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AHA 2019 Presentation Slides | RENAL-AF

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AHA 2019 Presentation Slides | RENAL-AF: Apixaban vs. Warfarin for Stroke Prevention in Patients With End Stage Renal Disease on Hemodialysis and AFib

Date: November 16, 2019    

Keywords: AHA Annual Scientific Sessions, AHA 19 Slides, Warfarin, Atrial Fibrillation, Renal Dialysis, Kidney Failure, Chronic, Stroke

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• 24 May 2024

Ozempic keeps wowing: trial data show benefits for kidney disease

• Rachel Fairbank

You can also search for this author in PubMed   Google Scholar

People who have kidney failure often need dialysis to help clean waste from their blood. Credit: Mohammed Huwais/AFP via Getty

The blockbuster diabetes drug Ozempic — also sold as the obesity drug Wegovy — can add another health condition to the list of maladies it alleviates. Researchers presented clinical-trial data today at a conference in Stockholm, showing that it significantly reduces the risk of kidney failure and death for people with type 2 diabetes and chronic kidney disease. Scientists are thrilled with the result, and think that the drug, otherwise known by its generic name, semaglutide, will eventually be proved to help a more general population of people with kidney disease. This trial is a first step towards that goal, they say.

Semaglutide manufacturer Novo Nordisk, based in Bagsværd, Denmark, announced in October that it had halted its kidney-disease trial because of a recommendation from an independent data-safety monitoring board that the overwhelmingly positive results made it unethical to continue to give some participants a placebo. But until now, it hadn’t revealed the full data analysis, which is also published today in The New England Journal of Medicine 1 .

Broad benefits

Obesity drugs have another superpower: taming inflammation

The phase IIIb trial, which enrolled 3,533 people, showed that those who received semaglutide injections weekly were 24% less likely to have ‘major kidney disease events’, including kidney failure and dying owing to kidney complications, than were those getting a placebo. Kidney failure occurs when one or both of the kidneys no longer functions on its own, and can be treated with dialysis or a kidney transplant.

Participants who received semaglutide were also 29% less likely to die from heart attacks and other major cardiovascular incidents than were those who got a placebo, and 20% less likely to die from any cause during the trial period. This is huge because “the links between kidney disease and heart disease are really profound”, says Samir Parikh, a nephrologist at the University of Texas Southwestern Medical Center in Dallas who was not involved in the study.

People with type 2 diabetes and chronic kidney disease often die of heart disease before their kidney problems progress to failure. Heart disease and chronic kidney disease are strongly linked, Parikh says, and “unfortunately, they are self-reinforcing”. Adding in type 2 diabetes is like throwing “rocket fuel” onto the fire, he adds. This is because type 2 diabetes can damage small blood vessels in the body, including those in the heart and kidneys.

“We are ecstatic that we are seeing real benefits” for people with chronic kidney disease, says Katherine Tuttle, a nephrologist at the University of Washington School of Medicine in Spokane who co-ran the trial. “These patients benefit broadly.”

Need for therapies

Anti-obesity drug also protects against heart disease — what happens next?

Globally, the death rate from heart disease dropped by about 30% between 1990 and 2019, owing to improvements in health care and people changing their behaviour — for instance, stopping smoking. But people with chronic kidney disease have not seen the same drop in heart-related deaths. “In many ways, they are one of the last pockets where the risk of cardiovascular death has not been reduced,” says Vlado Perkovic, a nephrologist at the University of New South Wales in Sydney, Australia, and a co-leader of the trial. The availability of semaglutide as a potential treatment could be game-changing, he says.

Historically, physicians have treated chronic kidney disease with drugs including blood-pressure medication. But these treatments offer only limited protection for the kidneys. In the past decade, options have expanded. For instance, researchers have demonstrated 2 that a class of diabetes drug called sodium-glucose co-transporter-2 (SGLT2) inhibitors can slow the progression of chronic kidney disease, as well as protect against major cardiovascular incidents.

But “there’s still substantial residual risk in this population”, Tuttle says. Diabetic kidney disease is the leading cause of chronic kidney disease worldwide, accounting for 50% of kidney-failure cases in wealthy countries. “There is a need for more therapies,” she adds.

