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| |  Amaryl For Type II Diabetes Now Available in the U.S. KANSAS CITY, Mo., April 1, 1996 -- Hoechst Marion Roussel, the pharmaceutical division of Hoechst AG, today announced that Amaryl(R) (glimepiride), a new insulin-sparing sulfonylurea agent for the treatment of type II diabetes, is now available in the United States. Amaryl, which was cleared for marketing in late 1995 by the U.S. Food and Drug Administration (FDA), is the only sulfonylurea agent indicated for use alone or in combination with insulin if oral medication alone does not provide adequate control. 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. Amaryl works primarily by increasing insulin secretion and lowering blood glucose concentration without putting patients at undue risk for low blood sugar. Type II diabetes, or non-insulin-dependent diabetes mellitus (NIDDM), is the more prevalent form of the disease and accounts for more than 90 percent of all cases. It occurs when the body does not produce enough insulin to control glucose levels and excess sugar in the blood occurs. Of the 8 million people diagnosed with diabetes, nearly 7.5 million have type II diabetes, and most of them require oral medication alone or in combination with insulin to keep blood sugar levels under control. "Effective glucose control is a key objective of diabetes care and management," said Peter W. Ladell, president, Hoechst Marion Roussel North America. "Amaryl offers once-daily dosing that will help many patients achieve 24-hour glucose control. Amaryl also has the advantage of being available for use as monotherapy or in combination with insulin." "Combination therapy can have a special effectiveness for certain groups of patients with type II diabetes," said Matthew Riddle, M.D., head, section of diabetes at Oregon Health Sciences University. "It is very heartening to clinicians and patients to know that there is another tool now available for patients with type II diabetes who do not respond adequately to the use of oral agents alone." Results from clinical studies indicate that when Amaryl is used as an adjunct to diet and exercise, it offers highly effective glucose control without putting patients at undue risk for low blood sugar. Highly effective glucose control was observed in a range of patients, including obese individuals, persons with high blood pressure, and traditional "at risk" populations such as Hispanics and African-Americans. Amaryl patients experienced effective control for periods of up to three years in two multicenter trials involving nearly 2,000 patients each. In a multicenter study, Amaryl helped 69 percent of patients meet the Diabetes Control and Complications Trial (DCCT) "gold standard" target for tighter glucose control (HbA1c<7.2 percent). The most common adverse reactions include dizziness, asthenia, headache, nausea, and hypoglycemia. Combined use of Amaryl and insulin may increase the potential for hypoglycemia. Amaryl is contraindicated in patients with known hypersensitivity to the drug or with Amaryl will be available by prescription in tablets of 1-mg, 2-mg and 4-mg strengths for oral administration. The usual starting dose of Amaryl as initial therapy is 1 mg to 2 mg once daily, administered with breakfast or the first main meal. The maximum recommended dose is 8 mg once daily. "The availability of Amaryl in the United States extends Hoechst Marion Roussel's commitment to providing quality products for patients with diabetes," Ladell added. "We are excited to offer patients with type II diabetes another option for managing this serious medical condition." Hoechst Marion Roussel, a world leader in pharmaceutical-based health care, is dedicated to extending and enhancing human life through the discovery, development and manufacture and sale of pharmaceutical products. Hoechst Marion Roussel, with global headquarters in Frankfurt, Germany, is a member of the Hoechst Group. Hoechst Marion Roussel's North American business is headquartered in Kansas City, Missouri.
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