Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus: Lessons Learned and Future Directions.

Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus: Lessons Learned and Future Directions. Circulation. 2020 Jan 29;: Authors: Sharma A, Pagidipati NJ, Califf RM, McGuire DK, Green JB, Demets D, George JT, Gerstein HC, Hobbs T, Holman RR, Lawson FC, Leiter LA, Pfeffer MA, Reusch J, Riesmeyer JS, Roe MT, Rosenberg Y, Temple R, Wiviott SD, McMurray JJV, Granger CB Abstract Responding to concerns about the potential for increased risk of adverse cardiovascular (CV) outcomes, specifically myocardial infarction, associated with certain glucose-lowering therapies, the U.S. Food and Drug Administration and the Committee for Medicinal Products for Human Use of the European Medicines Agency issued guidance to the pharmaceutical industry in 2008. Glucose-lowering therapies were primarily granted regulatory approval from smaller studies that have demonstrated reductions in glycated hemoglobin concentration. Such studies were overall underpowered and of insufficient duration to show any effect on CV outcomes. The 2008 guidance aimed to ensure CV safety of new glucose-lowering therapies to treat patients with type 2 diabetes mellitus. This resulted in a plethora of new CV outcome trials, most designed primarily as placebo-controlled noninferiority trials, but with many also powered for superiority. Several of these outcome trials demonstrated CV benefits of the newer...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research