Daily Archives: April 12, 2016

Case 6 “Surrogate Markers”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Now let’s take a look at the sixth case, surrogate cardiovascular markers. The brand examples I share here are Advicor, which was a combination statin and niacin for the reduction of cholesterol and other related lipid components. In addition, Enkaid was a class 1-C antiarrhythmic. Now, in the case of both Advicor and Enkaid, we were able to promote that they reduced surrogate markers of cardiovascular disease, but not necessarily reducing the end results of those diseases. Let me explain. Advicor could be shown to reduce total cholesterol, reduce triglycerides, and reduce LDL cholesterol, as well as increasing the HDL. […]