Abstract | AIMS: MATERIALS AND METHODS: Among participants from VERTIS CV, a trial of patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease randomized to ertugliflozin versus placebo, Cox proportional hazards regression models were used to evaluate the percentage mediation of ertugliflozin efficacy on the first HHF and kidney composite outcome in 26 potential mediators. Time-dependent approaches were used to evaluate associations between early (change from baseline to the first post-baseline measurement) and average (weighted average of change from baseline using all post-baseline measurements) changes in covariates with clinical outcomes. RESULTS: CONCLUSIONS: In these analyses from the VERTIS CV trial, markers of volume status and haemoconcentration and/or haematopoiesis were the strongest mediators of the effect of ertugliflozin on reducing risk of HHF and composite kidney outcomes in the early and average change periods. CLINICALTRIALS: GOV IDENTIFIER: NCT01986881.
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Authors | Matthew W Segar, Ahmed A Kolkailah, Robert Frederich, Annpey Pong, Christopher P Cannon, Francesco Cosentino, Samuel Dagogo-Jack, Darren K McGuire, Richard E Pratley, Chih-Chin Liu, Mario Maldonado, Jie Liu, Nilo B Cater, Ambarish Pandey, David Z I Cherney |
Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 24
Issue 9
Pg. 1829-1839
(09 2022)
ISSN: 1463-1326 [Electronic] England |
PMID | 35603908
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, N.I.H., Extramural)
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Copyright | © 2022 Pfizer Inc. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. |
Chemical References |
- Biomarkers
- Bridged Bicyclo Compounds, Heterocyclic
- Serum Albumin
- Uric Acid
- ertugliflozin
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Topics |
- Biomarkers
- Bridged Bicyclo Compounds, Heterocyclic
- Diabetes Mellitus, Type 2
(complications, drug therapy)
- Double-Blind Method
- Heart Failure
(prevention & control)
- Humans
- Kidney
- Serum Albumin
- Uric Acid
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