Home » Drug Information » FDA Approved Drugs » 1995
Medical Areas: Endocrinology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved September 6, 1995
Treatment Area: non-insulin-dependent diabetes mellitus
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.
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 consisted primarily of gastrointestinal symptoms,
such as diarrhea, cramping, abdominal pain, and increased gas
production. A smaller incidence of headache and hyperglycemia was
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
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):
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.
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