Precose (acarbose)
Company: Bayer
Approval Status: Approved September 6, 1995
Treatment for: non-insulin-dependent diabetes mellitus
Areas: Endocrinology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
Precose is an oral alpha-glucosidase inhibitor for use in the management of non-insulin-dependent diabetes mellitus (NIDDM). Precose, as monotherapy, is indicated as an adjunct to diet to lower blood glucose in subjects with NIDDM whose hyperglycemia cannot be managed on diet alone. Precose may also be used in combination with sulfonylurea when diet plus either Precose or a sulfonylurea do not result in adequate glycemic control. The effect of Precose to enhance glycemic control is additive to that of sulfonylurea when used in combination, presumably because its mechanism of action is different.
Clinical Results
To evaluate the long-term efficacy of precose in improving glycemic control in subjects with NIDDM, a one-year, multicenter, randomized, double-blind, placebo-controlled study was conducted. The study involved 354 subjects with NIDDM.
Clinical studies demonstrated a strong association between hyperglycemia and an increased risk of microvascular tissue damage. Trials involving Precose established that hemoglobin levels are a more significant predictor of the onset or progression of retinopathy in NIDDM diabetic patients than blood glucose concentration. Precose significantly reduced hemoglobin levels in NIDDM subjects maintained on dietary therapy alone. The magnitude of the treatment effect steadily increased during active treatment; diabetic retinopathy was reduced by approximately 30%. In addition, reduction in postprandial glucose concentrations were observed in subjects receiving Precose.
Side Effects
Side effects consisted primarily of gastrointestinal symptoms, such as diarrhea, cramping, abdominal pain, and increased gas production. A smaller incidence of headache and hyperglycemia was also reported.
Mechanism of Action
Precose is a complex oligosaccharide that delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, Precose reduces levels of glycosylated hemoglobin in subjects with type 2 (non-insulin-dependent) diabetes mellitus.
Literature References
Chaisson, J.-L. et al. The efficacy of acarbose in the treatment of patients with non-insulin-dependent diabetes mellitus. Annals of Internal Medicine 1994; 121(12): 928-935.
Coniff, R.F. et al. Long-term efficacy and safety of acarbose in the treatment of obese subjects with non-insulin-dependent diabetes mellitus. Archives of Internal Medicine 1994; 154: 2442-2448.
Coniff, R.F. et al. Reduction of glycosylated hemoglobin and postprandial hyperglycemia by acarbose in patients with NIDDM. Diabetes Care 1995; 18(6): 817-824.
Coniff, R.F. et al. Multicenter, placebo-controlled trial comparing acarbose with placebo, tolbutamide, and tolbutamide-plus-acarbose in non-insulin-dependent diabetes mellitus. American Journal of Medicine 1995; 98: 443-451.
Additional Information
The incidence of diabetes in the United States is on the rise. The National Institute of Diabetes and Digestive Kidney Diseases estimates that 16 million Americans have diabetes mellitus, which represents an increase of five million compared with the number affected by the disease ten years ago. Yet, only half of the people believed to have diabetes have been diagnosed. Diabetes is the fourth-leading cause of death by disease in the United States.
Type 2 diabetes, the more prevalent form of the disease, is often referred to as late-onset or non-insulin dependent diabetes mellitus (NIDDM). Of the eight million people diagnosed with diabetes, nearly 7.5 million have type 2 diabetes, and most of them require oral medication alone or in combination with insulin to keep blood sugar levels under control.
Depending on the disease severity, therapy for NIDDM subjects consists of diet, exercise, weight reduction, sulfonylurea drugs, and/or insulin therapy. The primary therapeutic endpoint in the treatment of diabetes has been to maintain near-normal levels of glycemia with the goal of reducing microvascular and macrovascular complications.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
