Medically reviewed by Anna Goldman, MD.
On Tuesday, the drug manufacturer Novo Nordisk announced that it will stop a significant trial testing the effect of semaglutide (Ozempic) on diabetic kidney disease one yr ahead of schedule. The trial was so effective, it seems, that an independent panel beneficial there was no have to proceed any further.
Though it can be months before the trial is officially accomplished and results are disseminated, it seems certain that we now have the reply to one among the key remaining questions on Ozempic’s advantages for individuals with diabetes. Health authorities similar to the American Diabetes Association (ADA) already recognized Ozempic as amongst probably the most effective drug treatments available for glycemic control, weight reduction, and cardiovascular protection, but its effect on kidney health was unclear. Now, it seems probable the drug may turn out to be a preferred option for individuals with chronic kidney disease (CKD), too.
Diabetes and Chronic Kidney Disease
Kidney damage (nephropathy) is one of the crucial common long-term complications of each type 1 and sort 2 diabetes. It could develop in as many as 40 percent of individuals with diabetes.
Based on the National Institute of Diabetes and Digestive and Kidney Diseases, chronic high blood sugar levels interfere with the kidneys’ ability to filter blood. This results in the unhealthy build-up of fluid and waste within the body.
In its earliest stages, kidney disease generally has no symptoms. Physicians screen for kidney damage by testing urine for the presence of a protein named albumin. Treatment can slow the progression of CKD, but when the damage can’t be stopped, the condition may turn out to be debilitating or deadly. When the kidneys fail, patients will eventually require either dialysis or a kidney transplant to live. Chronic kidney disease may also increase the likelihood of other negative health outcomes, similar to heart disease and metabolic bone disease.
Semaglutide and Kidney Health
Today, the popular medication for concurrently managing high blood sugar and reducing the danger of chronic kidney disease is the family of medicine generally known as SGLT2 inhibitors. These drugs, including empagliflozin (Jardiance) and canagliflozin (Invokana), help lower blood glucose levels by blocking the reabsorption of filtered glucose within the kidneys.
In contrast, semaglutide and other GLP-1 receptor agonists are currently beneficial only as secondary options for individuals with diabetic kidney disease. Based on the ADA’s recommendations, GLP-1 receptor agonists are indicated for patients with CKD who cannot tolerate an SLGT2 inhibitor or who need additional medication to succeed in blood sugar targets.
There was already some evidence that semaglutide had positive effects on kidney health. 2016’s SUSTAIN-6 trial, for instance, found that patients with type 2 diabetes using semaglutide had a 36 percent lower risk of experiencing recent or worsening nephropathy. But these analyses were “limited,” based on the ADA, since the trial hadn’t been designed to pick out and evaluate participants with CKD.
The FLOW trial was designed to prove definitively whether or not semaglutide (Ozempic) has a major effect on kidney health. This massive experiment enrolled over 3,500 people, from 28 countries and 6 continents. All were adults with type 2 diabetes, evidence of nephropathy, and a “high or very high risk of CKD progression.”
The trial was slated to finish in late 2024, but now it can be dropped at an early close. Based on a press release from Ozempic manufacturer Novo Nordisk, the choice to stop the trial was “based on a advice from the independent Data Monitoring Committee (DMC).” These committees are appointed to perform independent interim analyses of clinical trials to make sure the security of participants. When interim data shows that the tested intervention is causing unambiguous profit or harm, the DMC can recommend that the trial be terminated early. (To stop conflicts of interest, Novo Nordisk employees are still blinded to the trial results.)
It would take time before the small print emerge, however the news suggests that Ozempic had a robust protective effect on kidney health. To qualify for early termination, the drug needed to prove that it satisfied some or the entire trial’s primary endpoints, including a major reduction in the danger of kidney failure, dialysis, kidney transplantation, or death because of cardiorenal diseases.
Bloomberg reported that the stock prices of major dialysis firms fell sharply soon after the news of Ozempic’s kidney advantages broke.
It’s one more victory for semaglutide, which has been widely hailed as a game-changer and miracle drug. The sort 2 diabetes drug not only confers long-term blood sugar control and weight reduction, but has been celebrated for its surprising ability to quiet “food noise” and curb addictive behaviors. Though semaglutide can be related to a wide range of negative effects, the demand has been enough to cause persistent shortages, prompting some patients to hunt potentially dangerous Ozempic alternatives.
The Treatment of Diabetic Kidney Disease
Diabetes-related kidney disease is treated with each medication and lifestyle changes, based on the ADA. Glucose control is of paramount importance for slowing the progression of CKD, and patients are generally encouraged to accentuate their efforts to watch and manage their blood sugar.
Hypertension is second vital CKD risk factor. Patients are sometimes prescription drugs similar to ACE inhibitors to treat hypertension. High cholesterol may also exacerbate CKD, and will require treatment with statins.
Individuals with CKD are also often advised to eat a special kidney disease weight-reduction plan. Kidney disease diets generally start with the foundations of diabetes-friendly diets, similar to an emphasis on unprocessed foods and limits on sugar and refined starches. Individual patients may additionally be instructed to look at their intake of salt and of certain ingredients, such potassium, that their kidneys have difficulty processing. Dietary needs may also differ significantly depending on the stage of CKD. Patients with early CKD could also be asked to strictly limit protein intake, for instance, while those on dialysis may require extra protein.