A focus on kidneys

Scientists already knew from other trials that semaglutide, which moderates blood sugar, can help to protect the kidneys, says Hertzel Gerstein, an endocrinologist at McMaster University in Hamilton, Canada. But those trials were testing the drug’s effect on other conditions, such as heart disease , and clinicians just happened to notice kidney benefits.

Obesity drugs aren’t always forever. What happens when you quit?

What’s special about the latest trial is that it is the first to focus on the progression of kidney disease, Gerstein says.

The trial also hinted that semaglutide could slow the degradation of a person’s kidneys. Participants receiving the drug maintained a healthier ‘estimated glomerular filtration rate’, which is a measure of the kidneys’ ability to filter waste, and had lower amounts of a protein called albumin in their urine than did those receiving placebo. High levels of the protein are a sign of leaky blood vessels in the kidneys and point to kidney function declining.

Why exactly semaglutide benefits the kidneys is still unclear, say the researchers who conducted the trial. It could have multiple mechanisms, including reducing inflammation in the kidneys, but more tests are needed.

Other major questions remain, including whether semaglutide will offer a similar benefit to people who have chronic kidney disease, but who are not diabetic. Researchers must also find out how it stacks up against other medications used to treat chronic kidney disease, such as SGLT2 inhibitors, and whether combining these drugs can offer further benefits.

doi: https://doi.org/10.1038/d41586-024-01564-w

Perkovic, V. et al. N. Engl. J. Med . https://doi.org/10.1056/NEJMoa2403347 (2024).

Article   Google Scholar  

Perkovic, V. et al. N. Engl. J. Med. 380 , 2295–2306 (2019).

Article   PubMed   Google Scholar  

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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.

• Share full article

By Dani Blum

Dani Blum has reported on Ozempic and similar drugs since 2022.

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.”

Dani Blum is a health reporter for The Times. More about Dani Blum

A Close Look at Weight-Loss Drugs

Reduced Disease Complications: Semaglutide, the compound in 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.

Supplement Stores: GNC and the Vitamin Shoppe are redesigning displays and taking other steps  to appeal to people who are taking or are interested in drugs like Ozempic and Wegovy.

Senate Investigation: A Senate committee is investigating the prices that Novo Nordisk charges  for Ozempic and Wegovy, which are highly effective at treating diabetes and obesity but carry steep price tags.

A Company Remakes Itself: Novo Nordisk’s factories work nonstop turning out Ozempic and Wegovy , but the Danish company has far bigger ambitions.

Transforming a Small Danish Town: In Kalundborg, population under 17,000, Novo Nordisk is making huge investments to increase production  of Ozempic and Wegovy.

Acute Renal Failure

Mar 13, 2019

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Acute Renal Failure. Matthew L. Paden, MD Pediatric Critical Care Emory University Children’s Healthcare of Atlanta at Egleston. Structure and Function of the Kidney. Primary unit of the kidney is the nephron 1 million nephrons per kidney Composed of a glomerulus and a tubule

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Presentation Transcript

Acute Renal Failure Matthew L. Paden, MD Pediatric Critical Care Emory University Children’s Healthcare of Atlanta at Egleston

Structure and Function of the Kidney • Primary unit of the kidney is the nephron • 1 million nephrons per kidney • Composed of a glomerulus and a tubule • Kidneys receive 20% of cardiac output Renal Lecture Required Picture #1

Renal blood flow • Aorta  Renal artery  interlobar arteries  interlobular arteries  afferent arterioles  glomerulus  efferent arterioles • In the cortex  peritubular capillaries • In the juxtamedullary region vasa recta • Back to the heart through the interlobular  intralobar  renal veins

Glomerular Filtration Rate • Determined by the hydrostatic and oncotic pressure within the nephron • Hydrostatic pressure in the glomerulus is higher than in the tubule, so you get a net outflow of filtrate into the tubule • Oncotic pressure in the glomerulus is the result of non-filterable proteins • Greater oncotic pressure as you progress through the glomerulus • GFR = Kf (hydrostatic – oncotic pressure)

