May 24 (Reuters) - 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
(eGFR), 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 ( LLY ) 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.