Can Vivus Get Away Without Outcomes Study Of Obesity Drug Qsymia?
Fixed-dose combination of phentermine and topiramate is FDA-approved for chronic, long-term use, but the average duration in the real world is only about 2.1 months, which is reassuring for Qsymia’s cardiovascular safety, according to a new retrospective claims study.
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Claims that Vivus' obesity drug helps patients lose weight faster than diet and exercise alone are false and misleading because the clinical studies were not designed to evaluate the rate of weight loss over time, Office of Prescription Drug Promotion says in untitled letter; Vivus says it is finalizing revisions to its promotions.
Full results from a large cardiovascular outcomes study with Belviq show the Eisai/Arena obesity drug was not associated with higher such risk versus placebo, but neither did it show benefits in reducing major CV events, leaving uncertainty over its increased uptake amid lingering issues around diabetes and valvulopathy risks.