Newly Published Review Article Summarizes Cardiovascular Benefit-Risk Profile
MOUNTAIN VIEW, CA -- (Marketwired) -- 03/25/14 -- VIVUS, Inc.
(NASDAQ: VVUS) today announced that a review article has been
published online in the Journal of Hypertension, the official
publication of the International Society of Hypertension and the
European Society of Hypertension, summarizing the cardiovascular
benefit-risk profile of QsymiaÂ® (phentermine and topiramate
extended-release) capsules CIV. The data suggest that Qsymia can be a
safe and effective weight loss option for overweight/obese patients
with cardiovascular risk factors such as hypertension or type 2
The article examined pooled data of patients from two one-year
studies of Qsymia (EQUIP and CONQUER) and a two-year cohort of the
SEQUEL extension study. The significant and sustained weight loss
achieved by patients receiving Qsymia at recommended dose
(7.5mg/46mg) and top dose (15mg/92mg) was associated with significant
reductions in blood pressure. Heart rate was increased (1.6 bpm) in
patients receiving Qsymia top dose; however, rate pressure product
was decreased in all treatment arms, with no difference observed
between Qsymia and placebo. Due to the decrease in blood pressure and
the decrease in rate pressure product, heart rate changes were not
associated with an increase in myocardial oxygen demand over one or
two years of treatment.
Within the one-year safety cohort from Qsymia clinical trials, 14.6%
of patients were in a high cardiovascular risk category, 65.6% had
moderate cardiovascular risk, and 19.8% were considered to have low
cardiovascular risk (based on a modified Adult Treatment Panel (ATP)
III criteria). Major adverse cardiac events (MACE) composite
endpoints had a hazard ratio <1.0 for Qsymia versus placebo, but
due to a wide confidence interval, a larger sample is required to
make further conclusions. Available data from this analysis do not
indicate any increased cardiovascular risk associated with Qsymia.
About the Study
Authors: Jens Jordan, Arne Astrup, Stefan Engeli, Krzysztof
Narkiewicz, Wesley W. Day, Nick Finer
Title: "Cardiovascular Effects of Phentermine and Topiramate - a New
Drug Combination for the Treatment of Obesity"
Journal of Hypertension 2014, doi: 10.1097/HJH.0000000000000145
Qsymia 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/m2 or greater (obese) or 27 kg/m2 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
QsymiaÂ® (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.
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 fetus.
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
VIVUS is a biopharmaceutical company commercializing and developing
innovative, next-generation therapies to address unmet needs in
obesity 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.
These statements may be identified by the use of forward-looking
words such as "anticipate," "believe," "forecast," "estimate,"
"expect," "intend," "likely," "may," "plan," "potential," "predict,"
"opportunity" and "should," among others. There are a number of
factors that could cause actual events to differ materially from
those indicated by such forward-looking statements. VIVUS does not
undertake an obligation to update or revise any forward-looking
statements. Investors should read the risk factors set forth in the
VIVUS Form 10-K for the year ending December 31, 2013, and periodic
reports filed with the Securities and Exchange Commission.
Dana B. Shinbaum
Corporate Development & Investor Relations
The Trout Group
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