Magazine article Drug Topics

Who's on First?

Magazine article Drug Topics

Who's on First?

Article excerpt

Diabetes drug

is third to

premiere in

short stretch

One recent 13-month period was replete with "firsts" in the market for antidiabetes drugs. In December 1994, Glucophage (metformin, Bristol-Myers Squibb) became the first biguanide approved for noninsulin-dependent diabetes mellitus (NIDDM). In September 1995, acarbose (Precose, Bayer) became the first alpha-glucosidase inhibitor to be approved by the Food & Drug Administration. And last month, Amaryl (glimepiride, Hoechst Marion Roussel) became the first oral sulfonylurea that can be used either as monotherapy or in conjunction with insulin.

According to the package insert, glimepiride is indicated as an adjunct to diet and exercise to lower blood glucose in patients with NIDDM whose hyperglycemia cannot be controlled by diet and exercise alone. Glimepiride is also indicated for use in combination with insulin to lower blood glucose levels in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent.

At a telephone press briefing announcing the approval of glimepiride, Jill Schneider, M.D., director of endocrine metabolism clinical research at Hoechst Marion Roussel North America, told the press that glimepiride "provides highly effective glycemic control when used once a day."

According to Schneider, two large double-blind studies showed that use of glimepiride resulted in faster stabilization of blood glucose levels, compared with glipizide, as well as safer stabilization of blood glucose levels in comparison with glyburide.

Schneider said that in one doubleblind trial, 69% of all glimepiridetreated patients met the Diabetes Control & Complications Trial "gold standard" target for tight glucose control, defined as an Hb A^sub 1c^ less than or equal to 7.2%. Another 15% of individuals in this study were controlled with an Hb A^sub 1c^ of less than or equal to 8%, which the American Diabetes Association defines as the target for patients with NIDDM. …

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