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| |  FDA Grants Approval To Amaryl For Combination Use With Metformin KANSAS CITY, MO -- March 9, 1999 -- Hoechst Marion Roussel’s Amaryl(R) (glimepiride tablets), a first-line drug treatment for type II diabetes, has received United States Food and Drug Administration approval for second-line combination use with the type II diabetes drug metformin. Amaryl is the first and only oral diabetes drug in its class (sulfonylurea) to receive three indications. It has already been approved for use as an adjunct to diet and exercise as a monotherapy or in combination with insulin during second-line therapy. Type II diabetes results from the body's inability to process insulin at an effective rate, causing cell resistance to insulin action. Therefore, increasing insulin production and reducing insulin resistance are key therapies in treatment of this disease. In type II patients where monotherapy with either Amaryl or metformin has not produced adequate blood glucose control, the combination of Amaryl and metformin has the potential to achieve this control. Both agents act to improve glucose tolerance through different primary processes. Amaryl helps the body produce more insulin to reduce blood sugar and metformin acts as an aid to insulin acceptance in the cells. Diabetes is the sixth-leading cause of death by disease in the U.S., according to the American Diabetes Association. Formerly called non-insulin-dependent diabetes, type II diabetes is the most common type of diabetes, affecting about 15 million Americans. The disease usually occurs in people over 45 and in people who are overweight. In type II diabetes, the body does not make enough insulin or still makes insulin, but cannot properly use it. Without enough insulin, the body cannot move blood sugar into the cells, causing sugar to build up in the bloodstream. High blood sugar levels can cause serious health problems. Amaryl is indicated as an adjunct to diet and exercise to lower blood glucose in people with type II diabetes whose blood glucose cannot be controlled by diet and exercise alone. The most common adverse reactions include dizziness, asthenia, headache, nausea and hypoglycemia. Combined use of Amaryl with metformin or insulin may increase the potential for hypoglycemia. Amaryl is contraindicated in patients with known hypersensitivity to the drug or with diabetes ketoacidosis with or without coma, which should be treated with insulin. Related Links: Amaryl, Hoechst Marion Roussel
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