New Guidelines From American Association of Clinical Endocrinologists
Recommend Medical Treatment of Obesity
First Guidelines to Incorporate Anti-Obesity Medications as Recommended
Treatment for Cardiometabolic Diseases
MOUNTAIN VIEW, Calif., May 1, 2013 (GLOBE NEWSWIRE) -- A new comprehensive
treatment algorithm for diabetes from the American Association of Clinical
Endocrinologists (AACE) is the first to recommend active obesity management,
which includes lifestyle modification and, if appropriate, the use of
FDA-approved anti-obesity medications, as first-line therapy in the management
of chronic cardiometabolic diseases, including prediabetes, diabetes,
dyslipidemia and hypertension.
"As a respected and influential institution in the field of endocrinology, it
is encouraging to see the AACE has addressed the critical role of effective
medical obesity treatments in the management of chronic cardiometabolic
disease," said Peter Tam, president of VIVUS, Inc. (Nasdaq:VVUS)
"Endocrinologists are the thought leaders in weight management and metabolic
diseases, and we believe that healthcare providers, including primary care
physicians, along with payors and public policy makers, will recognize the
significance of these new guidelines."
The AACE Comprehensive Diabetes Management Algorithm 2013 will be presented
and discussed during the AACE 22nd Annual Scientific and Clinical Congress,
May 1 – 5, 2013 in Phoenix, AZ. The guidelines are available online and in the
March/April 2013 issue of Endocrine Practice.
Qsymia^® (phentermine and topiramate extended-release) capsules CIV is
approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet
and increased physical activity for chronic weight management in adults with
an initial body mass index (BMI) of 30 kg/m^2 or greater (obese) or 27 kg/m^2
or greater (overweight) in the presence of at least one weight-related medical
condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been
established. The safety and effectiveness of Qsymia in combination with other
products intended for weight loss, including prescription and over-the-counter
drugs, and herbal preparations, have not been established.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV is
contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism;
in patients receiving treatment or within 14 days following treatment with
monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to
sympathomimetic amines, topiramate, or any of the inactive ingredients in
Qsymia can cause fetal harm. Females of reproductive potential should have a
negative pregnancy test before treatment and monthly thereafter and use
effective contraception consistently during Qsymia therapy. If a patient
becomes pregnant while taking Qsymia, treatment should be discontinued
immediately, and the patient should be informed of the potential hazard to the
The most commonly observed side effects in controlled clinical studies, 5% or
greater and at least 1.5 times placebo, include paraesthesia, dizziness,
dysgeusia, insomnia, constipation, and dry mouth.
VIVUS is a biopharmaceutical company commercializing and developing
innovative, next-generation therapies to address unmet needs in obesity, sleep
apnea, diabetes and sexual health. For more information about the company,
please visit www.vivus.com.
Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995 and are
subject to risks, uncertainties and other factors, including risks and
uncertainties related to whether healthcare providers, payors and public
policy makers will recognize the significance of the new AACE guidelines;
risks and uncertainties related to the implementation of the modified REMS
program and our ability to certify and sell Qsymia through certified retail
pharmacies in the anticipated time, or at all; and risks and uncertainties
related to our ability to develop and deploy effective educational programs
and direct-to-consumer advertising that along with increased access to Qsymia
and ongoing improvements in reimbursement will result in the accelerated
adoption of Qsymia. These risks and uncertainties could cause actual results
to differ materially from those referred to in these forward-looking
statements. The reader is cautioned not to rely on these forward-looking
statements. Investors should read the risk factors set forth in VIVUS's Form
10-K for the year ending December 31, 2012, and periodic reports filed with
the Securities and Exchange Commission. VIVUS does not undertake an obligation
to update or revise any forward-looking statements.
CONTACT: VIVUS, Inc.
Timothy E. Morris
Chief Financial Officer
Dana B. Shinbaum
The Trout Group
Morrow & Co., LLC
Joseph J. Mills
Joele Frank, Wilkinson Brimmer Katcher
Matthew Sherman | Jennifer Beugelmans
firstname.lastname@example.org | email@example.com
212-235-2665 | 212-895-8692
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