood sugar rise and risking kidney damage, blindness, heart disease and other complications.

Diet, exercise and pills to boost insulin production and decrease glucose production can help, but over 40 percent of Type II diabetics eventually need insulin shots. Even then, many can't get high enough doses to stay healthy - or the inconvenience of taking shots and the weight gain insulin can cause dissuade patients from taking proper care.

Only these poorly controlled Type II patients - an estimated 1 million people - should be considered for Rezulin treatment, the FDA panel decided.

In one study of 222 patients, those taking 400 milligrams of Rezulin a day for six months slashed their daily insulin dose by 58 percent, Parke Davis reported. Some 15 percent of patients were able to stop taking insulin altogether.

Another trial found Rezulin helped patients with average glucose levels of 215 milligrams per deciliter of blood - extraordinarily high - drop their blood sugar by about 50 milligrams. Normally, glucose should be below 140 milligrams.

The FDA is not bound by advisory panel decisions but usually follows them. The American Diabetes Association expects approval of Rezulin, which was discovered in Japan and already is sold there.

``It will be easier to take care of patients with pills than insulin,'' said ADA president-elect Dr. Mayer Davidson.