An expert in chronic kidney disease (CKD) discusses the importance of showing data at the 3-year mark for the DAPA-CKD study, released at AMCP.
Robert Toto, MD: What is the importance of showing the data of the savings at the 3-year mark when the model was carried out for 4 years? It’s important to show data all along the way. The average time on the study was less than 3 years because the DAPA-CKD study was stopped early by the data monitoring committee for overwhelming efficacy. The data monitoring committee monitors the safety of clinical trials, and if they see that a drug is saving lives, they recommend stopping the study. It would be unethical to continue a study if you know that you have a life-saving treatment. Adversely, if a drug is causing harm, then the data monitoring committee stops the study for that reason. The importance of looking at this at the 3-year mark is that if you look at the kidney function in patients with chronic kidney disease over time, there’s a lot of variability in the rate in which patients decline, even with patients who have the same disease with similar blood pressures. When you take a 3-year time frame, and you look at that in and of itself as a valued marker, that 3-year time frame would encompass a lot of events that you would see in the study. It would encompass a lot of the costs related to the care of patients within that 3-year time frame.
Transcript edited for clarity.