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Novo Nordisk announced that Ozempic is expected to slow the progression of chronic kidney disease. Image credit: Jaap Arrians/NurPhoto (Getty Images)
  • Type 2 diabetes is a condition that occurs when the body no longer responds to insulin, the hormone that controls blood sugar levels.
  • People with type 2 diabetes have an increased risk of developing chronic kidney disease.
  • Semaglutide (sold under the brand name Ozempic) is a drug that, when combined with diet and exercise, improves blood sugar (sugar) control in people with diabetes.
  • Trial results now show that semaglutide may slow the progression of kidney disease.

Effects of chronic kidney disease 1 in 3 adults with diabetes. Both type 1 and type 2 diabetes increase the risk of chronic kidney disease when blood glucose (sugar) levels are not controlled.

The resulting damage to blood vessels, nephron It means that the kidneys cannot function properly.

In the early stages of kidney disease, there are few or no symptoms, so people with diabetes need to manage their blood sugar, blood pressure, and cholesterol levels. You should also have regular check-ups from your doctor.

SemaglutideSold as Ozempic, it is one of a group of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. They mimic GLP-1, a hormone that causes your body to produce more insulin, lower your appetite, and make you feel full.

The Food and Drug Administration (FDA) has approved Ozempic as a treatment for type 2 diabetes in addition to diet and exercise.

In addition to helping control blood sugar, it may also reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes or heart disease. One study shows that it may reduce inflammation, which may explain these other health effects.

said Joshua J. Neumiller, Ph.D., Pharm.D., incoming president of the American Diabetes Association Board of Directors for Health Care and Education. Today’s medical news that “[b]Evidence is building to suggest that GLP-1 receptor agonists suppress kidney inflammation, reduce oxidative stress and fibrosis, and together slow kidney inflammation. [chronic kidney disease] progress. ”

Now, Novo Nordisk, the manufacturer of Ozempic, has announced top-line results from its latest trial suggesting that semaglutide can reduce the risk of kidney disease progression by 24% in people with type 2 diabetes and chronic kidney disease.

For detailed results, FLOW trial It is scheduled to be presented at an academic conference later this year. They have not yet been published in a peer-reviewed journal.

Professor Peter Lossing, research leader at the Steno Diabetes Center in Copenhagen, Denmark, and one of the researchers involved in the trial, said: MNT Regarding these findings.

He emphasized that:

“This is a very important discovery. More than 500 million people have diabetes and 30-40% have chronic kidney disease, and we hope to not only reduce the burden of cardiovascular disease in this population. Treatment is needed to stop or reduce the progression of kidney disease.”

Professor Rossing previously co-authored a paper explaining the rationale, design and baseline data for the FLOW trial.

Dr. Neumiller, who was not involved in the study, agreed with this view, saying:[t]The headline results from FLOW are very important for people who have problems such as: [type 2 diabetes] and [chronic kidney disease] and the clinicians who care for them. ”

“The person who has [type 2 diabetes] and [chronic kidney disease] Cardiovascular-related morbidity and mortality and risk of progression to renal failure are increased. “Treatment options that can reduce heart and kidney risks in this population are critically needed,” he told us.

Researchers in the FLOW trial recruited 3,533 people with type 2 diabetes and chronic kidney disease from 418 sites in 28 countries.

They randomly assigned them to semaglutide or a placebo. Participants self-administered both semaglutide and an identical-looking placebo via weekly subcutaneous injections.

Subjects in the semaglutide group started at a dose of 0.25 milligrams (mg) per week for 4 weeks, increasing the dose to 0.5 mg, and then increasing to 1 mg after 8 weeks and for the remainder of the study.

Additionally, all participants took the maximum labeled or tolerated dose of the drug. RAAS blocker — Unless contraindicated or tolerated — Helps control high blood pressure. acute myocardial infarction (heart attack), chronic systolic heart failure, stroke, diabetic kidney disease, etc.

The average age of participants was 66.6 years, 69.7% were male, and 65.7% were Caucasian. All participants had been diagnosed with type 2 diabetes and chronic kidney disease on average 17.4 years before the start of the trial.

The trial was due to run until the end of 2024, but was stopped early after reaching its primary endpoint, Professor Rossing explained.

“Endpoints consist of kidney disease progression, cardiovascular and renal death, particularly progression to renal failure and mortality from cardiovascular events, which are frequently seen in this population. [type 2 diabetes] and [chronic kidney disease]Reducing this by 24% is important and meaningful for patients. ”

Novo Nordisk said in a statement that the trial demonstrated “a statistically significant 24% reduction in kidney disease progression and cardiovascular and renal death in patients treated with semaglutide 1.0 mg compared to placebo. He said that a reduction in the number of people’s lives has been achieved.

But Jagdish Khubchandani, a professor of public health at New Mexico State University who was not involved in the trial, cautioned that these are still early findings.

He advised:

“Evaluations need to be repeated with different samples of participants around the world. In real-world settings, people behave differently and have other conditions. Therefore, more efficacy trials are needed. Is required – [because] Efficacy testing examines how effective a drug is [unlike] Efficacy testing to measure how well it works in RCTs/clinical studies. ”

Dr. Neumiller agreed with this view.

“FLOW is the first specialized kidney outcomes trial using a GLP-1 receptor agonist in people with: [type 2 diabetes] and [chronic kidney disease],” he told us.

“While the recently published headline results are impressive, we await the presentation and publication of the full trial results to fully understand the trial’s efficacy and safety results,” Dr. Neumiller cautioned. .

According to the latest announcement, Ozempic is effective in regulating blood sugar levels and may reduce the risk of complications from chronic kidney disease, but it also has side effects, so people should be careful when taking it.

Many people taking this medication report the following mild side effects:

  • gas and burp
  • nausea, vomiting, diarrhea
  • abdominal pain
  • constipation
  • Malaise
  • Changes in taste.

Rare but more serious side effects include:

Dr. Ishita Prakash Patel, a board-certified endocrinologist with Texas Diabetes and Endocrinology who was not involved in the study, also commented on the results. MNT.

Expressing optimism, she said:

“If the claims are strong, this class of drugs could be used not only to treat blood sugar levels and weight, but also to treat chronic kidney disease, one of the more devastating consequences of uncontrolled diabetes. It will be another useful tool in our kit, which is good news for people who: [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: “In my opinion, the FLOW results will have a dramatic impact on the standard of care for people living with conditions such as: [type 2 diabetes] and [chronic kidney disease]. Primary evidence of renal benefit in the following settings has been obtained: [type 2 diabetes] and [chronic kidney disease]We now have a drug that has strong and sustained hypoglycemic effects at low eGFR and can reduce heart and kidney risks. ”

Professor Khubchandani agreed, saying: “Given that these drugs have multiple beneficial effects, help control blood sugar levels, and are well tolerated in renal dysfunction, these drugs have a place in the treatment setting for patients with renal failure. has the potential to change [type 2 diabetes] Kidney dysfunction is common in people who: [type 2 diabetes]”

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