-Retrospective analysis presented at the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management-
CAMPBELL, Calif., Aug. 27, 2018 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company"))), a biopharmaceutical company, has reported encouraging data from a retrospective analysis evaluating the cardiovascular safety of Qsymia® (phentermine and topiramate extended-release) capsules CIV. Results show that the risk of major adverse cardiovascular events (MACE) trended lower in patients taking Qsymia compared with similar patients who were not taking Qsymia. The results were presented yesterday in a poster at the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, which took place in Prague, Czech Republic, August 22-26.
"The results of this retrospective analysis add to the body of data demonstrating that Qsymia does not increase the risk of MACE," said John Amos, Chief Executive Officer at VIVUS. "We continue to believe that Qsymia provides patients with significant benefits as a platform for managing body mass index, and our ongoing dialogue with the U.S. Food and Drug Administration includes a label modification request to allow for the safe and effective short-term utilization of Qsymia while significantly reducing or eliminating the requirement for conducting a cardiovascular outcomes study."
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; 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.
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