Renal Lecture Required Picture #2

Glomerular Filtration Rate • The capillary endothelium is surrounded by a basement membrane and podocytes • Foot processes of the podocytes form filtration slits that : • Allow for ultrafiltrate passage • Limit filtration of large negatively charged particles • Less than 5,000 daltons = freely filtered • Large particles (albumin 69,000 daltons) not filtered

Tubular Function • Proximal • Most of reabsorption occurs here • Fluid is isotonic with plasma • 66-70% of sodium presented is reabsorbed • Glucose and amino acids are completely reabsorbed

Tubule Function • Loop of Henle • Urine concentration and dilution via changes in oncotic pressure in the vasa recta • Descending tubule – permeable to water, impermeable to sodium • Ascending tubule – actively reabsorbs sodium, impermeable to water

Tubular Function • Medullary thick ascending limb – critical for urinary dilution and most often damaged in ARF • ADH stimulates Na re-absorption in this area • Most sensitive to ischemia • Low oxygen tension, high oxygen consumption • Lasix use here inhibits the Na-K-2Cl ATPase which in the face of ARF, may decrease oxygen consumption and ameliorate the severity of the ARF

Tubular Function • All of those studies done in an in vitro model • In vivo, if you drop oxygen concentration even sub-atmospheric you do not get tubular damage even with increased tubular workload • In vivo models exist where you do see that damage, but appears to need a “second hit”

Tubule Function • Distal Tubule • Re-absorption of another ~12% of NaCl • Proximal segment – impermeable to water • Distal segment is the cortical collecting duct and secretes K and HCO3

Tubular Function • Collecting Duct • Aldosterone acts here to increase Na reuptake and K wasting • ADH enhances water re-absorption • Urea re-absorption to maintain the medullary interstitial concentration gradient

Acute Renal Failure - Definitions • Renal failure is defined as the cessation of kidney function with or without changes in urine volume • Anuria – UOP < 0.5 cc/kg/hour • Oliguria – UOP “more than 1 cc/kg/hour” • Less than?

Acute Renal Failure - Definitions • 70% Non-oliguric , 30% Oliguric • Non-oliguric associated with better prognosis and outcome • “Overall, the critical issue is maintenance of adequate urine output and prevention of further renal injury.” • Are we converting non-oliguric to oliguric with our hemofilters?

Acute Renal Failure - Diagnosis • Pre-renal • Decrease in RBF constriction of afferent arteriole which serves to increase systemic blood pressure by reducing the “shunt” through the kidney, but does so at a cost of decreased RBF • At the same time, efferent arteriole constricts to attempt to maintain GFR • As GFR decreases, amount of filtrate decreases. Urea is reabsorbed in the distal tubule, leading to increased tubular urea concentration and thus greater re-absorption of urea into the blood. • Creatinine cannot be reabsorbed, thus leading to a BUN/Cr ratio of > 20

Pre-Renal vs. Renal Failure Renal Lecture Required Picture #3

Acute Renal Failure - Diagnosis • Diagnosis • Ultrasound • Structural anomalies – polycystic, obstruction, etc. • ATN – • poor corticomedullary differentiation • Increased Doppler resistive index • (Systolic Peak – Diastolic peak) / systolic peak • Nuclear medicine scans • DMSA – Static - anatomy and scarring • DTPA/MAG3 – Dynamic – renal function, urinary excretion, and upper tract outflow

Acute Renal Failure • Overall, renal vasoconstriction is the major cause of the problems in ARF • Suggested ARF be replaced with vasomotor nephropathy • Insult to tubular epithelium causes release of vasoactive agents which cause the constriction • Angiotensin II, endothelin, NO, adenosine, prostaglandins, etc.

Regulation of Renal Blood Flow • In adults auto-regulated over a range of MAP’s 80-160 • Developmental changes • Doubling of RBF in first 2 weeks of life • Triples by 1 year • Approaches adult levels by preschool • Renal blood flow regulation is complex • No one system accounts for everything…..

