Ozempic Cuts Risk of
Chronic Kidney Disease Complications, Study Finds
A major clinical trial showed
such promising results that the drug’s maker halted it early.
Semaglutide, the compound in the blockbuster drugs Ozempic
and Wegovy, dramatically reduced the risk of kidney complications,
heart issues and death in people with Type 2 diabetes and chronic kidney disease
in a major clinical trial, the results of which were published on Friday. The findings
could transform how doctors treat some of the sickest patients with chronic kidney
disease, which affects more than one in seven adults in the United States but has
no cure.
“Those
of us who really care about kidney patients spent our whole careers wanting something
better,” said Dr. Katherine Tuttle, a professor of medicine
at the University of Washington School of Medicine and an author of the study. “And
this is as good as it gets.” The research was presented at a European Renal Association
meeting in Stockholm on Friday and simultaneously published in The New England
Journal of Medicine.
The
trial, funded by Ozempic maker Novo Nordisk, was so successful that the company
stopped it early. Dr. Martin Holst Lange, Novo Nordisk’s
executive vice president of development, said that the company would ask the Food
and Drug Administration to update Ozempic’s label to say it can also be used to
reduce the progression of chronic kidney disease or complications in people with
Type 2 diabetes.
Diabetes
is a leading cause of chronic kidney disease, which occurs when the kidneys don’t
function as well as they should. In advanced stages, the kidneys are so damaged
that they cannot properly filter blood. This can cause fluid and waste to build
up in the blood, which can exacerbate high blood pressure and raise the risk of
heart disease and stroke, said Dr. Subramaniam Pennathur, the chief of the nephrology division at Michigan
Medicine.
The
study included 3,533 people with kidney disease and Type 2 diabetes, about half
of whom took a weekly injection of semaglutide, and half
of whom took a weekly placebo shot.
Researchers
followed up with participants after a median period of around three and a half years
and found that those who took semaglutide had a 24 percent
lower likelihood of having a major kidney disease event, like losing at least half
of their kidney function, or needing dialysis or a kidney transplant. There were
331 such events among the semaglutide group, compared
with 410 in the placebo group.
People
who received semaglutide were much less likely to die
from cardiovascular issues, or from any cause at all, and had slower rates of kidney
decline.
Kidney
damage often occurs gradually, and people typically do not show symptoms until the
disease is in advanced stages. Doctors try to slow the decline of kidney function
with existing medications and lifestyle modifications, said Dr.
Melanie Hoenig, a nephrologist at Beth Israel Deaconess Medical Center who was not involved with the study. But even with treatment,
the disease can progress to the point that patients need dialysis, a treatment that
removes waste and excess fluids from the blood, or kidney transplants.
The
participants in the study were extremely sick — the severe complications seen in
some study participants are more likely to occur in people the later stages of chronic
kidney disease, said Dr. George Bakris,
a professor of medicine at the University of Chicago Medicine and an author of the
study. Most participants in the trial were already taking medication for chronic
kidney disease.
For
people with advanced kidney disease, in particular, the findings are promising.
“We can help people live longer,” said Dr. Vlado Perkovic, a nephrologist and renal researcher at the University
of New South Wales, Sydney, and another author of the study.
While
the data shows clear benefits, even the researchers studying drugs like Ozempic
aren’t sure how, exactly, they help the kidneys. One leading theory is that semaglutide may reduce inflammation, which exacerbates kidney
disease.
And
the results come with several caveats: Roughly two-thirds of the participants were
men and around two-thirds were white — a limitation of the study, the authors noted,
because chronic kidney disease disproportionately affects Black and Indigenous patients.
The trial participants taking semaglutide were more likely
to stop the drug because of gastrointestinal issues, which are common side effects
of Ozempic.
Doctors
said they wanted to know whether the drug might benefit patients who have kidney
disease but not diabetes, and some also had questions about the potential long-term
risks of taking semaglutide.
Still,
the results are the latest data to show that semaglutide
can do more than treat diabetes or drive weight loss. In March, the F.D.A. authorized
Wegovy for reducing the risk of cardiovascular issues
in some patients. And scientists are examining semaglutide
and tirzepatide, the compound in the rival drugs Mounjaro and Zepbound, for a range
of other conditions, including sleep apnea and liver disease.
If
the F.D.A. approves the new use, it could drive even more demand for Ozempic, which
has faced recurrent shortages.
“I
think it’s a game changer,” Dr. Hoenig said, “if I can
get it for my patients.”