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.
Company: Hoechst Marion Roussel
Approval Status: Approved December 1995
Treatment Area: type II diabetes
Amaryl is an insulin-sparing sulfonylurea agent for the
treatment of type II diabetes. It is indicated as a first-line
therapy to lower blood glucose in people with type II diabetes
whose high blood glucose cannot be controlled by diet and exercise
Clinical research supports the recommendation that Amaryl be
used as a monotherapy or in combination with insulin, a unique
distinction among members of the sulfonylurea class of diabetes
drugs. Amaryl provided highly effective glucose control with a once
daily dosing schedule, which helped many type II diabetes subjects
achieve 24-hour glucose control, without putting subjects at undue
risk for low blood sugar, a complication of overly rigorous
control. Highly effective glucose control was observed in a range
of subjects including obesity and hypertension--and in traditional
at risk populations such as Hispanics and African Americans.
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 incidence of
the disease 10 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 United States.
Type II 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 II diabetes, and most of
them require oral medication alone or in combination with insulin
to keep blood sugar levels under control.
Studies on type I (insulin-dependent) diabetics in the landmark
Diabetes Control and Complications Trial indicate that tight
control reduced some of the devastating complications of the
disease, such as retinopathy, kidney damage, and damage to the
nerves that can lead to amputations. According to the American
Diabetes Association, it is reasonable to recommend tighter glucose
control for the millions of NIDDM subjects because it is presumed
that the mechanisms by which glucose causes complications are the
same in both forms of diabetes.