VIVUS announces results from Qsymia cordiovascular safety study to be published
VIVUS announced that results from a new study evaluating the cardiovascular safety of Qsymia capsules CIV will be published in the February 1 issue of The Journal of Clinical Endocrinology & Metabolism and are currently available online. This retrospective study, conducted using medical claims databases, was prompted by the observation in clinical trials that participants taking Qsymia had higher heart rates than those taking placebo. The new findings indicate that the combined risk of major adverse cardiovascular events, or MACE, was not elevated in patients currently taking Qsymia, or concurrently taking both phentermine and topiramate, compared with former users of these medications. The number of MACE events was too few to draw a definitive conclusion from the data. Results from the study were previously presented in a poster at the International Conference on Pharmacoepidemiology & Therapeutic Risk Management in August 2018. More than 500,000 patients were included in this retrospective study, which evaluated risk of MACE among current users of Qsymia, phentermine and topiramate in combination, phentermine and topiramate, compared to the risk among patients who were former users who had discontinued these medications. MACE was defined as hospitalization for acute myocardial infarction or stroke or in-hospital cardiovascular-related death, as determined via discharge status and ICD-9-CM diagnoses.