Renin-Angiotensin Axis • For the one millionth time…. • Hypovolemia leads to decreased afferent arteriolar pressure which leads to decreased NaCl re-absorption which leads to decreased Cl presentation to the macula densa which increases the amount of renin secreted from the JGA which increases conversion angiotensinogen to AGI to AGII which increases Aldosterone secretion from the adrenal cortex and ADH which leads to increased sodium and thus water re-absorption from the tubule which increases your blood pressure……whew…

Renin Angiotensin Axis Renal Lecture Required Picture #4

Renin Angiotensin Axis • Renin’s role in pathogenesis of ARF • Hyperplasia of JGA with increased renin granules seen in patients and experimental models of ARF • Increased plasma renin activity in ARF patients • Changing intra-renal renin content modifies degree of damage • Feed animals high salt diet (suppress renin production)  renal injury  less renal injury than those fed a low sodium diet

Renin Angiotensin Axis • Not the only thing going on though • You can also ameliorate renal injury by induction of solute diuresis with mannitol or loop diuretics (neither affect the RAS) • No change in renal injury in animals given ACE inhibitors, competitive antagonist to angiotensin II • Overall, role of RAS in ARF is uncertain

Prostaglandins • PGE 2 and PGI • Very important for renal vasodilation, especially in the injured kidney • Act as a buffer against uncontrolled A2 mediated constriction • If you constrict the afferent arteriole, you will decrease GFR • The RAS and Prostaglandin pathways account for ~60% of RBF auto-regulation…

Adenosine • Potent renal vasoconstrictor • Peripheral vasodilator • Infusion of methylxanthines (adenosine receptor blockers) inhibits the decrease in GFR that is seen with tubular damage • Some animal models show that infusion of methylxanthines lessen renal injury in ARF

Adenosine • But…. Likely not a major factor in ARF • Methylxanthines have lots of other actions besides adenosine blockade • Adenosine is rapidly degraded after production • Intra-renal adenosine levels diminish very rapidly after reperfusion, but the vasocontriction remains for a longer period • Finally, if you block ADA, creating higher tissue adenosine levels, and then create ischemia  you actually get an enhancement of renal recovery

Endothelin • 21 amino acid peptide that is one of the most potent vasoconstrictors in the body • Can be used as a pressor • Its role in unclear in normal state • In ARF, overproduction by cells (both in and outside of the kidney) leads to decreased afferent flow and thus decreased RBF and GFR • Endothelin increases mesangial cell contraction which reduces glomerular ultrafiltration • Stimulates ANP release at low doses and can increase UOP • Anti-endothelin antibodies or endothelin receptor antagonists decrease ARF in experimental models

Nitric Oxide • Produced by multiple iso-enzymes of NOS • In addition to its role in vasodilation, likely has a role in sodium re-absorption • Give a NOS blocker and you get naturesis • Important in the overall homeostasis of RBF • Exact mechanisms not worked out completely…at least when Rogers was written….

Obligatory Incomprehensible Pathway for Jim #1

Nitric Oxide • Confusing results • Ischemic rat kidney model – inducing NOS causes increasing injury • Hypoxic tubular cell culture model – inducing NOS causes increasing injury • But if you block NOS production, you get worsening of renal function and severe vasoconstriction

Nitric Oxide • So stimulation of NO in the renal vasculature will modulate vasoconstriction and lead to lesser injury…but… • That same induction of NO in the tubular cells will cause increased cytotoxic effects

Dopamine • Dopamine receptors in the afferent arteriole • Dilation of renal vasculature at low doses, constriction at higher doses • Also causes naturesis (? Reason for increased UOP after starting) • Renal dose dopamine controversy……….

Renal Hemodynamics and ARF • Conclusions…. • Renal vasoconstriction is a well documented cause of ARF • Renal vasodilation does not consistently reduce ARF once established • Although renal hemodynamic factors play a large role in initiating ARF, they are not the dominant determinants of cell damage

ARF - Pathophysiology • Damage is caused mostly by renal perfusion problems and tubular dysfunction • Usual causes • Hypo-perfusion and ischemia • Toxin mediated • Inflammation

ARF – Pathophysiology • Hypo-perfusion • Well perfused kidney – 90% of blood to cortex • Ischemia – increased blood flow to medulla • Outcome may be able to be influenced by restoration of energy/supply demands • Lasix example • Leads to tubular damage

