DaVita issued the following statement in response to news this week from Novo Nordisk, manufacturer of Ozempic®, a glucagon-like peptide 1 (GLP-1) receptor agonist indicated for type 2 diabetes, related to its FLOW study that sought to demonstrate that Ozempic delays progression of chronic kidney disease (CKD) and lowers the risk of kidney and cardiovascular mortality. The following statement can be attributed to Dr. Jeff Giullian, chief medical officer for DaVita Inc.
“We’ve been closely monitoring the developments related to GLP-1s, and are excited about the potential benefits this class of drugs could have on society and patients with kidney disease. Like much of the medical community, we’re eager to understand the results of the study and whether the results demonstrate improvements over the known effects of SGLT2 inhibitors on kidney disease or the previously announced effects of GLP-1s on cardiovascular mortality.
Although it is nearly impossible to draw any conclusions from the FLOW study at this point because the study results have yet to be released, based on the inclusion criteria for study participants, we believe there may be limited application of the FLOW study findings to the overall CKD patient population.
We will continue monitoring closely as further evidence becomes available to identify the potential benefit of GLP-1s to those afflicted with kidney disease. In the meantime, DaVita remains focused on providing exceptional patient care and advancing the practice of kidney care.”
Our understanding of the FLOW clinical trial is the following:
- Patients enrolled in the study were required to have Type 2 diabetes, been diagnosed with CKD, and following a standard of care including ACE inhibitors or ARBs. These patients also needed to demonstrate a requisite amount of proteinuria, i.e., protein in the urine. DaVita estimates that fewer than 10% of all current CKD patients would have this combination of factors.
- The trial sought to demonstrate benefits for the composite endpoint comprised of five separate endpoints: death from kidney disease; death from cardiovascular disease; sustained reduction in GFR by at least 50%; progression to stage 5 CKD; and initiation of chronic kidney replacement therapy. Findings on any single endpoint, or any combination thereof, could be sufficient to halt the trial. It is unknown, however, which endpoint(s) was positive so as to close the study and whether it was a cardiovascular endpoint, a kidney endpoint, or both.
Once released, the detailed results of the FLOW trial will identify which endpoint was proven. If it confirms prior evidence that GLP-1s reduce cardiovascular mortality, since approximately six times more CKD patients die of cardiovascular disease than progress to kidney replacement therapy, any similar findings in the FLOW study would be an additional positive in prolonging life through CKD progression for those taking the therapy.1 As it relates to CKD progression, if the study proves effective with respect to GFR, it will be interesting to note the efficacy relative to other drugs with similar proven effects such as SGLT2 inhibitors.
- Future trials and research will be required to determine whether any findings derived from the FLOW study could benefit a CKD population beyond those studied in the trial.
- Novo Nordisk’s has announced that the FLOW study will be released in the first half of 2024 and the SELECT study will be released on or around November 11, 2023.
