The data was surprisingly positive for AHP:
Wyeth-Ayerst Provides Background Information on Redux And Pondimin and Current Redux Clinical Studies
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And Pondimin and Current Redux Clinical Studies
/ADVANCE FOR RELEASE AT 5:00 P.M. EST TODAY, MARCH 31/
/ADVANCE/ ATLANTA, March 31 /PRNewswire/ -- Today's release of clinical
data by Georgetown University and Wyeth-Ayerst Laboratories comparing
echocardiograms of patients who took Redux(TM) (dexfenfluramine hydrochloride
capsules) or placebo represents the first systematic step in investigating the
possible relationship between Redux and Pondimin(R) (fenfluramine
hydrochloride tablets) and heart valve abnormalities.
HISTORICAL BACKGROUND
On September 15, 1997, Wyeth-Ayerst Laboratories voluntarily withdrew from
the market two prescription drugs for the treatment of obesity, Redux and
Pondimin. This step was taken after FDA presented to Wyeth new and
preliminary information about possible heart valve abnormalities in patients
using these products.
Redux and Pondimin were indicated for the treatment of obesity as part of
a broader weight management program, including diet. Left untreated, obesity
can lead to a host of life-threatening health complications, including heart
disease, cancer, and diabetes.
The company's goal since the withdrawal of the drugs has been to try to
answer the scientific and clinical questions concerning Redux and Pondimin.
In September 1997, Wyeth-Ayerst Laboratories announced the formation of an
Expert Panel selected for its experience in heart disease, epidemiology,
cardiovascular pathology, and echocardiography. The panel is chaired by Dr.
Arthur Weyman, Professor of Medicine and Director of the Cardiac Ultrasound
Laboratory at Harvard Medical School. The panel is providing advice about
medical and scientific issues surrounding Redux and Pondimin, including close
consultation on the study presented at the annual meeting of the American
College of Cardiology (ACC).
STUDY RESULTS
Overview
Results of the clinical study presented at the ACC show that there was no
statistically significant increase in the prevalence of clinically relevant
heart valve regurgitation following Redux treatment for two to three months
compared to placebo. The data were presented by the study's principal
investigator, Dr. Neil J. Weissman, assistant professor of medicine, division
of cardiology and director of clinical echocardiography, Georgetown University
Medical Center.
The randomized, double-blinded, multi-center study involved 1,072 patients
who had been part of a trial of a new sustained release form of Redux which
was never marketed. Administration of the drugs was discontinued following
withdrawal of Redux and Pondimin from the market. At that time, the study was
modified to include systematic echocardiographic evaluations, subject to
rigorous quality controls, of the three groups of patients -- those taking
Redux, sustained-release dexfenfluramine, or placebo.
Patients in the study were representative of the population for whom Redux
was indicated. In order to be included in the study, patients could not have
used Redux or any prescription or over-the-counter diet drugs within six
months prior to the start of the study. The three groups were demographically
similar.
The echocardiograms were interpreted by cardiologists in a central
laboratory who did not know whether patients had taken Redux, sustained-
release dexfenfluramine or placebo. The study looked at the FDA's previously
reported case definitions of valvular abnormalities: mild or greater aortic
regurgitation and moderate or greater mitral regurgitation.
Duration of drug use in this study was generally representative of Redux
use by patients when the drug was marketed:
-- The Redux patients in this study were treated for a median duration of
77 days.
-- Market research indicates that, when the drug was on the market,
76 percent of Redux patients used the drug for 60 days or less and
86 percent for 90 days or less.
Principal Findings of the Redux Clinical Study
This study found that there was no statistically significant increase in
the prevalence of clinically relevant heart valve regurgitation following
Redux usage for two to three months compared to placebo.
-- Mild or greater aortic regurgitation occurred in 5.0 percent of Redux,
5.8 percent of sustained-release dexfenfluramine, and 3.6 percent of
the placebo-treated patients.
-- Moderate or greater mitral regurgitation occurred in 1.7 percent,
1.8 percent, and 1.2 percent, respectively.
-- Mild or greater aortic, moderate or greater mitral regurgitation, or
both occurred in 6.5 percent, 7.3 percent, and 4.5 percent,
respectively. None of these differences between drug and placebo
groups were statistically significant.
Other Study Findings
The study yielded additional findings. For example, when all degrees of
regurgitation (physiologic, mild, moderate, severe) were compared, there was a
higher prevalence of mitral regurgitation in treated than in placebo patients.
This was due to a slightly increased prevalence of physiologic or mild mitral
regurgitation -- generally considered not to be clinically significant -- in
patients treated with Redux or sustained-release dexfenfluramine, compared to
placebo (59 percent and 60 percent vs. 53 percent).
In addition to regurgitation, mobility of the mitral valve leaflets was
assessed. Anterior mitral leaflet mobility was similar across the three
treatment groups. Decreased posterior mitral leaflet mobility of any degree
(minimal, moderate and severe) occurred more frequently in treated than in
placebo patients (Redux 7.0 percent, sustained-release dexfenfluramine 9.5
percent, and placebo 4.3 percent). Moderate or severe restricted mobility of
the posterior mitral leaflet was rarely seen (Redux 2.0 percent, sustained-
release dexfenfluramine 1.5 percent, placebo 0.3 percent).
The study also found no differences among treatment groups for tricuspid
or pulmonary regurgitation, aortic or tricuspid leaflet morphology, estimated
pulmonary artery pressure, or serious cardiovascular adverse events.
Conclusion
Wyeth-Ayerst agrees with the study's principal author, Dr. Neil Weissman,
who concluded that:
-- The study results are reassuring for patients who have taken Redux for
up to three months, which was the typical use of the drug when it was
on the market.
-- The study results should not preclude appropriate evaluation of
patients who took diet drugs and display signs or symptoms of heart
valve disease.
-- Further scientific investigation is needed for other diet drugs, diet
drug combination use, and longer duration of use.
Rigorous, scientific studies exploring these matters are ongoing. Results
are expected later this year.
Wyeth-Ayerst Laboratories is a major research-oriented pharmaceutical
company with leading products in the areas of women's health care,
cardiovascular, and metabolic disease therapies, central nervous system drugs,
anti-inflammatory agents, vaccines, and generic pharmaceuticals. American
Home Products Corporation (NYSE: AHP) is one of the world's largest research-
based pharmaceutical and health care products companies. It is a leader in
the discovery, development, manufacturing, and marketing of prescription drugs
and over-the-counter medications. It is also a global leader in vaccines,
biotechnology, agricultural products, and animal health care.
NOTE: This release and the press release jointly issued under embargo by
Wyeth-Ayerst and Georgetown contain information which may be considered
material from a financial perspective for a publicly-traded entity.
Therefore, any trading in securities of that entity or dissemination of this
information by a recipient of this release prior to its general release (at
the embargo time) may be unlawful.
SOURCE Wyeth-Ayerst Laboratories
-0- 03/31/98/1700
/CONTACT: Doug Petkus of Wyeth-Ayerst at ACC, 404-222-3664 or Audrey
Ashby, 610-971-5823/
(AHP)
CO: Wyeth-Ayerst Laboratories; Georgetown University Medical Center; American
Home Products Corporation
ST: Georgia, District of Columbia
IN: MTC HEA
SU:
MS
-- DCTU034 --
6666 03/31/98 13:32 EST prnewswire.com |