ARF - Pathophysiology • Oxidative damage • Especially during reperfusion injuries • Main players • Super-oxide anion, hydroxyl radical – highly ionizing • Hydrogen peroxide, hypochlorous acid – not as reactive, but because of that have a longer half life and can travel farther and cause injury distal to the site of production

ARF - Pathophysiology • Ischemia • Damage to mitochondrial membrane and change of xanthine dehydrogenase (NAD carrier) to xanthine oxidase (produces O2 radicals) • Profound utilization of ATP  5-10 minutes of ischemia you use ~90% of your ATP • Make lots of adenosine, inosine, hypoxanthine

ATP ADP AMP Adenylosuccinate Adenosine Hypoxanthine IMP Inosine H20 ∙ O2 H2O2 Xanthine H20 ∙ O2 H2O2 Uric Acid H20 ∙ O2 CO2 Allantoin

ARF - Pathophysiology • Once you get reperfusion, the hypoxanthine gets metabolized to xanthine and uric acid – each creating one H2O2 and one super-oxide radical intermediate • Reactive oxygen species oxidize cellular proteins resulting in: • Change in function/inactivation/activation • Loss of structural integrity • Lipid peroxidation (leads to more radical formation) • Direct DNA damage

ARF Pathophysiology • Amount of damage depends on ability to replete ATP stores • Continued low ATP leads to disruption of cell cytoskeleton, increased intracellular Ca, activation of phospholipases and subsequently the apoptotic pathways

Obligatory Incomprehensible Pathway for Jim #2

ARF Pathophysiology • Amount of damage depends on ability to replete ATP stores • Continued low ATP leads to disruption of cell cytoskeleton, increased intracellular Ca, activation of phospholipases and subsequently the apoptotic pathways • This endothelial cell injury sparks an immune response….that can’t be good….

ARF - Prevention • Maintenance of blood flow • Cardiac output, isovolemia, etc • Avoidance of toxins • Aminoglycosides, amphoteracin, NSAIDs • Easy on paper….difficult in practice

ARF - Prevention • Lasix • May have uses early in ARF • Mannitol • May work by • Increasing flow through tubules, preventing obstruction • Osmotic action, decreasing endothelial swelling • Decreased blood viscosity with increased renal perfusion (???) • Free radical scavenging

ARF - Prevention • Renal dose dopamine…. • Endothelin antibodies • No human trials • Thyroxine • More rapid improvement of renal function in animals • Increased uptake of ADP to form ATP or cell membrane stabilization as a possible cause

ARF - Prevention • ANP • Improve renal function and decrease renal insufficiency • ? Nesiritide role • Theophyline • Adenosine antagonist – prevents reduction in GFR. • Growth Factors • After ischemic insult, infusion of IGF-I, Epidermal GF, Hepatocyte GF improved GFR, diminished morphologic injury, diminished mortality • None of these things are well tested…..

ARF – Prevention in Specific Cases • Hemoglobinuria/Myoglobinuria • Mechanism of toxicity • Disassociation to ferrihemate, a tubular toxin, in acidic urine • Tubular obstruction • Inhibition of glomerular flow by PGE inhibition or increased renin activation • Treatments (?) • Aggressive hydration to increase UOP • Alkalinization of urine • Mannitol/Furosemide to increase UOP • ?Early Hemofiltration

ARF – Prevention in Specific Cases • Uric Acid Nephropathy • A thing of the past thanks to Rasburicase? • Treatments • Aggressive hydration to drive UOP • Alkalinization of the urine • Xanthine oxidase inhibitors

ARF - Management • Electrolyte management • Sodium • Hyponatremia – fluid restriction first, 3% NaCl if AMS or seizing • Potassium • Calcium/Bicarb/Glucose/Insulin/Kayexalate • Hemodialysis

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acute renal failure

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Ozempic and Wegovy could double as kidney disease treatment, study suggests

Semaglutide medications — including Ozempic and Wegovy — have been shown to reduce the risk of kidney failure and the risk of death among people with kidney disease and type 2 diabetes.

In a trial led by UNSW Sydney between June 2019 and May 2021, researchers found that a small weekly dose of semaglutide lessened the likelihood of "major kidney events" by 24%, according to a press release.

