Precose Now Available For Type II Diabetes Patients

Precose Now Available For Type II Diabetes Patients


WEST HAVEN, Conn. -- Bayer Corporation, Pharmaceutical Division, announced today the commercial availability of Precose (acarbose tablets), the first of a new class of drugs for treating Type II (non-insulin-dependent) diabetes mellitus. Precose was granted marketing clearance by the U.S. Food and Drug Administration on Sept. 7, 1995.

Type II diabetes is a serious life-threatening condition that affects 15 million Americans. Diabetes results from an impairment of the body's ability to turn glucose (blood sugar) from food into usable energy. Treatment focuses on controlling blood glucose levels. Treatment initially begins with a diet and exercise regimen. If this approach fails, oral agents are added. If they too are unsuccessful, daily insulin injections may be required.

First of a New Therapeutic Class

"Precose is the first treatment for diabetes to focus on tackling the carbohydrate problem," said Robert F. Coniff, M.D., director of Metabolic Clinical Research at the Pharmaceutical Division of Bayer. "By slowing the digestion of carbohydrates, Precose is the first pharmacological agent to use the gut as a means to treat diabetes. Precose should be used as an adjunct to diet to lower blood glucose in Type II patients (alone or with sulfonylurea therapies) who cannot be managed on diet alone."

Precose is available in 50 mg and 100 mg tablets for oral use. The initial recommended daily dose is to take half of a 50 mg tablet with the first bite of food at each of the three main meals. After four to eight weeks, physicians will titrate their patients based on patient tolerability and post-prandial blood glucose levels. Bayer has manufactured adequate product to meet anticipated demand.

The suggested retail price for bottles of 100 tablets is $45.61 for 50 mg tablets and $58.80 for 100 mg tablets. The cost per day for patients ranges from $1.54 to $1.98 depending on dosage strength. Precose is expected to be covered by private and government insurance.

The most common side effects to Precose are abdominal discomfort, diarrhea and flatulence. These effects have been mild to moderate and generally diminish over time. Precose is contraindicated in patients with inflammatory bowel disease, colonic ulceration or partial intestinal obstruction. Precose is not recommended for patients with significant renal or kidney problems. The recommended dose should not be exceed because of reports of elevated liver enzyme levels at higher doses. It also is important that patients continue to adhere to dietary instructions, a regular exercise program, and regular testing of urine and/or blood glucose.

Bayer Committed to Diabetes Research and Education

With the launch of Precose, Bayer is initiating a 28-week trial involving 2,000 physicians and 10,000 diabetes patients. The goal of the trial is to acquire more information on the efficacy and safety of Precose in NIDDM patients. The trial is designed to confirm that lowering post-prandial glucose levels will result in HbA1c reduction. Although it is thought that reduction in HbA1c will decrease the risk of long-term complications in NIDDM patients, it has not yet been proven in this population.

The landmark Diabetes Control and Complication Trial (DCCT) in insulin-dependent patients showed that lowering and controlling blood glucose levels may help reduce the development of diabetes complications including eye, kidney and nerve damage. Bayer will launch an awareness campaign to educate NIDDM patients about the importance of knowing their blood glucose and HbA1c levels as a means to help reduce the potential of long-term complications. This campaign will include research, patient and provider forums, educational materials, patient counseling, and communications workshops.

Precose is a priority product for Bayer and will be supported by more than 1,000 pharmaceutical representatives.

Bayer Corporation, Pittsburgh, is a research-based company with major businesses in health care, chemicals and imaging technologies. The company is the U.S. subsidiary of Bayer, AG, the international chemical and health care company based in Leverkusen, Germany, one of the world's 50 largest industrial concerns. Bayer Corporation, with 24,000 employees, had 1994 sales of $7.1 billion, about 27 percent of the Bayer Group's worldwide sales.

CONTACT: Donald Hyman of Bayer, 203-498-6545, day, 203-255-9093, evening, or Gianfranco Chicco of chandler chicco agency, 212-274-1110


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