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VIVUS reports data from Qsymia analysis showing less risk of MACE.

VIVUS has reported data from a retrospective analysis evaluating the cardiovascular safety of Qsymia capsules CIV. Results show that the risk of major adverse cardiovascular events, or MACE, trended lower in patients taking Qsymia compared with similar patients who were not taking Qsymia. The results were presented at the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. The study was a retrospective cohort analysis conducted in MarketScan Commercial Claims and Medicare Supplemental data. The study evaluated MACE rates during periods of exposure to Qsymia, generic phentermine, or PHEN, and topiramate, or TPM, combinations and phentermine or topiramate alone, and compared each of these to MACE rates during unexposed periods in former users of these drugs. MACE was defined as a composite of hospitalization for acute myocardial infarction, stroke, or in-hospital cardiovascular-related death as determined via discharge status and ICD-9-CM diagnoses. Propensity scores were calculated to adjust for differences in cardiovascular risk factors among the cohorts. Propensity score-adjusted analyses showed that MACE risk trended lower with current Qsymia and PHEN/TPM use compared with the unexposed cohort. Compared to the unexposed cohort, MACE risk was also lower with current PHEN use and higher with current TPM use. The study authors note that the small number of events that occurred during exposure to Qsymia and PHEN/TPM produced considerable statistical uncertainty in the analysis of these cohorts.

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Publication:The Fly
Date:Aug 27, 2018
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