Results from REWIND, which have been 7 months in the making, were presented at the ADA 2019 conference and simultaneously published in The Lancet. In somewhat of a disappointing fashion, REWIND data demonstrated a 12% RRR in 3P-MACE (p=0.026) with nonstatistically significant benefit in both the primary (HR=0.87) and secondary prevention (HR=0.87) cohorts. However, as predicted by the FENIX team (but not Matt), the REWIND results were more in-line with Novo’s LEADER than SUSTAIN 6. Below, FENIX provides thoughts on the REWIND results as well as a favors/disfavors analysis.

With the upcoming Trulicity CVOT (REWIND) presentation at ADA 2019 (Sunday, June 9 at 4:30-6:30 pm PT), and in the context of the other GLP-1RA CVOTs (particularly LEADER, SUSTAIN 6, PIONEER 6, and HARMONY), the FENIX team is decidedly split on how positive the REWIND results will be. Below, FENIX presents Matt’s bold prediction for a hit on all-cause mortality vs. the team’s more moderate consensus of a LEADER-like ~13% RRR with a potential miss in the primary prevention cohort.

In advance of ADA 2019 beginning June 7, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at the AACE 2019 conference. In the first installment, FENIX analyzes GLP-1RA promotional materials, to be followed by a separate analysis on SGLT2i, insulin (+GLP-1RA/insulin FRC), and diabetes devices. The GLP-1RA FENIX analysis covers Ozempic, Trulicity, Bydureon, and Victoza.