Prediction of the effect of atrasentan on renal and heart failure outcomes based on short-term changes in multiple risk markers.

ABSTRACT:

Background

A recent phase II clinical trial (Reducing Residual Albuminuria in Subjects with Diabetes and Nephropathy with AtRasentan trial and an identical trial in Japan (RADAR/JAPAN)) showed that the endothelin A receptor antagonist atrasentan lowers albuminuria, blood pressure, cholesterol, hemoglobin, and increases body weight in patients with type 2 diabetes and nephropathy. We previously developed an algorithm, the Parameter Response Efficacy (PRE) score, which translates short-term drug effects into predictions of long-term effects on clinical outcomes.

Design

We used the PRE score on data from the RADAR/JAPAN study to predict the effect of atrasentan on renal and heart failure outcomes.

Methods

We performed a post-hoc analysis of the RADAR/JAPAN randomized cli

SUBMITTER: Schievink B 

PROVIDER: S-EPMC7735387 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature