There was a reduction in both the need for dialysis and progression to end-stage renal disease; finerenone was really well tolerated, stated Bertram Pitt, MD, professor of medicine emeritus, University of Michigan School of Medicine.
There was a reduction in both the need for dialysis and progression to end-stage renal disease. In addition, finerenone was really well tolerated, stated Bertram Pitt, MD, professor of medicine emeritus, Division of Cardiology, University of Michigan School of Medicine in Ann Arbor.
Can you explain the significance of your results on the renal end point in FIGARO-DKD?
We had a secondary outcome, which was renal progression of disease, and the primary outcome was a reduction in eGFR [estimated glomerular filtration rate] by 40% that was sustained. This trended positive, but it wasn't significant. We picked that end point because the FDA and EMA [European Medicines Agency], at one point, thought that was a very good renal end point. Subsequently, we've learned it's not very good, it was sensitive, and the more sensitive renal end point is a 57% reduction in eGFR, and that was significantly reduced.
Most importantly, we reduced the need for dialysis, we reduce the progression to end-stage renal disease. That is really important, that we save people dialysis and that we showed that. Now, finerenone is a nonsteroidal mineralcorticoid receptor antagonist [MRA]. And as a mineralcorticoid receptor antagonist, you would expect hyperkalemia. We got hyperkalemia—twice as much on finerenone as placebo. But what was really amazing to me is this was really well tolerated. Only 1.2% of the patients on finerenone had to stop because of hyperkalemia vs 0.4% on the control group. So that's less than 1% had to stop.
We know from all of our experience with the steroidal MRAs, spironolactone and eplerenone, that they're really poorly tolerated. In fact, there's a recent paper ... in JACC [Journal of the American College of Cardiology], from the Get With the Guidelines: Heart Failure registry [from the American Heart Association] on over 100,000 patients,1 where they looked at the use of the steroidal MRAs in people with heart failure and a reduced ejection fraction by that baseline renal function. And the use was pretty dismal, especially when you got to an eGFR less than 45%. And here we have a drug we've shown is effective in reducing heart failure, prevents end-stage renal disease, and is well tolerated.
So we think this is a great success for our patients. And when you look at the FIDELIO trial and FIGARO together, we have over 13,000 patients. And we can pretty confidently say that this drug works in people with diabetes across the spectrum of cardiovascular disease.
1. Patel RB, Fonarow GC, Greene SJ, et al. Kidney function and outcomes in patients hospitalized with heart failure. J Am Coll Cardiol. 2021;78(4):330-343. doi:10.1016/j.jacc.2021.05.002