Ann: Trading Halt, page-26

Just to make things easier: Friday E posters from above link in previous post. It’s publicly available now anyway:

Info

Abstract:

PromarkerD is a biomarker-based blood test that predicts renal function decline in type 2 diabetes (T2D). This study examined the association between canagliflozin, an approved diabetes therapy with additional renal benefits, and change in PromarkerD score (Δ score) over a three-year period in T2D patients in the CANagliflozin cardioVascular Assessment Study (CANVAS).

PromarkerD scores were measured at baseline and Year 3 in 2,008 participants with a baseline eGFR ≥60 mL/min/1.73m². Protein biomarker concentrations (CD5L, ApoA4, IGFBP3) were combined with clinical data (age, serum HDL-cholesterol, eGFR) to provide PromarkerD scores (0 to 100%). Scores were categorised as low-, moderate- or high-risk as determined by pre-specified cut-offs. Generalized estimating equations were used to assess the effect of canagliflozin versus placebo on PromarkerD scores.

At baseline, the participants (mean age 62 years, 69% males, median diabetes duration 12 years) had a mean PromarkerD score of 10.1%, with 67% categorised low-risk, 14% moderate-risk and 19% high-risk for renal function decline. After accounting for the known acute drop in eGFR following canagliflozin initiation, there was a significant treatment by time interaction (p<0.001) whereby patients on canagliflozin had decreased mean PromarkerD scores from week 6 to year 3 (Δ score: -1.0% [95% CI: -1.9%, -0.1%]; p=0.038), while those on placebo increased over the three-year period (Δ score: 3.9% [2.5%, 5.3%]; p<0.001). When stratified by PromarkerD risk category, patients with high-risk scores at baseline who were randomised to canagliflozin had significantly lower scores at Year 3 (Δ score: -5.6% [-8.6%, -2.6%]; p<0.001), while those on placebo remained high (Δ score: 3.2% [-1.3%, 7.7%]; p=0.17)(Time*TRT p=0.002).

This post-hoc analysis of data from CANVAS showed that canagliflozin significantly lowered PromarkerD risk scores, with the effect greatest in those T2D patients who were classified at study entry as at high-risk of a subsequent decline in renal function.

Authors

Kirsten Peters
Proteomics International

Katrina Spilsbury
Proteomics International

Jialin Xu
Janssen Research & Development, LLC

Scott Bringans
Proteomics International

Timothy Davis
University of Western Australia

Norman Rosenthal
Janssen Research & Development, LLC

Michael K. Hansen
Janssen Research & Development, LLC

Richard Lipscombe
Proteomics International

GLTAH $