The study, funded by Novo Nordisk and published in The New England Journal of Medicine, included more than 3,500 participants with type 2 diabetes and chronic kidney disease from 28 countries.

OZEMPIC, WEGOVY MAY BE LINKED TO STOMACH PARALYSIS AND OTHER DIGESTIVE ISSUES IN LARGE-SCALE STUDY

The participants received 1.0 mg per week of semaglutide, which is less than what is typically prescribed for weight loss or diabetes, the release noted. 

The median follow-up was 3.4 years.

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"It’s the same chemical compound, but we used a lower dose ... we did that deliberately because people with kidney disease tend to be more sensitive to the effects and side effects of drugs," said the study’s lead author, professor Vlado Perkovic of UNSW Sydney, in the release.

"That’s helpful in terms of being able to perhaps have the drug more widely used than might have otherwise been the case given the current supply limitations."

OZEMPIC DIABETES AND WEIGHT LOSS MEDICATION UNDER INVESTIGATION AFTER A FEW REPORTS OF SUICIDAL THOUGHTS

The group of people taking semaglutide were also 18% less likely to experience a heart attack, stroke and other cardiovascular events, the study found.

Patients with type 2 diabetes and chronic kidney disease are at a significant risk for kidney failure, cardiovascular events and death, according to Dr. Brett Osborn, a neurologist and longevity expert in Florida.

"The recent study published in the New England Journal of Medicine highlights semaglutide's potential to mitigate these risks," Osborn, who was not involved in the study, told Fox News Digital. 

Semaglutide works by improving glycemic control, Osborn noted — which is crucial in mitigating diabetic nephropathy (kidney disease). 

"It also lowers inflammation — particularly within the blood vessel lining," he said. 

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This reduces blood vessel damage and improves blood flow through the kidneys.

"Overall, semaglutide offers substantial renal and cardiovascular protection for patients with type 2 diabetes and chronic kidney disease," Osborn said.

"At a base level, semaglutide, through indirect mechanisms, improves vascular health. The better blood flow to your organs — be it your heart, brain or kidneys — the longer you are likely to live ."

Outside the spectrum of diabetes, Osborn said he believes these medications will have a major impact on human health, comparing them to the advent of antibiotics at the turn of the century.

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, also said this was a "very important" study.

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"This lifesaving result is likely due to the metabolic effects of the drug, which helps with reducing inflammation, overcoming insulin resistance, and improving insulin function and glucose metabolism at the cellular level," Siegel told Fox News Digital. 

"Improved kidney function means improved heart function, and pressure on the heart from failed kidneys is a major cause of heart attack and death ."

Siegel added, "This study has broader implications for all patients who have kidney failure or are at risk for it."

Novo Nordisk, the Denmark-based company that makes Ozempic and Wegovy, announced the positive primary results from the trial at the European Renal Association (ERA) Congress in Sweden last week.

"FLOW is the first ever renal outcomes trial with a GLP-1 receptor agonist, and demonstrated a statistically significant reduction in kidney disease progression, cardiovascular death, and all-cause mortality risk with semaglutide 1 mg," Michael Radin, executive medical director for diabetes at Novo Nordisk, said in a statement sent to Fox News Digital. 

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"This study highlights our drive to make a meaningful difference in the lives of people living with type 2 diabetes and CKD and to deliver innovations to address current unmet medical needs in CKD pending FDA approval."

To leverage semaglutide as a treatment for kidney disease, there is a need to overcome supply shortages and conduct research about combining the medication with other therapies, the researchers stated in the release.

Novo Nordisk will also need to seek regulatory approval for the drug to be used for chronic kidney disease patients.

"The challenge is to get these results into clinical practice, to get the drug used by the people who will benefit from it, who will live longer without dialysis, without heart attacks, without strokes, if they take this drug," Perkovic said.

For more Health articles, visit www.foxnews.com/health .

Original article source: Ozempic and Wegovy could double as kidney disease treatment, study suggests

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Ozempic cuts risk of death from kidney disease, major study finds

Novo Nordisk will seek FDA approval to dramatically expand the number of patients eligible for the shots.

