Review by Richard Lehman – 01/26/2016 – 8:51am

Data Request Number: 2015-0678 Please use this space to provide any comments, feedback or concerns (optional):

I think this can go through as it stands, but I question the need for an arbitrary 7% threshold for weight gain so as to create a binary model. The clinical question of greatest interest seems to me to lie in the relation between the total period of drug exposure and all degrees of weight gain and how both relate to cardiovascular events and all-cause mortality.

Recommendation for this data request: Approve