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| |  Precose Receives FDA Clearance For Combination Therapy In Type 2 Diabetes WEST HAVEN, CT -- November 6, 1998 -- Bayer Corporation, Pharmaceutical Division, announced today that it received clearance from the U.S. Food and Drug Administration (FDA) to market Precose (acarbose tablets) to be used in combination with insulin or metformin for patients with Type 2 diabetes. Insulin and metformin are drugs commonly used to treat Type 2 diabetes. Precose may be added to the treatment regimen for patients whose Type 2 diabetes is inadequately controlled by insulin or metformin to further reduce both the postprandial (after meal) blood glucose spikes (levels) and the HbAlc (a measure of long term blood glucose control). As monotherapy, Precose works with the diet to reduce blood glucose levels in patients with Type 2 diabetes whose disease cannot be managed by diet alone. The approval of Precose for combination therapy expands the clinician’s options for treating patients with Type 2 diabetes. The approval is well-timed in light of recent results from the United Kingdom Prospective Diabetes Study (UKPDS) in Type 2 diabetes. This study demonstrates that the combination of Precose with a patient’s existing therapy may be an important factor to help reduce the risks of diabetic complications such as limb loss, blindness and kidney disease. "The UKPDS clearly indicates that the use of a single medication to control blood glucose levels and diabetic complications may be inadequate," said Dr. James Magner, Deputy Director of Metabolics, Bayer Pharmaceutical Division, "Precose can be used safely in combination therapy with minimal side effects. We see this as being key to the future of diabetes management." Precose works with the diet in the small intestine. Taken with the first bite of the meal, Precose’s unique mechanism of action delays carbohydrate digestion and glucose absorption. "Precose specifically targets and lowers the sharp blood glucose spikes that occur after a meal (postprandial blood glucose). This makes Precose an appropriate addition to an existing therapy that only lowers fasting blood glucose," Dr. Magner added. Dr. Magner pointed out that sulfonylureas and biguanides -- classes of drugs commonly used to treat diabetes -- typically lower fasting blood glucose but the hazardous postprandial glucose spikes persist in more than 60 percent of patients(1). Postprandial blood glucose spikes are a significant predictor of specific diabetic complications. Precose used as monotherapy does not cause hypoglycemia, hyperinsulinemia, weight gain or lactic acidosis. Precose is contraindicated in patients with diabetic ketoacidosis, cirrhosis, inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction. The most common side effects are flatulence, abdominal pain and diarrhea. However, some patients may benefit from a gradual dose titration to minimize gastrointestinal side effects. Related Links: Precose and Bayer Corporation
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