WLA:is this a buy opp? Changes in NIH Diabetes Prevention Program Announced Today
PR Newswire, Friday, June 05, 1998 at 10:09
MORRIS PLAINS, N.J., June 5 /PRNewswire/ -- The Parke-Davis division of
Warner-Lambert Company (NYSE:WLA) announced today that it has been notified
by the National Institutes of Health (NIH) of its decision to discontinue the
troglitazone treatment arm of the Diabetes Prevention Program (DPP). The DPP
is a nationwide research study conducted by the National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK), a division of the NIH. The
objective of the DPP is to determine whether type 2 diabetes can be prevented
or delayed in people with impaired glucose tolerance (IGT), a possible
precursor to diabetes.
This action by NIH pertains to the experimental use of troglitazone in a
non-diabetic population. The NIH has informed Warner-Lambert that all
patients in the study taking troglitazone have been informed of this change.
However, it does not affect patients who take Rezulin (troglitazone) for the
treatment of type 2 diabetes. Rezulin is an effective and safe drug when used
as indicated for the treatment of type 2 diabetes. Patients currently taking
Rezulin for type 2 diabetes can continue to take this therapy with confidence.
The decision of the DPP's Data Safety Monitoring Board (DSMB) was the
result of one case of liver failure leading to transplantation in a
troglitazone-treated individual. The patient subsequently died, apparently
due to complications unrelated to the study or the medication. At the time of
transplant, this patient also was found to have a serious lesion and extensive
necrosis (localized death of living tissue) in the bowel, which appears to
have contributed to the cause of death. This necrosis may have been related
to a concurrent cytomegalovirus (CMV) infection. This bowel lesion was
potentially lethal and its cause, while undetermined, can not be attributed to
troglitazone or acute liver disease.
This complicated case, and the DSMB's decision with respect to the study,
does not change the benefit to risk relationship for Rezulin in patients with
type 2 diabetes. Recent changes in Rezulin labeling, which introduced new
liver monitoring guidelines, have proven effective. Since then, reported liver
events have steadily decreased. Parke-Davis began marketing Rezulin in March
1997 and has extensive post-marketing experience with the drug in nearly one
million patients.
There is a significant difference between the type 2 diabetes population
and those with IGT. IGT is not currently a recognized disease and is not
treated with medication. People with IGT may or may not develop type
2 diabetes. Conversely, Rezulin is indicated for the treatment of patients
with type 2 diabetes. When type 2 diabetes is left untreated, or when
treatments fail to control the disease, serious complications can arise,
including cardiovascular disease, blindness, kidney disease and central
nervous system disorders.
Parke-Davis, a division of Warner-Lambert Company, is devoted to
discovering, developing, manufacturing and marketing quality pharmaceutical
products. Its central research focus is on heart disease, diabetes,
infectious diseases, disorders of the central nervous system and women's
health care. Warner-Lambert is a worldwide company employing more than 40,000
people and, along with Parke-Davis, is headquartered in Morris Plains, New
Jersey.
SOURCE Warner-Lambert Company
-0- 06/05/98
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/CONTACT: Stephen Mock, 973-540-6696 - Media Relations; and George
Shields, 973-540-6916 or Jack Howarth, 973-540-4874 - Investor Relations, all
of Warner-Lambert/
Companies or Securities discussed in this article:
Symbol
Name
NYSE:WLA
Warner Lambert Co
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