DENVER, Oct. 12,
2023 /PRNewswire/ -- 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.
About DaVita Inc.
DaVita (NYSE: DVA) is a health care provider focused on
transforming care delivery to improve quality of life for patients
globally. The company is one of the largest providers of kidney
care services in the U.S. and has been a leader in clinical quality
and innovation for more than 20 years. DaVita cares for patients at
every stage and setting along their kidney health journey—from
slowing the progression of kidney disease to helping to support
transplantation, from acute hospital care to dialysis at home. As
of June 30, 2023, DaVita served approximately 201,000 patients
at 2,703 outpatient dialysis centers in the United
States. The company also operated 353 outpatient dialysis centers
in 11 other countries worldwide. DaVita has reduced
hospitalizations, improved mortality, and worked collaboratively to
propel the kidney care industry to adopt an equitable and
high-quality standard of care for all patients, everywhere. To
learn more, visit DaVita.com/About.
Information Concerning the FLOW Study
Statements about
the FLOW study are based on publicly available reports from third
parties. We have not independently verified the accuracy of this
information and such information may be subject to change without
notice. These statements involve risks and uncertainties and are
subject to change based on various factors, including those
discussed under Forward Looking Statements.
Forward Looking Statements
Certain statements in this
press release are forward-looking statements that are subject to
risks and uncertainties. All statements in this release, other than
statements of historical fact, are forward-looking statements.
These forward-looking statements could include, among other things,
statements about the results of current and future third party
clinical trials; the proportion of the CKD population to whom
results of the FLOW trial or other clinical trials may apply; and
the potential benefits of GLP-1s on individuals with kidney
disease, including the potential impacts of such drugs on the
development and progression of kidney disease among patients
diagnosed with CKD, the onset of dialysis or kidney transplant, and
cardiovascular or kidney-related mortality among patients diagnosed
with type 2 diabetes and CKD. These forward-looking statements
are based on DaVita's current expectations and are based solely on
information available as of the date of this press release. DaVita
disclaims any obligation to update or revise any forward-looking
statement contained in this press release, whether as a result of
changed circumstances, new information, future events or otherwise,
except as may be otherwise required by law. Actual future events
and results could differ materially from any forward-looking
statements due to numerous factors that involve substantial known
and unknown risks and uncertainties. These risks and uncertainties
include, among other things, changes in pharmaceutical practice
patterns, including in response to the introduction of new drugs,
treatments or technologies; continued increased competition from
dialysis providers and others, and other potential marketplace
changes, including any decline in the rate of growth of the ESKD
patient population, higher mortality rates for dialysis patients or
other reductions in demand for dialysis treatments, whether due to
the development of innovative technologies, treatments or
otherwise; the impact of marketplace conditions on DaVita's
revenues and non-acquired growth, treatment volumes, and the CKD
population and DaVita's patient population, including on the
mortality of these patients; and the other risk factors, trends and
uncertainties set forth in our Annual Report on Form 10-K for the
year ended December 31, 2022 and
Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, and the risks and uncertainties
discussed in any subsequent reports that we file or furnish with
the U.S. Securities and Exchange Commission from time to time.
CONTACTS
Newsroom@davita.com
IR@davita.com
- Dalrymple, L.S., Katz, R., Kestenbaum, B. et
al. Chronic Kidney Disease and the Risk of End-Stage Renal
Disease versus Death. J GEN INTERN MED 26, 379–385
(2011). https://doi.org/10.1007/s11606-010-1511-x
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SOURCE DaVita