Session 1: Non-inferiority (Deluca)

Learning Objectives:

Residents will be able to: 
  •  Identify methodological issues and difficulties in the design and interpretation of non-inferiority trials.
  •  Systematically critique a non-inferiority study.

Case:

You are seeing a 67-year-old man with HTN and chronic atrial fibrillation who is s/p stroke three months ago when he presented with left sided weakness, which has now completely resolved. Since that admission he has been hospitalized once with a supratherapeutic INR and has also been sub-therapeutic on several visits following dose adjustments, and today it is 1.4. Your preceptor suggests that you start him on edoxaban. However, you are not sure whether edoxaban is as effective as warfarin in preventing recurrent stroke, and are not even sure that it is on the market.  You are also alarmed that your preceptor is drinking coffee from a LixianaTM thermos. You decide to look in the literature yourself regarding the relative effectiveness of warfarin and edoxaban in preventing stroke in patients with atrial fibrillation.


Required Readings: 

Suggested Readings :