- Type 2 diabetes is a condition that results from the body no longer
responding to insulin, the hormone that controls blood glucose levels.
- People with type 2 diabetes are
at high risk of developing chronic kidney disease.
- Semaglutide — sold under the
brand name Ozempic — is a drug that, in conjunction with diet and exercise,
improves blood glucose (sugar) control in people with diabetes.
- Now, trial results show that
semaglutide may also reduce the progression of kidney disease.
Chronic
kidney disease affects
The
resulting damage to blood vessels and
As
the early stages of kidney disease cause few or no symptoms, people with
diabetes should manage their blood glucose, blood pressure and cholesterol
levels. They should also get regular checks from their doctor.
The
Food and Drug Administration (FDA) has approved Ozempic as a treatment for type
2 diabetes, in addition to diet and exercise.
As
well as helping control blood glucose, it may also reduce the risk of heart
attack, stroke, or death in adults with type 2 diabetes and heart disease. One study has
shown that it could also reduce inflammation, which may explain these other
health effects.
Dr. Joshua J. Neumiller, PharmD, American Diabetes Association Board president-elect for healthcare and education, told Medical News Today that “[b]uilding evidence suggests that GLP-1 receptor agonists suppress inflammation and reduce oxidative stress and fibrosis in the kidney, together slowing [chronic kidney disease] progression.”
Now, the
manufacturer of Ozempic — Novo Nordisk — has announced
headline results of their latest trial, suggesting that
semaglutide can reduce the risk of kidney disease progression by 24% in people
who have type 2 diabetes and chronic kidney disease.
The
detailed results of
Prof.
Peter Rossing, research leader at the Steno Diabetes Center in Copenhagen,
Denmark, one of the researchers involved in the trial, spoke to MNT about
these findings.
He
emphasized:
“This
is a very significant finding; over 500 million people have diabetes, and
30-40% have chronic kidney disease, and we need treatments to stop or reduce
progression of the kidney disease as well as to reduce the burden of
cardiovascular disease which is high in this population.”
Prof.
Rossing previously co-authored a paper explaining
the rationale, design and baseline data of the FLOW trial.
Dr.
Neumiller, who was not involved in this research agreed with this view, noting
that “[t]hese headline results from FLOW are very important for people with
[type 2 diabetes] and [chronic kidney disease] and the clinicians who care for
them.“
“People with [type 2 diabetes] and [chronic kidney disease] are at amplified risk for cardiovascular-related morbidity and mortality and progression to kidney failure. Treatment options capable of mitigating heart and kidney risk in this population are greatly needed,” he told us.
Ozempic trial stopped early as it reached endpoint
Researchers on
the FLOW trial recruited 3,533 people with type 2 diabetes and chronic kidney
disease from 418 locations in 28 countries
They
randomly allocated them to semaglutide or placebo. Participants self-administered
both semaglutide and the visually identical placebo by weekly subcutaneous
injection.
Those
in the semaglutide group started on a dose of 0.25 milligrams (mg) per week for
4 weeks, increasing the dose to 0.5 mg, then to 1 mg after 8 weeks and for the
rest of the trial.
In
addition, all participants received the maximum labelled or tolerated dose of a
Participants
had a mean age of 66.6 years, 69.7% were men and 65.7% were white. All
participants had type 2 diabetes diagnosed, on average, 17.4 years before the
start of the trial and chronic kidney disease.
The
trial was meant to run until the end of 2024, but was stopped early after it
reached its primary endpoint, which Prof. Rossing explained:
“The endpoint is composed of kidney disease progression and cardiovascular and kidney death, and in particular progression to kidney failure and mortality of cardiovascular events. These are frequent in this population of [type 2 diabetes] with [chronic kidney disease], so that we can reduce this with 24% is important and meaningful for patients.”
Ozempic could protect kidney health, reduce cardiac death risk
In the
announcement, Novo Nordisk stated that the trial had achieved “a statistically
significant and superior reduction in kidney disease progression as well as
cardiovascular and kidney death of 24% for people treated with semaglutide 1.0
mg compared to placebo.”
However, Prof.
Jagdish Khubchandani, professor of public health at the New Mexico
State University, not involved in the trial, cautioned that these are,
nevertheless, early-stage findings.
He
advised that:
“There
needs to be repeated assessment with different samples of participants across
the world. In the real world setting, people behave differently and have other
conditions as well. So, we need more effectiveness trials — [because] effectiveness
trials find how well a medication works [unlike] efficacy trials that measure
how well it works in RCT/lab studies.”
Dr.
Neumiller echoed this perspective.
“FLOW
represents the first dedicated kidney outcome trial with a GLP-1 receptor
agonist in people with [type 2 diabetes] and [chronic kidney disease],“ he told
us.
“The recently released headline results are impressive, yet we await presentation and publication of the complete trial results to fully understand the efficacy and safety outcomes of the trial,” Dr. Neumiller cautioned.
Ozempic is not without side effects
Although
Ozempic is effective in regulating blood glucose and, according to this
announcement, could reduce the risk of complications of chronic kidney disease,
it does have side effects,
which people taking the drug should be aware of.
Many
people taking the drug report the following mild side effects:
- gas
and burping
- nausea,
vomiting and diarrhea
- abdominal
pain
- constipation
- fatigue
- changes
in the sense of taste.
More
serious, but rare, side effects may include:
- hypoglycemia (low
blood sugar) when used with certain other diabetes
drugs
- pancreatitis (inflammation in
the pancreas)
- diabetic
retinopathy (eye damage caused by diabetes)
- kidney
damage or failure
- gallbladder
problems, such as gallstones and gallbladder
inflammation
- thyroid cancer (this is a boxed warning from the FDA).
Dr. Ishita Prakash Patel, M.D.,
board-certified endocrinologist at Texas Diabetes and Endocrinology, not
involved in this study, also commented on its findings for MNT.
She
expressed some optimism, noting that:
“If
the claims are sturdy, this class of medication would be another validated tool
in our kit to not only treat blood sugars and weight, but one of the more
devastating outcomes of uncontrolled diabetes – chronic kidney disease. This is
good news for people with [type 2 diabetes].”
Other
experts agreed that this could be an important step forward in the search for
effective treatments for chronic kidney disease in people with type 2 diabetes.
Dr.
Neumiller told us: “Results from FLOW will, in my opinion, have a dramatic
impact on the standard of care for people living with [type 2 diabetes] and
[chronic kidney disease]. With primary evidence of kidney benefit in the
setting of [type 2 diabetes] and [chronic kidney disease], we now have an agent
capable of mitigating heart and kidney risk with a robust and preserved
glucose-lowering effect at low eGFR.”
Prof.
Khubchandani agreed, saying: “Given that these medications have multiple
beneficial effects, help control blood sugar, and are reasonably well tolerated
with kidney dysfunction, these could change the landscape of treatment for
those with [type 2 diabetes] and kidney dysfunction which is common among
people with [type 2 diabetes].”
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