Ozempic slows kidney disease, more issues in trial
Novo Nordisk’s Ozempic slowed the worsening of kidney dysfunction in patients with type 2 diabetes and lowered the risk of kidney failure, heart problems, stroke and death, according to detailed results from a late-stage trial presented on Friday.
The company in March reported that the diabetes drug known chemically as semaglutide cut the combined risk of kidney complications and cardiovascular events by 24% over the next 3.4 years in patients who received weekly 1-milligram injections compared with those who got a placebo.
The benefits observed in the trial “reflect important clinical effects on kidney, cardiovascular, and survival outcomes among high-risk patients … and support a therapeutic role for semaglutide in this population,” study leader Dr. Vlado Perkovic of the University of New South Wales in Sydney, Australia, said in a statement.
The more detailed data on the trial of 3,533 patients with type 2 diabetes and chronic kidney disease was presented at the European Renal Association meeting in Stockholm and published in the New England Journal of Medicine.
Kidney health declined significantly faster in patients who received a placebo than in those who received Ozempic, as shown by a measure known as the estimated glomerular filtration rate, researchers found.
The trial was stopped early when an independent monitoring committee reviewed the data and determined the benefits of Ozempic were clear, the researchers said.
Ozempic belongs to a class of drugs known as GLP-1 receptor agonists and has the same active ingredient as Novo Nordisk’s wildly popular obesity drug Wegovy.
Obesity was not a requirement for participation in the current trial. But Novo and rival Eli Lilly are hoping to gain wider insurance coverage for their weight-loss drugs by demonstrating their other medical benefits.
Reductions in risk were similar when looking only at kidney-related events, such as starting dialysis, undergoing kidney transplantation or experiencing a precipitous decline in kidney function, researchers said.
Patients in the Ozempic group had an 18% lower risk of major adverse heart events and a 20% lower risk of death from any cause, the researchers said.
Withdrawal from the study mostly due to gastrointestinal issues were 13.2% in the Ozempic group versus 11.9% for placebo.