The active compound in the best-selling drug Ozempic markedly lowers the risk of complications from chronic kidney disease, according to a multiyear study published Friday — a finding that could dramatically expand the pool of patients eligible for the injections.

Funded by Ozempic maker Novo Nordisk and involving 3,533 patients around the world, a study released in Stockholm at the European Renal Association meeting and published in the New England Journal of Medicine found that patients receiving semaglutide — the key ingredient — experienced a 24 percent reduction in risk of death from cardiovascular and kidney disease compared with those who received a placebo. The finding proved so striking that the company announced in October that it was stopping the trial early, sending shares of some dialysis companies falling then.

“These findings offer great promise in reshaping treatment strategies for individuals at high risk of diabetes-related complications,” Vlado Perkovic, a kidney researcher at the University of New South Wales Sydney said in a statement announcing the results.

Novo Nordisk intends to seek Food and Drug Administration approval this year to update the Ozempic label for use in patients with chronic kidney disease, which affects an estimated 850 million people worldwide . In the United States, the condition affects more than 1 in 7 adults. The company declined to specify when it intends to file its request with the FDA.

“This study highlights our drive to make a meaningful difference in the lives of people living with type 2 diabetes” and kidney disease, said Michael Radin, an executive medical director with Novo Nordisk, in a statement.

Ozempic is part of a class of medications, known as GLP-1 agonists, that mimic a gut hormone that regulates hunger and blood sugar. Ozempic entered the market in 2017 as a treatment for Type 2 diabetes, a leading cause of kidney disease. The company repackaged the active ingredient semaglutide as Wegovy in 2021 for weight management in people who are obese or overweight and have another chronic medical condition.

The drugs were recently shown to have cardiovascular benefits, and research is being conducted regarding potential effects on other conditions, including addiction, sleep apnea and Parkinson’s disease. In March, the FDA approved Wegovy as a treatment to reduce cardiovascular risk in adults who are overweight, which was the first approval of its kind.

FDA spokeswoman Amanda M. Hils said the agency does not speculate on future regulatory action, such as expansion to Ozempic’s label.

“The FDA continues to monitor the safety of all approved products, including GLP-1 drugs for all approved uses, as well as working with firms that submit applications to the FDA for approval, ensuring that requirements are met and labeling accurately indicates the safety, quality, and effectiveness of an FDA-approved drug,” Hils wrote in an email.

The weight-loss drugs are highly sought after by consumers, leading to repeated shortages, and they have reshaped the culture and conversation surrounding weight, dieting and food consumption.

Early on, some physicians expressed concerns about the drugs’ effect on kidney function, said Melanie Jay, an associate professor of medicine at the NYU Grossman School of Medicine and director of the comprehensive program on obesity. The study, which encompasses more than three years of data, provides assurance the opposite is true, Jay said.

“Given that kidney disease is so deadly, the risk-benefit analysis is a no-brainer,” Jay said.

But she noted that study participants were overwhelmingly White; only 4.4 percent were Black. In the United States, African Americans are at higher risk of kidney disease and experience more severe illness, so Jay said studies need to determine whether the same impact from the drug is evident in those patients.

“It’s a big issue, and people need to be aware of that,” Jay said.

Federal law prohibits Medicare — the government health insurance plan for older Americans — from covering drugs used for weight loss. But plans participating in Medicare’s voluntary prescription drug benefit can cover GLP-1s for other medical purposes, such as diabetes and cardiovascular risk, according to researchers at KFF, a nonpartisan health research organization.

“In many ways, it’s a backdoor way of providing weight-loss drugs to people on Medicare,” said Tricia Neuman, a senior vice president at KFF.

Wall Street reaction to Friday’s release of the study results was muted given that preliminary results had been released earlier.

In a research note, Citigroup analyst Peter Verdult described as a “red herring” concerns about whether the promising results would hold true across races and ethnicities and among patients with varying baseline weights or degree of kidney damage.

“Subgroup analysis was almost entirely in favour of semaglutide,” he wrote.

Analysts believe the market for semaglutides, already hitting record sales, will grow significantly. According to Citigroup, “just” 20 percent of Type 2 diabetes patients in the United States and 6 percent globally take the GLP-1 drugs.

Daniel Gilbert contributed to this report.