INSÄNT AV Red DEN 06 :e FEBRUARI, 1997 vid 07 - tiden
Thursday January 30 8:57 AM EDTFirst Anti-Diabetic Therapy To Target The Underlying
Cause of Type II Diabetes Cleared For Marketing By
The FDAHas the Potential to Change the Lives of People With Type II Diabetes
on InsulinMORRIS PLAINS, N.J. Jan. 30 /PRNewswire/ -- Warner-Lambert Company announced today
that Rezulin(TM) (troglitazone) tablets have been cleared for marketing by the U.S. Food and Drug
Administration. A member of the thiazolidinedione class, also known as "insulin resistance
reducers", Rezulin is the first antidiabetes drug designed to target insulin resistance -- the
underlying cause of type II diabetes.Rezulin is indicated for use in patients with type II diabetes currently on insulin whose
hyperglycemia is inadequately controlled (HbA1c > 8.5 percent) despite insulin therapy of over 30
units per day given as multiple injections.Approximately three million people with type II diabetes take daily injected insulin, with more than
60% of these patients unable to adequately control their blood glucose levels. Although type II
diabetes is also known as non-insulin dependent diabetes mellitus (NIDDM), about half of all
NIDDM patients take insulin. This is due to significant insulin resistance -- a defect in the body's
ability to use insulin normally. Type I diabetes is characterized by the inability of the body to
produce insulin."This new drug has the potential to change the lives of people with type II diabetes who are
inadequately controlled on insulin," said Jerrold Olefsky, M.D., Professor of Medicine, Chief,
Division of Endocrinology and Metabolism, University of California, San Diego, School of
Medicine. "Rezulin works by improving insulin resistance. It provides better control of plasma
glucose levels, and at the same time offers the possibility of a reduction in insulin injection dosage
and frequency."In insulin-taking patients with type II diabetes, Rezulin decreases serum glucose, plasma insulin
and hemoglobin A1c.According to the American Diabetes Association (ADA) position statement concerning the
implications of the Diabetes Control and Complications Trial (DCCT), the benefits of controlling
blood glucose levels in type I patients could also be significant for patients with type II diabetes.
DCCT results showed that lowering blood glucose concentrations slows or prevents the
development of diabetic complications in type I patients. Although patients with type II diabetes
were not part of the DCCT, the ADA states that there is no reason to believe that the effects of better
control of blood glucose levels would not also apply to people with type II diabetes.Clinical Studies
Rezulin has been shown to be effective in clinical trials in over 5,000 patients, some of whom have
been treated with Rezulin for more than two years. Two pivotal, double-blind, placebo-controlled
multicenter studies examined the effects of Rezulin in a total of 573 insulin-requiring type II
diabetes patients over a six-month period. On average, patients involved in the trials had been
diagnosed with diabetes for 10 to 11 years and had been taking insulin for four to five years.The first clinical study, 991-040, demonstrated the efficacy of Rezulin therapy on glycemic (blood
sugar) control. In this study, 30 percent of patients treated with 200 mg Rezulin and 57 percent of
patients treated with 600 mg Rezulin achieved hemoglobin A1c (HbA1c) concentrations below 8
percent compared with 11 percent of placebo-treated patients. The HbA1c level is an integrated
measure of glucose control over the preceding three to four months. The American Diabetes
Association treatment guidelines recommend the physician adjust therapy when HbA1c levels are
greater than 8 percent with the ultimate goal being levels of less than 7 percent.The second clinical study, 991-068, evaluated the effects of Rezulin on insulin dose combined with
glycemic control. Rezulin not only improved glycemic control, but at the same time, had statistically
significant effects on insulin dose. Patients treated with 200 mg and 400 mg/day of Rezulin were
able to decrease their daily insulin doses by 41 and 58 percent respectively, compared to 14 percent
on placebo.A reduction in daily injections was also seen. Forty-one percent of patients on 400 mg/day
decreased the frequency of their insulin injections on average from three to one per day, while 19
percent of the group taking placebo decreased injection frequency on average from three to two
injections per day.Insulin injections were discontinued entirely in 15 percent of patients on 400 mg/day and seven
percent on 200 mg/day, compared to 1.5 percent on placebo.In general, Rezulin is well tolerated. Clinical studies have shown the overall incidence and types of
reactions to Rezulin to be comparable to placebo. The most common adverse events in placebo
controlled studies, reported with Rezulin at a frequency greater than 10 percent were infection (18
percent vs. 22 percent on placebo), headache (11 percent vs. 11 percent on placebo), and pain (10
percent vs. 14 percent on placebo). The incidence of withdrawals during clinical trials was similar
for patients treated with placebo or Rezulin (4%). Rezulin has only been shown to be effective in
the presence of insulin. Therefore, Rezulin should not be used in type I diabetes or for the treatment
of diabetic ketoacidosis. Rezulin should be used with caution in patients with moderate to severe
heart failure or liver disease.Management of type II diabetes should include diet control. Caloric restriction, weight loss and
exercise are essential for the proper treatment of the diabetic patient.Targets Insulin Resistance Directly
Insulin resistance is a condition in which the tissues of the body fail to respond normally to insulin.
Although normal levels of insulin are produced, the body is unable to use its own insulin to convert
food into energy. As a result, the bodies of people with insulin resistance begin secreting
abnormally high amounts of insulin to compensate for this defect. Eventually, however, their
systems can no longer properly stimulate glucose transport in muscle and fat and suppress hepatic
(liver) glucose production. Glucose that does not reach the cells remains in the blood stream and
blood sugar levels inevitably rise, leading to type II diabetes and other diseases. Over time,
excessive blood sugar levels can severely damage the heart, blood vessels, kidneys, eyes and
nerves.Rezulin is the first drug to work at the cellular level to improve insulin resistance directly --
enhancing the effects of circulating insulin, without causing the body to increase production of
insulin. Rezulin achieves these effects through direct stimulation of peripheral glucose uptake and
storage as well as through the inhibition of glucose production in the liver. Until now, other
therapies lowered blood glucose by increasing insulin production or decreasing hepatic glucose
output.Marketed by Parke-Davis
Rezulin 200 mg and 400 mg tablets are expected to be available to pharmacies nationwide in late
March. Information on this new treatment can be obtained by calling Parke-Davis at 800-223-0432.Rezulin was discovered by Sankyo Company, Ltd. of Japan and co-developed in the U.S. by
Parke-Davis and the Sankyo U.S.A. Corporation. Parke-Davis will co-promote Rezulin in the U.S.
with Sankyo/Parke-Davis, a joint venture that was announced in September.Parke-Davis, a division of Warner-Lambert Co., is devoted to discovering, developing,
manufacturing and marketing quality pharmaceutical products. Its central research focus is on heart
disease, diabetes, stroke, anti-infectives, central nervous system, cancer and women's healthcare.
Warner-Lambert is a worldwide company employing approximately 38,000 people, and along with
Parke-Davis is headquartered in Morris Plains, N.J.SOURCE Warner-Lambert Company
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