ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Thursday, December 12, 1996 TAG: 9612120046
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
DATELINE: BETHESDA, MD.
SOURCE: 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,'' Parke Davis researcher Dr. Randall Whitcomb said. ``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, or adult-onset, diabetes, where the pancreas produces more and more insulin but their blood sugar continues to rise. They are at risk for kidney damage, blindness, heart disease and other complications.
Diet, exercise and pills to boost insulin production and decrease glucose production can help, but more than 40 percent of Type II diabetics eventually need insulin shots. Even then, many cannot get high enough doses to stay healthy - or the inconvenience of taking shots and the weight gain the insulin can cause dissuade patients from taking proper care of themselves.
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.
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.
Parke Davis expects this to be just the first use of Rezulin. It is studying the drug as an alternative to insulin, and the National Institutes of Health is studying whether early use could actually help at-risk patients avoid getting diabetes.
But there are some questions about Rezulin's risks:
* In animal studies, it increased the size of rodents' hearts, apparently through fluid retention. So far, Parke Davis has found no sign that Rezulin hurts human hearts, nor was it cardiotoxic when monkeys and dogs were given very high doses. Still, the panel urged long-term monitoring to ensure Rezulin is heart-safe, and said people with heart disease should not take it in the meantime.
* Some rodents, given up to 47 times the human dose, developed vascular or liver tumors. But there is no sign yet that Rezulin is carcinogenic to people, FDA doctors and Parke Davis agreed.
* Rezulin can increase cholesterol levels, something the panel urged to be monitored.
LENGTH: Medium: 79 linesby CNB