MOUNTAIN VIEW, CA--(Marketwired - March 25, 2014) - 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 Qsymia® (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 diabetes.
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
(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 mouth.
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.