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Fda Clears New Drug For Diabetes Troglitazone May Reduce Need For Insulin Shots

The U.S. Food and Drug Administration approved a drug Thursday that offers a million diabetics the hope of reducing - and for some even stopping - their insulin shots.

Hitting pharmacy shelves by the end of March, Parke Davis’ troglitazone is the first drug to attack the underlying trigger of Type II diabetes, the disease’s most common form.

It somehow re-sensitizes the body to insulin, a hormone that converts blood sugar into energy.

Some patients - about 15 percent of those who tested the drug - no longer needed shots because the amount of insulin their bodies manufactured became sufficient again. Most patients still needed insulin but required fewer injections each day.

“It’s an exciting new drug,” said Dr. Philip Cryer, president of the American Diabetes Association.

He issued a caution: “Nobody ought to abruptly stop their insulin. They have to work with the doctor to see if troglitazone has an effect and then reduce insulin gradually.”

Troglitazone will be sold under the brand name Rezulin, but Parke Davis said a price has not been set.

About 16 million Americans have diabetes. Type I diabetes typically strikes children who cannot produce insulin and need daily shots of the hormone to survive. Rezulin should never be used by them.

Type II diabetes, also known as the noninsulin-dependent type, usually hits in adulthood. The body’s natural insulin gradually loses its ability to work, letting blood sugar, or glucose, rise. Unchecked, that can cause kidney damage, blindness, heart disease and other complications.

About 90 percent of American diabetics have this type. Diet, exercise and pills to boost insulin production and decrease glucose production can help. But as they age, most of these diabetics will need insulin shots - and a million of them still cannot adequately control the disease.

These are the patients Rezulin is expected to help.

Researchers believe the drug stimulates a gene to produce more insulin-controlled proteins that in turn remove glucose from the bloodstream - essentially giving insulin more opportunity to work. As a bonus, it decreases the body’s glucose production.

In clinical trials of Rezulin, some patients “did show a very considerable and significant effect,” said FDA’s Dr. Solomon Sobel, who said the drug is the first in a unique class of medicines.

In a study of 222 patients, those taking 400 milligrams of Rezulin a day for six months slashed their daily insulin dose by 58 percent. Fifteen percent stopped taking insulin.

Parke Davis expects Thursday’s FDA approval to be just the first use of Rezulin. The National Institutes of Health is studying whether people at high risk of developing Type II diabetes could actually avoid contracting the disease by taking the drug.

The drug’s side effects are rare and mild, the FDA said: some infections, pain and headache. It also can cause an increase in cholesterol levels, but the FDA said the rise is not alarming.

Sobel warned that the drug should be prescribed with caution in patients with advanced heart or liver disease, because animal studies found signals the drug might hurt those organs. It caused fluid retention that increased heart size in rodents, but the FDA said those effects have not been observed in people who have tried the drug.



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