A multi-year study finding that Ozempic markedly lowers the risk of complications from chronic kidney disease could dramatically increase the pool of patients eligible for the injection, says Novo Nordisk.
The company will now seek FDA approval to expand the number of patients who qualify for the drug, and update the label for use in patients with CKD.
Funded by Novo Nordisk and involving 3 533 patients around the world, the 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% reduction in risk of death from cardiovascular and kidney disease compared with those on a placebo.
“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, told The Washington Post.
Ozempic entered the market in 2017 as a treatment for type 2 diabetes, a leading cause of kidney disease, with the active ingredient semaglutide being repackaged 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 apnoea and Parkinson’s disease.
In March, the FDA approved Wegovy as a treatment to reduce cardiovascular risk in overweight adults, which was the first approval of its kind.
The popularity of the weight-loss drugs has led to repeated shortages, and they have reshaped the culture and conversation surrounding weight, dieting and food consumption.
Early on, some physicians had 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 programme on obesity, but the study, encompassing more than three years of data, provides assurance that the opposite is true.
However, she noted that study participants were mainly white – only 4.4% were black. In the US, African Americans have a 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.”
Study details
Effects of semaglutide on Chronic Kidney Disease in patients with type 2 diabetes
Vlado Perkovic, Katherine Tuttle, Richard Pratley, FLOW Trial Committees and Investigators et al.
Published online on 24 May 2024
Abstract
Background
Patients with type 2 diabetes and chronic kidney disease are at high risk for kidney failure, cardiovascular events, and death. Whether treatment with semaglutide would mitigate these risks is unknown.
Method
We randomly assigned patients with type 2 diabetes and chronic kidney disease (defined by an estimated glomerular filtration rate [eGFR] of 50 to 75 ml per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio [with albumin measured in milligrams and creatinine measured in grams] of >300 and <5000 or an eGFR of 25 to <50 ml per minute per 1.73 m2 and a urinary albumin-to-creatinine ratio of >100 and <5000) to receive subcutaneous semaglutide at a dose of 1.0 mg weekly or placebo.
The primary outcome was major kidney disease events, a composite of the onset of kidney failure (dialysis, transplantation, or an eGFR of <15 ml per minute per 1.73 m2), at least a 50% reduction in the eGFR from baseline, or death from kidney-related or cardiovascular causes. Prespecified confirmatory secondary outcomes were tested hierarchically.
Results
Among the 3 533 participants who underwent randomisation (1 767 in the semaglutide group and 1 766 in the placebo group), median follow-up was 3.4 years, after early trial cessation was recommended at a pre-specified interim analysis. The risk of a primary-outcome event was 24% lower in the semaglutide group than in the placebo group (331 vs. 410 first events; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.88; P = 0.0003). Results were similar for a composite of the kidney-specific components of the primary outcome (hazard ratio, 0.79; 95% CI, 0.66 to 0.94) and for death from cardiovascular causes (hazard ratio, 0.71; 95% CI, 0.56 to 0.89). The results for all confirmatory secondary outcomes favoured semaglutide: the mean annual eGFR slope was less steep (indicating a slower decrease) by 1.16 ml per minute per 1.73 m2 in the semaglutide group (P<0.001), the risk of major cardiovascular events 18% lower (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P = 0.029), and the risk of death from any cause 20% lower (hazard ratio, 0.80; 95% CI, 0.67 to 0.95, P = 0.01). Serious adverse events were reported in a lower percentage of participants in the semaglutide group than in the placebo group (49.6% vs. 53.8%).
Conclusions
Semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with type 2 diabetes and chronic kidney disease.
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