FIDELITY Pooled Analysis Results
Rajiv Agarwal, MD, MS: Before I give you the results, I can tell you that when you look at the aggregated data, it is not your usual patient that you might see in the clinic. This is an incredibly well treated population of a high risk group of patients. They all have type 2 diabetes and chronic kidney disease [CKD], with an average age of 65. The median duration of diabetes was 15 years, glycated hemoglobin was 7.7%, blood pressure was 137/76 mm Hg, and 46% of patients had a history of cardiovascular disease. Heart failure, unfortunate, was 7.7%. Remember we have excluded people with symptomatic HFrEF [heart failure with reduced ejection fraction] … Statins were used in 72% of patients, and GLP-1 and SGLT2 inhibitors were used in approximately 7% of patients. We are looking for an advantage in addition to this group of ideally treated patients, not a group of poorly treated patients.
If we were to look at a group of poorly treated patients, I would expect the benefit to be even greater. Imagine you have a lot of albuminuria, a lot of heart failure, a lot of blood pressure: you might see an even bigger effect. Forty percent of patients in the FIDELITY scan had eGFR [estimated glomerular filtration rate] over 60. This now means that if you are just looking at eGFR to diagnose chronic kidney disease, you need to change your practice. You will miss 40% of patients who are otherwise eligible for finerenone because you have never checked for albuminuria. If they have albuminuria, they are eligible to participate in the trial, and 40% of patients were in the eGFR zone of silence. Their creatinine is not high, and you are not going to detect them as having CKD unless you look at the urine and determine the UACR. [urine albumin-to-creatinine ratio].
The average eGFR in this population is actually 57.6. This is a very well preserved eGFR, but we have a broad characterization of the patients. A third of the patients have an eGFR below 45. A quarter of the patients have an eGFR between 45 and 60. You have a very wide range of patients who took part in this study, and what we’re seeing is a reduction in mortality. cardiovascular, non-fatal MI [myocardial infarction], non-fatal stroke and hospitalization for heart failure by 14%. The P the value is 0.0018, and the NNT [number needed to treat] after 3 years is 46. If you look at the kidney endpoint, which is the 57% composite, we have a 23% relative risk reduction with a P value of 0.0002 and NNT after 3 years is 60. These were very respectable figures for these events, as the FIDELITY analysis shows. It adds to a growing body of data showing that you may indeed impact cardiovascular and renal failure outcomes across a wide range of eGFR and albuminuria to prevent both cardiovascular disease and risk. kidney failure.
In other words, it’s never too early to start. If you have albuminuria, you can start. You can start as late as an eGFR of 25 or more, as long as the potassium is 5 mmol / L or less. You can treat a very large patient population. For the first time, we demonstrate that it can protect the heart and kidneys together in this composite analysis.
Transcription edited for clarity.